MANMED Change 121 - Chapter 21...21-4 Change 121 7 Feb 2005 (2) The number of pharmacists and technicians assigned to a facility is determined by the Bureau of Medicine and Surgery

Chapter 21

Pharmacy Operationand Drug Control

21-2 Change 121 7 Feb 2005

Chapter 21CONTENTS

Sections PageSection I. Pharmacy Administration 21-3

Section II. Controlled Substances 21-19

Section III. Forms, Records, and Reports 21-27

Section IV. Drug Dispensing without a Pharmacist 21-33

Chapter 21 Manual of the Medical Department

7 Feb 2005 Change 121 21-3

Section IPHARMACY ADMINISTRATION

Section I

Article Page21-1 Facilities (Regulatory) 21-3

21-2 Personnel (Regulatory) 21-3

21-3 Responsibilities (Regulatory) 21-4

21-4 Prescribers (Regulatory) 21-7

21-5 Outpatient Prescriptions (Regulatory) 21-8

21-6 Inpatient Dispensing (Regulatory) 21-14

21-7 Drug Stock (Regulatory) 21-15

21-8 Antidotes and Antidote Lockers (Regulatory) 21-17

21-1 Facilities(Regulatory)

(1) Naval medical treatment facilities (MTFs)dispensing drugs range from large hospitals to sup-port stations aboard the ships of the fleet and ashore.The overall mission of each facility will determinethe type and quantity of pharmacy personnel assignedand the drugs to be stocked.

21-2 Personnel(Regulatory)

(1) Pharmacists are graduates of accreditedpharmacy colleges and actively registered in one ofthe 50 United States, the District of Columbia, orPuerto Rico. Using the following guide, at least onepharmacist should be assigned duty at all fixed MTFsin the United States and overseas where a pharmacyis operated. The civilian standard of care requires apharmacy to operate only under the direct super-vision of a licensed pharmacist. The intent of thissection is to ensure the Navy emulates the civilianstandard. To achieve this goal, prudent use of military,civil service, and contract pharmacists is necessary.

Pharmacy Operation and Drug Control Article 21-2

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(2) The number of pharmacists and techniciansassigned to a facility is determined by the Bureau ofMedicine and Surgery (BUMED) Pharmacy StaffingStandard. The standard is based on several workloadfactors including: number of prescriptions dispensed,population, and scope of services provided. Thehours of operation also need to be part of the staffingdecision. If the complexity of services provided atthe clinic is high, (e.g., family practice or civilianprescriptions, family members or retirees are seenand treated), then the standard of care calls for apharmacist to supervise the pharmacy operation andreview all prescriptions prior to dispensing. TheDOD/JCAHO protocol outlines an “equivalency”standard.

(3) At fixed MTFs where the use of a full-timepharmacist would not be justified, pharmacies maybe operated:

(a) On a part-time basis by officers who arepharmacists, but who are assigned other primaryduties or who cover a number of such facilities.

(b) By a part-time civil service or contractpharmacist.

(c) By dispensing physicians.

(d) By military trained pharmacy techniciansat fixed MTFs and any mobile activities dispensingcomputerized provider-order-entry prescriptions,under the supervisory responsibility of a pharmacyofficer or a dispensing physician or dentist specifiedin writing by the commanding officer (CO).

Note: Care and attention in these situations should begiven to article 21-2(2) above.

(4) In general, positions for pharmacists in MTFpharmacies outside the United States will be filledwith experienced, commissioned military pharma-cists who rotate with pharmacy officers stationed inthe United States.

(5) Continuing education opportunities will bemade available to all pharmacy staff to update andincrease their knowledge of the drugs they dispense.

21-3 Responsibilities(Regulatory)

(1) The CO is responsible for the operation ofthe pharmacy. The CO must exercise careful super-vision over all phases of its operations, includingemployment of recognized professional proceduresand establishing policies to ensure conformity withthe highest standards of the pharmaceutical pro-fession. The pharmacy must be operated in accord-ance with Federal Law, service regulations, andaccepted standards of practice such as those definedby the Joint Commission on Accreditation ofHealthcare Organizations (JCAHO), and other pro-fessional organizations. Supervision is normallyexercised through a commissioned pharmacy officer,who is a graduate of a recognized school or collegeof pharmacy and actively licensed to practice pharm-acy in one of the 50 states, the District of Columbia,or Puerto Rico. When a commissioned officer(pharmacist) is not assigned to an MTF, a civilianpharmacist or a Medical or Dental Corps officer willbe assigned supervisory responsibilities. The CO and/or officer in charge (OIC) responsible for a claimancy18 MTF, without a pharmacist assigned (e.g., branchclinic), shall ensure that pharmacy operations arereviewed by a pharmacist through site visits andinspections. For mobile MTFs without a pharmacist(i.e., non-claimancy 18 activity), the CO may assignresponsibility to an enlisted pharmacy technician(NEC 8482), a Medical Corps officer, physicianassistant, nurse practitioner, certified nurse midwife,certified nurse anesthetist, privileged nurse provider,or a senior hospital corpsman. A claimancy 18 COor OIC of an MTF in the immediate area of anoperational unit, may assign a pharmacy officer toassist the commander and pharmacy staff of theoperational pharmacy in a manner similar to that fora branch clinic, if support is requested by thecommander of the operational unit.

(2) The CO must establish policies to ensurerational prescribing, to ensure quantities of drugs pre-scribed are not excessive, and to ensure drug dis-pensing is based on a formulary system.

Article 21-3 Manual of the Medical Department

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(3) The CO must ensure that the staffing levelsand funding are aligned to meet the mission require-ments.

(4) The pharmacy department head is responsiblefor recognizing, identifying, selecting, preparing,safeguarding, evaluating, dispensing, and patientcounseling on substances dispensed by and used inpreventive or curative medicine at the facility. Thepharmacy department head and assistants arerequired to keep abreast of new developments in thefield of pharmacy and serve as pharmaceuticalsubject matter experts to the MTF personnel theyserve. The pharmacy department head is responsiblefor:

(a) Providing drug information and policyassistance to authorized individuals in the properwriting of prescriptions. In particular, advise refer-ence to pharmacology and toxicology, dosage formsand strengths, precautions, side effects and adversedrug reactions, pharmacokinetics, parenteral nutritionsupport, availability of ingredients, size of standardpackages, equivalent agents, therapeutic and physicalincompatibilities, therapeutic equivalents, storagerequirements, drug stability, and dosage calculationsand any information that would assist the user.Additionally, support providers with information andrecommendations regarding pharmaceutical eleganceand palatability, use of agents and quantities formaximum effectiveness and economy, refill authori-zations, and any matter involving the use or misuseof medications.

