Rules of Department of Insurance, Financial Institutions ... · a photo of themselves not smaller than two inches by two inches (2" × 2") in the upper right-hand corner of the current

CODE OF STATE REGULATIONS 1ROBIN CARNAHAN (9/30/06)Secretary of State

Rules of

Department of Insurance,Financial Institutions andProfessional Registration

Division 2220—State Board of PharmacyChapter 2—General Rules

Title Page

20 CSR 2220-2.010 Pharmacy Standards of Operation .......................................................3

20 CSR 2220-2.015 Termination of Business as a Pharmacy ................................................5

20 CSR 2220-2.016 Pharmacy Operating Procedures During Declared Disasters........................5

20 CSR 2220-2.018 Prescription Requirements ................................................................6

20 CSR 2220-2.020 Pharmacy Permits ..........................................................................6

20 CSR 2220-2.025 Nonresident Pharmacies...................................................................7

20 CSR 2220-2.030 Educational and Licensing Requirements ..............................................8

20 CSR 2220-2.032 Licensure by Examination for Graduates of NonapprovedForeign Pharmacy Schools ............................................................10

20 CSR 2220-2.034 Licensure by Reciprocity for Graduates of Nonapproved ForeignPharmacy Schools Who Have Been Licensed in Another State.................11

20 CSR 2220-2.036 Temporary License .......................................................................11

20 CSR 2220-2.050 Public Complaint Handling and Disposition Procedure ............................12

20 CSR 2220-2.060 Gold Certificates ..........................................................................13

20 CSR 2220-2.080 Electronic Data Processing ..............................................................13

20 CSR 2220-2.085 Electronic Transmission of Prescription Data........................................14

20 CSR 2220-2.090 Pharmacist-in-Charge.....................................................................15

20 CSR 2220-2.100 Continuing Pharmacy Education .......................................................15

20 CSR 2220-2.110 PRN Refills ................................................................................17

2 CODE OF STATE REGULATIONS (9/30/06) ROBIN CARNAHAN

Secretary of State

20 CSR 2220-2.120 Transfer of Prescription Information for the Purpose of Refill ...................17

20 CSR 2220-2.130 Drug Repackaging ........................................................................18

20 CSR 2220-2.140 Prescription Services by Pharmacists/Pharmacies for Residents inLong-Term Care Facilities............................................................18

20 CSR 2220-2.145 Minimum Standards for Multi-Med Dispensing .....................................19

20 CSR 2220-2.150 Mandatory Reporting Rule ..............................................................20

20 CSR 2220-2.160 Definition of Disciplinary Actions .....................................................21

20 CSR 2220-2.165 Licensure Disciplinary Agreements....................................................21

20 CSR 2220-2.170 Procedure for Impaired Pharmacist ....................................................21

20 CSR 2220-2.180 Public Records.............................................................................22

20 CSR 2220-2.190 Patient Counseling ........................................................................23

20 CSR 2220-2.200 Sterile Pharmaceuticals ..................................................................23

20 CSR 2220-2.300 Record Confidentiality and Disclosure ................................................29

20 CSR 2220-2.400 Compounding Standards of Practice ...................................................29

20 CSR 2220-2.450 Fingerprint Requirements ................................................................31

20 CSR 2220-2.500 Nuclear Pharmacy—Minimum Standards for Operation ...........................31

20 CSR 2220-2.600 Standards of Operation for a Class F: Renal Dialysis Pharmacy .................33

20 CSR 2220-2.650 Standards of Operation for a Class J: Shared Services Pharmacy................34

20 CSR 2220-2.700 Pharmacy Technician Registration .....................................................34

20 CSR 2220-2.800 Vacuum Tube Drug Delivery System..................................................35

20 CSR 2220-2.900 Automated Dispensing and Storage Systems .........................................36

Title 20—DEPARTMENT OFINSURANCE, FINANCIAL

INSTITUTIONS ANDPROFESSIONAL REGISTRATIONDivision 2220—State Board of Pharmacy

Chapter 2—General Rules

20 CSR 2220-2.010 Pharmacy Standards ofOperation

PURPOSE: This rule defines terms used inthe regulations of the State Board of Pharma-cy and outlines the conditions necessary forthe operation of a pharmacy.

(1) The word medicine or medicines is aword similar or of like import to the wordspharmacist, pharmacy, apothecary shop,chemist shop, drug store, druggist and drugs,and no person shall carry on, conduct ortransact a business under a name which con-tains, as part of the name, the word medicineor medicines, unless the place of business issupervised by a licensed pharmacist.

(A) At all times when prescriptions arecompounded in a pharmacy or other estab-lishments holding a Missouri pharmacy per-mit, there shall be on duty and present in thatplace of business a pharmacist licensed inMissouri as provided by law. In any Class J:Shared Service pharmacy where a permit ismaintained at a location for the purpose ofremote dispensing as defined in 4 CSR 220-2.900 the pharmacist may be considered onduty and present as long as all required elec-tronic connection requirements are main-tained and the pharmacist is accessible at alltimes to respond to patient’s or other healthprofessionals’ inquiries or requests pertainingto drugs dispensed through the use of theautomated pharmacy system. When there isno pharmacist on duty, no prescription willbe compounded, dispensed or otherwise pro-vided and the public will be advised that nopharmacist is on duty by means of signs stat-ing this fact. The signs will be displayedprominently on the doors of all entrances andthe prescription counter of the pharmacy andthe signs will be composed of letters of aminimum height of two inches (2").

(B) Whenever, in a pharmacy or otherestablishment holding a Missouri pharmacypermit, a person other than a licensed phar-macist does compound, dispense or in anyway provide any drug, medicine or poisonpursuant to a lawful prescription, a licensedpharmacist must be physically present withinthe confines of the dispensing area, able torender immediate assistance and able todetermine and correct any errors in the com-pounding, preparation or labeling of thatdrug, medicine or poison before the drug,

medicine or poison is dispensed or sold. Inany Class J: Shared Service pharmacy wherea permit is maintained at a location for thepurpose of remote dispensing as defined in 4CSR 220-2.900 the pharmacist may be con-sidered on duty and present as long as allrequired electronic connection requirementsare maintained and the pharmacist is accessi-ble at all times to respond to patient’s orother health professionals’ inquiries orrequests pertaining to drugs dispensedthrough the use of the automated pharmacysystem. The pharmacist personally shallinspect and verify the accuracy of the con-tents of, and the label after it is affixed to,any prescribed drug, medicine or poisoncompounded or dispensed by a person otherthan a licensed pharmacist.

(C) No pharmacy shall be licensed underthe provisions of this chapter unless it isequipped with proper pharmaceutical equip-ment and reference manuals. Requirementsfor proper equipment and references mayvary between pharmacies and must insureaccuracy and safety of all pharmaceuticalactivity.

1. Basic equipment recognized by thelatest edition of the United States Pharma-copoeia (USP), the United States Pharma-copoeia/Drug Information (USP/DI) or Rem-ington’s Pharmaceutical Sciences shall beavailable for any procedures utilized in thedispensing, compounding or admixture ofdrugs and drug-related devices, and mustmaintain conformance with these publica-tions.

2. A suitable machine or electronic datadevice for the numbering of all prescriptionsmust be maintained along with appropriateprinting equipment for the production of pre-scription drug labels.

(D) Reference manuals may include anygenerally recognized pharmaceutical publica-tion other than periodicals or journals. Apharmacy must maintain, at a minimum, thecurrent or latest edition of a reference manu-al(s) which includes all Federal Drug Admin-istration (FDA)-approved drugs. The follow-ing topics must be included in thereference(s) selected:

1. Pharmacology of drugs; 2. Dosages and clinical effects of drugs;

and 3. Patient information.

(E) Pharmacies shall maintain at least one(1) current edition of statutes and rules gov-erning the pharmacy’s practice.

(F) All pharmacies shall be maintained ina clean and sanitary condition at all times.Any procedures used in the dispensing, com-pounding and admixture of drugs or drug-related devices must be completed under

clean and, when recommended, aseptic con-ditions.

1. Appropriate sewage disposal and ahot and cold water supply within the pharma-cy must be available.

2. Appropriate housekeeping and sanita-tion of all areas where drugs are stored ordispensed must be maintained.

(G) Adequate refrigeration must be avail-able to insure enough storage space for drugsrequiring refrigeration or freezing and undertemperatures adequate to maintain the drugproducts as recommended by the manufactur-er, the latest edition of the USP, or both.Drugs and drug-related devices must bestored separately from food and other items.

(H) Pharmacies must maintain adequatesecurity in order to deter theft of drugs bypersonnel or the public. Sufficient alarm sys-tems or locking mechanisms must be in placeif the pharmacy is located in a facility intowhich the public has access and the pharma-cy’s hours of operation are different fromthose of the remainder of the facility.

(I) Pharmacies which maintain storagesites or warehouse facilities for the storage ofpharmaceuticals at a separate address orpremises from the main pharmacy that holdsa pharmacy permit shall register those sites asstorage facilities of the licensed pharmacy.Information required for proper registrationof a storage facility shall include the addressof the facility, hours of operation (if applica-ble), pharmacy permit numbers of the phar-macies that it services and a certified state-ment that the facility is used for the solepurpose of distributing drugs only within itsown pharmacy operations.

1. Records must be maintained at thesefacilities to guarantee security, storage andaccountability of all drugs and drug-relateddevices under proper conditions.

2. All storage and warehouse locationswill be considered facilities of a pharmacy asdefined in section 338.240(2), RSMo andshall be subject to inspection by the board asdefined in section 338.150, RSMo.

3. No fee will be charged by the boardfor registering a facility as defined in subsec-tion (1)(I) of this rule.

(J) All pharmacists will be required to havea photo of themselves not smaller than twoinches by two inches (2" × 2") in the upperright-hand corner of the current renewallicenses. This photo and license renewal shallbe conspicuously exposed in the pharmacy ordrug store or place of business in which thepharmacist is employed as required by law.

(K) Pharmacists regularly working asrelief persons for more than one (1) storeshall have in their possession proper identifi-cation of their pharmacy licensure.


Chapter 2—General Rules 20 CSR 2220-2

(L) Pharmacy operations must be conduct-ed at all times under the supervision of aproperly designated pharmacist-in-charge.When a licensed pharmacist leaves theemployment of a pharmacy where s/he hasbeen pharmacist-in-charge, s/he immediatelyshall notify the executive director of theboard of the termination of his/her services inthe pharmacy. Likewise, the holder of thepermit shall notify the executive director ofthe board of the termination of the servicesand give the name of the new licensed phar-macist-in-charge.

(M) Pharmacists are responsible to informthe executive director of the board in the caseof changed address. Any mail or communica-tions returned to the executive director’soffice marked Unknown, Incorrect Address,and the like, will not be sent out a secondtime until the correct address is sent in.

(N) When a pharmacy permit holderknows or should have known, within theusual and customary standards of conductgoverning the operation of a pharmacy asdefined in Chapter 338, RSMo, that anemployee, licensed or unlicensed, has violat-ed the pharmacy laws or rules, the permitholder shall be subject to discipline underChapter 338, RSMo.

(O) Pharmacists must inform the executivedirector of the board of any change in theiremployment address. The notification of anemployment change must be provided in writ-ing to the board no later than fifteen (15) daysfollowing any effective change.

(2) Every pharmacy shall designate as its pri-mary means of record keeping either a man-ual system which provides for the consecutivenumbering of hard copy prescriptions andcomplies with the provisions of section (3) ofthis rule or an electronic system which com-plies with the provisions of 4 CSR 220-2.080. The designated record system shall beused to record the pharmacy’s dispensing ofall drugs, medicines and poisons.

(3) A pharmacy using a record keeping sys-tem other than an electronic system meetingthe requirements of 4 CSR 220-2.080 torecord its dispensing of drugs, medicines andpoisons shall provide a method of recordingall of the following information concerningthe refill of any prescription medication onthe back or reverse side of every prescriptionorder:

(A) The date the drug, medicine or poisonwas dispensed;

(B) The dispensing pharmacist’s initials;and

(C) The amount of drug, medicine or poi-son dispensed to the patient if different from

the amount on the face of the prescriptionorder.

(4) Each licensed pharmacy shall maintain atleast three (3) separate files of prescriptionsand they shall be as follows:

(A) All prescriptions for controlled drugslisted in Schedules I and II shall be main-tained in a separate prescription file;

(B) All prescriptions for controlled drugslisted in Schedules III, IV and V shall bemaintained in a separate prescription file; and

(C) All other prescriptions for noncon-trolled drugs shall be maintained in a separateprescription file(s).

(5) Pharmacies that distribute legend drugsseparate from prescription services and thedistributions fall below the threshold estab-lished for licensure as a drug distributor shallestablish and maintain inventories andrecords of all transactions regarding thereceipt and distribution or other dispositionof prescription drugs. Said records shall bemaintained for two (2) years.

(6) Drugs and devices that are maintained aspart of the pharmacy inventory or are beingprocessed for dispensing or other distributionpurposes must be physically separated at alltimes from articles, supplies or other drugsthat are for employee personal use or that areoutdated, distressed, misbranded or adulter-ated. An area separate from drug storagemust be used to store quarantined, nonusablesubstances. Areas used for this type of drugstorage must be clearly identified. Any pre-scription drugs that are present in a licensedpharmacy but are for the personal use ofpharmacy personnel must be labeled in accor-dance with section 338.059, RSMo.

(7) Except as provided for in section21 U.S.C. section 353(d)(1)(A)–(C),(d)(2)(A)(i)–(ii), (B)(i)–(iv) and (d)(3)(A)(i)–(ii) of the Federal Food, Drug andCosmetic Act, drug samples shall not bemaintained in pharmacies.

(8) A home health or hospice agency licensedor certified according to Chapter 197,RSMo, or any licensed nurses of such agency,may possess drugs in the usual course ofbusiness of such agency without beinglicensed as a pharmacist or a pharmacy.

(A) The list of drugs that may be possessedby a home health or hospice agency without alicense or permit, as defined in section (8), isas follows:

1. Injectable dosage forms of sodiumchloride and water;

2. Irrigation dosage forms of sodiumchloride and water that carry a federal pre-scription only restriction;

3. Injectable dosage forms or heparinand alteplase in concentrations that are indi-cated for maintenance of venous accessdevices;

4. Injectable dosage forms of diphenhy-dramine and epinephrine;

5. Vaccines indicated for public healthneeds, such as influenza, pneumonia, hepati-tis A and hepatitis B; and

6. Tuberculin test material.(B) The agency shall have a policy and pro-

cedure that addresses at least the following:1. Specific drugs authorized to be pos-

sessed by the agency and the nurse;2. Indications for use of the drugs pos-

sessed;3. Receiving physicians’ orders for

administration of the drugs;4. Leaving drugs with the patient for

routine care procedures;5. Conditions for storage and transport

of the drugs by the agency and the nurse; and6. Quantity of drugs possessed by the

agency and the nurse.(C) The nurse must have a physician’s

authorization, such as an individual patientorder, protocol or standing order, to adminis-ter the drugs.

(D) When the patient or the patient’s rep-resentative has been instructed, verbally andin writing, in the performance of routine careprocedures, up to a two (2)-week supply ofsodium chloride, water and heparin, may beleft with the patient for these procedures.Drugs left with the patient shall be labeledwith instructions for use. A record shall bemade of all drugs left with the patient in thepatient’s medical record. Drugs left with thepatient may not be returned to the agency.

(E) Drugs may be stored at the agency ortransported by the nurse, and shall be storedor transported at all times in accordance withthe manufacturer’s storage requirements.Refrigerator units used by the agency for stor-ing drugs shall not be used for storing non-drug items.

(F) All drugs must be received from alicensed pharmacy or drug distributor. Thequantity of drugs possessed by an agencyshall be limited to that necessary to meet theneeds of the agency’s patient population fortwo (2) weeks.

AUTHORITY: sections 338.010, 338.140,338.240 and 338.280, RSMo 2000 and338.210, RSMo Supp. 2004.* This rule origi-nally filed as 4 CSR 220-2.010. Original rulefiled July 18, 1962, effective July 28, 1962.Amended: Filed Nov. 9, 1966, effective Nov.


Secretary of State

20 CSR 2220-2—DEPARTMENT OF INSURANCE,FINANCIAL INSTITUTIONS ANDPROFESSIONAL REGISTRATION Division 2220—State Board of Pharmacy

19, 1966. Amended: Filed Oct. 27, 1970,effective Nov. 6, 1970. Amended: Filed Dec.31, 1975, effective Jan. 10, 1976. Amended:Filed May 21, 1979, effective Nov. 12, 1979.Amended: Filed April 14, 1982, effective July11, 1982. Amended: Filed April 16, 1985,effective Sept. 27, 1985. Amended: FiledNov. 4, 1985, effective March 13, 1986.Amended: Filed Dec. 15, 1987, effectiveApril 28, 1988. Amended: Filed Oct. 12,1988, effective March 11, 1989. Amended:Filed Jan. 30, 1991, effective July 8, 1991.Amended: Filed Jan. 27, 1995, effective Sept.30, 1995. Amended: Filed June 29, 1999,effective Jan. 30, 2000. Amended: FiledMarch 15, 2000, effective Sept. 30, 2000.Amended: Filed July 24, 2001, effective Feb.28, 2002. Amended: Filed Feb. 18, 2003,effective Sept. 30, 2003. Amended: Filed May13, 2005, effective Oct. 30, 2005. Moved to20 CSR 2220-2.010, effective Aug. 28, 2006.

*Original authority: 338.010, RSMo 1939, amended 1951,1989, 1990; 338.140, RSMo 1939, amended 1981, 1989,1997; 338.210, RSMo 1951, amended 2001; 338.240,RSMo, 1951; and 338.280, RSMo 1951, amended 1971,1981.

20 CSR 2220-2.015 Termination of Busi-ness as a Pharmacy

PURPOSE: This rule establishes guidelinesfor the termination of business as a pharma-cy.

(1) A licensed pharmacy who plans to termi-nate business activities shall file a writtennotice with the State Board of Pharmacy. Thewritten notice shall be submitted to the StateBoard of Pharmacy in person or by registeredor certified mail within fifteen (15) days afterthe date of termination. This notice shall bemade on a form provided by the board or inletter form from the licensee and shallinclude the following information:

(A) The name, address, license (permit)number and effective date of closing;

(B) The name, address, and license (per-mit) number of the entity to which any of thestock/inventory will be transferred;

(C) The name and address of the locationto which records, required to be maintainedby law, have been transferred.

1. Any records that are transferred to anunlicensed location must be retrievable forboard review within seven (7) working daysof a request made by an authorized official ofthe board.

2. Any records that are transferred to alicensed (permitted) pharmacy or licenseddrug distributor must be maintained in accor-

dance with record requirements as set forth insection 338.100, RSMo.

(2) The licensee (permit holder) terminatingbusiness may transfer all drugs and records inaccordance with the following:

(A) On the date of termination, a completeinventory of all controlled substances beingtransferred or disposed of shall be completedaccording to state and federal laws. Thisinventory shall serve as the final inventory ofthe pharmacy terminating business and as theinitial inventory of the licensed entity towhich the controlled substances are beingtransferred. A copy of the inventory shall beincluded in the records of each licensee orpermit holder involved in the transfer.

(B) A pharmacy terminating business shallnot transfer misbranded, outdated or adulter-ated drugs, except for purposes of proper dis-posal; and

(C) Upon the actual termination of busi-ness, the license (permit) of the pharmacyshall be returned to the State Board of Phar-macy for cancellation either in person or byregistered or certified mail.

(3) A one (1)-time transfer of drugs anddevices due to a termination of business thatis in compliance with this rule will notrequire a pharmacy to seek licensure as adrug distributor under sections 338.330 and338.333, RSMo.

(4) The requirements of this rule are notintended to replace or be in conflict with anyother laws or regulations governing theappropriate licensure, change of ownership orchange of location of a pharmacy.

(5) The termination date is the date on whichthe permit holder ceases to practice pharma-cy as defined in sections 338.010 and338.210, RSMo, at the permitted location.

AUTHORITY: sections 338.210 and 338.280,RSMo 1994.* This rule originally filed as 4CSR 220-2.015. Original rule filed May 4,1995, effective Dec. 30, 1995. Moved to 20CSR 2220-2.015, effective Aug. 28, 2006.

*Original authority: 338.210, RSMo 1951 and 338.280,RSMo 1951, amended 1971, 1981.

20 CSR 2220-2.016 Pharmacy OperatingProcedures During Declared Disasters

PURPOSE: This rule is to establishes guide -lines for the operation and temporary reloca-tion of a pharmacy during a declared disas-ter.

(1) Declared disaster areas are defined asspecified geographical counties within thestate that have been designated by the gover-nor or federal authorities as counties thathave been adversely affected by a natural orman-made disaster and requires extraordinarymeasures to provide adequate, safe and effec-tive health care for the affected population.

(2) In cases where a disaster as defined insection (1) has been declared, any pharmacylocated within the disaster area may arrangeto move to a temporary location to betterserve the public or provide pharmacy servicesfrom a mobile unit that is under the controland management of the pharmacist-in-charge.

(A) The following constitutes requirementsfor maintaining temporary or mobile facili-ties:

1. Temporary or mobile pharmacy facil-ities shall only be located within the disasterarea or adjacent county;

2. Temporary facilities may be main-tained by a pharmacy operation for a periodof up to six (6) months without applying fora change of location. Any pharmacy wishingto maintain a temporary site for more than six(6) months or desires to remain permanentlyat the temporary site, must apply for a changeof location as outlined in 4 CSR 220-2.020(4);

3. Mobile pharmacy operations mustcease services once the immediate disaster isover;

4. Temporary or mobile pharmacy facil-ities must inform the board of their locationand provide an estimate of the time period forwhich the temporary or mobile pharmacyoperation will be needed; and

5. The executive director shall have theauthority to approve or disapprove temporaryor mobile pharmacy facilities and shall makearrangements for appropriate monitoring andinspection of the pharmacy on a case by casebasis.

A. Approval of this type of operationwill be based on the need, type and scope ofdisaster, as well as the ability of the pharma-cy to comply with state and federal drug lawsin addition to section 338.240, RSMo.

B. Temporary or mobile pharmacyfacilities shall cease operations under the pro-visions of this rule if any previous approval iswithdrawn.

C. Any decision made concerning theapproval of a temporary or mobile pharmacyshall not interfere with any rights or privi-leges of a pharmacy permit holder at the orig-inal location of operation or prevent a permitholder from applying for a change of locationas outlined in 4 CSR 220-2.020(4).



AUTHORITY: sections 338.210 and 338.280,RSMo 1994.* This rule originally filed as 4CSR 220-2.016. Original rule filed May 4,1995, effective Dec. 30, 1995. Moved to 20CSR 2220-2.016, effective Aug. 28, 2006.

*Original authority: 338.210, RSMo 1951 and 338.280,RSMo 1951, amended 1971, 1981.

20 CSR 2220-2.018 Prescription Require-ments

PURPOSE: This rule establishes require-ments for information required on prescrip-tions.

(1) In order for a prescription to be valid forpurposes of dispensing a medication by apharmacy, it must conform to all require-ments as outlined in sections 338.056 or338.196, RSMo, and contain the followinginformation:

(A) The prescription date and a unique,readily retrievable identifier;

(B) The name of the patient(s);(C) The prescriber’s name, if an oral pre-

scription, signature if a written prescription;(D) Any prescriber indication of name and

dosage of drug, directions for use, name anddosage of drug dispensed;

(E) The number of refills, when applica-ble;

(F) The quantity dispensed in weight, vol-ume or number of units;

(G) The initials or name of the pharmacistresponsible for processes in dispensing orcompounding of the prescription;

(H) Any change or alteration made to theprescription dispensed based on contact withthe prescriber to show a clear audit trail.This shall include, but is not limited to, achange in quantity, directions, number ofrefills or authority to substitute a drug;

(I) The address of the prescriber and thepatient when the prescription is for a con-trolled substance;

(J) The prescriber’s Drug EnforcementAdministration (DEA) number when the pre-scription is for a controlled substance; and

(K) Any prescription, when it is for a con-trolled substance, must comply with allrequirements of federal and state controlledsubstance laws.

(2) The information specified in section (1)shall be required and recorded on all hand-written, telephone, oral and electronicallyproduced prescriptions that are processed fordispensing by a pharmacist/pharmacy.

AUTHORITY: sections 338.095, 338.100,338.140, 338.240 and 338.280, RSMo

2000.* This rule originally filed as 4 CSR220-2.018. Original rule filed May 4, 1995,effective Dec. 30, 1995. Amended: FiledMarch 15, 2000, effective Sept. 30, 2000.Amended: Filed Nov. 1, 2000, effective June30, 2001. Moved to 20 CSR 2220-2.018,effective Aug. 28, 2006.

*Original authority: 338.095, RSMo 1939; 338.100,RSMo 1939, amended 1971, 1990, 1997, 1999; 338.140,RSMo 1939; amended 1981, 1989, 1997; 338.240, RSMo1951; and 338.280, RSMo 1951, amended 1971, 1981.

20 CSR 2220-2.020 Pharmacy Permits

PURPOSE: This rule outlines the require-ments for obtaining and maintaining a phar-macy permit.

(1) All permits for the operation of a phar-macy shall expire on the date specified by thedirector of the Division of Professional Reg-istration pursuant to 4 CSR 230-2.031.

(2) A pharmacy permit may be issued on theapplication of the owners. If the owner is acorporation, an officer of the corporationmust sign the application as the applicant. Ifthe owner is a partnership, a partner mustsign the application as the applicant. If theowner is a limited liability partnership, a gen-eral partner must sign the application as theapplicant. If the owner is a limited liabilitycompany, a member must sign the applicationas the applicant. In the case where a pharma-cy is owned and operated by a person(s) whois a licensed pharmacist and in active chargeof the pharmacy, the application for permitcan be made by either party.

(A) An application for a pharmacy permitwill become null and void if the applicantfails to complete the process for licensurewithin six (6) months of receipt of the appli-cation by the board.

(3) When a pharmacy changes ownership, theoriginal permit becomes void on the effectivedate of the change of ownership. Before anynew business entity resulting from the changeopens a pharmacy for business, it must obtaina new permit from the board. A temporarylicense shall be issued once a completedapplication and fee have been received by theboard. The effective date of the temporarylicense shall be the date the change of owner-ship is listed as effective on the application.Such license shall remain in effect until a per-manent license is issued or denied by theboard.

(A) A change of ownership of a pharmacyowned by a sole proprietor is deemed to haveoccurred when—

1. The business is sold and the salebecomes final;

2. The proprietor enters into a partner-ship with another individual or business enti-ty; or

3. The proprietor dies; provided, how-ever, that the proprietor’s estate may contin-ue to operate the pharmacy under the licensedpharmacist in good standing in this state, butin no case for a period of more than one (1)year and only so long as appropriate pharma-cy permit fees are paid.

(B) If a corporation owns a pharmacy, it isnot necessary to obtain a new license if theowners of the stock change. If a limited lia-bility partnership or a limited liability com-pany owns a pharmacy, it is not necessary toobtain a new license if the partners or mem-bers of the company change, as long as thepartnership or company is not dissolved bythat change. It is necessary to file writtennotice with the State Board of Pharmacywithin ten (10) days after a change occurs inpartners in a limited liability partnership, orin members in a limited liability company.This notification must be in writing and cer-tified. However, when a corporation, limitedliability partnership, or limited liability com-pany begins ownership of a pharmacy ortransfers ownership of a pharmacy, a newlicense must be obtained regardless of therelationship between the previous and subse-quent owners.

(C) All individuals or business entitiesowning twenty-five percent (25%) or more ofthe ownership of any entity owning a phar-macy must notify the board within thirty (30)days of acquiring the percentage.

(4) If an individual or business entity operat-ing a pharmacy changes the location of thepharmacy to a new facility (structure), thepharmacy shall not open for business at thenew location until the board or its duly autho-rized agent has inspected the premises of thenew location and approved it and the phar-macy as being in compliance with section338.240, RSMo and all other provisions ofthe law. Upon the approval and receipt of achange of location fee, the board shall issue apermit authorizing operation of a pharmacy atthe new location and the permit shall bear thesame number as the previous pharmacy per-mit. However, the permit remains valid if thepharmacy address changes, but not the loca-tion and an amended permit will be issuedwithout charge under these circumstances.

(A) Remodeling of a licensed pharmacywithin an existing structure shall be deemedto have occurred when any change in the stor-age conditions of the Schedule II controlledsubstances is made or new connections to


Secretary of State




water/sewer resources are made or anychanges in the overall physical security ofdrugs stored in the pharmacy as defined in 4CSR 220-2.010(1)(H) are made. Remodelingas defined within this section will not requirethe initiation of any change of location proce-dures. Satisfactory evidence of plans for anyremodeling of a pharmacy must be providedto the board office thirty (30) days in advanceof commencing such changes along with anaffidavit showing any changes to the pharma-cy physical plant and the projected comple-tion date for any remodeling.

(5) Permits, when issued, will bear an origi-nal number. Permits must be posted in a con-spicuous place in the pharmacy to which it isissued.

(6) No pharmacy permit will be issued unlessthe pharmacy area is under the direct super-vision of a licensed pharmacist in good stand-ing with the Missouri State Board of Phar-macy, who meets the requirements of 4 CSR220-2.090.

(7) If the owner/applicant is not the licensedpharmacist-in-charge, then the pharmacist-in-charge must meet the requirements of 4 CSR220-2.090 and complete the pharmacist-in-charge affidavit of the permit application andhave it notarized.

(8) The names of all pharmacists regularlyworking in a pharmacy shall be clearly dis-played on the premises of every establishmenthaving a pharmacy permit.

(9) The following classes of pharmacy per-mits or licenses are hereby established:

(A) Class A: Community/Ambulatory. Apharmacy that provides services as defined insection 338.010, RSMo to the general public;

(B) Class B: Hospital Outpatient Phar-macy. A pharmacy operated by and locatedwithin a hospital that provides services asdefined in section 338.010, RSMo to patientsother than to the hospital’s inpatient popula-tion;

(C) Class C: Long-Term Care. A pharma-cy that provides services as defined in section338.010, RSMo by the dispensing of drugsand devices to patients residing within long-term care facilities. A long-term care facili-ty means a nursing home, retirement care,mental care or other facility or institutionwhich provides extended health care to resi-dent patients;

(D) Class D: Non-Sterile Compounding. Apharmacy that provides services as defined insection 338.010, RSMo and provides a non-sterile compounded product as defined in 4CSR 220-2.400(1) which comprises five per-

cent (5%) or more of the annual prescriptionvolume of the pharmacy;

(E) Class E: Radiopharmaceutical. Apharmacy that is not open to the general pub-lic and provides services as defined in section338.010, RSMo limited to the preparationand dispensing of radioactive drugs asdefined by the Food and Drug Administration(FDA) to health care providers for use in thetreatment or diagnosis of disease and thatmaintains a qualified nuclear pharmacist asthe pharmacist-in-charge;

(F) Class F: Renal Dialysis. A pharmacythat is not open to the general public that pro-vides services as defined in section 338.010,RSMo limited to the dispensing of renal dial-ysis solutions and other drugs and devicesassociated with dialysis care;

(G) Class G: Medical Gas. A pharmacythat provides services as defined in section338.010, RSMo through the provision of oxy-gen and other prescription gases for thera-peutic uses;

(H) Class H: Sterile Product Compound-ing. A pharmacy that provides services asdefined in section 338.010, RSMo and pro-vides a sterile pharmaceutical as defined in 4CSR 220-2.200(11)(I) and (AA). Pharmaciesproviding sterile pharmaceuticals within theexemptions outlined in 4 CSR 220-2.200 (25)shall not be considered a Class H pharmacy;

(I) Class I: Consultant. A location whereany activity defined in section 338.010,RSMo is conducted, but which does notinclude the procurement, storage, possessionor ownership of any drugs from the location;and

(J) Class J: Shared Service. A pharmacythat provides services as defined in section338.010, RSMo, and is involved in the pro-cessing of a request from another pharmacyto fill or refill a prescription drug order, orthat performs or assists in the performance offunctions associated with the dispensingprocess, drug utilization review (DUR),claims adjudication, refill authorizations andtherapeutic interventions.

(10) Pharmacy applications for initial licen-sure or renewals of a license shall accuratelynote each class of pharmacy that is practicedat the location noted on the application orrenewal thereof. The permit (license) issuedby the board shall list each class of licensurethat the pharmacy is approved to engage in.Whenever a change in service classificationoccurs at a pharmacy the permit must be sentto the board with a notarized statementexplaining any additions or deletions of phar-macy classes that are to be made.

(11) Prescriptions processed by any classifi-cation of licensed pharmacy must be provid-ed by a practitioner licensed in the United

States authorized by law to prescribe drugsand who has performed a sufficient physicalexamination and clinical assessment of thepatient. A pharmacist shall not dispense aprescription drug if the pharmacist hasknowledge, or reasonably should know underthe circumstances, that the prescription orderfor such drug was issued on the basis of anInternet-based questionnaire, an Internet-based consultation, or a telephonic consulta-tion, all without a valid preexisting patient-practitioner relationship.

AUTHORITY: sections 338.140, RSMo 2000and 338.220, RSMo Supp. 2004.* This ruleoriginally filed as 4 CSR 220-2.020. Originalrule filed July 18, 1962, effective July 28,1962. Amended: Filed Nov. 9, 1966, effectiveNov. 19, 1966. Amended: Filed Oct. 27,1970, effective Nov. 6, 1970. Amended: FiledDec. 31, 1975, effective Jan. 10, 1976. Emer-gency amendment filed July 15, 1981, effec-tive Sept. 28, 1981, expired Nov. 11, 1981.Amended: Filed Aug. 10, 1981, effective Nov.12, 1981. Amended: Filed April 14, 1982,effective July 11, 1982. Amended: FiledMarch 14, 1983, effective June 11, 1983.Amended: Filed Feb. 11, 1985, effective May11, 1985. Amended: Filed Dec. 16, 1985,effective May 11, 1986. Amended: Filed Aug.1, 1986, effective Nov. 13, 1986. Amended:Filed Jan. 27, 1995, effective Sept. 30, 1995.Amended: Filed Jan. 6, 1998, effective Aug.30, 1998. Amended: Filed June 29, 1999,effective Jan. 30, 2000. Amended: FiledMarch 15, 2000, effective Sept. 30, 2000.Amended: Filed Nov. 30, 2001, effective June30, 2002. Amended: Filed Dec. 3, 2002,effective June 30, 2003. Amended: Filed May13, 2005, effective Oct. 30, 2005. Moved to20 CSR 2220-2.020, effective Aug. 28, 2006.

*Original authority: 338.140, RSMo 1939, amended 1981,1989, 1997; and 338.220, RSMo 1951, amended 1969,1981, 1989, 1997, 1999, 2001, 2004.

20 CSR 2220-2.025 Nonresident Pharma-cies

PURPOSE: This rule establishes licensureguidelines for nonresident pharmacies.

(1) Nonresident pharmacies shall not ship,mail or deliver prescription drugs into Mis-souri without first obtaining a pharmacylicense from the Missouri Board of Pharma-cy. An exemption to licensure is allowedwhen a nonresident pharmacy provides a pre-scription drug in an emergency situation orsupplies lawful refills to a patient from a pre-scription that was originally filled and deliv-ered to a patient within the state in which the

nonresident pharmacy is located or providesmedications upon receipt of a prescription orphysician order for patients in institutionalsettings and the nonresident pharmacy is notrecognized as a primary provider.

(2) To obtain a license as a pharmacy, a non-resident pharmacy must comply with each ofthe following:

(A) Maintain a license in good standingfrom the state in which the nonresident phar-macy is located;

(B) Submit an application as provided bythe Missouri Board of Pharmacy for licensurein compliance with 4 CSR 220-2.020(2) and(3);

(C) Pay all appropriate licensing fees;(D) Submit a copy of the state pharmacy

license from the state in which the nonresi-dent pharmacy is located; and

(E) Submit a copy of the state and federalcontrolled substance registrations from thestate in which it is located, if controlled sub-stances are to be shipped into Missouri.

(3) When requested to do so by the MissouriBoard of Pharmacy, each nonresident phar-macy shall supply any inspection reports,warning notices, notice of deficiency reportsor any other related reports from the state inwhich it is located concerning the operationof a nonresident pharmacy for review of com-pliance with state and federal drug laws.

(4) The Missouri Board of Pharmacy willextend reciprocal cooperation to any state thatlicenses and regulates nonresident pharma-cies for the purpose of investigating com-plaints against pharmacies located in Mis-souri or the sharing of information andinvestigative reports, as long as the otherstate will extend the same reciprocal cooper-ation to the Missouri Board of Pharmacy.

AUTHORITY: sections 338.140 and 338.280,RSMo 2000 and 338.220, RSMo Supp.2001.* This rule originally filed as 4 CSR220-2.025. Original rule filed Jan. 16, 1990,effective May 11, 1990. Amended: Filed June28, 2002, effective Jan. 30, 2003. Moved to20 CSR 2220-2.025, effective Aug. 28, 2006.

*Original authority: 338.140, RSMo 1939, amended 1981,1989, 1997; 338.220, RSMo 1951, amended 1969, 1981,1989, 1997, 1999, 2001; and 338.280, RSMo 1951,amended 1971, 1981.

20 CSR 2220-2.030 Educational andLicensing Requirements

PURPOSE: This rule outlines requirementsfor internship standards and training, exam

scoring procedures, procedures for examina-tion score transfer and licensure transfer anddefines accredited colleges.

(1) An approved school or college of phar-macy means a school or college of pharmacywhose curriculum, physical equipment,course of instruction and teaching personnelconform to the standards and specificationsor the equivalent required by the AmericanCouncil on Pharmaceutical Education foraccreditation and is approved annually by theboard.

(2) Application shall be made on forms pro-vided by the executive director. The candidateshall furnish satisfactory evidence on theapplication that s/he has graduated from anapproved school of pharmacy and presentaffidavits certifying the completion of allpractical experience programs that arerequired and are approved by the board. Anapplication will be considered filed eventhough it may have to be returned to theapplicant for minor correction or completion.However, an application will not be consid-ered filed if it has to be returned to the appli-cant for any one (1) or more of the followingreasons:

(A) Incorrect or missing fee;(B) Incomplete or missing college affi-

davit; or(C) Incomplete or missing signature and

notarization. In this instance, the applicationwill be returned to the applicant and will notbe considered filed until it has been returnedwith all corrections made. The applicant musttake the examination(s) within three hundredsixty-five (365) days of having been deter-mined eligible, to avoid forfeiture of eligibil-ity and fees.

(3) Requirements for Practical Experience.(A) Advanced practice experience is

defined as practice based training which isdocumented as required, complies with train-ing standards outlined in this rule and is con-sidered a part of the school curriculum fortraining students within standards approvedby the board of pharmacy.

(B) Requirements for Training as a Phar-macy Intern.

1. Every person who desires to gainpractical experience in Missouri toward licen-sure as a pharmacist must apply for a licenseas an intern pharmacist. An application forlicensure shall be made on forms provided bythe Missouri Board of Pharmacy and must beaccompanied by the appropriate licensurefee.

2. An applicant for licensure as a phar-macy intern shall be currently enrolled in or

graduated from a college that is approved bythe Missouri Board of Pharmacy and thatapplicant may apply for licensure after thecompletion of thirty (30) hours of collegecourse work in an approved school of phar-macy.

3. Advanced practice experience hoursshall include a minimum of one hundred sixty(160) hours in a community/ambulatorypharmacy practice component, an institution-al pharmacy practice component and a clini-cal and/or related area of pharmacy practicecomponent.

4. Advanced practice experience may begained within non-licensed programs, provid-ed these programs have received priorapproval by the board. The board shall makeits determination concerning programapproval and the number of hours to grant toan approved program through review of anapplication. The board may request addition-al information, interview program partici-pants or complete site inspections before adecision on an application is made.

(C) Advanced practice experience shall becomputed from the date of licensure as apharmacy intern.

(D) Reports must be filed by the internwith the board in order for any hours to becounted toward the required practical experi-ence. The reports shall include, but not belimited to:

1. Application for licensure as an intern;and

2. Academic internship reports(s).(E) Advanced practice experience in intern

training given in a state other than Missourimay be allowed by the board if, in the opin-ion of the board, the requirements of the stateof the applicant’s residence and experienceare equal in the minimum requirements of theboard for intern training in Missouri. Internhours earned in another state must be certi-fied directly to the Missouri Board of Phar-macy from the board of pharmacy of the statein which the training occurred.

(F) A pharmacy preceptor shall be alicensed pharmacist in good standing with theboard.

(G) Emphasis must be on activities con-nected with pharmaceutical care through theinterpretation and evaluation of prescriptionorders; the compounding, dispensing andlabeling of drugs and devices pursuant to pre-scription orders; the proper and safe storageof drugs and devices and the maintenance ofproper records of them; and consultation withpatients and other health care practitionersabout the safe and effective use of drugs anddevices.

(H) The provisions of this rule are notapplicable to those students who gain their


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advanced practice experience in another state.The minimum practical experience shall befifteen hundred (1,500) hours of advancedpractice experience to qualify to take theexamination for licensure as a pharmacist. Ifany portion of the required fifteen hundred(1,500) hours are to be earned in Missouri,the applicant must be licensed as an internunder the provisions of this rule. Whenintern hours are to be earned within the stateof Missouri by a student enrolled in or by agraduate of an out-of-state accredited schoolof pharmacy, the candidate must apply direct-ly to the board of pharmacy to seek approvalof any site and preceptor to be used. Anypharmacy that is submitted for approval as anintern training site for an out-of-state studentor graduate shall meet the criteria outlined in(4)(B)1.–3.

(4) Requirements for a Advanced PracticeExperience Training Pharmacy.

(A) Requirements for a licensed pharmacyto participate as a site for practical experiencetraining that is approved by the board includethe following:

1. It must be a pharmacy with a clearrecord with respect to the observance of allfederal, state and municipal laws and ordi-nance governing any phase of activity inwhich the pharmacy is engaged;

2. It must be a pharmacy operatingunder a pharmacy permit issued by the boardand it must remain in good standing with theboard; and

3. All interns will be under the directsupervision of a licensed pharmacist in goodstanding.

(B) Institutional settings that are involvedin training interns must maintain a pharmacypermit and comply with all other provisionsof this rule. In addition, any inpatient areas ofan institution used to train interns will besubject to regular inspection by the board. Aschool of pharmacy may petition the boardfor an exception to this requirement in orderto allow the facility to be approved for pro-viding advanced practice experience training.

(C) Accredited schools of pharmacy locat-ed within this state shall provide to the board,on an annual basis, a list of all preceptors andsites that are used in providing advancedpractice experience through rotations towardthe advanced practice experience require-ment. The board shall approve any site fortraining interns that will be used within thecollege curriculum to fulfill the advancedpractice experience requirements for licen-sure as a pharmacist. Any preceptors or sitesthat may be added by a school outside theannual approval process of the board must beapproved by the board before the site can be

used for practical experience purposes. Inaddition, the board shall approve the trainingstandards, policies and procedures that areproposed by the schools of pharmacy in ful-filling the advanced practice experiencerequirements.

(D) Interns that have accumulated hoursoutside of the school of pharmacy programmay submit those hours for credit up to one(1) year from the date that the requirementsfor advanced practice experience are ineffect. All other requirements involvinglicensure, training and reporting to the boardof pharmacy shall be adhered to before anycredit of hours is provided.

(5) Examination.(A) Each applicant for licensure by exami-

nation must pass the National AssociationBoards of Pharmacy Licensure Examination(NAPLEX) and the Multistate PharmacyJurisprudence Examination (MPJE). The ap-plicant is responsible for payment of anyrequired fee for the NAPLEX and the MPJEexaminations, as established by the NationalAssociation of Boards of Pharmacy.

(B) A minimum score of seventy-five (75)is required for each of the examinations list-ed in subsection (5)(A).

(C) All examinations are scored indepen-dently and may be retaken independentlyupon payment of the appropriate fee.

(D) The MPJE will consist of questions onMissouri and federal pharmacy laws and reg-ulations and the Missouri and federal con-trolled substance laws and regulations.

(E) If a candidate fails to achieve a score ofseventy-five (75) in any of the examinationslisted in subsection (5)(A), it will be neces-sary to take that examination again and passthat examination before a license can beissued. The candidate must complete anyrequired application(s) and pay any requiredfee(s) to reestablish eligibility to retake any ofthe examinations listed in subsection (5)(A).

(F) A candidate scheduled to write theNAPLEX may apply for licensure by com-pleting the NAPLEX Score Transfer Formsupplied by the National Association ofBoards of Pharmacy. In addition to comple-tion of the form, the candidate must fulfill allnecessary requirements as set forth by theNational Association of Boards of Pharmacyand the Missouri Board of Pharmacy. Anyfees required to transfer scores must accom-pany the completed form. Transfer scoreswill be accepted by the board from any statewhich accords similar privileges to Missouricandidates. Scores transferred by the candi-date to Missouri must meet all minimumgrade requirements as set forth in section (5)of this rule. Once this has been determined,

the board office will send an application formfor Missouri licensure to the successful can-didate. The candidate must return the com-pleted form along with all appropriate fees tothe board office. The candidate must suc-cessfully complete the Multistate PharmacyJurisprudence Examination (MPJE) at thenext regular examination date. Any candidatewho fails to achieve a passing score on any ofthe examinations required may retake theexamination upon proper reapplication andupon payment of appropriate fees.

(G) When the applicant’s examinationapplication has been accepted, the board willnotify the National Association of Boards ofPharmacy that the applicant is an eligiblecandidate for the NAPLEX automated exam-ination and/or the MPJE automated examina-tion. The applicant is responsible for com-pleting any necessary application(s) andpayment of fee(s) as required by the NationalAssociation of Boards of Pharmacy.

(H) The National Association of Boards ofPharmacy will then create an applicant data-base of eligible candidates for the NAPLEXand/or the MPJE which will be provided tothe entity or entities which manages the test-ing centers. The National Association ofBoards of Pharmacy will cause an Authoriza-tion to Test and instructions for scheduling atest appointment for either or both computer-ized examinations (NAPLEX and MPJE) tobe mailed directly to the candidate. It will bethe candidate’s responsibility to schedulehis/her testing date, time and location foreither or both computerized examinations(NAPLEX and MPJE).

(I) The score on the NAPLEX examinationwill be reported to the National Associationof Boards of Pharmacy by the testing cen-ter(s) and subsequently to the board of phar-macy.

(6) Licensure Transfer.(A) An applicant for licensure transfer

must fully meet all the requirements in effectin Missouri on the date of registration in thestate of original licensure.

(B) An applicant for licensure transfershall meet all requirements of the state fromwhich they are transferring including, but notlimited to, that state’s continuing educationrequirements.

(C) An applicant for licensure transfermust have attained the equivalent of fifteenhundred (1,500) practice hours, as set forth insection (3) of this rule, either as a pharmacyintern/extern or have maintained a pharmacistlicense in good standing for a period of notless than one (1) year in the state from whichthey are transferring.



(D) The board, in its discretion, may grantlicensure transfer to an applicant when theapplicant previously has taken and failed topass an examination given by the Missouriboard and who is eligible for licensure trans-fer, having later passed the examination forregistry in another state.

(E) Applicants for licensure transfer mustpass the Multistate Pharmacy JurisprudenceExamination (MPJE), a computerized exami-nation provided through the National Associ-ation of Boards of Pharmacy. The applicantfor licensure transfer is responsible for com-pleting any necessary application(s) and pay-ment of fee(s) as required by the NationalAssociation of Boards of Pharmacy. If theapplicant fails the MPJE two (2) consecutivetimes, the application will be provided to thefull board at its next regular meeting forappropriate review and action.

(F) No person shall be eligible for licen-sure transfer against whom there is pendingany indictment or any alleged violation of thelaws governing the practice of pharmacy,alcohol or other regulated law or who hasbeen convicted of any crime within the pastten (10) years.

(G) All required fees must be paid prior toapproval of a licensure transfer.

(H) The Missouri Board of Pharmacyreserves the right to reject any licensuretransfer application for good and just reasonsand, in the event of so doing, the fee paid toit will be refunded.

(I) No application for licensure transferwill remain valid if the applicant fails to com-plete the transfer process as outlined in thisrule within six (6) months of receipt of theapplication by the board. Any failure by theapplicant to complete the licensure transferprocess will result in a forfeiture of all feespaid to the board.

(J) Any application for licensure transferwhich is pending for three (3) months ormore and is still a valid application mayrequire an additional review by the board oflicensure information from any state in whichthe applicant holds a license. Any applicantwho provides a complete and truthful appli-cation to the board, completes the licensureprocess in less than three (3) months and issuccessful in passing the Multistate Jurispru-dence Examination on the first attempt, willnot be required to register as a technicianwhile working in a licensed pharmacy or act-ing in any capacity that would require licen-sure as a pharmacist as defined in section338.010.1, RSMo. Direct supervision of anapplicant by a licensed pharmacist is requiredat all times when any functions related to sec-tion 338.010, RSMo are performed. Anylicensure transfer applicant who must subse-

quently apply for registration as a technicianwill not be required to provide fingerprints ifall fingerprinting requirements have previous-ly been fulfilled within the licensure transferprocess.

(7) Licenses.(A) No duplicate certificates or renewals

for licenses or permits shall be issued exceptupon the return of the original or upon thesworn statement that the certificate has beenlost or destroyed. The duplicate certificate orrenewal fee shall accompany the affidavit.

(B) No assistant or apprentice-pharmacistlicense is recognized by the board inasmuchas the members of the State Missouri Boardof Pharmacy in session in Kansas City, Mis-souri on January 24, 1938, ruled, and theadopted minutes so state, that March 1, 1938,would be the last day a license as a pharma-cist could legally be issued to an assistantpharmacist as per Missouri statutes, sectionno. 13151 and the secretary was ordered atthat time to accept no fees and to issue nolicense as a pharmacist to assistant pharma-cists after that date. Furthermore, this portionof section no. 13151, relating to convertingover of assistant pharmacists to registeredpharmacists, was deleted by the 66th GeneralAssembly, effective as of August 1, 1952.

AUTHORITY: sections 338.020, 338.035,338.040, 338.070, 338.140 and 338.280,RSMo 2000 and 338.030, RSMo Supp.2004.* This rule originally filed as 4 CSR220-2.030. This version of rule filed July 18,1962, effective July 28, 1962. Amended:Filed Nov. 9, 1966, effective Nov. 19, 1966.Amended: Filed Nov. 27, 1967, effective Dec.7, 1967. Amended: Filed Sept. 30, 1969,effective Oct. 10, 1969. Amended: Filed Dec.31, 1975, effective Jan. 10, 1976. Emergencyamendment filed July 15, 1981, effectiveSept. 28, 1981, expired Nov. 11, 1981.Amended: Filed Aug. 10, 1981, effective Nov.12, 1981. Amended: Filed April 14, 1982,effective July 11, 1982. Amended: Filed Dec.12, 1983, effective May 11, 1984. Amended:Filed Dec. 11, 1984, effective March 11,1985. Amended: Filed June 14, 1985, effec-tive Aug. 26, 1985. Amended: Filed Feb. 25,1986, effective June 12, 1986. Amended:Filed Oct. 1, 1987, effective Jan. 29, 1988.Amended: Filed Jan. 3, 1990, effective April26, 1990. Amended: Filed Jan. 30, 1991,effective July 8, 1991. Amended: Filed Jan.3, 1992, effective June 25, 1992. Amended:Filed Aug. 4, 1992, effective April 8, 1993.Amended: Filed Sept. 26, 1994, effectiveMarch 30, 1995. Amended: Filed Jan. 27,1995, effective Sept. 30, 1995. Amended:Filed March 19, 1996, effective Oct. 30,

1996. Amended: Filed Dec. 9, 1996, effectiveJuly 30, 1997. Amended: Filed April 23,1998, effective Nov. 30, 1998. Amended:Filed Nov. 1, 2000, effective June 30, 2001.Amended: Filed June 28, 2002, effective Jan.30, 2003. Amended: Filed Nov. 13, 2002,effective June 30, 2003. Amended: Filed Dec.1, 2004, effective June 30, 2005. Moved to 20CSR 2220-2.030, effective Aug. 28, 2006.

*Original authority: 338.020, RSMo 1939, amended1947, 1949, 1981, 1990; 338.030, RSMo 1939, amended1949, 1951, 1981, 1990, 2001; 338.035, RSMo 1990,amended 1993, 1995; 338.040, RSMo 1939, amended1961, 1969, 1981, 1990; 338.070, RSMo 1939, amended1947, 1953, 1961, 1969, 1981, 1985, 1997; 338.140,RSMo 1939, amended 1981, 1989, 1997; and 338.280,RSMo 1951, amended 1971, 1981.

20 CSR 2220-2.032 Licensure by Exami-nation for Graduates of Nonapproved For-eign Pharmacy Schools

PURPOSE: This rule defines requirementsfor licensure by examination of applicantswho are graduates of foreign colleges/schoolsof pharmacy not approved by the board asoutlined in 4 CSR 220-2.030(1).