(b) Assisting and advising personnel of nurs-ing care units and clinics or departments within theMTF whose duties involve stocking pharmaceuticalitems by conducting inspections at least monthly, ormore often if required. Provide inspections of allareas where pharmaceuticals are dispensed, adminis-tered, or stored. The inspections should include, butnot necessarily be limited to: review of adequacy ofidentification, sufficiency of storage, safeguards, andevaluation of condition and potency of stocked itemsbased on normal expiration dates, assays, observa-tions or such other criteria as are accepted as goodpractice by the pharmaceutical profession.

(c) Maintaining current drug informationresources, and routinely disseminating drug informa-tion to medical and dental staff and patients.

(d) Providing information concerningadvances in the field of pharmacy and related matters.

(e) Maintaining and publicizing, either elec-tronic or hard copy, an MTF formulary for use in thefacility. MTFs must have the basic core formularyas the basis for their individual MTF formulary. Apharmacy newsletter may be used to publish timelyinformation on pharmaceuticals and preparationsavailable for use, along with other prescribingpolicies and items of interest to the professional staff.

(f) If the facility conducts research withinvestigational drugs: Providing proper storage,safeguarding, labeling, and dispensing of investiga-tional drugs. Maintaining investigational drug files.Publishing essential information concerninginvestigational drugs to personnel who administersuch drugs or care for patients receiving such drugs.Maintaining a reference file copy in the pharmacy ofthe current protocols for all investigational drugsbeing used in the MTF.

(g) Where required to support inpatient care:Operating a pharmacy sterile products program toinclude the preparation and delivery of pharma-ceutical sterile products. Maintaining laminar flowhood quality control requirements which mustinclude cleaning of the equipment used on each shift,and periodic checks for operational efficiency by aqualified inspector at least twice yearly, or when thehood is moved. Maintaining written records of theseactions. Centralizing all sterile compounding pro-cedures within the pharmacy department or itssatellites.

(h) Providing, for safety and economy, a unit-dose system or automatic medication dispensingsystem as the preferred method to distribute pharma-ceuticals to hospital patients at fixed MTFs. Thoughthese systems may differ in form depending onspecific needs, resources, and characteristics of eachMTF, four elements are common to all:


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(b) A distance factor or geographic boundarylimitation will not be the reason for the denial of pre-scription services for outside of the continentalUnited States (OCONUS) MTFs. Inside of thecontinental United States (CONUS) MTFs may onlyaccept civilian prescriptions from CONUS providers.Prescriptions for controlled substances will be filledonly from prescribers in the local area, as defined bythe MTF CO.

(c) Civilian practitioner prescription servicemay not be withdrawn or curtailed without consentof BUMED.

(6) Military, civil service, and contract nursepractitioners, midwives, nurse anesthetists, optome-trists, pharmacists, physical therapists, and physicianassistants privileged to practice in the MTF are autho-rized to prescribe medications and durable productsconsistent with their scope of practice and privileges.

(7) IDCs may write prescriptions when autho-rized, in writing, by the CO. They must prescribeonly those drugs and quantities approved by the COas recommended by the P&T Committee.

(8) Prescriptions from civilian optometrists, nursepractitioners, physician’s assistants, pharmacists, orother non-physician health care providers authorizedto prescribe by State law and not under the employof the Navy will be dispensed following the law ofthe governing State where the MTF resides.

21-5 Outpatient Prescriptions(Regulatory)

(1) Authorized prescribers in the employ of, orserving in, the Navy as described in article 21-4 willuse electronic-order-entry, DOD Prescription (DD1289), or Poly Prescription (NAVMED 6710/6). Seespecial provisions for IDC personnel in article 21-50(1). Prescriptions are acceptable when written byauthorized prescribers on prescription forms autho-rized by other services and forms conforming to theState pharmacy laws from civilian practitioners.

Retired military physicians, possessing a currentlicense, may use the DD 1289 to write prescriptionsfor personal use, except for controlled substances.(See article 21-22(5).)

(2) Prescriptions must be written in ink, indeliblepencil, or typewritten and must show the following:

(a) Patient’s full name.

(b) Date prescription was written.

(c) Patient’s age or date of birth and weight(if 12 years or younger). If the child’s age or weightis omitted, the pharmacy may record the child’s ageor weight on the prescription.

(d) Full name of drug, form of drug, dosagesize or strength written in the metric system, andquantity to be dispensed. Prescriptions should bewritten generically.

(e) Directions for the patient.

(f) Legible signature of the prescriber.

(g) Refill authorization (as applicable).

(h) Additional requirements for controlledsubstances are found in article 21-27.

(i) When prescriber-order-entry electronicpharmacy systems are used, the electronic signatureis acceptable for all prescriptions, non-controlledsubstances and for controlled substances in SchedulesII through V. However, if a patient chooses to havea prescription filled in a community pharmacy orthrough the TRICARE Mail Order Program (e.g.,TMOP), the physician is required to write a tradi-tional prescription and sign it as required by 21 CFR1306.05(a). Prescriptions for Drug EnforcementAdministration (DEA) scheduled medications filledoutside the MTF must also have the practitioner’sDEA number on the prescription.

(3) Outpatient prescription containers must belabeled properly and include:

(a) The MTF dispensing the prescription,including the pharmacy telephone number.

(b) Identifying serial number (prescriptionnumber).

(c) Patient’s full name.


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(d) Date the prescription is originally filledor date refilled.

(e) Clear, concise directions to the patient.

(f) Full name of drug, strength, and quantitydispensed. Pharmaceutical preparations will norm-ally be identified and labeled with the generic name.However, trade or brand names may be used if thetrade or brand name product actually is in the con-tainer. The use of the word “type” or “equivalent” isacceptable on the label (such as, Tenormin “type”).

(g) Prescriber’s name.

(h) Typist’s initials.

(i) Number of refills remaining.

(j) Expiration date, if applicable.

(k) Proper auxiliary or cautionary labels asindicated.

(4) Telephone or oral prescriptions will not beaccepted, except in an emergency or under extra-ordinary situations, directly from an authorizedprescriber. Emergency prescriptions must be reducedto writing within 72 hours. Civilian prescriptionsmay be faxed to the pharmacy, in accordance withlocal policy, and State law for the State in which theMTF resides. Orders from providers within the MTFmay be faxed, and will be considered as the originalorder. Prescription information intended for thepurpose of filling or refilling a prescription throughthe establishment of a virtual pharmacy (Internet)may be used if safeguards for patient privacy andprovider identification are established. Each trans-action must comply with the requirements in article21-5(2).