(1) An individual who is a graduate of a for-eign college/school of pharmacy which is notcurrently accredited by the board may applyto write the examination for licensure, if cur-rent requirements for licensure in Missouriare met.

(2) The board shall consider an applicationonly after the applicant submits all of the fol-lowing required credentials:

(A) Photostatic copy of a certificate, stat-ing name, date of birth and place of birth, byone (1) of the following methods:

1. Birth certificate;2. Baptismal certificate; or3. Notarized statement from an autho-

rized agency;(B) Documentation as required by the

board showing proof of practical experiencewhich is equal to the requirements of 4 CSR220-2.030(2), (3) and (6)(C);

(C) Documentation of name change, ifname on the credentials supplied for evalua-tion purposes is different than the presentname appearing on the application;

(D) Copy of current visa, along with acopy of an employment authorization docu-ment such as an Alien Registration ReceiptCard, Form I-551 or Employment Authoriza-tion Card Form I-688-B, or any other docu-ment approved or issued by the United Statesgovernment permitting employment, if appli-cant is not a United States citizen, or proof ofUnited States citizenship;


Secretary of State


(E) One (1), two-inch by two-inch (2"×2") frontal view portrait photograph of theapplicant; and

(F) Foreign Pharmacy Graduate Equi-valency Certification (FPGEC) as providedby the National Association of Boards ofPharmacy Foundation Foreign PharmacyGraduate Examination Committee.

(3) An applicant who successfully completesall requirements as set forth in this rule willbe considered eligible to apply and take thelicensure examination as outlined in sections338.020 and 338.030, RSMo and 4 CSR220-2.030.

(4) An applicant who does not meet the cur-rent minimum requirements as set forth bythe board for licensure shall be advised of thedecision of the board. This decision mayinclude recommendations as to what actionthe applicant can take to obtain licensure.

(5) Application pursuant to this rule shouldbe submitted to the board’s office six (6)months prior to the date for which the candi-date wishes to sit for a regularly scheduledlicensing examination.

(6) Documents in a foreign language shall betranslated into English, notarized by anauthorized individual and attached when sub-mitted to the Missouri Board of Pharmacy.

(7) All fees are nonrefundable.

AUTHORITY: sections 338.020, 338.030 and338.140, RSMo 2000.* This rule originallyfiled as 4 CSR 220-2.032. Original rule filedOct. 16, 1985, effective Feb. 24, 1986.Amended: Filed Dec. 24, 1990, effective June10, 1991. Amended: Filed Dec 15, 1995,effective July 30, 1996. Amended: Filed Nov.21, 1997, effective June 30, 1998. Amended:Filed March 1, 2001, effective Sept. 30, 2001.Moved to 20 CSR 2220-2.032, effective Aug.28, 2006.

*Original authority: 338.020, RSMo 1939, amended1947, 1949, 1981, 1990; 338.030, RSMo 1939, amended1949, 1951, 1981, 1990; 338.140, RSMo 1939, amended1981, 1989, 1997.

20 CSR 2220-2.034 Licensure by Reciproc-ity for Graduates of Nonapproved ForeignPharmacy Schools Who Have BeenLicensed in Another State

PURPOSE: This rule defines requirementsfor licensure by reciprocity of applicants whoare graduates of foreign colleges/schools ofpharmacy not approved by the board as out-

lined in 4 CSR 220-2.030(1) who have beenlicensed in another state.

(1) An individual who is a graduate of a for-eign college/school of pharmacy not approvedby the Missouri Board of Pharmacy and islicensed as a pharmacist by another state mayapply for licensure in this state by reciproci-ty, if the requirements for licensure by theother state are equivalent to those of thisstate.

(2) The applicant for reciprocal licensuremust fulfill all requirements as set forth in 4CSR 220-2.032.

(3) Appropriate fees must accompany allapplications and are nonrefundable.

(4) Once the credentials of a candidate havebeen approved by the board, application tothe National Association of Boards of Phar-macy for reciprocity to Missouri may begin.All reciprocal licensure requirements as setforth in 4 CSR 220-2.030(6) must then besatisfactorily completed.

AUTHORITY: sections 338.020 and 338.030,RSMo Supp. 1990.* This rule originally filedas 4 CSR 220-2.034. Original rule filed Oct.16, 1985, effective Feb. 24, 1986. Amended:Filed Aug. 29, 1986, effective Dec. 25, 1986.Amended: Filed Dec. 24, 1990, effective June10, 1991. Moved to 20 CSR 2220-2.034,effective Aug. 28, 2006.

*Original authority: 338.020, RSMo 1939, amended1947, 1949, 1981, 1990 and 338.030, RSMo 1939,amended 1949, 1951, 1981, 1990.

20 CSR 2220-2.036 Temporary License

PURPOSE: This rule defines requirements toobtain a temporary license to practice phar-macy for persons completing residency pro-grams.

(1) Temporary licenses issued under authori-ty granted to the board in section 338.043,RSMo for purposes of completing a residen-cy training or fellowship program shall limitthe right of the licensee to practice only inlocations approved by the board under thesupervision of a pharmacist licensed to prac-tice pharmacy in this state.

(A) The pharmacist license of the super-vising pharmacist must be an active, unre-stricted license and be in good standing withthe board.

(B) All locations where the temporarylicensee shall practice must be provided tothe board when initially applying for a tem-

porary license and must be updated whenchanges occur during the licensing period.

(2) An applicant for a temporary license foruse in completing a postgraduate training pro-gram in pharmacy as recognized by the boardis required to make application upon a formsupplied by the board.

(A) No application will be consideredunless it is fully completed and properlyattested.

(B) A frontal view portrait photographwhich measures two inches by two inches (2"× 2") must accompany the application for atemporary license.

(C) The application shall be submittedalong with the appropriate licensure fee asrequired by the board.

(D) The application must be accompaniedby a protocol which will outline the duties ofthe temporary licensee as well as any docu-mentation concerning affiliations withlicensed pharmacies, other institutions orassociations, or both. The protocol shalldefine and provide, at a minimum, the fol-lowing:

1. Type of practice to be performed anda specific job description of professionalduties and functions to be completed;

2. Identity of the supervising pharmacistwhich includes a statement attesting to theability and understanding of responsibilitiesinvolved;

3. A complete listing of all affiliations tobe utilized during the licensure period; and

4. A complete listing of all locationswhere professional services shall occur.

(3) In the event that an applicant for tempo-rary licensure is not a graduate of a boardapproved school or college of pharmacy asoutlined in 4 CSR 220-2.030(1), then all therequirements as outlined in 4 CSR 220-2.032must be completed.

(4) A Missouri licensed pharmacist whoagrees to supervise a temporary licensee shallconduct general supervision during his/hertenure.

(A) General supervision is defined assupervision required to fulfill the statedrequirements of the practice protocol or maybe required by the board and to insure appro-priate outcomes as to training received orprovided. In addition, general supervisionrequires that the supervisor be available forconsultation with the licensee whenever nec-essary. Any proposed methods for supervis-ing temporary licensees shall be stated in thepractice protocol.

(B) General supervision also will includethe timely submission of reports to the board



as may be required through protocol or by theboard in assessing outcomes or adherence toboard requirements.

(5) The board may terminate a temporarylicense at its own discretion if, in the opinionof the board, any of the requirements of theboard or the approved protocol have not beenadhered to. The licensee shall be notified inwriting by personal service or certified mailwhen board action results in the terminationof a temporary license.

(6) No applicant for a temporary license shallcommence practicing until the temporarylicense is issued.

(7) The temporary licensing program is notintended to replace or conflict with anyrequirements or provisions of 4 CSR 220-2.030 as regards internship or externship.Students who rotate through a licensed phar-macy or other accredited internship site shallapply for a temporary license when the stu-dent is not currently licensed as an intern orregistered as a technician. For purposes ofthis section to qualify for a temporary licensethe rotation shall be no more than six (6)weeks in length and the student cannot havebeen previously licensed as an intern by theboard.

(8) If a temporary licensee desires to acquirea permanent license or desires to practicepharmacy outside of the provisions of thisrule, then all provisions as outlined in 4 CSR220-2.030 must be completed.

(9) A temporary license automatically expiresat the end of the applicant’s Missouri-basedtraining program identified in the applicationand protocol. No temporary licensee shallcontinue to practice pharmacy beyond theexpiration date of the license.

(10) Temporary licenses may be issued tolicensure transfer candidates or licensureexamination candidates who successfullycomplete the requirements for permanentlicensure if background criminal checks arenot complete.

(11) Any temporary license issued in lieu ofa permanent license while a criminal back-ground check is completed shall remain ineffect until the permanent license is issued ordenied. If a permanent license is denied, theboard shall inform the applicant in writing ofthe denial. The temporary license will beconsidered invalid after notification is sent tothe applicant by certified mail.

(12) All fees are nonrefundable.

AUTHORITY: sections 338.043 and 338.140,RSMo Supp. 1999.* This rule originally filedas 4 CSR 220-2.036. Original rule filed May24, 1993, effective Dec. 9, 1993. Amended:Filed Nov. 21, 1997, effective June 30, 1998.Amended: Filed March 15, 2000, effectiveSept. 30, 2000. Moved to 20 CSR 2220-2.036, effective Aug. 28, 2006.

*Original authority: 338.043, RSMo 1990, amended 1997and 338.140, RSMo 1939, amended 1981, 1989, 1997.

20 CSR 2220-2.050 Public Complaint Han-dling and Disposition Procedure

PURPOSE: This rule establishes a procedurefor the receipt, handling and disposition ofpublic complaints by the board, pursuant tothe mandate of section 620.010.16(6), RSMo.

(1) The State Board of Pharmacy shallreceive and process each complaint madeagainst any licensee or registrant or otherperson or entity, which complaint alleges cer-tain acts or practices which may constituteone (1) or more violations of the provisionsof Chapter 338, RSMo. Any member of thepublic, the profession or any federal, state orlocal official may make and file a complaintwith the board. Complaints shall be receivedfrom sources outside Missouri and will beprocessed in the same manner as those origi-nating within Missouri. No member of theState Board of Pharmacy shall file a com-plaint with this board while s/he holds thatoffice, unless that member excuses him/her-self from further board deliberations or activ-ity concerning the matters alleged within thatcomplaint. Any staff member or employee ofthe board may file a complaint pursuant tothis rule in the same manner as any memberof the public.

(2) Complaints should be mailed or deliveredto the following address: State Board of Phar-macy, 3605 Missouri Blvd., PO Box 625, Jef-ferson City, MO 65102. However, actualreceipt of the complaint by the board at itsadministrative offices in any manner shall besufficient. Complaints may be based uponpersonal knowledge or upon information andbelief, reciting information received fromother sources.

(3) All complaints shall be made in writingand shall fully identify their maker by nameand address. Complaints may be made onforms provided by the board, which shall beavailable upon request. Complaints need notbe made by affidavit, but oral or telephonecommunications will not be considered orprocessed as complaints. Any person attempt-

ing to make an oral or telephone complaintagainst an individual will be provided with acomplaint form and requested to complete itand return it to the board. Any staff memberor employee of the board may make and filea complaint based upon information andbelief, in reliance upon oral, telephone orwritten but unsigned communicationsreceived by the board, unless those commu-nications are believed by that staff member oremployee to be false.

(4) Each complaint received under this ruleshall be recorded by the board. Complaintsshall be logged in consecutive order asreceived. The record shall contain each com-plainant’s name and address; the name andaddress of the subject(s) of the complaint; thedate each complaint is received by the board;a brief statement of the acts complained of,and the ultimate disposition of the complaint.This record shall be a closed record of theboard.

(5) The complainant shall be informed inwriting as to whether the complaint has beendismissed by the board or is being referred tolegal counsel for legal action. The com-plainant may be notified of the ultimate dis-position of the complaint, excluding judicialappeals and may be provided with a copy ofthe decisions (if any) of the AdministrativeHearing Commission and the board. The pro-visions of this section shall not apply to com-plaints filed by staff members or employeesof the board, based upon information andbelief, acting in reliance on third-party infor-mation received by the board.

(6) Both the complaint and any informationobtained as a result of the complaint investi-gation shall be considered a closed record ofthe board and shall not be available forinspection by the public.

(7) This rule shall not be deemed to limit theboard’s authority to file a complaint with theAdministrative Hearing Commission or witha court, charging a licensee, permittee orother person or entity with any actionableconduct or violation, whether or not thiscomplaint exceeds the scope of the actscharged in a preliminary public complaintfiled with the board and whether or not anypublic complaint has been filed with theboard.

(8) The board interprets this rule, which isrequired by law, to exist for the benefit ofthose members of the public who submitcomplaints to the board. This rule is notdeemed to protect, or to inure to the benefitof those licensees, permit holders, registrants


Secretary of State




or other persons or entities against whom theboard has instituted or may institute adminis-trative or judicial proceedings concerningpossible violations of provisions of Chapter338, RSMo.

(9) To facilitate the investigation, evaluationand disposition of complaints, which involveviolations of federal and state law governingcontrolled substances, the Board of Pharmacymay designate Bureau of Narcotics and Dan-gerous Drugs personnel and other state per-sonnel as pharmacy inspectors. These inspec-tors shall be authorized pursuant to section338.150, RSMo to enter and inspect variouspremises.

(10) Persons designated by the Board of Phar-macy as pharmacy inspectors and other Boardof Pharmacy personnel may attend boardmeetings in order to assist the board in itsdeliberations.

AUTHORITY: sections 338.140 and 338.280,RSMo 2000 and 620.010.15(6), RSMo Supp.2004.* This rule originally filed as 4 CSR220-2.050. Original rule filed Jan. 11, 1982,effective June 1, 1982. Amended: Filed Aug.27, 1985, effective Nov. 11, 1985. Amended:Filed Aug. 29, 1986, effective Dec. 25, 1986.Amended: Filed Sept. 26, 1994, effectiveMarch 30, 1995. Amended: Filed June 28,2002, effective Jan. 30, 2003. Amended:Filed May 13, 2005, effective Oct. 30, 2005.Moved to 20 CSR 2220-2.050, effective Aug.28, 2006.

*Original authority: 338.140, RSMo 1939, amended 1981,1989, 1997; 338.280, RSMo 1951, amended 1971, 1981;and 620.010.15(6), RSMo 1973, amended 1981, 1983,1986, 1989, 1990. 1993, 1994, 1995, 1999, 2001.

20 CSR 2220-2.060 Gold Certificates

PURPOSE: This rule sets requirements con-cerning the issuance of honorary gold certifi-cates to pharmacists licensed in Missouri forfifty years.

(1) The Missouri Board of Pharmacy shallissue gold certificates to all pharmacistlicensees who have been regularly licensed aspharmacists in Missouri for fifty (50) years.These gold certificates shall be distinctive incoloration and text from other documentarylicenses issued by the board and shall bedesigned to appropriately recognize eachrecipient pharmacist for his/her half centuryof professional practice. Gold certificates arehonorific in nature and confer no right topractice pharmacy upon the recipient.

(2) The awarding of gold certificates shall bemade by the Missouri Board of Pharmacyroutinely and without charge to the recipient.

AUTHORITY: section 338.140, RSMo Supp.1989.* This rule originally filed as 4 CSR220-2.060. Original rule filed March 14,1983, effective June 11, 1983. Moved to 20CSR 2220-2.060, effective Aug. 28, 2006.

*Original authority: 338.140, RSMo 1939, amended 1981,1989.

20 CSR 2220-2.080 Electronic Data Pro-cessing

PURPOSE: This rule establishes require-ments for utilizing an electronic data process-ing system in a pharmacy.

(1) All information concerning the com-pounding, dispensing or selling at retail ofany drug, medicine or poison pursuant to alawful prescription which is entered into anelectronic data processing (EDP) system atany pharmacy shall be entered only by alicensed pharmacist or by an individual underthe direct supervision and review of alicensed pharmacist. That pharmacist shall bepersonally responsible for the accuracy of theinformation.

(2) Any EDP system used by any pharmacyfor record keeping shall comply with therequirements of section 338.100, RSMo,including the capability to store and retrievethe following information concerning the fill-ing or refilling of any prescription:

(A) A prescription label number that islinked to the unique readily retrievable iden-tifier;

(B) Date of original prescription, expira-tion date of the prescription or both;

(C) Date original prescription was filled;(D) Patient’s full name;(E) Patient’s address when a prescription

prescribes a controlled substance;(F) Prescriber’s full name;(G) Prescriber’s address and Drug En -

force ment Administration (DEA) numberwhen a prescription specifies a controlledsubstance;

(H) Name of drug, medicine or poison dis-pensed;

(I) Quantity of drug, medicine or poisonoriginally dispensed;

(J) Quantity of drug, medicine or poisondispensed on each refill;

(K) Initials or code of the pharmacistresponsible for input or review of data oneach original prescription and each refill;

(L) Date of each refill; and

(M) If a new prescription is transmitted byphone, a hard copy representation must bemade and contain all of the information insubsections (2)(A)–(L) plus an indication ofwhether or not a generic substitution is per-mitted and made in accordance with 4 CSR220-3.011.

(3) Prescription hard copies must be filed byeither the prescription label number or by theunique readily retrievable identifier. Pre-scription hard copies must be retrievable atthe time of inspection.

(4) Any pharmacy using an EDP system asdescribed in section (1) shall provide docu-mentation that the information concerning therefills of prescriptions entered into the systemfor all prescription drugs is accurate. Thisdocumentation shall include:

(A) The initials or code designation of thedispensing pharmacist for each refill;

(B) The date of the refill;(C) The quantity of substances refilled;(D) The number of authorized refills or

dispensable units remaining;(E) If additional refills are authorized and

added to an existing prescription, a notationindicating the method and source of theauthorization must be a part of the EDPrecord or hard copy, in that case the expira-tion date of the original prescription shallremain the same; and

(F) If any other alteration is made in theoriginal prescription record, a clear audit trailmust be maintained. This shall include, but isnot limited to, a change in authorizing physi-cian, a change in total quantity ordered or achange in directions.

(5) Any pharmacy using an EDP system asdescribed in section (1) shall maintain the fol-lowing:

(A) A bound logbook or separate file inwhich each pharmacist involved in the phar-macy’s record keeping system shall sign astatement each day attesting that informationconcerning the refill of prescriptions has beenentered into the system for that day and thatthe pharmacist has reviewed the informationfor accuracy. The logbook or file shall bemaintained at the pharmacy for at least five(5) years after the date the drugs, medicinesor poisons are dispensed.

(6) Any hospital pharmacy using an EDP sys-tem, as described in section (1), for outpa-tient prescriptions, employee prescriptionsand take-home prescriptions shall conform toall sections of this rule.

(7) Any EDP system, as described in section(1), must be capable of producing the record

required in subsections (2)(A)–(M) and saidrecords shall be readily retrievable on-line.Readily retrievable is defined as providingEDP records within two (2) hours of time ofrequest by an inspector or by making a com-puter terminal available to the inspector forimmediate use.

(8) An auxiliary record keeping system shallbe established for the documentation of refillsif the EDP system is inoperative for any rea-son. The auxiliary system shall insure that allrefills are authorized by the original prescrip-tion or prescriber. When this EDP system isrestored to operation, the information regard-ing prescriptions filled and refilled during theinoperative period shall be entered into theEDP system within seven (7) working days.However, nothing in this section shall pre-clude the pharmacist from using his/her professional judgment for the benefit of apatient’s health and safety.

(9) If a prescription is transferred from apharmacy using an EDP system, a notation ordeactivation must be made on the transferredrecord to preclude any further dispensing. Ifthe same prescription is transferred back intothe original pharmacy, it shall be treated as anew record, showing the original date writtenand expiration date.

(10) Prior to or simultaneously with the purg-ing of any EDP system, the pharmacist-in-charge or permit holder shall make certainthat a record of all prescription activity beingerased exists in readable form, either onpaper, microfiche or electronic media stor-age. A pharmacy that desires to discard hardcopy prescriptions that are more than three(3) years old must maintain all prescriptioninformation on microfiche or electronicmedia. Any process utilizing microfiche mustensure that all data is available and in read-able form. Any pharmacy opting for the uti-lization of microfiche records must alsomaintain a microfiche reader so that recordsmay be reviewed on-site by pharmacy person-nel or board inspectors. Electronic mediastorage is defined as any medium such as acomputer, floppy disk or diskette, compactdisk (CD) or other electronic device that canreproduce all prescription information asrequired by section 338.100, RSMo and thisrule and is retrievable within three (3) work-ing days.

(11) If coded information exists in the elec-tronic EDP, the board inspector may requestthe definitions of the codes from the pharma-cist on duty for immediate review.

(12) The EDP system shall be able to providea listing of drug utilization for any drug for aminimum of the preceding twelve (12)-monthperiod. Drug utilization information shall beavailable by specific drug product, patientname or practitioner. If requested to do so,the pharmacy shall have three (3) workingdays to provide the report.

(13) The provisions of this rule shall not con-flict with any federal laws or regulations. Ifany part of this rule is declared invalid by acourt of law, that declaration shall not affectthe other parts of the rule.

AUTHORITY: sections 338.100, 338.140 and338.280, RSMo 2000.* This rule originallyfiled as 4 CSR 220-2.080. Original rule filedMarch 8, 1984, effective Aug. 11, 1984.Amended: Filed Nov. 4, 1985, effective Feb.24, 1986. Rescinded and readopted: FiledDec. 5, 1988, effective March 11, 1989.Amended: Filed March 15, 2000, effectiveSept. 30, 2000. Amended: Filed Nov. 1,2000, effective June 30, 2001. Moved to 20CSR 2220-2.080, effective Aug. 28, 2006.

*Original authority: 338.100, RSMo 1939, amended 1971,1990, 1997, 1999; 338.140, RSMo 1939, amended 1981,1989, 1997; and 338.280, RSMo 1951, amended 1971,1981.

20 CSR 2220-2.085 Electronic Transmis-sion of Prescription Data

PURPOSE: This rule establishes basicguidelines to address new technology for thetransmission of prescription data utilizingelectronic mediums.

(1) Definitions.(A) Electronic transmission prescription—

Includes transmission of both image and dataprescriptions.

(B) Electronic image transmission pre-scription—Any prescription order for whichan exact visual image of the order is receivedby a pharmacy from a licensed prescriber.

(C) Electronic data transmission prescrip-tion—Any prescription order, other than anelectronic image transmission prescription,which is electronically transmitted from alicensed prescriber to a pharmacy.

(D) Electronic signature—Means a confi-dential personalized digital key, code, numberor other identifier used for secure electronicdata transmissions which identifies andauthenticates the signatory. Electronic signa-tures may be sent as part of an electronictransmission prescription to a pharmacy or itmay be applied to a hard copy to be providedto the patient.

(2) When a prescription is transmitted to apharmacy electronically, the followingrequirements must be met:

(A) The original electronic facsimile trans-mission (FAX) document or all informationfrom an electronic source must be readilyretrievable through the pharmacy computersystem;

(B) To maintain the confidentiality ofpatient records, the system shall have ade-quate security and systems safeguardsdesigned to prevent and detect unauthorizedaccess, modification, or manipulation ofpatient records. Once the drug has been dis-pensed, any alterations in prescription drugorder data shall be documented including theidentification of the pharmacist responsiblefor the alteration;

(C) In verifying the authenticity of a trans-mitted prescription, the pharmacist shallensure the validity of the prescription as to itssource of origin. Measures to be consideredin authenticating prescription drug ordersreceived via electronic transmission include:

1. Maintenance of a practitioner’s fac-simile number reference or other electronicsignature file;

2. Verification of the telephone numberof the originating facsimile equipment;

3. Telephone verification with the prac-titioner’s office that the prescription as bothwritten by the practitioner and transmitted bythe practitioner or the practitioner’s autho-rized agent;

4. Other efforts which, in the profes-sional judgment of the pharmacist, may benecessary to ensure the transmission was ini-tiated by the prescriber;

(D) At the option of the patient, an elec-tronically produced prescription may be sentto a pharmacy electronically or provided as ahard copy generated from the prescriber’selectronic prescribing system;

(E) Hard copy prescriptions presented tothe patient generated from electronic mediashall be applied to paper that utilizes securityfeatures that will ensure that the prescriptionis not subject to any form of copying and/oralteration; and

(F) Electronic transmission technology uti-lized by pharmacy personnel shall not be usedto circumvent or violate any provision of stateand federal drug laws or the Pharmacy Prac-tice Act and accompanying regulations.

AUTHORITY: sections 338.010, 338.095338.140 and 338.280, RSMo 2000.* Thisrule originally filed as 4 CSR 220-2.085.Original rule filed Sept. 25, 1995, effectiveApril 30, 1996. Amended: Filed July 28,2000, effective Jan. 30, 2001. Amended:Filed April 16, 2001, effective Nov. 30, 2001.


Secretary of State


Moved to 20 CSR 2220-2.085, effective Aug.28, 2006.

*Original authority: 338.010, RSMo 1939, amended 1951,1989, 1990; 338.095, RSMo 1993; 338.140, RSMo 1939,amended 1981, 1989, 1997; and 328.280, RSMo 1951,amended 1971, 1981.

20 CSR 2220-2.090 Pharmacist-in-Charge

PURPOSE: This rule defines the term phar-macist-in-charge, sets the requirements andstandards for this title, and defines the termfull-time pharmacy.

(1) A pharmacist may be a pharmacist-in-charge of a licensed pharmacy; provided, thats/he complies with all provisions of this rule.

(2) The responsibilities of a pharmacist-in-charge, at a minimum, will include:

(A) The management of the pharmacymust be under the supervision of a Missouri-licensed pharmacist at all times when pre-scriptions are being compounded, dispensedor sold;

(B) The traffic in the prescription areamust be restricted to authorized personnelonly so that proper control over the drugs canbe maintained at all times;

(C) All the required signs are displayed inthe appropriate places when there is no phar-macist on duty;

(D) The licenses of all pharmacistsemployed are conspicuously displayed in thepharmacy;

(E) Assurance that all procedures of thepharmacy in the handling, dispensing andrecordkeeping of controlled substances are incompliance with state and federal laws;

(F) Any excessive or suspicious requests,or both, for the dispensing of controlled sub-stances be verified prior to dispensing;

(G) All labeling requirements are compliedwith according to section 338.059, RSMo,federal laws where required and board regu-lations governing auxiliary labeling of drugsand devices;

(H) The prescription files are maintainedaccording to the requirements of this boardand the other state and federal controlled sub-stance laws and regulations;

(I) The Missouri Revised Negative DrugFormulary and state laws governing drug sub-stitution be complied with when generic sub-stitution takes place;

(J) If exempt narcotics are sold, completerecords be kept of all exempt narcotics in abound exempt narcotic register;

(K) If poisons are sold, the pharmacymaintain a poison register;

(L) The pharmacy maintain and have onfile at all times the required reference library;

(M) The pharmacy be kept in a clean andsanitary condition;

(N) The pharmacist-in-charge will beresponsible for the supervision of all pharma-cy personnel, to assure full compliance withthe pharmacy laws of Missouri;

(O) All Missouri and federal licenses arekept up-to-date;

(P) Policies and procedures are in force toinsure safety for the public concerning anyaction by pharmacy staff members or withinthe pharmacy physical plant;

(Q) All equipment, as prescribed throughregulation, is available and in good workingorder;

(R) Security is sufficient to insure the safe-ty and integrity of all legend drugs located inthe pharmacy;

(S) Any changes of the following areappropriately carried out:

1. Pharmacy permit transfer of any typeor manner;

2. Regulation requirements completedsatisfactorily when a change of pharmacist-in-charge occurs;

3. Change of pharmacist’s own addressas it appears on his/her license;

(T) When the board-recognized pharma-cist-in-charge is changed at that licensedfacility, an appropriate documented inventoryof controlled substances must be taken;

(U) Assure that the appropriate handlingand disposal of controlled substances is doneand verified through appropriate documenta-tion and when necessary that controlled sub-stances be disposed of through appropriateprocedures involving the Missouri Board ofPharmacy or the Bureau of Narcotics andDangerous Drugs;

(V) No outdated drugs are dispensed ormaintained within the active inventory of thepharmacy, including prescription and relatednonprescription items;

(W) Assure full compliance with all stateand federal drug laws and rules;

(X) Compliance with state and federalrequirements concerning drug samples;

(Y) Assure that all state and federal lawsconcerning drug distribution and control arecomplied with and that no violations occurthat would cause a drug or device or anycomponent thereof to become adulterated ormisbranded;

(Z) Maintain compliance with all state andfederal laws governing drug distributor activ-ities and assure that appropriate licensure asa drug distributor is secured if lawful thresh-olds for unlicensed drug distributions areexceeded;

(AA) Assure overall compliance with stateand federal patient counseling requirements;

(BB) Maintain a current list of all person-nel employed by the pharmacy as pharmacytechnicians. The list shall include the name,registration number or a copy of an applica-tion for registration that has been submittedto the board and a description of duties to beperformed by each person contained on thelist;

(CC) Maintain written standards settingout the responsibilities of registered pharma-cy technicians as well as the procedures andpolicies for supervision of registered pharma-cy technicians, as required by 4 CSR 220-2.700(1). Said standards shall be available tothe board and its designated personnel forinspection and/or approvals;

(DD) Any person other than a pharmacistor permit holder who has independent accessto legend drug stock on a routine basis in apharmacy shall be required to register withthe board as a pharmacy technician. Thedetermination of whether or not an individualmust register as a pharmacy technician willbe the responsibility of the pharmacist-in-charge; and

(EE) Maintain compliance of automateddispensing and storage systems with applica-ble board rules and regulations.

AUTHORITY: sections 338.140, 338.240 and338.280, RSMo 2000.* This rule originallyfiled as 4 CSR 220-2.090. Emergency rulefiled April 12, 1984, effective April 22, 1984,expired Aug. 20, 1984. Original rule filedApril 12, 1984, effective Aug. 11, 1984.Amended: Filed Feb. 25, 1986, effective Aug.11, 1986. Amended: Filed Jan. 27, 1995,effective Sept. 30, 1995. Amended: FiledAug. 21, 1998, effective Feb. 28, 1999.Amended: Filed Dec. 30, 1998, effective June30, 1999. Amended: Filed Nov. 1, 2000,effective June 30, 2001. Moved to 20 CSR2220-2.090, effective Aug. 28, 2006.

*Original authority: 338.140, RSMo 1939, amended 1981,1989, 1997; 338.240, RSMo 1951; and 338.280, RSMo1951, amended 1971, 1981.

20 CSR 2220-2.100 Continuing PharmacyEducation

PURPOSE: This rule defines continuing edu-cation requirements for relicensure of phar-macists in Missouri.

(1) Commencing with the licensing periodbeginning November 1, 1985 and for eachlicensing period after that, no active pharma-cist license will be renewed by the MissouriBoard of Pharmacy unless the applicant has



fulfilled the continuing education require-ments as set forth in section 338.060, RSMoof the Pharmacy Practice Act.

(2) A continuing education program for phar-macists means postgraduate studies that haveprior approval of the Missouri Board of Phar-macy to fulfill the requirements of continuingeducation for renewal in Missouri. This mayinclude institutes, seminars, lectures, confer-ences, workshops, extension study, corre-spondence courses, teaching, professionalmeetings, self-study courses and any othermethods which may be approved by theboard, but in any case, the studies must bepharmacy-related.

(A) Programs shall provide for evaluationmethods or examinations to assure satisfacto-ry completion by participants.

(B) The person(s) who is to instruct or whois responsible for the delivery or content ofthe program shall be qualified, as determinedby the board, in the subject matter by educa-tion, experience or preparation in the prepa-ration and methods of delivery.

(C) Continuing pharmacy education pro-grams shall be approved by one (1) of the fol-lowing methods:

1. All continuing pharmacy educationprograms offered by providers approved bythe American Council on PharmaceuticalEducation will be accepted as meeting therequirements of continuing education forrenewal as a pharmacist in Missouri;

2. The Missouri Board of Pharmacy mayapprove continuing education programsoffered by providers who are not approved bythe American Council on PharmaceuticalEducation. Criteria for approval of those pro-grams shall be based on the criteria promul-gated by the American Council on Pharma-ceutical Education in its publication“Accreditation Standards and Guidelines”section on Approval of Providers of Pharma-ceutical Education, Pages III-1 through III-C.Application to the board for this approvalmust be made at least thirty (30) days inadvance of the program date to guaranteenotification of certification status prior to thedate of the program. Applications receivedless than thirty (30) days prior to the date ofthe program cannot be guaranteed to be cer-tified prior to the date of the program. Appli-cation to the board for this approval shall bemade on and in accordance with forms estab-lished by the board. The forms shall requiredetailed information relating to administra-tion and organization, budget and resources,teaching staff, educational content and devel-opment, methods of delivery, facilities andevaluation. No applications for approval ofcontinuing education programs will beaccepted less than ten (10) business days fromthe date such program is offered for continu-

ing education purposes. Applicationsreturned due to errors or for purposes ofrequesting more information shall not be con-sidered to be received by the office until therequested corrections or information aremade and received by the board office. Theexecutive director shall review applicationsfor continuing education programs and mayapprove or deny such requests. Applicantsshall be notified on a timely basis once thedecision to approve or deny a program hasbeen made. If an application was received bythe board office sixty (60) days or more priorto the date it is scheduled to be offered andthe program is denied, the applicant mayrequest an appeal to further review the appli-cation by the continuing education commit-tee. The request for appeal must be in writ-ing. In no case shall an applicant be able toappeal a denial of an application if suchapplication was initially received by the boardoffice less than sixty (60) days prior to thedate it is scheduled to be offered;

3. Any pharmacist whose primaryresponsibility is not the education of healthprofessionals who leads, instructs or lecturesto groups of nurses, physicians, pharmacistsor others on pharmacy-related topics in orga-nized continuing education or in-service pro-grams shall be granted continuing educationcredit for the time expended during actualpresentation upon adequate documentation tothe Missouri Board of Pharmacy. Applicationfor approval shall be made in accordance withprocedures in section (2) of this rule. Creditfor the same presentation or program will beallowed only once during a renewal period;

4. Any pharmacist whose responsibilityis the education of health professionals shallbe granted continuing education credit onlyfor time expended in leading, instructing orlecturing to groups of physicians, pharma-cists, nurses or others on board-approvedpharmacy-related topics in an organized con-tinuing education or in-service program out-side his/her formal responsibilities in a learn-ing institution. Approval will be requestedusing procedures in section (2) and submittedto the Missouri Board of Pharmacy. Creditfor the same presentation or program will beallowed only once during a renewal period;

5. Credit will be given for undergradu-ate or graduate studies in any regionallyaccredited pharmacy, medical or dental edu-cational institution of higher learning. Satis-factory proof of course completion, asrequired by the board, must be submittedwith the renewal notice. The following hourlyequivalents will be used by the board inassessing credits:

3 hours college credit = 15 contact hours2 hours college credit = 10 contact hours1 hour college credit = 5 contact hours

6. One and one-half (1.5) continuingeducation unit (CEU) will be the equivalentof fifteen (15) clock hours of participation inprograms approved by the Missouri Board ofPharmacy; and

7. Continuing education hours earned inanother state will be accepted by the MissouriBoard of Pharmacy provided the hours areacquired within the same renewal period andare certified by the other state board of phar-macy.

(D) No information or advertisements shallcontain information that a continuing educa-tion program has been approved by the boardof pharmacy unless the program is accreditedby American Council on PharmaceuticalEducation (ACPE) or notification has beenreceived that the program has been approvedby the board of pharmacy.

(3) Each licensed pharmacist, instead of sub-mitting proof of the completion of therequired continuing education courses, mayapply for an inactive license at the time s/hemakes application for the renewal of his/herlicense and pay the required renewal fee. Aninactive license then shall be issued and maybe renewed during the renewal period. Whilethe inactive license is in effect, the pharma-cist shall not practice pharmacy.

(4) The renewal fee will be the same foractive and inactive licenses.

(5) Before any inactive license can be reacti-vated to active status, the licensee shall sub-mit proper evidence that s/he has obtained atleast fifteen (15) contact hours for each yearthat his/her license was inactive. It shall bepermissible for the licensee to obtain therequired contact hours during any time peri-od, while the license is on inactive status, aslong as they are obtained prior to activation toactive status.

(6) Any licensee who has a lapsed license andseeks to have it renewed pursuant to section338.060.2, RSMo shall present proper evi-dence that s/he has obtained the requirednumber of contact hours during the periodthat his/her license was lapsed.

(7) A pharmacist first licensed by the boardwithin nine (9) months immediately preced-ing the biennial renewal date shall be exemptfrom the continuing pharmacy educationrequirements for that licensure period.

(8) The president of the board annually willselect two (2) board members who will servealong with the executive director as the con-tinuing education committee. The committeewill review and decide on applications thathave been denied approval and an appeal forfurther review has been submitted. In addi-


Secretary of State


tion, the committee will report on its activi-ties and continuing education at board meet-ings and make recommendations to the boardconcerning continuing education require-ments.

(9) The proof of completion of continuingeducation requirements shall be submittedwith the renewal notice and the appropriatefees by submitting an affidavit that clearlyattests to the fact that all continuing educationrequirements for the purpose of renewal of apharmacist license have been met and thatproof of completion of continuing educationcredits are maintained by the pharmacist inthe form of one (1) or more of the following:

(A) Completed certification from theAmerican Council on Pharmaceutical Educa-tion;

(B) Completed certification from the Mis-souri Board of Pharmacy; or

(C) A letter from another state board ofpharmacy stating the program, dates of atten-dance and number of contact hours that havebeen approved for renewal by that stateboard.

(10) Continuing education credits must beearned from the time a renewal cycle begins,until the cycle ends as prescribed by theboard. For purposes of this section, therenewal cycle begins on September 1 andends on a biennial cycle on August 31. Eachsuch form of proof of completion of therequired continuing education credits shall beretained by the licensee for the preceding two(2) reporting periods prior to renewal.

(11) The renewal application must be com-pleted correctly and in its entirety in order forit to be processed and the license renewed.Any portion of the application that is incom-plete or inaccurate shall result in the rejectionof the renewal application and require itsreturn to the applicant for corrections.

(12) The Missouri Board of Pharmacy mayelect to audit, with the appropriate accredit-ing body, any licensee to assess the authen-ticity and validity of contact hours submittedfor relicensure. Failure to provide proof ofcompletion of the necessary required contin-uing education credits when requested to doso by the board, shall be considered a viola-tion. In accordance with section 338.060,RSMo any licensee that has not completedand retained the required evidence of allrequired continuing education shall pay anydelinquent fees as prescribed by the boardand may be subject to disciplinary action pur-suant to 338.055, RSMo. The board may alsoinitiate auditing of other past renewal periodsand/or require proof of completion of futurecontinuing education credits be submitted

with any application for a renewal of alicense.

AUTHORITY: sections 338.060 and 338.140,RSMo 2000.* This rule originally filed as 4CSR 220-2.100. Original rule filed Nov. 9,1984, effective April 11, 1985. Amended:Filed Nov. 21, 1997, effective June 30, 1998.Amended: Filed March 15, 2000, effectiveSept. 30, 2000. Amended: Filed June 28,2002, effective Jan. 30, 2003. Amended:Filed April 1, 2004, effective Sept. 30, 2004.Amended: Filed June 15, 2005, effective Jan.30, 2006. Moved to 20 CSR 2220-2.100,effective Aug. 28, 2006.

*Original authority: 338.060, RSMo 1939, amended1943, 1947, 1949, 1951, 1981, 1984, 1997, 1999 and338.140, RSMo 1939, amended 1981, 1989, 1997.

20 CSR 2220-2.110 PRN Refills

PURPOSE: This rule clarifies the board’srequirements for refills as needed so that thepracticing pharmacists in Missouri will haveadequate guidelines in this area.

(1) A pharmacist shall not fill or refill anyprescription which was written more than one(1) year before being presented to the phar-macist, unless the pharmacist consults withthe prescriber and confirms—

(A) That the person for whom the drugs ormedicines were prescribed is still under theprescriber’s care or treatment;

(B) That the prescriber desires for the per-son to continue receiving the drugs or medi-cines; or

(C) If the prescriber answers negatively ineither case listed in subsection (1)(A) or(B), the pharmacist shall not fill or refill theprescription, even if the prescription autho-rizes refills as needed (PRN).

(2) If a pharmacist knows or has reason tobelieve that a person for whom a prescriptionhas been written is not under the prescriberscare or treatment at the time the prescriptionis presented for filling or refilling, the phar-macist shall consult with their prescriber andascertain that the prescriber intends for theperson to receive the drugs or medicines. Thepharmacist shall do this no matter when theprescription originally was written and evenif the prescription authorizes refills PRN.

(3) After the pharmacist has confirmed theinformation required in sections (1) and (2) ofthis rule, s/he shall record it in his/herrecords in a uniform fashion so as to make itreadily available for verification by the boardor its authorized agents.

AUTHORITY: section 338.280, RSMo 1994.*This rule originally filed as 4 CSR 220-2.110.Original rule filed Dec. 11, 1984, effectiveMarch 11, 1985. Moved to 20 CSR 2220-2.110, effective Aug. 28, 2006.

*Original authority: 338.280, RSMo 1951, amended 1971,1981.

20 CSR 2220-2.120 Transfer of Prescrip-tion Information for the Purpose of Refill

PURPOSE: This rule defines record keepingrequired for transfer of prescription informa-tion for the purpose of refill.

(1) Prescription information may be trans-ferred for the purposes of refill betweenlicensed pharmacies, provided the prescrip-tion information to be transferred meets all ofthe following criteria:

(A) The prescription information indicatesauthorization by the prescriber for refilling;

(B) The drug on the prescription informa-tion is not a Schedule II controlled substance;

(C) The number of lawfully allowablerefills has not been exceeded or the maximumallowable time limit has not been exceeded;and

(D) If the transfer involves a controlledsubstance, all information must be trans-ferred directly between two (2) licensed phar-macists.

(2) When a prescription on record is trans-ferred, the following record keeping isrequired:

(A) The prescription record at the transfer-ring pharmacy shall show all of the following:

1. The word void must appear on theface of the invalidated prescription or beimmediately voided within the electronic sys-tem when the prescription is transferred;

2. The prescription record shall providethe name of the pharmacy to which it wastransferred, the date of transfer and the iden-tity of the transferring pharmacist; and

3. If the transfer involves a controlledsubstance, the address and Drug EnforcementAdministration (DEA) registration number ofthe pharmacy to which it was transferred andthe full name of the pharmacist receiving theprescription information must be recorded;

(B) The prescription record at the receiv-ing pharmacy shall show all of the following,in addition to all other lawfully requiredinformation of an original prescription:

1. The prescription record is a trans-ferred prescription record from anotherlicensed location;

2. Date of original issuance;3. Date of original filling, if different

from original issuance date;



4. Original number of refills authorizedon the original prescription and the numberof remaining authorized refills;

5. Date of last refill;6. Prescription label number;7. Identity of licensed pharmacy from

which the record was transferred;8. The identity of the transferring phar-

macist provided that pharmacies that sharethe same data base and are under the sameownership may, instead of transferring pre-scriptions directly between two (2) pharma-cists, transfer a prescription electronically bygenerating a computer based report at thetransferring pharmacy of any prescriptionsthat have been transferred out. This recordshall be readily retrievable to the transferringpharmacy and board representatives and com-ply with all of the requirements of this rule,except that the requirement to documentpharmacist identity shall not be required un-less otherwise required by federal law;

9. If the transfer involves a controlledsubstance, the address and DEA registrationnumber from the transferring pharmacy mustbe recorded; and

10. Any electronic transfer must main-tain patient confidentiality in accordance with4 CSR 220-2.300; and

(C) A computerized transfer of prescrip-tion information between licensed pharma-cies for the purpose of refill shall meet all therequirements stated in sections (1) and (2) ofthis rule.

AUTHORITY: sections 338.100 and 338.140,RSMo Supp. 1999 and 338.280, RSMo1994.* This rule originally filed as 4 CSR220-2.120. Original rule filed April 16,1985, effective Aug. 11, 1985. Amended:Filed May 2, 1989, effective Aug. 24, 1989.Amended: Filed April 23, 1998, effectiveNov. 30, 1998. Amended: Filed July 28,2000, effective Jan. 30, 2001. Moved to 20CSR 2220-2.120, effective Aug. 28, 2006.

*Original authority: 338.100, RSMo 1939, amended 1971,1990, 1997, 1999; 338.140, RSMo 1939, amended 1981,1989, 1997; 338.280, RSMo 1951, amended 1971, 1981.

20 CSR 2220-2.130 Drug Repackaging

PURPOSE: This rule establishes require-ments for drug repackaging.

PUBLISHER’S NOTE: The secretary of statehas determined that the publication of theentire text of the material which is incorpo-rated by reference as a portion of this rulewould be unduly cumbersome or expensive.Therefore, the material which is so incorpo-rated is on file with the agency who filed thisrule, and with the Office of the Secretary ofState. Any interested person may view this

material at either agency’s headquarters orthe same will be made available at the Officeof the Secretary of State at a cost not toexceed actual cost of copy reproduction. Theentire text of the rule is printed here. Thisnote refers only to the incorporated by refer-ence material.

(1) A pharmacist or pharmacy may prepack-age drugs for other than immediate dispens-ing purposes provided that the following con-ditions are met:

(A) Only products which will be directlyprovided to the patient may be prepackaged;

(B) Containers utilized for prepackagingshall meet, as a minimum requirement, thatof Class B container standards as referencedby the United States Pharmacopoeia (USP),which has been incorporated herein by refer-ence. Where applicable, light sensitive con-tainers shall be used;

(C) The maximum expiration date allowedfor prepacked drugs shall be the manufactur-er’s expiration date or twelve (12) months,whichever is less; and

(D) Any prepacked drug must have a labelaffixed to it which contains, at a minimum,the name and strength of the drug, the nameof the manufacturer or distributor, an expira-tion date as defined in subsection (1)(C) andlot number. Pharmacies that store drugs with-in an automated counting device may, inplace of the required label, maintain recordsfor lot numbers and expiration dates that arerequired on the label as long as it is fullytraceable and is readily retrievable during aninspection.

(2) The term prepacked as used in this rule isdefined as any drug which has been removedfrom the original manufacturer’s containerand is placed in a dispensing container forother than immediate dispensing to a patient.

AUTHORITY: sections 338.140 and 338.280,RSMo 2000.* This rule originally filed as 4CSR 220-2.130. Original rule filed Dec. 10,1986, effective May 28, 1987. Amended:Filed Nov. 15, 1988, effective March 11,1989. Emergency amendment filed July 1,1991, effective July 26, 1991, expired Nov.22, 1991. Amended: Filed July 1, 1991, effec-tive Jan. 13, 1992. Amended: Filed July 28,2000, effective Jan. 30, 2001. Amended:Filed Jan. 31, 2003, effective Aug. 30, 2003.Moved to 20 CSR 2220-2.130, effective Aug.28, 2006.

*Original authority: 338.140, RSMo 1939, amended 1981,

1989, 1997 and 338.280, RSMo 1951, amended 1971,

1981.

20 CSR 2220-2.140 Prescription Servicesby Pharmacists/Pharmacies for Residentsin Long-Term Care Facilities

PURPOSE: This rule establishes standardsfor pharmacists providing prescription ser-vices to residents in long-term care facilities. The standards are directed to licensed phar-macists and pharmacies, and not to long-termcare facilities.

PUBLISHER’S NOTE: The secretary of statehas determined that the publication of theentire text of the material which is incorpo-rated by reference as a portion of this rulewould be unduly cumbersome or expensive.Therefore, the material which is so incorpo-rated is on file with the agency who filed thisrule, and with the Office of the Secretary ofState. Any interested person may view thismaterial at either agency’s headquarters orthe same will be made available at the Officeof the Secretary of State at a cost not toexceed actual cost of copy reproduction. Theentire text of the rule is printed here. Thisnote refers only to the incorporated by refer-ence material.

(1) Licensure. A pharmacist who or pharma-cy which provides prescription services to along-term care facility must be licensed topractice pharmacy in this state. A long-termcare facility means a nursing home, retire-ment care, mental care or other facility orinstitution which provides extended healthcare to resident patients.

(2) Medication Services.(A) Policies and procedures shall be for-

mulated to cover all packaging and dispensingresponsibilities of the pharmacist/pharmacyto the residents of the long-term care facilityand shall include, at a minimum:

1. Methods used to dispense medica-tions in a timely fashion to the facility;

2. Proper notification to the facilitywhen a medication is not readily available;

3. Proper labeling requirements to meetthe needs of the facility and which are con-sistent with state and federal laws; and

4. Appropriate medication destruction,return of unused medication, or both, whichis consistent with state and federal laws.

(B) Container labeling, at all times, shallconform to Chapter 338, RSMo. If a labelchange is required to reflect a change indirections, the pharmacist personally shallaffix the correct label to the container. How-ever, direction change labels which aredefined as indicator labels that notify long-term care facility personnel that a change indirections for medication has taken place,may be used and affixed to the container bynursing home personnel in a way as not to


Secretary of State


deface the original label. Labeling of unitdose packages may be distinguished from therequirements as set forth in section 338.059,RSMo by insuring that the drug name andstrength, control number and expiration dateand manufacturer’s name appear on the pack-age itself. A patient’s name and directionsmay not have to appear directly on the med-ication container but a mechanism shouldexist to identify for the personnel administer-ing medications, what medications eachpatient is to receive and the directions foradministration.

(C) All prescription containers, including,but not limited to, single unit, unit dose andunit-of-use containers utilized for distributionwithin a long-term care facility shall meetminimum requirements as referenced by theUnited States Pharmacopoeia (USP) which isincorporated herein by reference. Whereapplicable, light-sensitive packaging shall beused.

(3) Any drug, repackaged or prepacked thatis dispensed into a long-term care facility, asdefined in section (1) of this rule, in otherthan the manufacturer’s original container,shall bear the manufacturer’s expiration dateor twelve (12) months, whichever is less.

(4) Remote dispensing systems are defined asany system of an automated or manual designthat is used to provide doses of medication topatients for the immediate administration byauthorized health care personnel and is notlicensed under Chapter 338, RSMo as a phar-macy. Any medication obtained in excessiveamounts shall constitute the practice of phar-macy and will require adherence to all applic-able licensure and drug laws.

(A) If personnel other than a pharmacistrestocks a remote dispensing system, thenany drugs or other items that are to be placedwithin a remote dispensing system must bechecked and approved by a licensed pharma-cist.

(B) Any products that are repackaged foruse in a remote dispensing system must com-ply with all provisions of 4 CSR 220-2.130.

(C) Appropriate security must be main-tained over any remote dispensing system andthere must be policies and procedures utilizedin the delivery and storage of drugs anddevices that deter misuse or theft.

(5) A prescription drug order is defined forthe purpose of this rule as an order originat-ing from a long-term care facility that is ini-tiated by a prescriber and entered into thepatient’s medical record by the prescriber orqualified personnel for the purpose of initiat-ing or renewing an order for a medication or

device. All prescription drug orders shallcomply with 4 CSR 220-2.018.

(A) A prescription drug order may betransferred to a licensed pharmacy for thepurpose of providing an order to prepare,compound or dispense a medication or forthe purpose of providing drug or medicalinformation for use by the pharmacist in pro-viding patient care services.

(B) In order for a generic substitution asdefined in section 338.056, RSMo to takeplace, a prescription drug order must eithercomply with the prescription form as definedin section 338.056.2(1), RSMo or providean alternate method for documenting whethera generic substitution has been authorized asdetermined by the long-term care medicalstaff. When a generic substitution is autho-rized and is executed by the pharmacist aclear documentation must be completed inaccordance with 4 CSR 220-2.018(1)(H) and4 CSR 220-2.080(2)(M).

(C) A pharmacy may elect to maintain aseparate file system for prescription drugorders that are dispensed. When a separatefile is utilized, it must comply with all applic-able laws governing the maintenance and useof a prescription file by a pharmacy and thenumbering system used to number prescrip-tion drug orders must be distinct from anyother prescription file that is maintained.

(D) Packaging and labeling of containersshall comply with all applicable state and fed-eral laws for any medications that leave thefacility or are provided to the patient by thepharmacy for use outside the facility. Pre-scription drug orders issued for use withinthe long-term care facility are not valid forrefill outside the facility.

(6) Nothing in this rule shall be deemed toconstitute a waiver or abrogation of any of theprovisions of Chapter 338, RSMo or otherapplicable provisions of state and federal lawsand rules, nor should this rule be construedas authorizing or permitting any person notlicensed as a pharmacist to engage in thepractice of pharmacy.

(7) The provisions of this rule are declaredseverable. If any portion of this rule is heldinvalid by a court of competent jurisdiction,the remaining provisions of this rule shallremain in full force and effect unless other-wise determined by the court.

AUTHORITY: sections 338.010, 338.210,338.240 and 338.280, RSMo 1994 and338.140, RSMo Supp. 1999.* This rule orig-inally filed as 4 CSR 220-2.140. Originalrule filed Oct. 16, 1987, effective March 25,1988. Amended: Filed July 5, 1988, effective

March 1, 1989. Amended: Filed July 19,1991, effective Jan. 13, 1992. Amended:Filed Jan. 27, 1995, effective Sept. 30, 1995.Amended: Filed July 28, 2000, effective Jan.30, 2001. Moved to 20 CSR 2220-2.140,effective Aug. 28, 2006.