(5) Prescriptions should be personalized. If morethan one member of a family is prescribed the samemedication, a separate prescription blank will be usedfor each member. Should more than one member ofa family be prescribed the same medication on a sin-gle prescription blank, each member must be identi-fied on said prescription. In the case of CompositeHealth Care System (CHCS) provider generatedlabels, each family member must have their ownprescription entered and label generated. Thepharmacy may record the identification of themember upon receipt of the prescription, if omitted

by the prescriber, to facilitate proper labeling andwhere available, record the medication in thepharmacy’s patient medication profile system.

(6) Prescriptions for animals, other than thoseowned by the Government, will not be filled.

(7) MTFs will not be routinely dispensed pre-scriptions by mail. A TRICARE mail order benefit(e.g., TMOP) has been established as an option andshould be used by eligible beneficiaries. Pharmacystaff will refer patients who choose to use a mail orderprogram to the TRICARE program. Exceptions, withprior approval by the MTF CO or pharmacy depart-ment head may be authorized, but each situationshould be evaluated on an individual basis. In allcases, an individual’s eligibility and entitlement toprescription services will be determined before fillingand mailing any prescriptions. Mailing of pre-scriptions will follow the United States Postal ServiceDomestic Mail Manual.

(8) Each MTF must have written procedures fordrugs recalled by the Food and Drug Administration(FDA). These procedures must be implementedreadily and the results documented. The recall pro-cedures will require the inspection of all MTF areasand recall of products quarantined. Drug recallsaffecting outpatients will apply only if directed bythe recall notice or the CO. Information pertainingto drug manufacturer, lot number, and expiration dateis not required if there is a drug recall procedure thatcan be readily implemented.

(9) All controlled substances prescribed, includ-ing those for medical and dental staff members, willbe noted in the member’s health or dental record atthe time prescribed.

(10) Except in extraordinary situations, practi-tioners may not prescribe controlled substances forpatients who are not under their direct care.

(11) At their discretion, MTFs may direct patientswith civilian prescriptions to use the TMOP or theManaged Care Support Contractors (MCSC) pharm-acies to fill certain special medications not routinelyprovided by the MTF formulary. However, the MTFpharmacy must fill, or provide the opportunity to havefilled, all prescriptions written by its providers. Thisdoes not preclude the patient from choosing to havethe prescription filled elsewhere. MTFs should fill100 percent of their enrollees prescriptions.


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(12) Prescriptions will be honored when writtenby a military medical facility acting in a consultantcapacity. If the drug is not on the formulary, it willbe processed according to the MTF’s policies andprocedures for evaluation and acquisition of non-formulary drugs. Prescriptions from non-referralMTFs and civilian providers for non-formulary drugsneed not be honored.

(13) Prescription medications for oral use byoutpatients will normally be dispensed in child resis-tant containers unless the patient or prescribingpractitioner requests conventional (non-childresistant) closures. These requests for non-child proofcontainers must be authorized by a notation in CHCSfor the individual prescriptions or in the pharmacycomment section in accordance with the PoisonPrevention Packaging Act of 1974. If CHCS is notavailable, then these prescriptions must be authorizedby the patient’s signature and such documentationmust remain on file within the MTF.

(14) Acceptance of pharmaceutical samples fromsales representatives for dispensing to patients isprohibited. Should a practitioner desire to evaluatea pharmaceutical, the pharmacy department head willrequest a review by the P&T Committee. If approvedby the P&T Committee:

(a) Parameters will be established to allowevaluation.

(b) The product will be purchased via estab-lished procedures.

(c) After a reasonable evaluation period, theP&T Committee must determine if the product war-rants formulary status.

(15) Pharmacy personnel will not fill pre-scriptions that are illegible, incompatible, or if thereis question of dosage, interaction, allergy, or methodof administration. Pharmacy personnel may clarifythese prescriptions with the prescriber, and fill theprescription after the patient safety concerns havebeen addressed.

(16) A system designed to protect patient privacyand assure accurate identification of outpatients atthe time they receive prescribed medications mustbe established. A pharmacist may use professionaljudgment and experience with common practice tomake reasonable inferences of the patient’s bestinterest in allowing a person, other than the patient,

to pick up the prescription. Individuals receivingmedications for beneficiaries other than themselvesor their minor children should provide reasonableproof of patient consent for the release of medicalinformation and prescriptions.

(17) Use of over the counter (OTC) self-caremedications. The MTF CO or OIC may authorize alimited number of OTC drugs to be dispensed fromthe pharmacy in conjunction with a self-care program.A self-care program is defined as a program that usesa non-physician health care screener to assess apatient’s symptoms. The provider or screener eitherrecommends which OTC drugs to select from a listat the pharmacy, or refers the patient for moredefinitive care. When authorized by the CO, the P&TCommittee will develop a list of OTC items that maybe dispensed without a prescription using the follow-ing guidelines:

(a) Quantities dispensed are limited to onetreatment regimen or a few days supply for relief ofa current condition.

(b) OTC items are limited to treatment ofminor problems such as headaches, common cold,indigestion, or mild dermatitis.

(c) OTC items must be labeled per Federalregulations and provide adequate directions to thelayman for safe and effective use and also providewarnings and cautions against misuse. OTC itemsmust be dispensed in the manufacturer’s originalcontainer.

(d) MTFs with an operational, fully capable,automated pharmacy computer system must recordthe OTC drug, strength, and quantity into the patientprofile. MTFs not having a pharmacy computersystem do not have to enter OTC items into thepatient’s medical record, but pharmacies must keepseparate records to preclude abuse of the service.

(e) Each OTC item dispensed must becounted as a pharmacy work unit equal to a pre-scription.

(f) Each OTC encounter must be documentedas outlined in the coding instruction.

(g) When pharmacies are closed, OTC itemsmay only be dispensed consistent with policiesgoverning dispensing from treatment centers.


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(h) The following items must be included onthe locally developed pharmacy dispensing form:

1. Title - OTC medication request.2. Certification by signing the following

statement: “I understand the medicationis for use in minor illnesses or conditionsand if symptoms worsen or do notimprove within 48 hours, the person forwhom the medication is intended shouldbe seen by a medical provider.”

3. Sponsor’s name.4. Sponsor’s social security number.5. Recipient’s name.6. Duty or home telephone number.7. Date.8. Signature of recipient.9. List OTC items approved by the P&T

Committee.10. Appropriate Privacy Act statement.

(18) MTFs must have written procedures forobtaining drugs when the pharmacy is closed andpharmacy personnel are unavailable.

(19) Report and record dispensing errors involv-ing incorrect medication, strength, dosage, directions,etc.

Note: A form or electronic method similar to Figure 21-1 below is suggested for tabulating and reporting medica-tion misadventures to the P&T Committee and any qualityimprovement activities deemed appropriate at thecommand.

Type of Errors:

A - Wrong MedicationB - Wrong StrengthC - Incorrect SIGD - Wrong PatientE - Mixed Medications in VialF - OmissionG - Wrong Dosage Form or RouteH - Wrong Preparation or QuantityI - Extra DoseJ - Wrong DoseK - Wrong RateL - Other

Break Down Point in Process:

0 - Wrong Medication Dispensed1 - Labeling Problem2 - Physician Order Problem3 - Communication Problem4 - Medication Administration Error5 - Transcribing Error6 - Charting Error7 - Verbal Order vs. Written Order8 - Other

[Figure 21-1]

(20) When a pharmacy receives a prescriptionrefill request but no further refills are authorized, andthe patient is unable to readily obtain a new pre-scription, the pharmacist may use professional judge-ment to dispense a one-time emergency refill. Theamount should be of a reasonable amount, up to a 1-month supply, to maintain the patient until the patientcan contact the prescriber. The decision should beguided by:

(a) The prescription is not for a controlledsubstance drug listed in DEA Schedules II throughV. An exception: Controlled substance medicationsused for seizure control may be provided in a quantitynot to exceed a 72-hour supply (e.g., Clonazepamand Phenobarbital).

(b) The medication is essential to maintainlife or continue therapy of a chronic condition.

(c) The interruption of therapy might reason-ably produce undesirable health effects or causephysical or mental discomfort.

Note: The pharmacy must record on the front of theprescription or on another uniformly maintained, readilyretrievable record, such as a computerized patient profile;the date, quantity dispensed, the words “emergencyrefill” and the dispenser’s initials or name.


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(a) Inpatients will be provided therapeuticdietary supplements consistent with appropriate pro-fessional care as directed by a physician or dentist.For inpatients, the dietary department, supply depart-ment, or appropriate department must store, prepare,and distribute these items. If any medication is addedto a dietary product, the pharmacy department willprepare the compound.

(b) Outpatients, under the care of an MTFphysician or dentist, will be provided these items onlyin exceptional cases. The Nutritional Support Com-mittee or P&T Committee and the CO will reviewthe need on an individual basis. For outpatients, theseitems will be stored and dispensed by the MTFdietary department.

(c) Patients with aminoacidopathies consist-ing of phenylketonuria, maple syrup urine disease,homocystinuria, histidinemia, and tyrosinemia whoare under the care of an MTF provider, will be givenspecial amino acid modified nutrient preparations bythe pharmacy or dietary department upon presenta-tion of a valid prescription. The CO will ensure thatsuch individuals are under close medical supervisionand are supplied with required dietary supplements.The pharmacy or dietary departments will maintainadequate supplies to avoid disruption of patient care.

(31) Refills for maintenance medications may berequested when 75 percent or more of the prior pre-scription has been used. A pharmacy officer mayauthorize an early refill, under special circumstances(e.g., patient on travel out of the area, contingencyoperations).

(32) Prescriptions from MTF authorized pro-viders for formulary drugs will be honored.

(33) Prescriptions for formulary medications,written by physician extenders who are duly cre-dentialed at one MTF, may be filled or refilled atother MTFs at the discretion of the CO.

(34) Prescriptions written by MTF prescribersshall be dispensed from that facility unless thebeneficiary chooses another option.

(35) The MTF CO and P&T Committee shall re-view the alignment of the MTF formulary to themission and scope of care of the MTF and the needsof the population the MTF serves. The MTF CO shallconsider enterprise impact of formulary decisions.

Cost-effective formulary management does notinclude selective deletion of medications commonlyprescribed by MTF providers, but considered by theMTF as too costly to maintain on the MTF formulary.Major changes to the MTF formulary must becoordinated through BUMED.

21-6 Inpatient Dispensing(Regulatory)

(1) The primary means of inpatient drug distribu-tion in fixed inpatient treatment facilities will be theunit-dose system or automated medication dispensingsystems which must include the pharmacist interpret-ing the physicians orders and monitoring inpatientmedication needs.

(2) The preparation of sterile products, (e.g.,chemotherapeutics, large and small volume intra-venous admixtures, and irrigations) is an importantpart of the drug delivery system. Centralizing allsterile compounding within the pharmacy departmentis recommended where resources permit. COs willensure USC 795 and 797 are observed. The phar-macy department head is responsible for providingwritten guidelines and approving procedures for pre-paring, sterlizing, and labeling parenterals wheneverthese functions are not performed under directpharmacy supervision.

(3) Monthly checks will be made by the pharmacyof all nursing care units or other areas where medi-cations are dispensed, administered, or stored, toverify that at the minimum:

(a) Drugs for external use and disinfectantshave been stored separately from internal and inject-able medications.

(b) Drugs are not overstocked.

(c) Drugs are stored following current estab-lished standards.

(d) Outdated or unusable drugs have beenidentified and their distribution and administrationprevented.


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(e) There is an adequate and proper supplyof medical staff-approved emergency drugs.

(f) All drugs in the area are properly labeled.

(4) Automatic stop orders for drugs dispensedto inpatients are to be determined by the medical staffand the P&T Committee. Drugs to be included inautomatic stop order policies are antibiotics, anti-coagulants, controlled substances, hypnotics, andsedatives. Standing drug orders must be automat-ically canceled when a patient undergoes surgery.There must be a system to notify the practitionerresponsible for the patient of the impending expira-tion of a drug order, so the practitioner may determinewhether the drug administration is to be continuedor altered. NPSG and medication reconcilationprocedures must be followed.

(5) The pharmacy is responsible for labeling ofmedications. All medications issued in bulk con-tainers to nursing care units or clinics not dispensedin the original container, must be labeled by the phar-macy with the date of issue, generic and trade name,strength, quantity, expiration date, name of the manu-facturer, and lot number or appropriate code toidentify the drugs. A repacking expiration date, notto exceed 1 year or the actual manufacturer’s expira-tion date whichever is less, will be added to drugsdistributed in other than the original manufacturer’spackage. To minimize contamination, waste, andfloor stocks, the use of unit-dose drugs available incommercial packages is recommended for fixedMTFs. This permits drug identification up to theactual time of administration.

(6) Drugs issued to clinics for subsequent reissueto patients will be adequately labeled in the pharmacy.Information listed in article 21-5(3)(a), (e), (f), (j),and (k) must be included on the label in the pharmacyor must be added in the clinic.

(7) Inpatient self-care and discharge medicationsshould be labeled as outpatient prescriptions follow-ing article 21-5(3).

(8) Nursing personnel will collect all medicationsbrought to the hospital by patients admitted to nursingcare units. Whenever possible, these drugs will begiven to a member of the patient’s family to return tothe patient’s home for safekeeping. Medicationscollected in this manner will not be retained by thepatient, unless an order is written by the practitionerresponsible for the patient that the patient may use

his or her own medication, (e.g., “keep personalmedications at bedside,” or “patient may take ownmedications”). Those medications not given to afamily member will be stored at the nursing unit, inthe pharmacy, or at a central location (e.g., valuablesvault). All medications will be identified, inventor-ied, secured, and held until the patient is discharged.The medications may be returned to the patient upondischarge. Any medications remaining 15 days afterdate of discharge may be destroyed following locallyestablished destruction procedures.