*Original authority: 338.010, RSMo 1939, amended 1951,1989, 1990; 338.140, RSMo 1939, amended 1981, 1989,1997; 338.210, RSMo 1951; 338.240, RSMo 1951; and338.280, RSMo 1951, amended 1971, 1981.

20 CSR 2220-2.145 Minimum Standardsfor Multi-Med Dispensing

PURPOSE: This rule establishes standardsfor multi-med dispensing.

(1) In lieu of dispensing two (2) or more pre-scribed drug products in separate containers,a pharmacist may, with the consent of thepatient, the patient’s caregiver, or a pre-scriber, provide a customized patient medica-tion package (patient med pak).

(2) A patient med pak is a package preparedby a pharmacist for a specific patient com-prising a series of containers and containingtwo (2) or more prescribed solid oral dosageforms. The patient med pak is so designed oreach container is so labeled as to indicate theday and time, or period of time that the con-tents within each container are to be taken.

(A) The patient med pak shall bear a labelstating:

1. The name of the patient;2. A serial number for the patient med

pak itself and a separate identifying serialnumber for each of the prescription orders foreach of the drug products contained therein;

3. The name, strength, physical descrip-tion or identification and total quantity ofeach drug product contained therein;

4. The directions for use and cautionarystatements if any, contained in the prescrip-tion order for each drug product therein;

5. Any storage instructions or caution-ary statements required by the official com-pendia;

6. The name of the prescriber of eachdrug product;

7. The date of preparation of the patientmed pak and the beyond-use date assigned tothe patient med pak (such beyond-use dateshall be not later than sixty (60) days fromthe date of preparation);

8. The name, address, and telephonenumber of the dispenser; and

9. Any other information, statements, orwarnings required for any of the drug prod-ucts contained therein.



(B) If the patient med pak allows for theremoval or separation of the intact containerstherefrom, each individual container shallbear a label identifying each of the drug prod-ucts contained therein.

(C) The patient med pak shall be accom-panied by a patient package insert, in theevent that any medication therein is requiredto be dispensed with such insert as accompa-nying labeling. Alternatively, such requiredinformation may be incorporated into a sin-gle, overall, educational insert provided bythe pharmacist for the total patient med pak.

(D) In the absence of more stringent pack-aging requirements for any of the drug prod-ucts contained therein, each container of thepatient med pak shall comply with the mois-ture permeation requirements for a Class Bsingle-unit or unit-dose container. Each con-tainer shall be either not reclosable or sodesigned as to show evidence of having beenopened.

(E) It is the responsibility of the dispenser,when preparing a patient med pak, to takeinto account any applicable compendiarequirements or guidelines and the physicaland chemical compatibility of the dosageforms placed within each container, as well asany therapeutic incompatibilities that mayattend the simultaneous administration of themedications. In this regard, pharmacists areencouraged to report to USP headquartersany observed or reported incompatibilities.

(F) In addition to any individual prescrip-tion filing requirements, a record of eachpatient med pak shall be made and filed.Each record shall contain, at a minimum:

1. The name and address of the patient;2. The serial number of the prescription

order for each drug product contained there-in;

3. The name of the manufacturer orlabeler and lot number for each drug productcontained therein;

4. Information identifying or describingthe design, characteristics, or specificationsof the patient med pak sufficient to allow sub-sequent preparation of an identical patientmed pak for the patient;

5. The date of preparation of the patientmed pak and the beyond-use date that wasassigned;

6. Any special labeling instructions; and7. The name or initials of the pharmacist

who prepared the patient med pak.(G) There is no special exemption for

patient med paks from the requirements ofthe Poison Prevention Packaging Act. Thusthe patient med pak, if it does not meet child-resistant standards, shall be placed in anouter package that does comply, or the neces-sary consent of the purchaser or physician, to

dispense in a container not intended to bechild-resistant, shall be obtained.

(H) Once a patient med pak has been deliv-ered to an institution or to a patient it shallnot be returned to the pharmacy.

(I) Multi-med packaging of controlled sub-stances is prohibited.

AUTHORITY: sections 338.010, RSMo 1994and 338.059 and 338.140, RSMo Supp.1999.* This rule originally filed as 4 CSR220-2.145. Original rule filed March 15,2000, effective Sept. 30, 2000. Moved to 20CSR 2220-2.145, effective Aug. 28, 2006.

*Original authority: 338.010, RSMo 1939, amended 1951,1989, 1990; 338.059, RSMo 1971, amended 1973, 1978,1997; and 338.140, RSMo 1939, amended 1981, 1989,1997.

20 CSR 2220-2.150 Mandatory ReportingRule

PURPOSE: This rule defines the responsibil-ities of a director of pharmacy or the phar-macist-in-charge, or both, in a hospital orambulatory surgical center in reporting disci-plinary actions against pharmacist employeesto the chief executive officer of the employinginstitution.

(1) The board of pharmacy shall receive andprocess any report from a hospital or ambu-latory surgical center concerning any disci-plining action against a licensed pharmacistor the voluntary resignation of any licensedpharmacist against whom any complaints orreports have been made which might have ledto final disciplinary action.

(2) Reports to the board shall comply withthe minimum requirements as set forth in sec-tion 383.133, RSMo and this rule. This infor-mation shall include, but not be limited to:

(A) The name, address and telephone num-ber of the person making the report;

(B) The name, address and telephone num-ber of the person who is the subject of thereport;

(C) A brief description of the facts whichgave rise to the issuance of the report, includ-ing the dates of occurrence deemed to neces-sitate the filing of the report;

(D) If court action is involved and knownto the reporting agent, the identity of thecourt, including the date of filing and thedocket number of the action;

(E) A statement as to what final action wastaken by the institution; and

(F) That the report is being submitted inorder to comply with the reporting provisionsof Chapter 383, RSMo.

(3) The director of pharmacy or pharmacist-in-charge shall report any actions asdescribed in section (1) to the chief executiveofficer (CEO) or his/her designee. Any activ-ity that is construed to be a cause for disci-plinary action according to section 338.055,RSMo or results in potential or actual harmto the public shall be deemed reportable tothe board. Nothing in this rule shall be con-strued as limiting or prohibiting any pharma-cist from reporting a violation of the Phar-macy Practice Act directly to the MissouriBoard of Pharmacy.

(4) In response to an inquiry from a hospitalor ambulatory surgical center regardingreports received by the board on a specificpharmacist, the board shall provide the fol-lowing information:

(A) Whether any reports have beenreceived;

(B) The nature of each report; and(C) The action which the board took on

each report or if the board has taken actionon the report.

(5) Each report received shall be acknowl-edged in writing. The acknowledgment shallstate that the report is being reviewed by theboard or is being investigated and shall bereferred to the board or an appropriate boardsubcommittee for consideration. The institu-tion subsequently shall be informed in writ-ing as to whether the report has been dis-missed by the board or is being referred tolegal counsel for filing with the Administra-tive Hearing Commission or for other legalaction. The institution may be notified of theultimate disposition of the report excludingjudicial appeals and may be provided with acopy of the decisions (if any) of the Adminis-trative Hearing Commission and the board.

(6) The provisions of this rule are declaredseverable. If any portion of this rule is heldinvalid by a court of competent jurisdiction,the remaining provisions of this rule shallremain in full force and effect, unless other-wise determined by a count of competentjurisdiction.

AUTHORITY: sections 338.140, RSMo Supp.1989 and 383.133, RSMo 1986.* This ruleoriginally filed as 4 CSR 220-2.150. Originalrule filed Aug. 4, 1987, effective Jan. 29,1988. Moved to 20 CSR 2220-2.150, effectiveAug. 28, 2006.

*Original authority: 338.140, RSMo 1939, amended 1981,1989 and 383.133, RSMo 1986.


Secretary of State


20 CSR 2220-2.160 Definition of Discipli-nary Actions

PURPOSE: This rule defines disciplinaryactions which may be imposed by the Mis-souri Board of Pharmacy.

(1) The Missouri Board of Pharmacy maypublish or cause to be published all disci-plines of certificates of registration or licens-es or both, including the name of thelicensee, the license number, the terms of dis-cipline and a summary of the Findings of Factand Conclusions of Law of the AdministrativeHearing Commission, in any professionaljournal or newsletter read by licensed phar-macists practicing in Missouri or in anynewspaper of general circulation or both.

(2) The Missouri Board of Pharmacy maypublicize the terms of disciplinary agree-ments, including the name of the licensee, thelicense number and a summary of the com-plaint, in any professional journal or newslet-ter read by licensed pharmacists practicing inMissouri or in any newspaper of general cir-culation.

(3) Any licensee whose certificate of regis-tration, license to practice pharmacy, or both,has been revoked or suspended shall—

(A) Surrender his/her certificate of regis-tration or license, or both, to the MissouriBoard of Pharmacy to be held by the Mis-souri Board of Pharmacy for the duration ofthe suspension period;

(B) Refrain from misrepresenting the statusof his/her license to practice pharmacy to anypatient or to the general public; and

(C) Refrain from maintaining a physicalpresence in any location which is licensed asa pharmacy in Missouri during the period ofsuspension, except as a customer.

(4) The Missouri Board of Pharmacy mayimpose any other terms or requirementswhich, in its discretion, it may deem neces-sary to enforce an order of discipline.

(5) Any violation of a disciplinary order shallconstitute grounds for the Missouri Board ofPharmacy to impose further discipline orterms on the licensee’s certificate of registra-tion, license to practice pharmacy, or both.

(6) Any violation of a disciplinary agreementshall constitute grounds for the MissouriBoard of Pharmacy to impose a further peri-od of discipline unless the disciplinary agree-ment provides otherwise.

(7) If at any time when any disciplinary sanc-tions have been imposed under section338.055, RSMo or under any provision, the

licensee removes him/herself from Missouri,ceases to be currently licensed under the pro-visions of sections 338.010–338.310, RSMoor fails to keep the Missouri Board of Phar-macy advised of his/her current place ofemployment and residence, the time ofhis/her absence or unlicensed status or un-known whereabouts may, at the discretion ofthe board, not be deemed or taken as any partof the time of discipline so imposed.

(8) The provisions of this rule are declaredseverable. If any portion of this rule is heldinvalid by a court of competent jurisdiction,the remaining provisions of this rule shallremain in full force and effect, unless other-wise determined by a court of competentjurisdiction.

AUTHORITY: sections 338.140, RSMo Supp.1998 and 338.280, RSMo 1994.* This ruleoriginally filed as 4 CSR 220-2.160. Originalrule filed Oct. 1, 1987, effective March 11,1988. Amended: Filed June 29, 1999, effec-tive Jan. 30, 2000. Moved to 20 CSR 2220-2.160, effective Aug. 28, 2006.

*Original authority: 338.140, RSMo 1939, amended 1981,1986 and 338.280, RSMo 1951, amended 1971, 1981.

20 CSR 2220-2.165 Licensure DisciplinaryAgreements

PURPOSE: This rule establishes guidelinesto be used by the board for licensure discipli-nary agreements.

(1) The board may elect to enter into anagreement for discipline with the holder of apharmacist or pharmacy license for the pur-pose of informally resolving a complaintwhich the board has prepared.

(2) The use of licensure disciplinary agree-ments shall be subject to the following:

(A) Agreements of this type will be used atthe option of the board and shall not bar theboard from filing any complaints with theAdministrative Hearing Commission in orderto seek disciplinary action for any violationof Chapter 338, RSMo;

(B) All licensure disciplinary agreementsshall contain a public notice clause whichprovides that the board will publish thelicensing action in its quarterly newsletterand shall treat the information contained inthe agreement as public information;

(C) When entering into a licensure disci-plinary agreement, the board and the licenseeshall waive any rights attendant to a hearingbefore the Administrative Hearing Commis-sion and will consent that the licensure disci-plinary agreement is in lieu of proceedings

before the Administrative Hearing Commis-sion; and

(D) If the board determines that a licenseehas violated a term or condition of the agree-ment, or has otherwise failed to comply withthe provisions of Chapter 338, RSMo, whichviolation would be actionable in a proceedingbefore the State Board of Pharmacy, theAdministrative Hearing Commission, or in acircuit court, the board may elect to pursueany lawful remedies or procedures affordedto it.

(3) The provisions of this rule are declaredseverable. If any portion of this rule is heldinvalid by a court of competent jurisdiction,the remaining provisions of this rule shallremain in full force and effect unless other-wise determined by a court of competentjurisdiction.

AUTHORITY: sections 338.140, RSMoSupp. 1989 and 338.280, RSMo 1986.* Thisrule originally filed as 4 CSR 220-2.165.Original rule filed Jan. 3, 1990, effectiveMay 11, 1990. Amended: Filed July 19, 1991,effective Jan. 13, 1992. Moved to 20 CSR2220-2.165, effective Aug. 28, 2006.

*Original authority: 338.140, RSMo 1939, amended 1981,1989 and 338.280, RSMo 1951, amended 1971, 1981.

20 CSR 2220-2.170 Procedure forImpaired Pharmacist

PURPOSE: This rule establishes an efficientand timely process for the disposition ofinformation and tentative board action con-cerning impaired pharmacists to the attorneygeneral’s office for purposes of preparing acomplaint and streamlines the procedure uti-lized in interviewing pharmacists who arechemically impaired.

(1) The executive director shall receive infor-mation concerning the impairment oflicensees and coordinate any investigationsthat seek to substantiate information concern-ing a possible impairment.

(2) Investigations by board inspectors or divi-sion investigators concerning chemicallyimpaired licensees will be collected andreviewed by the executive director. Cases willbe divided into two (2) categories.

(A) Category A. Chemically impairedlicensees where additional information is evi-dent that known distribution of controlledsubstances or legend drugs to other individu-als has taken place.

(B) Category B. Chemical impairment of alicensee where controlled substances, legend



drugs or alcohol have been acquired for per-sonal use only.

(3) Cases which fall into Category A will bereferred to the board for appropriate action.

(4) Cases which fall within Category B willbe subject to administrative review as a pre-liminary action to facilitate any correctiveactions deemed necessary by the board.

(5) The following shall constitute office pro-cedures involving Category B cases:

(A) Normal procedures for completingfield investigations and assimilating otherpertinent information will be followed;

(B) If the director believes that a case fallsinto Category B of this policy, s/he shall con-sult with the president of the board concern-ing the appropriateness of an administrativereview;

(C) If approval by the president is given,the director shall take actions necessary to setup a meeting with the licensee who is thesubject of the investigation. In addition, otherindividuals such as legal counsel for theboard may be asked to attend, along with anystaff member, as necessary;

(D) A statement concerning due processprocedures and the rights of the licensee willbe read at the beginning of the review meet-ing. A complete record of the administrativereview meeting shall be maintained by theboard office. Notice that the president of theboard has been notified and that s/he hasgiven approval for an administrative fact-find-ing meeting shall be entered into the record;

(E) A format during the fact-finding meet-ing will be followed that allows the licensee toprovide a statement of his/her own as well asa question/answer period allowed to discussthe aspects of the case centering on the chem-ical impairment issues or on any related con-cerns about the individual’s ability to practicepharmacy;

(F) After the fact-finding meeting is con-cluded, a summary will be provided to eachmember of the board within the appropriateagenda, along with recommendations fromthe director as to any action to be taken. Inaddition, the president will be contacted andprovided any follow-up information thatcould warrant changes in administrative pro-cedures. The president, by executive order,may initiate an affidavit to the board attorneyof an intent to file a complaint with theAdministrative Hearing Commission. Oncean order is executed, the information on thecase shall be forwarded to the attorney fornecessary legal preparation; and

(G) The entire board shall consider thecase in closed session as to whether or not to

file a complaint against the licensee and con-sider the recommendations made as to terms.Once the board authorizes a complaint, theattorney for the board shall assure that theappropriate filings take place.

(6) When an impaired pharmacist is disci-plined by the board and a term of the disci-pline is that s/he participate in a chemicaldependence treatment program, the impairedpharmacist shall select a program whichmeets the following guidelines:

(A) Persons who are involved in the treat-ment or counseling of a Missouri board-licensed pharmacist must submit written doc-umentation of their credentials andqualifications to provide treatment or coun-seling;

(B) A written agreement or contract mustbe provided and executed between the coun-selor(s) and the licensee, outlining theresponsibilities of each party for a successfultreatment and monitoring program. Theagreement must include a provision for shar-ing information concerning all aspects oftherapy between the treatment facility orcounselors, or both, and the Missouri Boardof Pharmacy;

(C) An initial evaluation report must becompleted and provided to the board outlin-ing the licensee’s present state of impairment,the recommended course(s) of treatment, thebeginning date of treatment and an assess-ment of future prospects for recovery;

(D) A copy of the proposed treatment planmust be provided to the board and mustinclude a provision outlining the method ofreferral to an appropriate after-care program;

(E) The counselor(s) must provideprogress reports to the board as follows:

1. Inpatient therapy—monthly reports;2. Outpatient therapy—quarterly re -

ports; and3. After-care programs—semiannual

reports;(F) The treatment program must include

randomized and witnessed body fluid testingand analysis, with any drug presence not sup-ported by a valid prescription to be reportedto the Missouri Board of Pharmacy;

(G) The treatment program must include aprovision for reporting any violation of thetreatment contract or agreement by thelicensee to the board; and

(H) All reports outlined in this protocolmust be provided in writing to the board fora counselor or treatment facility, or both, tobe approved for the treatment of a licenseeundergoing disciplinary board action.

AUTHORITY: sections 338.140, RSMo Supp.1989 and 338.240, RSMo 1986.* This rule

originally filed as 4 CSR 220-2.170. Origi-nal rule filed Oct. 1, 1987, effective Jan. 14,1988. Amended: Filed Nov. 15, 1988, effec-tive March 11, 1989. Moved to 20 CSR 2220-2.170, effective Aug. 28, 2006.

*Original authority: 338.140, RSMo 1939, amended 1981,1989 and 338.240, RSMo 1951.

20 CSR 2220-2.180 Public Records

PURPOSE: This rule establishes standardsfor compliance with Chapter 610, RSMo as itrelates to public records of the State Board ofPharmacy.

(1) All public records of the State Board ofPharmacy shall be open for inspection andcopying by any member of the general publicduring normal business hours, holidaysexcepted, except for those records closed pur-suant to section 610.021, RSMo. All publicmeetings of the Board of Pharmacy not closedpursuant to the provisions of section 610.021,RSMo will be open to any member of thepublic.

(2) The Board of Pharmacy establishes theexecutive director of the board as the custodi-an of its records as required by section610.023, RSMo. The executive director isresponsible for the maintenance of theboard’s records and is responsible forresponding to requests for access to publicrecords.

(3) When a request for inspection of publicrecords is made and the individual inspectingthe records requests copies of the records, theboard will collect the appropriate fee forcosts for inspecting and copying of therecords, as outlined in the board’s fee rule, 4CSR 220-4.020. The board may require pay-ment of the fees prior to making available anypublic records.

(4) When a request for access to publicrecords is made and the custodian believesthat access is not required under the provi-sions of Chapter 610, RSMo, the custodianshall inform the individual or entity makingthe request that compliance with the requestcannot be made, specifying in particular whatsections of Chapter 610, RSMo require thatthe record remain closed. Any such corre-spondence or documentation of the denialmade for access to records shall be copied tothe Board of Pharmacy general counsel.Whenever the custodian denies access to therecords, the custodian also shall inform theindividual requesting the records that s/he


Secretary of State


may appeal directly to the Board of Pharma-cy for access to the records requested. Theappeal and all information pertaining to theappeal shall be placed on the meeting agendaof the Board of Pharmacy for its next regu-larly scheduled meeting. In the event that theboard decides to reverse the decision of thecustodian, the board shall direct the custodi-an to so advise the person requesting accessto the information and supply the access tothe information during regular business hoursat the convenience of the requesting party.

(5) The custodian shall maintain a file whichwill contain copies of all written requests foraccess to records and responses to therequests. These requests shall be maintainedon file with the board for a period of one (1)year and will be maintained as a publicrecord of the board open for inspection byany member of the general public during reg-ular business hours.

(6) Pursuant to section 620.111, RSMo anycomplaints, investigation reports and accom-panying documents or exhibits that are con-sidered closed documents under Chapter 610or 620, RSMo, and are possessed by theboard or any of its agents shall not be dis-closed to any member of the public or to alicensee until the investigation is completed.

(A) Federal or state agency documentsshall not be released without the written con-sent of the federal or state agency involved.

AUTHORITY: sections 338.140, 338.280,Chapters 610 and 620, RSMo 1994.* Thisrule originally filed as 4 CSR 220-2.180.Original rule filed Jan. 19, 1988, effectiveApril 28, 1988. Amended: Filed June 26,1995, effective Feb. 25, 1996. Moved to 20CSR 2220-2.180, effective Aug. 28, 2006.

*Original authority: 338.140, RSMo 1939, amended 1981,1989 and 338.280, RSMo 1951, amended 1971, 1981. ForChapters 610 and 620, please consult the Missouri RevisedStatutes.

20 CSR 2220-2.190 Patient Counseling

PURPOSE: This rule establishes minimumstandards for patient counseling to complywith the federal Omnibus Budget Reconcilia-tion Act of 1990 which requires that all statesestablish standards by January 1, 1993.

(1) Upon receipt of a prescription drug orderand following a review of the available patientinformation, a pharmacist or his/her designeeshall personally offer to discuss matterswhich will enhance or optimize drug therapywith each patient or caregiver of each patient.

Counseling shall be conducted by the phar-macist or a pharmacy extern under the phar-macist’s immediate supervision to allow thepatient to safely and appropriately utilize themedication so that maximum therapeutic out-comes can be obtained. If the patient or care-giver is not available, then a written offer tocounsel with a telephone number of the dis-pensing pharmacy at no cost to the patientmust be supplied with the medication so thatthe patient or caregiver may contact the phar-macist for counseling when necessary. Theelements of counseling shall include matterswhich the pharmacist deems significant in theexercise of his/her professional judgment andis consistent with applicable state laws.

(2) Pharmacies shall maintain appropriatepatient information to facilitate counseling.This may include, but shall not be limited to,the patient’s name, address, telephone num-ber, age, gender, clinical information, diseasestates, allergies and a listing of other drugsprescribed.

(3) Alternative forms of patient informationshall be used to supplement patient counsel-ing when appropriate. Examples may include,but shall not be limited to, written informa-tion leaflets, pictogram labels, video pro-grams, and the like.

(4) Patient counseling, as described in thisrule, shall not be required for inpatients of ahospital, institution or other setting whereother licensed or certified health care profes-sionals are authorized to administer medica-tions.

(5) A pharmacist shall not be required tocounsel a patient or caregiver when thepatient or caregiver refuses consultation.

AUTHORITY: sections 338.010.1 and338.015.2, RSMo Supp. 1990, 338.140,RSMo Supp. 1989 and 338.280, RSMo1986.* This rule originally filed as 4 CSR220-2.190. Original rule filed May 1, 1992,effective Feb. 26, 1993. Amended: FiledMarch 4, 1993, effective Oct. 10, 1993.Moved to 20 CSR 2220-2.190, effective Aug.28, 2006.

*Original authority: 338.010.1, RSMo 1939, amended1951, 1989, 1990; 338.015.2, RSMo 1990; 338.140,RSMo 1939, amended 1981, 1989; and 338.280, RSMo1951, amended 1971, 1981.

20 CSR 2220-2.200 Sterile Pharmaceuti-cals

PURPOSE: This rule establishes standardsfor the preparation, labeling and distribution

of sterile pharmaceuticals by licensed phar-macies, pursuant to a physician’s order orprescription.

(1) The provisions of sections (2)–(9) expireJune 30, 2004.

(2) Definitions. (A) Biological safety cabinet—containment

unit suitable for the preparation of low tomoderate risk agents where there is a needfor protection of the product, personnel andenvironment, according to National Sanita-tion Foundation (NSF) Standard 49.

(B) Class 100 environment—an atmospher-ic environment which contains less than onehundred (100) particles 0.5 microns in diam-eter per cubic foot of air, according to Feder-al Standard 209B.

(C) Compounded sterile drug—a steriledrug dosage form that has been prepared by apharmacist, to include a commercially pre-pared sterile drug dosage form which hasbeen altered by a pharmacist.

(D) Cytotoxic Therapeutic Class—a phar-maceutical product that has the capability ofdirect toxic action on living tissue that canresult in severe leukopenia and thrombocy-topenia, depression of the immune systemand the alteration of the host’s inflammatoryresponse system.

(E) Parenteral—sterile preparation of drugsfor injection through one (1) or more layersof skin.

(F) Sterile pharmaceutical—a dosage formfree from living microorganisms (aseptic).

(3) Policy and Procedure Manual. A policyand procedure manual, as it relates to sterileproducts, shall be available for inspection atthe pharmacy. The manual shall be reviewedand revised on an annual basis and shallinclude, but is not limited to, policies andprocedures for any of the following servicesprovided by the pharmacy:

(A) Clinical services; (B) Cytotoxics handling, storage and dis-

posal; (C) Disposal of unused supplies and med-

ications; (D) Drug destruction and returns; (E) Drug dispensing; (F) Drug labeling/relabeling; (G) Drug storage; (H) Duties and qualifications for profes-

sional and nonprofessional staff; (I) Equipment; (J) Handling of infectious wastes; (K) Infusion devices and drug delivery sys-

tems; (L) Investigational drugs; (M) Obtaining a protocol on investigation-



al drugs from the principal investigator; (N) Quality assurance procedures to

include: 1. Recall procedures; 2. Storage and dating; 3. Educational procedures for profes-

sional staff, nonprofessional staff and patient; 4. Sterile procedures to include a log of

the temperature of the refrigerator, routinemaintenance and report of hood certification;and

5. Sterility testing; (O) Record keeping; (P) Reference material; (Q) Sanitation; (R) Security; (S) Sterile product preparation procedures;

and (T) Transportation.

(4) Physical Requirements. (A) Space. The licensed pharmacy shall

have a designated area with entry restricted todesignated personnel for preparing com-pounded, sterile products. This area shall beisolated from other areas and must bedesigned to avoid unnecessary traffic and air-flow disturbances from activity within thecontrolled facility. It shall be used only forthe preparation of sterile pharmaceuticalproducts. It shall be of sufficient size toaccommodate a laminar airflow hood and toprovide for the proper storage of drugs andsupplies under appropriate conditions of tem-perature, light, moisture, sanitation, ventila-tion and security.

(B) Equipment. The licensed pharmacypreparing sterile products shall have—

1. Appropriate environmental controldevices capable of maintaining at least Class100 conditions in the work area where criti-cal objects are exposed and critical activitiesare performed; furthermore, the devices arecapable of maintaining Class 100 conditionsduring normal activity. Examples of appro-priate devices include laminar airflow hoodsand zonal laminar flow systems of high effi-ciency particulate air filter (HEPA)-filteredair;

2. A sink with hot and cold runningwater and proper sewage disposal that is con-venient to the compounding area for the pur-pose of hand scrubs prior to compounding;

3. Appropriate disposal containers forused needles, syringes, and if applicable,cytotoxic waste from the preparation ofchemotherapy agents and infectious wastesfrom patients’ homes;

4. When cytotoxic drug products areprepared, appropriate environmental controlalso includes appropriate biohazard cabi-netry;

5. Refrigerator/freezer with a ther-mometer;

6. Temperature-controlled delivery con-tainer; and

7. Infusion devices, if appropriate. (C) Supplies.

1. Disposable needles, syringes andother supplies needed for aseptic admixture;

2. Disinfectant cleaning solutions; 3. Hand washing agent with bactericidal

action; 4. Disposable, lint free towels or wipes; 5. Appropriate filters and filtration

equipment; 6. Oncology drug spill kit; and 7. Disposable masks, caps, gowns and

sterile disposable gloves. (D) Reference Library. The pharmacy shall

have adequate current reference materialsrelated to sterile products. Some suggestedsources include: Handbook on InjectableDrugs, America Society for Hospital Phar-macists (ASHP); King’s Guide to ParenteralAdmixtures; United States Pharmacopeia(USP)/Negative Formulary (NF); AmericanHospital Formulary Service; Procedures forHandling Cytotoxic Drugs, American Societyfor Hospital Pharmacists (ASHP). In addi-tion, the pharmacy shall maintain copies ofcurrent Occupational Safety and HealthAdministration (OSHA) requirements.

(5) Drug Distribution and Control. (A) Medication Record System. A phar-

macy generated medication record systemmust be separate from the prescription file.The patient medication record system shall bemaintained under the control of the pharma-cist-in-charge for a period of sixty (60) daysafter the last dispensing activity. The medica-tion record system, at a minimum, shall con-tain:

1. Patient’s full name; 2. Date of birth or age; 3. Weight; 4. Sex; 5. Sterile products dispensed; 6. Date dispensed; 7. Drug content and quantity; 8. Patient direction; 9. Identifying prescription number; 10. Identification of dispensing pharma-

cist; 11. Other drugs patient is receiving; 12. Known drug sensitivities and aller-

gies to drugs and food; and 13. Primary diagnosis.

(B) Labeling (supplemental). Each sterilepharmaceutical dispensed to patients shall belabeled in accordance with section 338.059,RSMo and with the following supplementalinformation affixed to a permanent label:

1. Directions for administration includ-ing infusion rate, where applicable;

2. Date of compounding; 3. Expiration date and time; 4. Identity of pharmacist compounding

and dispensing; 5. Storage requirements; 6. Auxiliary labels, where applicable;

and 7. Cytotoxic drug auxiliary labels,

where applicable. (C) Records and Reports. The pharmacist-

in-charge shall maintain access to, and sub-mit as appropriate, records and reportsrequired to insure the patient’s health, safetyand welfare. These reports shall be main-tained for two (2) years and shall be readilyretrievable, subject to inspections by the StateBoard of Pharmacy or its agents. Such shallinclude, at a minimum, the following:

1. Purchase records; 2. Policy and procedure manual; 3. Training manuals, where applicable; 4. Policies and procedures for cytotoxic

waste, where applicable; 5. Other records and reports as may be

required by law and the rules of the StateBoard of Pharmacy; and

6. Information regarding individualpatients shall be maintained in a manner toassure confidentiality of the patient’s record.Release of this information shall be in accor-dance with federal or state laws, or both.

(D) Delivery Service. The pharmacist-in-charge shall assure the environmental controlof all products shipped. A sterile pharmaceu-tical product must be shipped or delivered toa patient in appropriate temperature con-trolled delivery containers (as defined byUSP standards) and assurances must be madethat appropriate storage facilities are avail-able. Chain of possession for the delivery ofSchedule II controlled substances via couriersmust be documented and a receipt required.

(6) Cytotoxic Drugs. The following addition-al requirements are necessary for thoselicensed pharmacies that prepare cytotoxicdrugs to insure the protection of the person-nel involved:

(A) All cytotoxic drugs should be com-pounded in a vertical flow, Class II biologicalsafety cabinet. If used for other products, thecabinet must be thoroughly cleaned;

(B) Protective apparel shall be worn bypersonnel compounding cytotoxic drugswhich shall include disposable masks, glovesand gowns with tight cuffs;

(C) Appropriate safety and containmenttechniques for compounding cytotoxic drugsshall be used in conjunction with the aseptic


Secretary of State


techniques required for preparing sterileproducts;

(D) Disposal of cytotoxic waste shall com-ply with all applicable local, state and feder-al requirements;

(E) Written procedures for handling bothmajor and minor spills of cytotoxic agentsmust be developed and must be included inthe policy and procedure manual; and

(F) Prepared doses of cytotoxic drugs mustbe labeled with proper precautions inside andoutside, and shipped in a manner to minimizethe risk of accidental rupture of the primarycontainer.

(7) Quality Assurance.(A) There shall be a documented, ongoing

quality assurance control program that moni-tors personnel performance, equipment andfacilities. Appropriate samples of finishedproducts shall be examined to assure that thepharmacy is capable of consistently preparingsterile products meeting specifications. Theseexaminations shall include: visual inspectionunder a direct light source in the preparationof products in order to determine the pres-ence of inappropriate particulate matter orsigns of deterioration; policies and proce-dures for monitoring of sterile productswhereby any untoward effects exhibited by apatient that may be due to the product, arereported to the pharmacy; and appropriatesamples are collected and microbial tests arecompleted to ascertain the presence of micro-bial contamination of suspect products. Qual-ity assurance procedures shall include:

1. Recall procedures; 2. Storage and dating; and 3. Environmental procedures which

include a log of the temperature of the refrig-erator, routine maintenance and report of anyhood certification.

(B) Clean Room and Hood Certification.All clean rooms and laminar flow hoods shallbe certified by an independent contractoraccording to Federal Standard 209B orNational Sanitation Foundation Standard 49for operational efficiency at a minimum ofevery twelve (12) months. Certificationrecords shall be maintained as a part of thepharmacy record.

(C) Prefilters. Prefilters for the clean airsource shall be replaced on a regular basisand the replacement date documented.

(D) Nonsterile Compounding. If bulkcompounding is performed utilizing nonster-ile chemicals, extensive end-product testing,as referenced in the Remington ReferenceManual, must be documented prior to therelease of the product from quarantine. Thisprocess must include appropriate tests forparticulate matter and testing for pyrogens.

(E) Expiration Dates. There shall be writ-ten justification of the chosen expiration datefor compounded products. If a written stan-dard is not available, a maximum of twenty-four (24) hours expiration date shall be used.

(F) Quality Assurance Audits. There shallbe documentation of quality assurance auditsat regular, planned intervals and shouldinclude infection control and sterile techniqueaudits.

(8) Pharmacists and pharmacies where sterilecompounding is provided may be exemptfrom this rule when that compounding isrestricted to the following:

(A) The method of compounding utilizescompounds or products that are containedonly in a closed or sealed system and can betransferred or compounded within this self-contained system or topical products thatrequire further transfer or combination inorder to achieve a finished product withoutfurther modification of the product; or

(B) The amount of compounding providedby the pharmacy is for emergency situations.An emergency is defined as—

1. Situations where the sterile com-pound is needed and is unavailable from orinconvenient to obtain from other sources;

2. Compounding will be provided to thepatient immediately and used within a twen-ty-four (24)-hour period; and

3. Products are provided to the patientas a single dosage unit and the drug is notintended to be provided beyond an immediateemergency period.

(9) This rule is not intended to include anypharmacy that provides sterile pharmaceuti-cals on a prescription order that has not beencompounded by the pharmacy or had thepackaging or labeling of the product alteredby the pharmacy.

(10) The provisions of sections (11)–(26)become effective July 1, 2004.

(11) Definitions. (A) Aseptic processing: The technique

involving procedures designed to precludecontamination of drugs, packaging, equip-ment, or supplies by microorganisms duringprocessing.

(B) Batch: Compounding of multiple ster-ile product units in a single discrete process,by the same individuals, carried out duringone (1) limited time period.

(C) Beyond-Use date: A date after which acompounded preparation should not be usedand is determined from the date the prepara-tion is compounded. Because compoundedpreparations are intended for administrationimmediately or following short-term storage,

their beyond-use dates must be assignedbased on criteria different from those appliedto assigning expiration dates to manufactureddrug products.

(D) Biological safety cabinet: Containmentunit suitable for the preparation of low tomoderate risk agents where there is a needfor protection of the product, personnel andenvironment, according to NSF Internationalstandards.

(E) Class 100 environment: an atmospher-ic environment which contains less than onehundred (100) particles 0.5 microns in diam-eter per cubic foot of air, according to feder-al standards.

(F) Class 10,000 environment: An atmos-pheric environment which contains less thanten thousand (10,000) particles 0.5 micronsin diameter per cubic foot of air, according tofederal standards.

(G) Clean room: A room—1. In which the concentration of air-

borne particles is controlled;2. That is constructed and used in a

manner to minimize the introduction, genera-tion, and retention of particles inside theroom; and

3. In which other relevant variables(e.g., temperature, humidity, and pressure)are controlled as necessary.

(H) Clean zone: Dedicated space—1. In which the concentration of air-

borne particles is controlled; 2. That is constructed and used in a

manner that minimizes the introduction, gen-eration, and retention of particles inside thezone; and

3. In which other relevant variables(e.g., temperature, humidity, and pressure)are controlled as necessary.This zone may be open or enclosed and mayor may not be located within a clean room.

(I) Compounding: For the purposes of thisregulation, compounding is defined as in 4CSR 220-2.400(1). Compounded sterilemedications may include, but are not limitedto, injectables, parenteral nutrition solutions,irrigation solutions, inhalation solutions,intravenous solutions and ophthalmic prepa-rations.

(J) Controlled area: For purposes of theseregulations, a controlled area is the area des-ignated for preparing sterile products. This isreferred to as the buffer zone (i.e., the cleanroom in which the laminar airflow work-bench is located) by the United States Phar-macopoeia (USP).

(K) Critical area: Any area in the con-trolled area where products or containers areexposed to the environment.

(L) Critical site: An opening providing adirect pathway between a sterile product and



the environment or any surface coming intocontact with the product or environment.

(M) Critical surface: Any surface thatcomes into contact with previously sterilizedproducts or containers.

(N) Cytotoxic drugs: A pharmaceuticalproduct that has the capability of direct toxicaction on living tissue that can result insevere leukopenia and thrombocytopenia,depression of the immune system and thealteration of a host’s inflammatory responsesystem.

(O) Emergency dispensing: Is a situationwhere a Risk Level 3 product is necessary forimmediate administration of the product andno alternative product is available and theprescriber is informed that the product isbeing dispensed prior to appropriate testing.Documentation of the dispensing of the prod-uct, the prescriber’s approval for dispensingprior to the receipt of test results and the needfor the emergency must appear within theprescription record. A separate authorizationfrom the prescriber is required for each emer-gency dispensing.

(P) High-Efficiency Particulate Air(HEPA) filter: A filter composed of pleats offilter medium separated by rigid sheets ofcorrugated paper or aluminum foil that directthe flow of air forced through the filter in auniform parallel flow. HEPA filters removeninety-nine point ninety-seven percent(99.97%) of all particles three-tenths (0.3)microns or larger. When HEPA filters areused as a component of a horizontal- or ver-tical-laminar-airflow workbench, an environ-ment can be created consistent with standardsfor a Class 100 clean room.

(Q) Isolator (or barrier isolator): A closedsystem made up of four (4) solid walls, an air-handling system, and transfer and interactiondevices. The walls are constructed so as toprovide surfaces that are cleanable with cov-ing between wall junctures. The air-handlingsystem provides HEPA filtration of inlet air.Transfer of materials is accomplished throughair locks, glove rings, or ports. Transfers aredesigned to minimize the entry of contamina-tion. Manipulations can take place througheither glove ports or half suits.

(R) Parenteral: A sterile preparation ofdrugs for injection through one (1) or morelayers of skin.

(S) Process validation or simulation:Microbiological simulation of an asepticprocess with growth medium processed in amanner similar to the processing of the prod-uct and with the same container or closuresystem.

(T) Quality assurance: For purposes ofthese regulations, quality assurance is the setof activities used to ensure that the processes

used in the preparation of sterile drug prod-ucts lead to products that meet predeterminedstandards of quality.

(U) Quality control: For the purposes ofthese regulations, quality control is the set oftesting activities used to determine that theingredients, components and final sterileproducts prepared meet predeterminedrequirements with respect to identity, purity,nonpyrogenicity and sterility.

(V) Repackaging: The subdivision ortransfer of a compounded product from onecontainer or device to a different container ordevice.

(W) Sterile pharmaceutical: A dosage formfree from living microorganisms.

(X) Sterilization: A validated process usedto render a product free of viable organisms.

(Y) Temperatures:1. Frozen means temperatures between

twenty below zero and ten degrees Celsius(−20 and 10°C) (four below zero and four-teen degrees Fahrenheit (−4 and 14°F)).

2. Refrigerated means temperaturesbetween two and eight degrees Celsius (2 and8°C) (thirty-six and forty-six degrees Fahren-heit (36 and 46°F)).

3. Room temperatures means room tem-peratures between fifteen and thirty degreesCelsius (15 and 30°C) (fifty-nine and eighty-six degrees Fahrenheit (59 and 86°F)).

(Z) Validation: Documented evidence pro-viding a high degree of assurance that specif-ic processes will consistently produce a prod-uct meeting predetermined specifications andquality attributes.

(AA) Definitions of sterile compoundedproducts by risk level:

1. Risk Level 1: Applies to compound-ed sterile products that exhibit characteristicsA., B., and C., stated below. All Risk Level1 products shall be prepared with sterileequipment, sterile ingredients and solutionsand sterile contact surfaces for the final prod-uct. Risk Level 1 includes the following:

A. Products:(I) Stored at room temperature and

completely administered within forty-eight(48) hours after preparation; or

(II) Stored under refrigeration forseven (7) days or less before complete admin-istration to a patient over a period not toexceed forty-eight (48) hours; or

(III) Frozen for thirty (30) days orless before complete administration to apatient over a period not to exceed forty-eight(48) hours.

B. Unpreserved sterile products pre-pared for administration to one (1) patient orbatch-prepared products containing suitablepreservatives prepared for administration tomore than one (1) patient.

C. Products prepared by closed-sys-tem aseptic transfer of sterile, nonpyrogenic,finished pharmaceuticals (e.g., from vials orampules) obtained from licensed manufactur-ers into sterile final containers obtained fromlicensed manufacturers.

2. Risk Level 2: Sterile products exhib-it characteristic A., B., or C., stated below.All Risk Level 2 products shall be preparedwith sterile equipment, sterile ingredients andsolutions and sterile contact surfaces for thefinal product and with closed-system transfermethods. Risk Level 2 includes the follow-ing:

A. Products stored beyond seven (7)days under refrigeration, stored beyond thirty(30) days frozen or administered beyondforty-eight (48) hours after preparation andstorage at room temperature.

B. Batch-prepared products withoutpreservatives that are intended for use bymore than one (1) patient.

C. Products compounded by complexor numerous manipulations of sterile ingredi-ents obtained from licensed manufacturers ina sterile container or reservoir obtained froma licensed manufacturer by using closed-sys-tem aseptic transfer (e.g., automated com-pounder).

3. Risk Level 3: Sterile products exhib-it either characteristic A. or B.:

A. Products compounded from non-sterile ingredients or compounded with non-sterile components, containers or equipmentbefore terminal sterilization.

B. Products prepared by combiningmultiple ingredients (sterile or nonsterile) byusing an open-system transfer or open reser-voir before terminal sterilization.

(12) Policy and Procedure Manual.(A) A manual, outlining policies and pro-

cedures encompassing all aspects of RiskLevel 1, 2 and 3 products, shall be availablefor inspection at the pharmacy. The manualshall be reviewed on an annual basis.

(13) Personnel Education, Training and Eval-uation.

(A) Risk Level 1: All pharmacy personnelpreparing sterile products must receive suit-able didactic and experiential training

(B) Risk Level 2: In addition to Risk Level1 requirements, personnel training includesassessment of competency in all Risk Level 2procedures via process simulation.

(C) Risk Level 3: In addition to Risk Level1 and 2 requirements, operators have specificeducation, training and experience to prepareRisk Level 3 products. The pharmacist knowsprinciples of good compounding practice forrisk level products, including—


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1. Aseptic processing;2. Quality assurance of environmental,

component, and end-product testing;3. Sterilization; and4. Selection and use of containers,

equipment, and closures.

(14) Storage and Handling in the Pharmacy.(A) Risk Level 1 and 2: Solutions, drugs,

supplies and equipment must be storedaccording to manufacturer or USP require-ments. Refrigeration and freezer tempera-tures shall be documented daily. Other stor-age areas shall be inspected regularly toensure that temperature and lighting meetrequirements. Drugs and supplies shall beshelved above the floor. Removal of productsfrom boxes shall be done outside controlledareas. Removal of used supplies from thecontrolled area shall be done at least daily.Product recall procedures must permitretrieving affected products from specificinvolved patients.

(B) Risk Level 3: In addition to Risk Level1 and 2 requirements, procedures includeprocurement, identification, storage, han-dling, testing, and recall of components andfinished products. Finished but untested RiskLevel 3 products must be quarantined underminimal risk for contamination.

(15) Facilities and Equipment.(A) Risk Level 1: The controlled area shall

be separated from other operations. The con-trolled area must be clean and well lit. A sinkwith hot and cold water must be near, but notin, the controlled area. The controlled areaand inside equipment must be cleaned anddisinfected regularly. Sterile products mustbe prepared in at least a Class 100 environ-ment (the critical area). Computer entry,order processing, label generation, andrecord keeping shall be performed outside thecritical area. The critical area must be disin-fected prior to use. A workbench shall berecertified every six (6) months and when itis moved; prefilters must be visually inspect-ed on a regularly scheduled basis andreplaced according to manufacturer’s specifi-cations. Pumps utilized in the compoundingprocess shall be recalibrated and documentedaccording to manufacturer procedures.

(B) Risk Level 2: In addition to all RiskLevel 1 requirements, the controlled areamust meet Class 10,000 clean room stan-dards; cleaning supplies should be selected tomeet clean room standards; critical area worksurface must be cleaned between batches;floors should be disinfected daily; equipmentsurfaces weekly; and walls monthly; withapplicable environmental monitoring of airand surfaces. Automated compounding

devices must be calibrated and verified as toaccuracy, according to manufacturer proce-dures. Clean rooms not utilized on a dailybasis must be cleaned prior to use as statedabove.

(C) Risk Level 3: In addition to Risk Level1 and 2 requirements, products must be pre-pared in a Class 100 workbench in a Class10,000 clean room, in a Class 100 cleanroom or within a positive pressure barrierisolator. Access to the clean room must belimited to those preparing the products andwho are in appropriate garb. Equipment mustbe cleaned, prepared, sterilized, calibrated,and documented according to manufacturer’sstandards. Walls and ceilings must be disin-fected weekly. All non-sterile equipment thatis to come in contact with the sterilized finalproduct must be sterilized before introductionin the clean room. Appropriate cleaning anddisinfection of the environment and equip-ment are required.

(16) Apparel.(A) Risk Level 2: In the controlled area,

personnel wear low particulate, clean cloth-ing covers. Head and facial hair is covered.Gloves, gowns, and masks are required. Dur-ing sterile preparation gloves shall be rinsedfrequently with a suitable agent and changedwhen integrity is compromised.

(B) Risk Level 3: In addition to Risk Level2 requirements, clean room apparel must beworn inside the controlled area at all timesduring the preparation of Risk Level 3 sterileproducts except when positive pressure barri-er isolation is utilized. Attire shall consist ofa low-shedding coverall, head cover, facemask, and shoe covers.

(17) Aseptic Technique and Product Prepara-tion.

(A) Risk Level 1: Sterile products must beprepared in a Class 100 environment. Per-sonnel shall scrub their hands and forearmsfor an appropriate period at the beginning ofeach aseptic compounding process. Eating,drinking and smoking are prohibited in thecontrolled area. Talking shall be minimized toreduce airborne particles. Ingredients shall bedetermined to be stable, compatible, andappropriate for the product to be prepared,according to manufacturer, USP, or scientificreferences. Ingredients and containers shallbe inspected for defects, expiration andintegrity before use. Only materials essentialfor aseptic compounding shall be placed inthe workbench. Surfaces of ampules and vialsshall be disinfected before placement in theworkbench. Sterile components shall bearranged in the workbench to allow uninter-rupted laminar airflow over critical surfaces

of needles, vials, ampules, etc. Automateddevices and equipment shall be cleaned, dis-infected and placed in the workbench toenable laminar airflow. Aseptic techniqueshall be used to avoid touch contamination ofcritical sites of containers and ingredients.Particles shall be filtered from solutions.Needle cores shall be avoided. The pharma-cist shall check before, during, and afterpreparation to verify the identity and amountof ingredients before release.

(B) Risk Level 2: In addition to Risk Level1 requirements, a file containing formula,components, procedures, sample label, andfinal evaluation shall be made for each prod-uct batch. A separate work sheet and lotnumber for each batch shall be completed.When combining multiple sterile products, asecond verification of calculations shall takeplace. The pharmacist shall verify dataentered into any automatic compounderbefore processing and check the end productfor accuracy.

(C) Risk Level 3: In addition to Risk Level1 and 2 requirements, nonsterile componentsmust meet standards if available, as verifiedby a pharmacist and a certificate of analysis.Batch preparation files shall also includecomparisons of actual with anticipated yields,sterilization methods, and quarantine specifi-cations. Presterilized containers shall be usedwhen feasible. Final containers must be ster-ile and capable of maintaining productintegrity throughout the shelf life. Steriliza-tion methods must be based on properties ofthe product.

(18) Process Validation.(A) Risk Level 1: All pharmacy personnel

who prepare sterile products shall pass aprocess validation of aseptic technique beforecompounding sterile products. Pharmacy per-sonnel competency must be reevaluated byprocess validation at least annually, wheneverthe quality assurance program yields an unac-ceptable result, or whenever unacceptabletechniques are observed. If microbial growthis detected, the entire sterile process must beevaluated, corrective action taken, and theprocess simulation test performed again.

(B) Risk Level 2: In addition to Risk Level1 requirements, process simulation proce-dures shall cover all types of manipulations,products and batch sizes.

(C) Risk Level 3: In addition to all RiskLevel 1 and 2 requirements, written policiesshall be maintained to validate all processes,procedures, components, equipment andtechniques.

(19) Record Keeping.(A) Risk Level 1: The following must be




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documented: 1. Training and competency evaluation

of pharmacy personnel involved in sterileproduct preparation;

2. Refrigerator and freezer temperaturelogs;

3. Certification of workbenches;4. Copies of any manufacturer standards

that are relied upon to maintain compliancewith this rule; and

5. Other facility quality control logs asappropriate including all maintenance, clean-ing, and calibration records.

(B) Risk Level 2: In addition to Risk Level1 requirements, records of any end-producttesting and batch preparation records must bemaintained.

(C) Risk Level 3: In addition to Risk Level1 and 2 requirements, record requirementsfor Risk Level 3 products must include:

1. Preparation work sheet;2. Sterilization records; 3. Quarantine records, if applicable; 4. End-product evaluation and testing

records as required in section (22); and 5. Ingredient validation records as

required in section (22).(D) All records and reports shall be main-

tained for two (2) years and shall be readilyretrievable, subject to inspections by theboard of pharmacy or its agents.

(20) Labeling.(A) Risk Level 1: Sterile products dis-

pensed to patients shall be labeled in accor-dance with section 338.059, RSMo and withthe following supplemental informationaffixed to a permanent label:

1. Beyond-use date;2. Storage requirements;3. Any device specific instructions; and 4. Auxiliary labels, when applicable.

(B) Risk Level 2: All requirements forRisk Level 1 must be met.

(C) Risk Level 3: All requirements forRisk Level 1 must be met.

(21) Beyond-Use Dating.(A) Risk Level 1: All sterile products must

bear a beyond-use date. Beyond-use dates areassigned based on current drug stability infor-mation and sterility considerations.


(C) Risk Level 3: In addition to all RiskLevel 1 requirements, there must be a reliablemethod for establishing all expiration dates,including laboratory testing of product stabil-ity, pyrogenicity, particulate contaminationand potency. Expiration dating not specifical-ly referenced in the product’s approved label-ing or not established by product specific

instrumental analysis, shall be limited to thir-ty (30) days. Beyond-use dating not specifi-cally referenced in the products approvedlabeling or not established by product specif-ic instrumental analysis shall be limited tothirty (30) days. There must be a reliablemethod for establishing all beyond-use dat-ing. Products maintaining beyond-use datingof greater than thirty (30) days shall have labtesting of product stability and potency.

(22) End-Product Evaluation.(A) Risk Level 1: The final product must

be inspected for container leaks, integrity,solution cloudiness or phase separation, par-ticulates in solution, appropriate solutioncolor, and solution volume. The pharmacistmust verify that the product was compoundedaccurately as to the ingredients, quantities,containers, and reservoirs. Background lightor other means for the visual inspection ofproducts for any particulate and/or foreignmatter must be used as part of the inspectionprocess.

(B) Risk Level 2: All Risk Level 1 require-ments must be met.

(C) Risk Level 3: In addition to all RiskLevel 1 requirements, the process validationprocedure shall be supplemented with a pro-gram of end-product sterility testing accord-ing to a formal sampling plan. Samples shallbe statistically valid to ensure that batches aresterile. A method for recalling batch productsshall be established if end-product testingresults are unacceptable. All sterile productsmust be tested for sterility. All parenteralsterile products must also be tested for pyro-genicity. Sterile products compounded fromnonsterile components must be quarantinedpending results of end-product testing.

1. Sterility testing: Sampling for thesterility test shall occur promptly upon thecompletion of preparation. The sterility test,including the sampling scheme, shall be con-ducted according to one (1) of the USP meth-ods.

2. Pyrogen/Endotoxin testing: Eachsterile parenteral product prepared from non-sterile drug components shall be tested forpyrogen or endotoxin according to recom-mended USP methods.