21-7 Drug Stock(Regulatory)

(1) Personnel handling medications must under-stand their actions and know the dosage range andcontraindications. Pharmacy leaders will ensurenecessary continuing education is provided to indivi-duals dispensing medications and counselingpatients.

(2) The Prime Vendor System exists to serve theneeds of the Medical Department. Generally, PrimeVendor will be used for pharmaceutical purchasing.Exceptions may be made for small purchases of pro-ducts unavailable from the Prime Vendor.

(3) Pharmaceutical inventory will be managed toensure the stock levels of pharmaceuticals on-handare not excessive, generally not greater than 7 days.

(a) MTFs will establish drug inventory paror stock levels that reflect the level of care, prescrip-tion workload, and mission.

(b) Pharmacies may have situations thatrequire stocking levels that are greater than 7 days,examples include: OCONUS facilities, controlledsubstances, special pricing, and end of year buys.The pharmacy must be able to justify the costs andbenefits of situations that may require greaterstocking levels.

(c) Facilities will verify, at least annually, thatpharmaceutical stock levels are adequate but notexcessive, and are aligned with the MTF mission.


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(a) Use strict aseptic technique.

(b) Upon reconstitution, date an MDV thatrequires addition of a diluent, and discard followingthe manufacturer’s stability data.

(c) Discard any opened MDV, which does notrequire addition of a diluent, on the expiration datespecified by the manufacturer’s label.

(d) Discard contaminated vials immediatelyupon detection.

(e) Do not store MDVs in the MTF refrigera-tor unless required to do so by the manufacturer.

(f) Include observation of adherence to thisarticle in the monthly inspections required by article21-3(4)(b).

(13) A log of all medication placed in storagecounting cells (e.g., Baker cells, drug-o-matic) willbe maintained to include initials of the pharmacistor senior technician checking the filled cell, manu-facturer, lot number, and expiration date.

21-8 Antidotes andAntidote Lockers

(Regulatory)

(1) MTFs having emergency room services arenot required to have antidote lockers, but must haveall appropriate medications as determined by theP&T Committee.

(2) MTFs without emergency room servicesshould maintain an antidote locker as prescribed byNAVMED P-5095, Drugs, Poison Overdoses, Anti-dotes, and Emergency First Aid, available at: http:/navymedicine.med.navy.mil/default.cfm?selTab=Directives (select the Publications tab on the left-hand side of the page) or through the Navy SupplySystem, NSN 0510-LP-096-9000; however it is atthe discretion of the MTF CO.

Note: There are no articles 21-9 through 21-19.

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(a) Schedule I. Drugs with no acceptablemedical use and a very high abuse potential.

(b) Schedule II. Drugs having an acceptablemedical use and a very high abuse potential.

(c) Schedules III, IV, and V. Drugs having anacceptable medical use which are considered to havelessening degrees of abuse potential.

Note: Products may migrate between schedules and newproducts may be added.

21-20 General(Regulatory)

(1) Controlled substances, as used herein, aredrug schedules in the Controlled Substance Act of1970 (Public Law 91-513) and ethyl alcohol.

(2) There are five schedules designated by section202 of the Federal Act:

Section IICONTROLLED SUBSTANCES

Article Page21-20 General (Regulatory) 21-19

21-21 Accountability (Regulatory) 21-20

21-22 Prescribing (Regulatory) 21-20

21-23 Custody (Regulatory) 21-21

21-24 Security (Regulatory) 21-21

21-25 Reporting Theft or Loss (Regulatory) 21-22

21-26 Deterioration (Regulatory) 21-22

21-27 Dispensing by Pharmacy (Regulatory) 21-23

21-28 Control by Nursing Care Units and Clinics (Regulatory) 21-24

21-29 Control by Branches to Pharmacy Service (Regulatory) 21-25


21-20 Change 121 7 Feb 2005

(3) Local commands may designate certain drugsas having abuse potential and require security mea-sures similar to those for controlled substances. TheCO will establish special security and accounting pro-cedures for these command-sensitive items desig-nated as “Locally Controlled Substances.”

(4) Alcoholic beverages must not be stocked ordispensed from Navy MTFs. Ethyl alcohol will notbe dispensed to patients.

21-21 Accountability(Regulatory)

(1) Schedule I and II controlled substancesrequire vault or safe storage and inventory by theControlled Substance Inventory Board (CSIB) (perarticle 21-24). Working stock may be kept in a lockedarea within the pharmacy. A copy of the safe com-bination must be kept in a sealed envelope depositedwith the CO or representative.

(2) Schedule III, IV, and V controlled substancesrequire locked cabinet security for storage of bulkdrugs. A minimum amount of working stock may bedispersed among other pharmacy stock, provided thepharmacy itself is secure. Otherwise, all stock in thiscategory must be kept in a locked cabinet. Theappointed pharmacy custodian will conduct an annualinventory and audit of all Schedule III, IV, and Vcontrolled medications. See article 21-7(3)(d) forinventory management control requirements.

21-22 Prescribing(Regulatory)

(1) All prescribers authorized in Section I mustprescribe controlled substances either by electronic-order-entry or on the DD 1289 or by coded facsimileif appropriate. NAVMED 6710/6, the Poly Prescrip-tion, may be used to prescribe for a controlled sub-stance only if no other type of drug is prescribed onthe poly prescription at the same time.

(2) Authorized prescribers, when prescribingdrugs in an official capacity within the scope of theControlled Substances Act, are exempt from registra-tion under provision of section 1301.25 of the Act.A prescriber exempted from registration under sec-tion 1301.25 must include on all prescriptions theprescriber’s branch of service or agency (e.g., “USN”or “Public Health Service”) and social security num-ber in lieu of the DEA registration number requiredon civilian prescriptions. In addition, section 1306.05of the Act requires each prescription have the nameof the prescriber stamped, typed, or hand printed onit, as well as the signature of the prescriber. Practi-tioners using prescriber-order-entry electronicpharmacy systems are exempt from the signaturerequirement of 2l CFR 1306.05(a) and 21 CFR1306.11 when the prescription is filled at the MTF.This exemption does not apply when the prescriberprovides professional treatment outside officialduties.

(3) An officer or civilian employed by the Navy,who has been designated by the command to purchaseor procure from commercial sources controlled sub-stances or preparations for official use, must be sodesignated on the command’s registration filed withthe Registration Branch, Drug Enforcement Adminis-tration, Department of Justice, Washington, DC20537. Only individuals so designated may sign theofficial order form for Schedule II substances. Gov-ernment registration is for 1 year, but individualsdesignated may be changed as necessary by letter toDEA, signed by the CO.