3. Potency: The pharmacy shall have aprocedure for a pre-release check of thepotency of the active ingredients in the com-pounded sterile product prepared from non-sterile bulk active ingredients. The procedureshall include at least the following verifica-tions by a pharmacist:

A. The lot of the active ingredientsused for compounding have the necessarylabeling, potency, purity, certificate of analy-sis and other relevant qualities;

B. All weighings, volumetric mea-surements, and additions of ingredients werecarried out properly;

C. The compounding or controlrecords include documentation that the fillvolumes of all units available for release werechecked and were correct; and

D. The final potency is confirmed byinstrumental analysis for sterile products thathave been assigned a beyond-use date of morethan thirty (30) days.

(D) Emergency Dispensing of a Risk Level3 Sterile Product: When a compounded RiskLevel 3 product must be released prior to thecompletion of testing, the sterile productmay be dispensed pending test results.

(23) Handling Sterile Products Outside thePharmacy.

(A) Risk Level 1: The pharmacist-in-charge shall assure the environmental controlof all sterile compounded products shipped.Sterile products shall be transported so as tobe protected from excesses of temperaturesand light within appropriate packaging ordelivery containers that maintain necessarystorage conditions to preserve the quality andintegrity of sterile products. The pharmacyshall follow written procedures that specifypacking techniques, configuration, and mate-rials for groups of products with commonstorage characteristics and for specific prod-ucts where unique storage conditions arerequired to retain adequate stability and prod-uct quality.


(C) Risk Level 3: All requirements forRisk Level 1 must be met.

(24) Cytotoxic Drugs.(A) The following additional requirements

are necessary for those licensed pharmaciesthat prepare cytotoxic drugs to insure the pro-tection of the personnel involved:

1. Cytotoxic drugs shall be compoundedin a vertical flow, Class II biological safetycabinet or an isolator. If used for other prod-ucts, the cabinet must be thoroughly cleaned;

2. Protective apparel shall be worn bypersonnel compounding cytotoxic drugswhich shall include disposable masks, glovesand gowns with tight cuffs;

3. Appropriate safety and containmenttechniques for compounding cytotoxic drugsshall be used in conjunction with the aseptictechniques required for preparing sterileproducts;

4. Appropriate disposal containers forused needles, syringes, and if applicable,cytotoxic waste from the preparation ofchemotherapy agents and infectious waste

from patients’ homes. Disposal of cytotoxicwaste shall comply with all applicable local,state and federal requirements;

5. Written procedures for handlingmajor and minor spills and generated wasteof cytotoxic agents must be developed andmust be included in the policy and proceduremanual;

6. Prepared doses of cytotoxic drugsmust be labeled with proper precautionsinside and outside, and shipped in a mannerto minimize the risk of accidental rupture ofthe primary container.

(25) Exemption: Pharmacists and pharmacieswhere sterile compounding is provided maybe exempt from this rule when compoundingis restricted to utilizing compounds or prod-ucts that are contained only in a closed orsealed system and can be transferred or com-pounded within this self-contained system ortopical products that require further transferor combination in order to achieve a finishedproduct without further modification of theproduct.

(26) In addition to the requirements outlinedin this rule, all standards and requirements asoutlined in 4 CSR 220-2.400 must be main-tained.

AUTHORITY: sections 338.010, 338.140,338.240 and 338.280, RSMo 2000.* Thisrule originally filed as 4 CSR 220-2.200.Original rule filed May 4, 1992, effectiveFeb. 26, 1993. Amended: Filed Oct. 28,1994, effective May 28, 1995. Rescinded andreadopted: Filed Dec. 3, 2002, effective July30, 2003. Moved to 20 CSR 2220-2.200,effective Aug. 28, 2006.

*Original authority: 338.010, RSMo 1939, amended 1951,1989, 1990; 338.140, RSMo 1939, amended 1981, 1989,1997; 338.240, RSMo 1951; and 338.280, RSMo 1951,amended 1971, 1981.

20 CSR 2220-2.300 Record Confidentialityand Disclosure

PURPOSE: This rule establishes require-ments for the confidentiality and disclosure ofrecords related to patient care.

(1) Prescription records, physician orders andother records related to any patient care ormedical condition(s) of a patient that aremaintained by a pharmacy in accordance withsection 338.100, RSMo shall be consideredconfidential. Adequate security shall bemaintained over such records in order to pre-vent any indiscriminate or unauthorized useof any written, electronic or verbal commu-nications of confidential information.

(2) Confidential records shall not be releasedto anyone except—

(A) The patient;(B) A health care provider involved in

treatment activities of the patient;(C) Lawful requests from a court or grand

jury;(D) A person authorized by a court order;(E) Any other person or entity authorized

by a patient to receive such information;(F) For the transfer of medical or prescrip-

tion information between pharmacists as pro-vided by law;

(G) Government agencies acting within thescope of their statutory authority; or

(H) A person or entity to whom suchinformation may be disclosed under 45 CFRParts 160, 164 and 165 (the Privacy Stan-dards of the Health Insurance Portability andAccountability Act of 1996).

(3) This rule does not change or otherwisealter the authority of the board, its inspectorsor other authorized designees to review,inspect, copy or take possession of any suchrecords.

(4) Methods to access, transmit, store, ana-lyze, or purge confidential information shallbe implemented using procedures generallyrecognized as secure by experts qualified bytraining and experience. Procedures shall bein place to ensure that purged confidentialinformation cannot be misused or placed intoactive operation without appropriate autho-rization as provided in this rule. Internetconnectivity or remote access tied directly tosystems containing confidential informationmust be secure as provided for in 4 CSR 220-2.085(2)(B).

AUTHORITY: sections 338.100, 338.140 and338.280, RSMo 2000.* This rule originallyfiled as 4 CSR 220-2.300. Original rule filedMay 4, 1995, effective Dec. 30, 1995.Rescinded and readopted: Filed Nov. 1,2000, effective June 30, 2001. Amended:Filed Dec. 15, 2003, effective July 30, 2004.Moved to 20 CSR 2220-2.300, effective Aug.28, 2006.

*Original authority: 338.100, RSMo 1939, amended 1971,1990, 1997, 1999; 338.140, RSMo 1939, amended 1981,1989, 1997; 338.280, RSMo 1951, amended 1971, 1981.

20 CSR 2220-2.400 Compounding Stan-dards of Practice

PURPOSE: This rule defines compoundingand establishes guidelines for the compound-ing of drugs.

(1) Compounding is defined as the prepara-tion, incorporation, mixing and packaging or

labeling of a drug or device as the result of aprescriber’s prescription or prescription drugorder based on the prescriber/patient/phar-macist relationship in the course of profes-sional practice. Compounding may also bedefined as the preparation, incorporation,mixing and packaging or labeling of a drug ordevice, for the purpose of, or as an incidentto, research, teaching or chemical analysisand not for sale or dispensing purposes.

(2) Manufacturing is defined as the produc-tion, preparation, propagation, conversion,or processing of a drug or device, eitherdirectly or indirectly, by extraction from sub-stances of natural origin or independently bymeans of chemical or biological synthesis,and includes any packaging or repackaging ofthe substance(s) or labeling or relabeling ofits container, and the promotion and market-ing of such drugs or devices.

(3) Batch compounded product is defined asa product compounded in advance of receiptof a prescription or a product compounded ina supply that will be used on more than one(1) dispensing to a patient or patients or anyproduct compounded in excess of the fillingof an individual prescription. A batch is aspecific quantity of product compounded in asingle, discrete process, by the same individ-uals, carried out during one (1) limited timeperiod.

(4) Beyond-use date: A date after which acompounded preparation should not be usedand is determined from the date the prepara-tion is compounded. Because compoundedpreparations are intended for administrationimmediately or following short-term storage,their beyond-use dates must be assignedbased on criteria different from those appliedto assigning expiration dates to manufactureddrug products.

(5) Compounding Area and EquipmentRequirements.

(A) The area(s) used for the compoundingof drugs shall be maintained in a sanitarycondition and shall be free of infestation byinsects, rodents and other vermin. Trash shallbe held and disposed of in a timely and sani-tary manner.

(B) If drug products with special precau-tions for contamination, such as penicillin,are involved in a compounding operation,appropriate measures, including either thededication of equipment for such operationsor the meticulous cleaning of contaminatedequipment prior to its return to inventory,must be utilized in order to prevent cross-contamination.



(C) Equipment used in the compounding ofdrug products shall be of appropriate design,adequate size and suitably located to facilitateoperations for its intended use and for itscleaning and maintenance. Equipment used inthe compounding of drug products shall be ofsuitable composition so that surfaces thatcontact ingredients, in-process materials ordrug products shall not be reactive, additiveor absorptive so as to alter the safety, identi-ty, strength, quality or purity of the drugproduct beyond that desired.

(6) Proper controls shall be maintained overdrug products/ingredients, containers andcontainer closures.

(A) Bulk drugs and other materials used inthe compounding of drugs must be stored inadequately labeled containers in a clean, dryarea or, if required, under proper refrigera-tion.

(B) Pharmacists shall only receive, store oruse drug substances for compounding thathave been made and/or distributed by Mis-souri licensed/registered drug distributors.

(C) Pharmacists shall only use nondrugsubstances for compounding that are free ofany contaminants and which maintain fullpotency.

(D) Drug products/ingredients, containersand container closures used in the com-pounding of drugs shall be handled andstored in a manner to prevent contamination.

(E) Drug product/ingredient containersand container closures shall not be reactive,additive or absorptive so as to alter the safe-ty, identity, strength, quality or purity of thecompounded drug beyond the desired result.Container systems shall provide adequateprotection against foreseeable external factorsin storage and use that can cause deteriora-tion or contamination of the compoundeddrug product.

(7) Appropriate quality control measuresshall be maintained by the pharmacy and itsstaff over compounding methods.

(A) Such methods shall include the follow-ing and shall be followed in the execution ofthe drug compounding process. A separatelog shall be maintained which includes:

1. Methods for the compounding of drugproducts to insure that the finished productshave the identity, strength, quality and puritythey purport or are represented to possess;

2. Date of compounding;3. Identity of the compounding pharma-

cist;4. A listing of the drug products/ingre-

dients and their amounts by weight or vol-ume;

5. Description of the compoundingprocess and the order of drug product/ingre-dient addition, if necessary for proper com-pounding;

6. The identity of the source, lot numberand the beyond-use date of each drug prod-uct/ingredient, as well as an in-house lotnumber and a beyond-use date for bulk com-pounded products; and

7. An identifying prescription numberor a readily retrievable unique identifier forwhich the compound was dispensed.

(B) Information related to and the methodsof compounding shall be available uponrequest.

(C) Pharmacists may compound drugs inlimited quantities prior to receiving a validprescription based on a history of receivingvalid prescriptions that have been generatedsolely with an established pharmacist/patient/prescriber relationship.

1. The compounding of drug products inanticipation of receiving prescriptions with-out an appropriate history of such prescrip-tions on file or a documented need, shall beconsidered manufacturing instead of com-pounding of the drug(s) involved. Limitedquantities, for purposes of this rule, are fur-ther defined as an amount of batched productthat represents a three (3)-month supply.

2. Creams, ointments, lotions, linimentsor other compounded products intended forexternal use may be batched in the same man-ner as provided for in paragraph (5)(C)1. ofthis rule that represents a one (1)-year supply.

(D) Any excess compounded products shallbe stored and accounted for under conditionsdictated by its composition and stability char-acteristics to insure its strength, quality andpurity. Excess product shall be labeled withthe name of the drug(s), an in-house lot num-ber and beyond-use date.

(E) Records as outlined in this rule shall beretained and made readily retrievable forinspection for two (2) years from the date ofcompounding.

(F) The actual name of each active or ther-apeutic ingredient contained in a compoundshall be listed on the container of any productprovided to a consumer.

(8) Management of Compounding.(A) A pharmacist dispensing any com-

pounded drug is responsible for ensuring thatthe product has been prepared, labeled, con-trolled, stored, dispensed and distributedproperly. The pharmacist is responsible forensuring that quality is built into the prepara-tion of products, with key factors including atleast the following general principles:

1. Personnel are capable and qualified toperform their assigned duties;

2. Ingredients used in compoundinghave their expected identity, quality and puri-ty. Drug components must meet compendialstandards or maintain a certificate of analy-sis on file when bulk drug substances areinvolved. Visual inspection of bulk drug sub-stances must be performed;

3. Reasonable assurance that processesare always carried out as intended or speci-fied;

4. Preparation conditions and proce-dures are adequate for preventing mix-ups orother errors; and

5. All finished products, as a conditionof release, must be individually inspected forevidence of visible particulates or other for-eign matter and for container-closure integri-ty and any other apparent visual defects.

(B) The pharmacy is responsible for devel-oping a drug monitoring system for com-pounded products. The outcome monitoringsystem shall provide readily retrievable infor-mation suitable for the evaluation of the qual-ity of pharmaceutical services. This shallinclude but not be limited to reported infec-tion rates, incidence of adverse drug reac-tions, incidence of recalls and complaintsfrom prescribers or clients.

(C) A recall must be initiated when a prod-uct is deemed to be misbranded or adulterat-ed. The pharmacy shall notify the prescriberof the nature of the recall, the problem(s)identified and any recommended actions toensure public health and safety.

1. In cases where the compounded prod-uct has the potential to harm the patient, thesame recall notification, as provided for inthis subsection, shall be provided to allpatients that have received the recalled com-pounded product(s).

2. Any recall initiated by a pharmacyshall be reported, in writing, to the boardwithin three (3) business days.

(9) Compounding of drug products that arecommercially available in the marketplace orthat are essentially copies of commerciallyavailable Federal Drug Administration (FDA)approved drug products is prohibited. Thereshall be sufficient documentation within theprescription record of the pharmacy of thespecific medical need for a particular varia-tion of a commercially available compound.

(10) Any alteration, change or modificationto the contents of a commercially manufac-tured over-the-counter product shall require aprescription or prescription drug order froman authorized prescriber. The compoundingof any drug product to be sold without a pre-scription is prohibited.


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(11) Any person shown at any time, either bymedical examination or pharmacist determi-nation, to have an apparent illness or openlesion(s) that may adversely affect the safetyor quality of a drug product being com-pounded shall be excluded from direct con-tact with drug products/ingredients, drugproduct containers, container closures and in-process materials, until the condition is cor-rected or determined by competent medicalpersonnel not to jeopardize the safety orquality of the products being compounded.

(12) Pharmacists shall not offer compoundeddrug products to other pharmacies, practi-tioners or commercial entities for subsequentresale or administration, except in the courseof professional practice for a prescriber toadminister to an individual patient by pre-scription. A pharmacist or pharmacy mayadvertise or otherwise provide informationconcerning the provision of compoundingservices; however, no pharmacist or pharma-cy shall attempt to solicit business by makingspecific claims about compounded products.

(13) In addition to the requirements outlinedin this rule, all standards and requirements asoutlined in 4 CSR 220-2.200 Sterile Pharma-ceuticals must be adhered to whenever com-pounding involves the need for aseptic proce-dures or requires the use of or results in anintended sterile pharmaceutical product.

AUTHORITY: sections 338.010, 338.140,338.240 and 338.280, RSMo 2000.* Thisrule originally filed as 4 CSR 220-2.400.Original rule filed Aug. 25, 1995, effectiveApril 30, 1996. Amended: Filed Dec. 3,2002, effective July 30, 2003. Moved to 20CSR 2220-2.400, effective Aug. 28, 2006.

*Original authority: 338.010, RSMo 1939, amended 1951,1989, 1990; 338.140, RSMo 1939, amended 1981, 1989,1997; 338.240, RSMo 1951; and 338.280, RSMo 1951,amended 1971, 1981.

20 CSR 2220-2.450 Fingerprint Require -ments

PURPOSE: This rule establishes guidelinesfor the submission of fingerprint cards forapplicants for licensure.

(1) Applicants for licensure or registrationthat must provide fingerprints to the Board ofPharmacy shall include:

(A) Pharmacist examination for licensure;(B) Pharmacist score transfer for licen-

sure;

(C) Pharmacist examination for licensureby graduates of nonapproved foreign pharma-cy schools;

(D) Pharmacist licensure by reciprocity(license transfer);

(E) Drug distributor license manager-in-charge (unless currently licensed as a phar-macist in the state of Missouri); and

(F) Pharmacy technician.

(2) No application shall be considered com-plete without two (2) sets of fingerprints andthe required fingerprinting fee.

(3) Information collected under this back-ground review will be held as confidential inaccordance with state and federal laws gov-erning the dissemination of criminal historyinformation.

(4) Any application which is found to containincomplete, inaccurate or false statementsshall be deemed null and void. Any licenseor registration issued under such circum-stances shall be considered a license or regis-tration issued under the pretense of fraud,deception or misrepresentation and the boardmay file a complaint with the AdministrativeHearing Commission to revoke or disciplinethe license or registration.

(5) The board may, in the course of an inves-tigation of a licensee, require that two (2) setsof fingerprints be submitted for a backgroundcheck as provided for in this rule.

AUTHORITY: sections 338.185 and 338.280,RSMo 1994 and 338.013, 338.140 and338.350, RSMo Supp. 1997.* This rule orig-inally filed as 4 CSR 220-2.450. Originalrule filed Jan. 6, 1997, effective July 30,1997. Amended: Filed April 23, 1998, effec-tive Nov. 30, 1998. Moved to 20 CSR 2220-2.450, effective Aug. 28, 2006.

*Original authority: 338.013, RSMo 1997; 338.140,RSMo 1939, amended 1981, 1989, 1997; 338.185, RSMo1990; 338.280, RSMo 1950, amended 1971, 1981; and338.350, RSMo 1989, amended 1993, 1995.

20 CSR 2220-2.500 Nuclear Pharmacy—Minimum Standards for Operation

PURPOSE: This rule defines minimum stan-dards for the operation of nuclear pharma-cies, a specialty of pharmacy practice. Thisregulation is intended to supplement otherregulations of the Board of Pharmacy, as wellas those of other state and/or federal agen-cies.

(1) Definitions.

(A) The “practice of nuclear pharmacy”means a patient-oriented service that embod-ies the scientific knowledge and professionaljudgment required to improve and promotehealth through the assurance of the safe andefficacious use of radiopharmaceuticals andother drugs.

(B) The term “nuclear pharmacy” meansthe location where radioactive drugs, andchemicals within the classification of legenddrugs, are compounded, dispensed, stored,or sold. The term “nuclear pharmacy” doesnot include the nuclear medicine facilities ofhospitals or clinics where radiopharmaceuti-cals are compounded or dispensed to patientsunder the supervision of a licensed physician,authorized by the Nuclear Regulatory Com-mission and/or the Missouri Department ofHealth.

(C) A “qualified nuclear pharmacist”means a pharmacist who holds a currentlicense issued by the board and who is eithercertified as a nuclear pharmacist by the Boardof Pharmaceutical Specialties, a pharmacistwho meets minimal standards of training forstatus as an authorized nuclear pharmacist oran authorized user of radioactive material, asspecified by the Nuclear Regulatory Com-mission or by agencies of states that maintaincertification agreements with the NuclearRegulatory Commission.

(D) “Radiopharmaceutical services”means the procurement, storage, handling,compounding, preparation, labeling, qualitycontrol testing, dispensing, distribution,transfer, record keeping and disposal ofradiochemicals, radiopharmaceuticals andancillary drugs, and also includes qualityassurance procedures, radiological healthactivities, any consulting activities associatedwith the use of radiopharmaceuticals, healthphysics, and any other activities required forprovision of pharmaceutical care.

(E) “Quality control testing” means theperformance of appropriate chemical,biological and physical tests on compoundedradiopharmaceuticals and the interpretationof the resulting data to determine their suit-ability for use in humans and animals.

(F) “Quality assurance procedures” meansall activities necessary to assure the quality ofthe process used to provide radiopharmaceu-tical services, including authentication ofproduct history and maintenance of allrecords as required by pertinent regulatoryagencies.

(G) “Authentication of product history”means identifying the purchasing source, theultimate fate, and any intermediate handlingof any component of a radiopharmaceuticalor other drug.


Secretary of State


(H) “Radiopharmaceutical” means anydrug which exhibits spontaneous disintegra-tion of unstable nuclei with the emission ofnuclear particles or photons and includes anynonradioactive reagent kit or nuclide genera-tor which is intended to be used in the prepa-ration of any such substance but does notinclude drugs such as carbon-containingcompounds or potassium-containing saltswhich contain trace quantities of naturallyoccurring radionuclides. The term “radio-pharmaceutical” also includes any biologicalproduct which is labeled with a radionuclideor intended solely to be labeled with aradionuclide.

(2) General Requirements for PharmaciesProviding Radiopharmaceutical Services.

(A) No person may receive, acquire, pos-sess, compound or dispense any radiophar-maceutical except in accordance with the pro-visions of this rule and the conditions of rulesand regulations promulgated by the NuclearRegulatory Commission and/or the MissouriDepartment of Health. The requirements ofthis rule are in addition to and not in substi-tution of, other applicable statutes and regu-lations administered by the State Board ofPharmacy or the Missouri Department ofHealth.

(B) Nothing in this rule shall be construedas requiring a licensed physician to obtain aseparate license as a nuclear pharmacist,when the use of radiopharmaceuticals is lim-ited to the diagnosis and treatment of patientsunder the supervision of the physician.

(C) Nothing in this rule shall be construedas requiring a licensed clinical laboratory,which is also licensed by the Nuclear Regu-latory Commission and/or the MissouriDepartment of Health to handle radioactivematerials, to obtain the services of a nuclearpharmacist, or to have a pharmacy permit,unless the laboratory is engaged in the com-mercial sale or resale of radiopharmaceuti-cals.

(D) Nothing in this rule shall be construedto require a department of nuclear medicinewhich is located in a hospital, which has aphysician board certified in his/her specialtyand which is licensed by the Nuclear Regula-tory Commission and/or the MissouriDepartment of Health to handle radioactivematerials, to obtain the services of a pharma-cist or to have a nuclear pharmacy license forradiopharmaceutical preparation and distribu-tion to patients within that institution.

(3) Permits.(A) A permit to operate a nuclear pharma-

cy shall only be issued to a person who is, orwho employs, a qualified nuclear pharmacist.

All personnel performing tasks in the prepa-ration and distribution of radiopharmaceuti-cals and ancillary drugs shall be under thedirect supervision of a qualified nuclear phar-macist, who shall be in personal attendance.The pharmacist-in-charge shall be responsi-ble for all operations of the pharmacy.

(B) The permit to operate a nuclear phar-macy is effective only so long as the pharma-cy also holds a current Nuclear RegulatoryCommission and/or Missouri Department ofHealth license. Copies of inspection reportsshall be made available upon request to theboard for inspection.

(C) Any nuclear pharmacy which provides(transfers) product outside of a patient specif-ic prescription service must be licensed as adrug distributor in order to provide a productfor a prescriber’s use.

(4) Space, Security, Record Keeping andEquipment.

(A) Nuclear pharmacies shall have ade-quate space and equipment, commensuratewith the scope of services required and pro-vided and as required by the Nuclear Regula-tory Commission. All pharmacies handlingradiopharmaceuticals shall include, but notbe limited to, the following areas:

1. Radiopharmaceutical preparation/dis-pensing area;

2. Radioactive material shipping/receiv-ing area;

3. Radioactive material storage area;and

4. Radioactive waste decay area.(B) The nuclear pharmacy professional

service area shall be secured against unau-thorized personnel and must be totallyenclosed and lockable.

(C) Nuclear pharmacies shall maintainrecords of acquisition, inventory and disposi-tion of all radioactive drugs and otherradioactive materials in accordance with StateBoard of Pharmacy, Nuclear RegulatoryCommission and/or Missouri Department ofHealth statutes and regulations.

(D) Nuclear pharmacies shall compoundand dispense radiopharmaceuticals in accor-dance with accepted standards of radiophar-maceutical quality assurance. The StateBoard of Pharmacy recognizes that the prepa-ration of radiopharmaceuticals involves thecompounding skills of the nuclear pharmacistto assure that the final drug product meetsaccepted professional standards of purity andquality.

(E) A nuclear pharmacy shall have avail-able the following resources:

1. A vertical laminar airflow hood thatis annually certified to assure aseptic condi-tions within the working areas;

2. A sanitary work area that is designedto avoid outside traffic and outside airflowand that is ventilated so that it does not inter-fere with sanitary conditions. The sanitarywork area shall not be used for bulk storageof supplies or other materials;

3. A sink located nearby that is suitablefor cleaning purposes;

4. A current policy and procedure man-ual that includes the following subjects:

A. Sanitation;B. Storage;C. Dispensing;D. Labeling;E. Record keeping;F. Recall procedures;G. Responsibilities and duties of sup-

portive personnel;H. Training and education in aseptic

technique; andI. Compounding procedures.

(5) Dispensing, Packaging, Labeling.(A) A radiopharmaceutical shall be dis-

pensed only to a licensed physician autho-rized by the Nuclear Regulatory Commissionand/or the Missouri Department of Health topossess, use and administer such drug. Aradiopharmaceutical shall be dispensed onlyupon receipt of a prescription or medicationorder from such licensed physician. Exceptthat a radiopharmaceutical may be transferredto a person who is authorized to possess anduse the drug for nonclinical applications.

(B) Radioactive drugs are to be dispensedonly upon a non-refillable prescriptionorder from a licensed physician or thephysician’s designated agent. Upon receiv-ing an oral prescription order for a radio-pharmaceutical, the nuclear pharmacy shallimmediately have the prescription orderreduced to writing or recorded in a dataprocessing system. The order must be takenby a pharmacist, intern pharmacist, nuclearmedicine technologist or designated agents.Nuclear medicine technologists may onlyreceive prescription orders for diagnosticradiopharmaceuticals, and all such prescrip-tions must be reviewed and initialed by thepharmacist. The prescription record shallcontain all information as required in 4 CSR220-2.018 Prescription Requirements andshall also include:

1. The date of dispensing and the cali-bration time of the radiopharmaceutical; and

2. The name of the procedure.(C) The immediate outer container shield

of a radiopharmaceutical to be dispensedshall be labeled with—

1. The name and address of the pharma-cy;

2. The name of the prescriber;

3. The date of dispensing;4. The serial number assigned to the

order for the radiopharmaceutical;5. The standard radiation symbol;6. The words “Caution Radioactive

Material”;7. The name of the procedure;8. The radionuclide and chemical form;9. The amount of radioactivity and the

calibration date and time;10. If a liquid, the volume;11. If a solid, the number of items or

weight;12. If a gas, the number of ampules or

vials;13. Molybdenum-99 content to United

States Pharmacopoeia (USP) limits; and14. The patient name or the words

“Physician’s Use Only” in the absence of apatient name. When the prescription is for atherapeutic or blood-product pharmaceutical,the patient name shall appear on the label.The requirements of this paragraph shall bemet when the name of the patient is readilyretrievable from the physician upon demand.

(D) The immediate inner container label ofa radiopharmaceutical to be dispensed shallbe labeled with—

1. The standard radiation symbol;2. The words “Caution Radioactive

Material”;3. The identity of the radionuclide;

and4. The serial number of the radio-

pharmaceutical.(E) When a radiopharmaceutical is dis-

pensed under the authority of an Investi-gational New Drug Application (IND), thenuclear pharmacy records shall include aninvestigator’s protocol for the preparation ofthe radiopharmaceutical, a copy of the Insti-tutional Review Board approval form (or let-ter) and a letter from the manufacturer (spon-sor) indicating that the physician requestingthe radiopharmaceutical is a qualified investi-gator.

(6) Reference Manuals.(A) Each nuclear pharmacy shall have a

copy of the Missouri Pharmacy Practice Actand current regulations under the act; onerecognized text in nuclear pharmacy, and acurrent copy of state and federal regulationsgoverning the safe storage, handling, use, dis-pensing, transport and disposal of radioactivematerial.

(7) Any preparation of Positron EmissionTomographic (PET) radiopharmaceuticalsshall comply with 4 CSR 220-2.200 SterilePharmaceuticals and with applicable USPstandards.

AUTHORITY: sections 338.210, 338.240,338.250, 338.280, 338.330(3), RSMo 1994and 338.220 and 338.350, RSMo Supp.1997.* This rule originally filed as 4 CSR220-2.500. Original rule filed Sept. 2, 1997,effective April 30, 1998. Moved to 20 CSR2220-2.500, effective Aug. 28, 2006.

*Original authority: 338.210, RSMo 1951; 338.220, RSMo1951, amended 1969, 1981, 1989, 1997; 338.240, RSMo1951; 338.250, RSMo 1951, amended 1990; 338.280,RSMo 1951, amended 1971, 1981; 338.330, RSMo 1989,amended 1993; and 338.350, RSMo 1989, amended 1993,1995.

20 CSR 2220-2.600 Standards of Opera-tion for a Class F: Renal Dialysis Pharma-cy

PURPOSE: This rule incorporates the provi-sions of SB 141 and defines minimum stan-dards for a Class F: Renal Dialysis Pharma-cy.

(1) A Class F pharmacy (renal dialysis) shallbe limited in scope to the provision of dialy-sis products and supplies to persons withchronic kidney failure for self-administrationat the person’s home or specified address.Pharmacy services and dialysis supplies andproducts provided by a Class F pharmacyshall be limited to the distribution and deliv-ery of drugs and devices as provided withinthis rule. All drugs and devices must beordered by an authorized prescriber foradministration or delivery to a person withchronic kidney failure for self-administrationat the person’s home or specified address.All dialysis supplies and products providedby a Class F pharmacy shall be prepackagedand shall be covered by an approved NewDrug Application (NDA) or 510(k) applica-tion issued by the Food and Drug Adminis-tration (FDA).

(2) A Class F pharmacy shall maintain apharmacist-in-charge on a consultant basiswho shall review pharmacy operations atleast weekly. The pharmacist-in-charge of aClass F pharmacy will be responsible for thefollowing requirements:

(A) Ensure that the use of legend drugsand devices that are provided to a person forthe treatment of chronic kidney disease forself-administration at the person’s home orspecified address shall be under the profes-sional supervision of an appropriate practi-tioner licensed under Missouri law.

(B) Ensure that only drugs and devices thathave been ordered by an authorized pre-scriber and are included on the list ofapproved formulary drugs and devices areprovided to patients;

(C) Ensure that no drugs or devices shallbe dispensed to a patient until adequate train-ing in the proper use and administration ofsuch products has been completed;

(D) Ensure that proper documentation ofdrug and device distributions and deliveriesare maintained by the Class F pharmacy andare made available upon request to practition-ers involved in the care of the patient and toboard of pharmacy representatives;

(E) Maintain a policy and procedure man-ual that shall be available for inspection byboard of pharmacy personnel. The manualshall include a quality assurance programwith which to monitor the qualifications,training and performance of personnel; and

(F) The pharmacist-in-charge shall beresponsible for the drug/device delivery sys-tem and shall establish a written protocol forthe implementation of the delivery systemincluding methods for supervisingdrug/device deliveries to patients of the phar-macy.

1. Any written protocols shall be avail-able for inspection by board of pharmacy per-sonnel.

2. Any changes to the policy and pro-cedure manual or to written protocols mustbe approved by the pharmacist-in-charge.

(3) Drug Formulary List/Device List. Thepharmacy shall submit a list of drugs and/ordevices which must be approved by the boardof pharmacy.

(4) A Class F pharmacy shall deliver prod-ucts to a person with chronic kidney failureonly upon the receipt of a valid prescriptionfrom an authorized prescriber specifying orincluding:

(A) Documents that the intended recipientwill require such products for the appropriatetreatment of the disease and that the intendedrecipient has been trained in home dialysistherapy;

(B) The duration of the prescriber’s order,not to exceed one (1) year, including allauthorized refills; and

(C) The name and product code of eachproduct prescribed and the quantity pre-scribed.

(5) Personnel of the pharmacy shall assemblethe products to be delivered pursuant to theprescriber’s order(s). In assembling suchproducts for delivery, the pharmacy shall takesteps necessary to assure the following:

(A) The code numbers and quantities of theproducts assembled match the code numbersidentified in the prescriber’s order(s);

CODE OF STATE REGULATIONS 33ROBIN CARNAHAN (9/30/06)*Secretary of State


(B) Any products bearing an expirationdate have a minimum of three (3) full monthsof shelf-life remaining;

(C) A visual inspection of all drugs anddevices for compliance with the prescriber’sorder(s) and with all labeling requirements asset forth in 338.059, RSMo. Manufacturersealed case lots shall be labeled with thename of the patient, date, and a control num-ber that serves as a unique patient identifiernumber; and

(D) Products ordered by a prescriber andprovided to patients of the pharmacy shall bedelivered either by personnel of the pharma-cy or by a carrier authorized by the pharma-cy.

1. Upon the delivery to patients of anydrugs/devices, pharmacy personnel or theapproved carrier shall confirm receipt by thepatient or the patient’s designee and that thenumber of units delivered equals the numberof units identified by documentation suppliedby the pharmacy.

(6) Class F pharmacies shall comply with allof the following:

(A) The license of the pharmacy shall bedisplayed in plain view at the pharmacy loca-tion;

(B) The pharmacy shall be open such hoursas are necessary to safely and effectively dis-pense and deliver supplies to those personsdesignated by the applicable prescriber;

(C) The pharmacy must maintain sufficientspace and storage capabilities as necessary tocarry out its operations; and

(D) All drugs and/or devices shall beproperly identified and any outdated, mis-branded or adulterated items shall be segre-gated from the active inventory within aclearly separate and defined area and shall beheld separately until the item is destroyed orreturned to a licensed drug distributor.

AUTHORITY: sections 338.140 and 338.220,RSMo Supp. 1997 and 338.280, RSMo1994.* This rule originally filed as 4 CSR220-2.600. Original rule filed Jan. 20, 1998,effective Aug. 30, 1998. Moved to 20 CSR220-2.600, effective Aug. 28, 2006.

*Original authority: 338.140, RSMo 1939, amended 1981,1989, 1997; 338.220, RSMo 1951, amended 1969, 1981,1989, 1997; and 338.280, RSMo 1951, amended 1971,1981.

20 CSR 2220-2.650 Standards of Opera-tion for a Class J: Shared Services Phar-macy

PURPOSE: The purpose of this rule is toestablish minimum standards of operation for

Class J: Shared Services Pharmacy, in com-pliance with House Bill 567 of the 91st Gen-eral Assembly.

(1) Class J: Shared Services: Shared ServicePharmacy is defined as the processing by apharmacy of a request from another pharma-cy to fill or refill a prescription drug order, orthat performs or assists in the performance offunctions associated with the dispensingprocess, drug utilization review (DUR),claims adjudication, refill authorizations, andtherapeutic interventions.

(A) A pharmacy may perform or outsourcecentralized prescription processing servicesprovided the parties:

1. Have the same owner, or have a writ-ten contract outlining the services to be pro-vided and the responsibilities and account-abilities of each party in fulfilling the termsof said contract in compliance with federaland state laws and regulations;

2. Maintain separate licenses for eachlocation involved in providing shared ser-vices; and

3. Share a common electronic file toallow access to sufficient information neces-sary or required to fill or refill a prescriptiondrug order.

(B) There must be record keeping systemsbetween shared service pharmacies with realtime on-line access to shared services by bothpharmacies. Transfer of prescription informa-tion between two (2) pharmacies that areaccessing the same real-time, on-line data-base pursuant to the operation of a sharedservice pharmacy operation shall not be con-sidered a prescription transfer and, therefore,is not subject to the requirements of 4 CSR220-2.120.

(C) The parties performing or contractingfor centralized prescription processing ser-vices shall maintain a policy and proceduresmanual and documentation that implementa-tion is occurring in a manner that shall bemade available to the board for review uponrequest and that includes, but is not limitedto, the following:

1. A description of how the parties willcomply with federal and state laws and regu-lations;

2. The maintenance of appropriaterecords to identify the responsible pharma-cist(s) in the dispensing and counselingprocesses;

3. The maintenance of a mechanism fortracking the prescription drug order duringeach step in the process;

4. The provision of adequate security toprotect the confidentiality and integrity ofpatient information;

5. The maintenance of a quality assur-ance program for pharmacy services designedto objectively and systematically monitor andevaluate the quality and appropriateness ofpatient care, pursue opportunities to improvepatient care and resolve identified problems.

AUTHORITY: sections 338.140, 338.240,and 338.280, RSMo 2000 and 338.210 and338.220, RSMo Supp. 2001.* This rule orig-inally filed as 4 CSR 220-2.650. Originalrule filed Nov. 30, 2001, effective June 30,2002. Amended: Filed Dec. 3, 2002, effectiveJune 30, 2003. Moved to 20 CSR 2220-2.650,effective Aug. 28, 2006.

*Original authority: 338.140, RSMo 1939, amended 1981,1989, 1997; 338.210, RSMo 1951, amended 2001;338.220, RSMo 1951; amended 1969, 1981, 1989, 1997,1999, 2001; 338.240, RSMo 1951 and 338.280, RSMo1951, amended 1971, 1981.

20 CSR 2220-2.700 Pharmacy TechnicianRegistration

PURPOSE: This rule defines the require-ments for pharmacy technician registration.

(1) A pharmacy technician is defined as anyperson who assumes a supportive role underthe direct supervision and responsibility of apharmacist and who is utilized according towritten standards of the employer or the phar-macist-in-charge to perform routine functionsthat do not require the use of professionaljudgement in connection with the receiving,preparing, compounding, distribution or dis-pensing of medications.

(A) No person shall assume the role of apharmacy technician without first registeringwith the board in accordance with therequirements in section 338.013, RSMo andthis rule. Nothing in this rule shall precludethe use of persons as pharmacy technicianson a temporary basis as long as the individ-ual(s) is registered as or has applied to theboard for registration as a technician inaccordance with 338.013.1 and .2, RSMo.

(B) A person may be employed as a tech-nician once a completed application and therequired fee(s) are received by the board.Except that, persons already employed as apharmacy technician at the time this rulebecomes effective will have sixty (60) days tosubmit a completed application for registra-tion and the required fee(s) to the board. Theboard will notify an applicant of the receipt ofan application for registration and will laterprovide either a registration certificate thatshall be conspicuously displayed or a letter ofdisqualification preventing the applicant’semployment within a pharmacy.

34 CODE OF STATE REGULATIONS (9/30/06)* ROBIN CARNAHAN

Secretary of State


(C) Information required on the applicationshall include, but is not limited to—

1. The name and residential address ofthe applicant;

2. Full-time and part-time addresseswhere the applicant will be employed as atechnician;

3. Information concerning the appli-cant’s compliance with state and federal laws,as well as any violations that could be con-sidered grounds for discipline as outlined insection 338.013.5, RSMo;

4. One (1) two-inch by two-inch (2" ×2") frontal view portrait photograph of appli-cant; and

5. Two (2) sets of fingerprint cards asrequired by 4 CSR 220-2.450.

(D) A copy of the application must bemaintained by the applicant at the site(s) ofemployment during and until notice of regis-tration or disqualification is received by theapplicant and must be readily retrievable forreview by the board of pharmacy or theboard’s representatives.

(2) Registered technicians as well as appli-cants for registration as a technician areresponsible for informing the executive direc-tor of the board in the case of a changed res-idential address. Any mail or communica-tions returned to the executive director’soffice marked unknown, incorrect address,and the like, will not be sent out a secondtime until the correct address is provided.

(3) Registered technicians as well as appli-cants for registration as a technician shallinform the executive director of the board ofany change in their employment address. Thenotification of an employment change mustbe provided in writing to the board no laterthan fifteen (15) days following the effectivedate of the change.

(4) Any person whose name appears on theboard of pharmacy employment disqualifica-tion list shall be barred from employment asa pharmacy technician except as provided insection (5) of this rule.

(A) Information on the disqualification listshall include, at a minimum, the name andlast known residential address of the persondisqualified, as well as any previous registra-tion number, the date on which the person’sname was entered on the list and the date atwhich time the person will again become eli-gible for employment in a pharmacy. Theboard may place a person on the disqualifica-tion list for an indefinite period of time if thedisqualified person fails to maintain a currentmailing address with the board or fails to

communicate with the board on a timely basiswhen contacted in writing by the board.

(B) Once the board has made a determina-tion to place a person’s name on the disqual-ification list, the board shall notify the personin writing by mailing the notification to theperson’s last known address. The disqualifi-cation notice shall include:

1. The name, address of residence and,if already registered as a technician, the reg-istration number;

2. The reasons for being placed on thedisqualification list;

3. The consequences of the person’sname appearing on the list;

4. The time period of disqualification;5. Any alternative restrictions or provi-

sions for conditional employment, if provid-ed by the board; and

6. The right to appeal the decision of theboard as provided in Chapter 621, RSMo.

(5) Any person whose name appears on thedisqualification list may be employed as apharmacy technician subject to any restric-tions or conditions ordered by the board. Asan alternative to barring an individual fromemployment in a pharmacy, the board mayconsider restricted forms of employment oremployment under special conditions for anyperson who has applied for or holds a regis-tration as a pharmacy technician. Any regis-tered technician subject to restrictions or con-ditions who violates any portion thereof maybe further restricted in employment or haveadditional conditions placed on their registra-tion. The board may also implement full dis-qualification on a registrant who has violatedany restrictions or conditions.

(6) The letter of notice of intent to disqualifyand the disqualification list shall be consid-ered an open record of the board as well asany notice of appeal or pending litigation thatpertains to the disqualification of any personfrom employment as a pharmacy technician.

AUTHORITY: sections 338.013 and 338.140,RSMo 2000.* This rule originally filed as 4CSR 220-2.700. Original rule filed Aug. 21,1998, effective Feb. 28, 1999. Amended:Filed Nov. 13, 2002, effective June 30, 2003.Moved to 20 CSR 2220-2.700, effective Aug.28, 2006.

*Original authority: 338.013, RSMo 1997 and 338.140,RSMo 1939, amended 1981, 1989, 1997.

20 CSR 2220-2.800 Vacuum Tube DrugDelivery System

PURPOSE: This rule defines the minimumstandards for a vacuum tube drug deliverysystem utilized in licensed pharmacies.

(1) Vacuum tube systems are for use in thedelivery of drugs to the patient or his/heragent.

(A) Any drug delivery system that utilizesa vacuum tube to deliver drugs outside of alicensed pharmacy must be designed andengineered in such a way as to ensure securi-ty of all drugs and that drugs are deliveredcorrectly and efficiently to the intendedrecipient.

(B) Only systems that are dedicated for thedelivery of drugs from a location within alicensed pharmacy to another location specif-ic for drug delivery and are not connected,combined or attached to other systems shallbe used. Multiple or switchable stationswhere the delivery of drugs could occur atmore than one destination outside of thepharmacy are prohibited.

1. When the pharmacy is closed or thereis no pharmacist on duty, the vacuum tubesystem must be turned off and no drugs shallbe delivered to consumers during these timeperiods.

(C) Any pharmacy, which cannot maintaina direct and identifiable line of sight with theconsumer, must maintain a video camera andaudio system to provide for effective commu-nication between pharmacy personnel andconsumers. It must be a system that willallow for the appropriate exchange of oral aswell as written communications to facilitatepatient counseling and other matters involvedin the correct transaction or provision ofdrugs.

1. Video monitors used for the properidentification of persons receiving prescrip-tion drugs shall be a minimum of twelveinches (12") wide.

2. Both the video monitor and the audiosystem must be in good working order oroperations utilizing the vacuum tube systemshall cease until appropriate corrections orrepairs are made to the system(s).

3. Backlighting or other factors that mayinhibit video or audio performance must betaken into account when using such systemsto identify recipients of prescription drugs.Positive identification of recipients must bemade before any drug is delivered.

(2) All vacuum tube delivery systemsinstalled after September 1, 1998, shallcomply with the minimum standards setforth in this rule. Any vacuum tube delivery




Secretary of State


system already installed in a pharmacy priorto September 1, 1998, will not be required tocomply with this rule; except that, should thevacuum tube delivery system or any partthereof require replacement, change, orupgrading after September 1, 1998, the sys-tem or any part of the system being replaced,changed or upgraded shall comply with theminimum standards set forth in this rule. Thisexemption does not relieve a pharmacy of itsduty to maintain adequate security measuresas required by 4 CSR 220-2.010(1)(H); nordoes it relieve pharmacists from their duty toprovide patient counseling as required by 4CSR 220-2.190.

AUTHORITY: sections 338.140, RSMo Supp.1997 and 338.280, RSMo 1994.* This ruleoriginally filed as 4 CSR 220-2.800. Origi-nal rule filed Aug. 21, 1998, effective Feb.28, 1999. Moved to 20 CSR 2220-2.800,effective Aug. 28, 2006.

*Original authority: 338.140, RSMo 1939, amended 1981,1989, 1997 and 338.280, RSMo 1951, amended 1971,1981.

20 CSR 2220-2.900 Automated Dispensingand Storage Systems

PURPOSE: This rule establishes guidelinesfor the use of automated dispensing and stor-age systems.

(1) Automated dispensing and storage sys-tems (hereafter referred to as automated sys-tem or system) are hereby defined to include,but are not limited to, mechanical systemsthat perform operations or activities, relativeto the storage, packaging or dispensing ofmedications, and which collect, control, andmaintain all transaction information. Suchsystems may be used in pharmacies andwhere a pharmacy permit exists, for main-taining patient care unit medication invento-ries or for a patient profile dispensing system,provided the utilization of such devices isunder the supervision of a pharmacist. Apharmacist is not required to be physicallypresent at the site of the automated pharmacysystem if the system is supervised electroni-cally by a pharmacist. In order to supervisethe system, the pharmacist must maintainconstant visual and auditory communicationwith the site and full control of the automat-ed system must be maintained by the phar-macist and shall not be delegated to any otherperson or entity.

(A) Documentation shall be maintained bythe owner/operator of an automated systemfor the type of equipment, locations where allsystems are located, identification of all per-

sons accessing the automated system, theidentity of persons stocking or restocking thesystem and the pharmacist responsible forchecking the accuracy of medicationsstocked.

(B) Automated systems that are used with-in licensed health care facilities shall be usedonly in settings that ensure medication ordersare reviewed by a pharmacist in accordancewith established policies and procedures andlaws governing the practice of pharmacy. Apharmacist shall control all operations of theautomated system and approve the release ofthe initial dose of a prescription drug order.Subsequent doses from an approved prescrip-tion drug order may be removed from theautomated system after this initial approval.Any change made in the prescription drugorder shall require a new approval by a phar-macist to release the drug.

(C) In ambulatory care settings, a pharma-cist must input all information from a pre-scription or prescription drug order into theelectronic data system utilized for the initia-tion of the dispensing of a drug at a remotesite and maintain proper oversight over theentire dispensing process. A pharmacist shallbe accessible at all times to respond topatient’s or other health professionals’inquiries or requests pertaining to drugs dis-pensed through the use of the automatedpharmacy system. No prescription shall beprepared or dispensed from a remote auto-mated system unless it is from a prescriberproviding clinical services at the same loca-tion. Labeling of drug containers must be inaccordance with section 338.059, RSMo, andapplication of labels to containers must occurprior to release of the prepared prescriptiondrug from the automated system. Labels shallcontain both the name, address and phonenumber of the supervising pharmacy and theremote dispensing site.

(D) When automated systems are located atremote sites the central pharmacy responsiblefor the operation and supervision of a remotesite must maintain separate and readilyretrievable records of all transactions and pre-scriptions processed by each remote automat-ed system. Remote automated sites must pro-vide the name, address and toll free telephonenumber of the supervising pharmacy dis-played on the automated dispensing system ina prominent location.

(E) Automated systems shall maintain ade-quate security systems and procedures to pre-vent unauthorized access or use and shall atall times maintain compliance with all stateand federal drug laws including all controlledsubstance requirements and patient confiden-tiality laws.

1. Any remote automated system thatstocks controlled substances must maintain aperpetual inventory from each site.

2. Automated systems in ambulatorycare settings must be located in an area thatwill provide adequate space for private con-sultations to occur and must only be installedwithin the same area utilized by the pre-scriber for the provision of clinical services.

(F) Restocking of automated systems shallbe done by registered technicians under thesupervision of a pharmacist or by a pharma-cist.

(G) All events involving access to the con-tents of the automated system must be record-ed electronically.

(H) No medication or device shall bereturned directly to the system for reissue orreuse by a person not licensed or registeredby the board of pharmacy.

(I) Quality assurance documentation forthe use and performance of the automatedsystems shall be maintained for a minimumperiod of two (2) years and shall include at aminimum the following:

1. Breach of security of the automatedsystem;

2. Failure of the system to operate cor-rectly along with the frequency of any failuresand the necessary repairs completed;

3. Tests completed to measure the effec-tiveness and accuracy of the system. every six(6) months and whenever any upgrade orchange is made to the system.

(J) Drugs that are repackaged for use inautomated systems must comply with 4 CSR220-2.130 Drug Repackaging requirements.

(K) If an automated system uses removablecartridges or containers to hold drugs, theprepackaging of the cartridges or containersmust occur at the pharmacy where the origi-nal inventory is maintained unless providedby a Federal Drug Administration (FDA)approved repackager and who is licensed as adrug distributor. The prepackaged cartridgesor containers may be sent to the automatedsystem to be loaded into the machine by reg-istered technicians under the supervision of apharmacist or by a pharmacist providedthat—

1. A pharmacist has verified the con-tainer has been properly filled and labeled;

2. The individual containers are trans-ported to the automated system in a secure,tamper-evident container; and

3. The automated system utilizes tech-nologies to ensure that the containers areaccurately loaded in the automated system.

(L) Any pharmacy that maintains an auto-mated system for remote dispensing to ambu-latory patients must maintain a video cameraand audio system to provide for effective



communication between pharmacy personneland consumers. It must be a system that willallow for the appropriate exchange of oral aswell as written communications to facilitatepatient counseling as provided in 4 CSR 220-2.190 and other matters involved in the cor-rect transaction or provision of drugs.

1. Video monitors used for the properidentification and communication with per-sons receiving prescription drugs shall be aminimum of twelve inches (12") wide andprovided at both the pharmacy and remotelocation for direct visual contact betweenpharmacist and patient.

2. Both the video monitor and the audiosystem must be in good working order oroperations utilizing the automated systemshall cease until appropriate corrections orrepairs are made to the system(s).

3. Backlighting or other factors that mayinhibit video or audio performance must betaken into account when using such systemsto identify recipients of prescription drugs.Positive identification of recipients must bemade before any drug is delivered.

(2) Each automated system shall maintain amanual of policies and procedures that, at aminimum, shall include the following:

(A) System operations that include specif-ic and measurable accountability for safety,security, accuracy, patient confidentiality,access, data retention and retrieval, downtimeprocedures, emergency or first dose proce-dures, inspection of systems by pharmacypersonnel, installation requirements, mainte-nance, medication security, quality assur-ance, inventory levels and control, staff edu-cation and training and system set-up andmalfunction.

(B) Documentation by the automated sys-tem for on-site patient administration andremote dispensing of medications thatincludes specific identification of patients,medications used along with dates and timesthe system is utilized.

(C) Effective procedures for securing andaccounting for wasted medications or dis-carded medications.

(D) Access to and limits on access (securi-ty levels) to the automated system must bedefined and must comply with applicablestate and federal laws and regulations.

(3) The pharmacist-in-charge is responsiblefor the overall compliance of the automatedsystem in the same manner as other pharma-cy operations as outlined in 4 CSR 220-2.090. In addition, responsibilities will alsoinclude:

(A) Establishment of a quality assuranceprogram prior to implementation of an auto-

mated system and the supervision of an ongo-ing quality assurance program that monitorsappropriate use and performance of the auto-mated system, which is evidenced by writtenpolicies and procedures developed by thepharmacy;

(B) Assign, discontinue or change accessto the automated system;

(C) Assure that the automated system is ingood working order and accurately providesthe correct strength, dosage form and quanti-ty of a drug prescribed while maintainingappropriate record keeping and security safe-guards.

(D) Procedures used for notifying theboard on a timely basis and other state andfederal agencies, when warranted, of anybreach of security which results in the unau-thorized removal of drugs.

(4) Except where otherwise noted in this rule,all records specified must be retained as apart of the dispensing record of the pharmacyand in accordance with section 338.100,RSMo and board regulations governing theproper maintenance and retrieval of records.

(5) Pharmacies that maintain automated sitesfor dispensing drugs to ambulatory patientsshall maintain a Class J: Shared Service clas-sification on each pharmacy permit involvedin such activity.

(6) The supervising pharmacy shall have suf-ficient pharmacists on duty such that eachpharmacist may supervise no more than three(3) remote sites that are simultaneously opento provide services. An exception to thesupervision limit may be granted by the boardin situations where the provider has docu-mented a need for a pharmacist to superviseadditional remote sites and has demonstratedthat appropriate safeguards are in place toassure proper supervision of each remotesite.

AUTHORITY: sections 338.210 and 338.220,RSMo Supp. 2002 and 338.280, RSMo2000.* This rule originally filed as 4 CSR220-2.900. Original rule filed Nov. 1, 2000,effective June 30, 2001. Amended: Filed Feb.18, 2003, effective Sept. 30, 2003. Moved to20 CSR 2220-2.900, effective Aug. 28, 2006.

*Original authority: 338.210, RSMo 1951, amended 2001;338.220, RSMo 1951, amended 1969, 1981, 1989, 1997,1999, 2001; and 338.280, RSMo 1951, amended 1971,1981.