(4) Ordering, receipt, custudy, and issuance mustfollow Navy audit and chain of custudy businesspractices.

(5) Authority for physician assistants to prescribeSchedule II through V controlled substances may begranted by the CO, if within their scope of practiceand designated in their privileging documents.

(6) No person will prescribe or furnish a con-trolled substance for themselves or members of theirimmediate family.

(7) Providers will prescribe controlled substancesonly for patients under their direct care. Only underextraordinary circumstances will controlled sub-stances be prescribed for a patient that was notpersonally evaluated by the prescriber at the time acontrolled substance was prescribed.


21-22 Change 121 7 Feb 2005

will appoint each member, in writing. Senior enlistedpersonnel in pay grades E-7 through E-9 and Depart-ment of the Navy civilians in grades GS-7 and abovemay serve as members at the discretion of the CO.Additional members may be appointed per article21-29. The senior officer assigned to the board willbe designated as the senior member. At least oneofficer of the board must be a Medical Corps, DentalCorps, Medical Service Corps, or Nurse Corpsofficer, except when not available. No member ofthe board may be directly responsible for the sub-stances being inventoried. A sample of all prescribedaccounting records and prescriptions for the account-able substances for the audit period will be checkedfor compliance with regulations, particularly as todating, proper preparation, and required signature.The board must ensure the records inspected consti-tute a complete audit trail, and reflect transactionsthat occurred during the accounting period. Phar-macy stock, perpetual inventory records, requisitions,receipts, and issue documentation must be audited.The identity of any questionable items of inventoriedstock must be ascertained. Nursing records andoutpatient clinics that store controlled substancesmust be checked to verify proper accounting for alldocuments and medications. Supply departmentrecords must be checked, as required, to verify properaccounting for all documents. For this purpose, thesupply department must provide, directly to the seniormember of the board, a copy of all issue documentsfor Schedule I and II controlled substances and ethylalcohol.

(d) See article 21-46 concerning ControlledDrug Inventory Report. BUMEDINST 6710.70 ser-ies provides guidance for Controlled SubstancesInventory Boards.

21-25 ReportingTheft or Loss(Regulatory)

(1) Notify the nearest DEA regional office uponthe discovery of theft or significant loss of anycontrolled substance following DEA regulations. Thehead of the pharmacy department, in conjunction withthe senior member of the CSIB or other appropriatehigher authority, will determine if a significant lossoccurred. Report a theft or significant loss immedi-ately, using Report of Theft of Controlled Substances,DEA Form 106. Prepare an original and three copies.Send the original and one copy to the nearest DEAregional office, one copy to BUMED, and one copyto the nearest field representative of the NavalCriminal Investigative Service. The consignee mustsubmit a sworn statement of facts with the DEA Form106, if the controlled substances are stolen or lost intransit.

(2) Report any unreconciled narcotic inventorydiscrepancies to the senior member of the CSIB orappropriate higher authority.

21-26 Deterioration(Regulatory)

(1) The bulk stock custodian will report to theCO Schedule I through V controlled substances, ethylalcohol, and locally controlled drugs, which havedeteriorated and are not usable, are of questionablepurity or potency, or have had their identity com-promised. The appointed custodian may requestauthorization to destroy deteriorated products andrecommend a method of destruction (e.g., incinera-tion). If destruction is indicated and directed by theCO, destruction must be accomplished in the pre-sence of a member of the CSIB. A certification mustinclude the complete nomenclature and quantity ofthe substances to be destroyed, together with themethod to be used to accomplish destruction. After


7 Feb 2005 Change 121 21-23

certification is completed, approved by the CO, andsigned by the members witnessing destruction, thecertification must be retained in the files as authorityfor dropping the items from the appropriate record.DEA notification is not necessary.

(2) Destruction may also be accomplishedthrough a return goods contractor, if the contractoris authorized by the DEA.

21-27 Dispensing byPharmacy

(Regulatory)

(1) The pharmacy must serve as the source fromwhich nursing care units, clinics, and other depart-ments of a facility normally obtain controlled sub-stances for use in connection with the treatment ofpatients. Authorized outpatient prescriptions forcontrolled substances must be filled by the pharmacy.Ethyl alcohol may be issued directly to the laboratoryproviding such stocks are included in the quarterlyaudit conducted by the CSIB.

(2) Controlled substances must be dispensed tooutpatients on receipt of a prescription completedfollowing article 21-22 with the following additionalrequirements:

Exception: Schedules II through V controlled substanceswhen prescribed via prescriber-order-entry electronicpharmacy system.

(a) Prescriptions for controlled substancesmust be written in ink, typewritten, or entered throughprescriber-order-entry electronic pharmacy system.Duplicate, carbon copy, photographic reproduction,preprinted, rubber-stamped, or addressographedorders are not valid prescriptions for controlled sub-stances, unless authorized by law of the State in whichthe MTF resides, and approved by the MTF CO orOIC. In all cases, the prescriber’s signature must behandwritten.

Exception: See article 21-5(28).

(b) Must contain the complete address of theperson for whom the prescription is written and maybe supplied by patient or agent at time of dispensing.

(c) The legible signature and social securitynumber of the Medical Department member author-ized to prescribe per article 21-4. In addition, thename of the prescriber must be stamped, typed, orhand printed on the prescription.

(d) Erasures or interlineations on prescrip-tions for controlled substances are prohibited, unlessinitialed by the prescriber. This does not precludepharmacy personnel from annotating, after contactingthe prescriber, that a therapeutic substitution isnecessary due to the unavailability of the productprescribed.

(e) Each controlled substance prescriptionmust be a separate document. Controlled substanceprescriptions written on a poly prescription in com-bination with other prescriptions are not valid, unlessspecifically allowed by the law of State in which theMTF resides, and approved by the MTF CO and OIC.

(3) Controlled prescriptions will be reviewed forauthenticity before dispensing the prescription. ThePharmacist’s Manual, published by the U.S. Depart-ment of Justice, should be used as a guideline fordetecting fraudulent prescriptions. (The Pharmacist’sManual may be obtained from U.S. Department ofJustice, Drug Enforcement Administration, Washing-ton, DC 20357-0001.)

(4) Prescriptions for Schedule II controlled sub-stances must not be refilled. (See article 21-5(22)for time and refill limits on prescriptions.) If a suffi-cient supply of a Schedule II controlled substance isunavailable to fill a prescription, a partial quantitymay be dispensed if requested by the patient. In suchcases, the provider will be notified and a new pre-scription will be required for the balance. The quan-tity dispensed must be noted on the front of the pre-scription or by appropriate means for provider-order-entry prescriptions.

(5) Prescriptions for Schedule II controlled sub-stances must be dated, have the quantity dispensedannotated, numbered, and signed by the dispenseron the front of the prescription, at the time of filling.The reverse side of the prescription must include the


21-24 Change 121 7 Feb 2005

wording “received by” in addition to date, address,telephone number, and signature of the recipient ofthe drug item.

Exception: None.

(6) A separate prescription file must be main-tained for prescription records of Schedule II con-trolled substances.

(7) Prescription records of controlled substanceslisted in Schedules III, IV, and V must be maintainedseparately from all other records of the pharmacy.Discharge orders containing a Schedule III throughV controlled substance must be filed with the con-trolled substance prescription records.

(8) Ethyl alcohol, although not included in anyschedule of the Controlled Substances Act, must bereceived, accounted for, and dispensed in the samemanner as Schedules III, IV, or V substances. Patientprescriptions for this substance will not be filled.Internal prescriptions for ethyl alcohol for hospitalor clinic use must be given a serial file number andmust be filed with all other prescriptions of similarschedule.

(9) Schedule II controlled substances issued tonursing care units and branch medical clinics mustbe accompanied by forms outlined in Section III.

(10) Controlled substances must be dispensedwith labels affixed following Section I of this chapter.A label with a clear, concise warning that Federallaw prohibits transfer of the controlled substance toany person other than the patient for whom it wasprescribed must be affixed to the containers. In addi-tion, controlled substances dispensed to nursing careunits and clinics must identify the DEA schedule onthe pharmacy label or manufacturer’s label.

(11) Accounting is required for controlled sub-stances used in the manufacture of pharmaceuticalpreparations. Prescription forms will be used toaccount for all controlled substances used in themanufacture of pharmaceutical preparations. Suchorders will be authenticated and signed by thepharmacists in charge of manufacturing and filed inthe appropriate prescription file. The product willbe assigned a local prescription, batch, and lot num-ber. The scheduled product will be posted to thepharmacy stock record, unless it is an extempora-neous compound dispensed for a specific single

patient prescription, or a product containing alcoholwhere the only controlled substance in the productis alcohol.

(12) Controlled substance histories recorded inpatient medication profiles for prescriptions thatoriginate from civilian practitioners will be madeavailable to MTF prescribers. Based upon pharmacyautomation capability, controlled substances pre-scribed for patients by civilian practitioners are auto-matically recorded and maintained in the patient’scomputer-generated medication profile. Upon re-quest from MTF prescribers, the pharmacy depart-ment will provide the requesting practitioner’s a copyof the patient’s automated medication profile.

(13) A hard copy order and prescription file sys-tem is not required when an electronic-order-entrysystem approved by the DEA is used.

21-28 Control by NursingCare Units and Clinics

(Regulatory)

(1) To provide effective and adequate custodyand audit trail accountability for controlled substancedistribution and protection, the following controlsmust be enforced:

(a) A registered nurse or a medical or dentalofficer will be charged with custodial responsibilityfor controlled substances following this article andother directives that may be issued.

(b) The custodian of these substances mustnot permit any such substances to be placed in thepossession of other personnel in quantities greaterthan the amount required for immediate consumptionby the patients.

(c) The custodian must maintain a locked con-tainer, cabinet, or compartment of an approved natureto keep such substances. Medication storage andpreparation areas must be locked unless personnelworking in the area have a continuous, unobstructedview of the area. Keys to the containers must remainin the custody of the individual responsible and trans-ferred only to another authorized professional.


7 Feb 2005 Change 121 21-25

(2) Each nursing care unit, clinic, or other activitydrawing controlled substances from the pharmacymust maintain a loose-leaf notebook containing theNarcotic and Controlled Drug Inventory-24 Hour(NAVMED 6710/4) and the Narcotic and ControlledDrug Account Record (NAVMED 6710/1) or similarautomated forms following article 21-42. Thosefacilities using an automated medication dispensingsystem (e.g., Pyxis or SurMed) for inventory controlare exempted from maintaining the written forms,provided policies and procedures are in place cover-ing security, discrepancy resolution, and downtimeprocedures. Such a system must provide accuratedocumentation of the audit trail, including allinformation that would otherwise be documented onthe written form described in Section III.

(3) Controlled substances may be ordered fromthe pharmacy on any suitable form approved by thecommand, and may be signed by an authorizedofficial following article 21-4(1) or by the nursingcare unit charge nurse. The supply of controlled sub-stances to nursing care units and clinics may also beby automatic replacement of dispensed stock at a setlevel by the pharmacy without a signed form.

(4) Pharmacy personnel may deliver controlledsubstances from the pharmacy to various nursing careunits and MTF clinics. If time does not permit, con-trolled substances ordered for nursing care units andambulatory clinics must be picked up by personnelwith custodial responsibility following article 21-28(1). For branch clinic pharmacies refer to article21-29.

(5) Upon receipt of these substances from thepharmacy, the nurse in charge, medical officer, ordental officer must check the amount of drug andcompare serial numbers on the NAVMED 6710/1and the order form or prescription. This step may bewaived in an MTF with a pharmacy controlled auto-matic replenishment system.

(6) The NAVMED 6710/1, and the reverse sideof the DD 1289 or other order form, must be signedand dated in the appropriate space. (See articles 21-42 and 21-43 for information.)

(7) Regulations governing the automatic stoporder for controlled substances are in article 21-6(4).

(8) If a discrepancy exists and cannot be resolved,a report must be made immediately through the nurs-ing supervisor to the director of nursing services or

respective head of service (medical officer custo-dian). Such discrepancies must also be reported tothe head of the pharmacy department and the seniormember of the CSIB.

(9) Schedules III through V controlled substances,stocked in quantities intended for emergency useonly, may be stored within an emergency drug kit orin emergency crash carts. The kits or carts shouldbe equipped with a disposable locking or sealingdevice, and provide adequate security for such con-trolled substances. The stock must be maintained,inventoried, and all required record keeping pro-cedures complied with. The medical staff and COmust approve the medications and quantities stocked.See article 21-24(2)(b).

21-29 Control by Branchesto Pharmacy Service

(Regulatory)

(1) For branch clinic pharmacies not able to ordercontrolled substances directly from a Prime Vendor,controlled substances must be requested and deliv-ered to pharmacy branches by the main pharmacy inthe same manner as hospital nursing care units andclinics are supplied. The branch pharmacy must senda prescription signed by responsible pharmacy per-sonnel for bulk quantities to the main pharmacy. ANAVMED 6710/1, per Section III of this chapter,must accompany issue of Schedule II controlled sub-stances. The command is responsible for deliverymethods. In regions where geographical limitationsor quantities of controlled substances used by thebranch clinic make the above process impracticable,the branch clinic may order its controlled substancesas it does other medical supplies. The same controlsnecessary for the regional supply office pertain. Allreceipts must be signed for by a commissioned offi-cer, pharmacist, or a person appointed by the CO.

(2) The unannounced inventory of Schedule IIcontrolled substances at branch pharmacies must beaccomplished by an additional member to the CSIB,stationed at the MTF being inventoried but havingno custodial responsibilities. Such inventory mustbe called by the senior member of the board and the


21-26 Change 121 7 Feb 2005

results sent to such member, with copies to the branchclinic OIC, or senior medical officer, or representa-tive, as applicable, and the pharmacy department.

(3) At those branch clinics with insufficient staffto form a CSIB in accordance with article 21-24(2),personnel from the host command may be used tocomprise the CSIB.

Note: There are no articles 21-30 through 21-39.


7 Feb 2005 Change 121 21-27

Section IIIFORMS, RECORDS, AND REPORTS

Article Page21-40 General (Regulatory) 21-27

21-41 Prescription Forms (Regulatory) 21-27

21-42 Controlled Substances Forms (Regulatory) 21-28

21-43 Quality Control Forms (Regulatory) 21-30

21-44 Availability of Forms (Regulatory) 21-30

21-45 Publications (Regulatory) 21-30

21-46 Report (Regulatory) 21-30

21-47 Disposition of Records (Regulatory) 21-31

21-40 General(Regulatory)

(1) Records must be maintained describing cer-tain procedures conducted within all Navy medicaland dental facilities. Among mandatory requirementsfor record keeping are the prescribing of drugs, hand-ling of controlled substances, quality control proce-dures, and investigational drug handling. Standard-ized forms are available for all procedures exceptquality control.

(2) All requirements for record keeping may beaccomplished by using pharmacy automated data sys-tems capable of producing readily retrievable reports.

21-41 Prescription Forms(Regulatory)

(1) When electronic provider-order-entry is notavailable, use DD 1289, except as provided in articles21-50(10) and 21-5(2)(i) for all single prescriptions.

(2) The Poly Prescription (NAVMED 6710/6)may be used when a number of drugs are prescribedfor one patient. If used for controlled or investi-gational drugs, no other drugs may be written on theprescription. Restrictions outlined in article 21-5(2)apply.

(3) Prescription blanks provided by or preprintedby a commercial company (i.e., drug manufactureror distributor) will not be used in an MTF. Rubberstamp or addressograph plate may be used on DD1289 or NAVMED 6710/6 for commonly prescribed


21-30 Change 121 7 Feb 2005

(c) Upon completion of inspection, one boardmember must initial the receipts and expenditurescolumns.

(d) The foregoing procedures may be modi-fied to record the information and maintain sur-veillance using computers.

21-43 QualityControl Forms

(Regulatory)

(1) A locally prepared compounding and pre-paration form will be used to provide clearly defin-able material sources (manufacturers’ names, lotnumber, and expiration dates), procedures used,intermediary and final checks by supervisorypersonnel, and sample labeling for all compoundedand repackaged pharmaceuticals.

21-44 Availabilityof Forms

(Regulatory)

(1) Reports generated by electronic data pro-cessing systems may be substituted provided itemsrequired by this chapter are included in such report.

(2) DD 1289 (Rev. 5-72), S/N 0102-LF-012-6201is available through normal supply channels.

(3) NAVMED 6710/1 (Rev. 1-2002); NAVMED6710/4 (Rev. 4-72); NAVMED 6710/5 (Rev. 4-72);and NAVMED 6710/6 (Rev. 3-84) are available onthe Web at: http://navymedicine.med.navy.mil/default.cfm?seltab=directives at the Forms tab.

(4) DEA Form 106, Report of Theft of ControlledSubstances may be obtained from the nearest regionaldrug enforcement office or the Drug EnforcementAdministration, 1405 “I” Street, NW, Washington,DC 20537.

21-45 Publications(Regulatory)

(1) NAVMED P-5095, First Aid for Poisoningand Overdoses, is available at: http://navymedicine.med.navy.mil/default.cfm?selTab=Directives (SelectPublications Tab).

21-46 Report(Regulatory)

(1) Controlled Substances Inventory Report

(a) The Controlled Substances InventoryReport must be prepared and submitted by the seniormember of the CSIB after each inventory. Thepharmacy department may assist in the preparationof the report, but the senior member of the CSIBwill be responsible for the content and delivery ofthe report to the CO or his or her designee. This reportmust list each item in stock, together with its strengthand unit of issue. The pharmacy department mayassist in the preparation of the report. This reportmust list each item in stock, together with its strengthand unit of issue. The report must show the amountremaining from last report, quantity received,quantity expended, and balance on hand.

(b) The Controlled Drug Inventory Reportmust be submitted for approval to the CO by the CSIBstating the inventory was conducted per this chapterand existing local instructions. In addition, this reportmust state the findings (discrepancies) of the boardand any recommendations. MTFs must use theControlled Substance Inventory Audit Criteria andReport forms outlined in BUMEDINST 6710.70series.


7 Feb 2005 Change 121 21-31

21-47 Dispositionof Records

(Regulatory)

(1) All prescriptions, formularies, and drug listsmay be destroyed when 2 years old or supersededand no longer needed for reference. All SchedulesII through V controlled substance prescriptions andaccounting records will be available for at least 2years.

Note: There are no articles 21-48 or 21-49.

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21-32 Change 121 7 Feb 2005

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7 Feb 2005 Change 121 21-33

Section IVDRUG DISPENSING

WITHOUT A PHARMACIST

Article Page21-50 Physician Assistants, Nurse Providers, and Hospital Corps 21-33

Personnel on Independent Duty (Regulatory)

21-51 Operational or Emergency Situations (Regulatory) 21-34

21-50 Physician Assistants,Nurse Providers,

and Hospital CorpsPersonnel on

Independent Duty(Regulatory)

(1) Physician assistants, privileged nurse pro-viders, and hospital corps personnel may be assignedto medical duties on small vessels, shore stations,Fleet Marine Force, and mobile field units to whicha medical officer is not attached. They perform allduties required of the Medical Department. Theseduties include Medical Department administrationand to the extent for which qualified, the professionalduties prescribed for medical officers of ships andstations.

(2) Custodial responsibility for controlled sub-stances and ethyl alcohol must be vested in a com-missioned officer.

(3) Members of the Medical Department of theNavy must not take nor receive into custody, on boardship or in any Navy or Marine Corps establishment,any controlled substances except as authorized:

(a) For medicinal purposes.

(b) For retention as evidence in disciplinaryactions.

(c) By Navy Regulations.

(4) Working stocks of controlled substances maybe issued from the main pharmacy from time to timefor dispensing purposes to the individual in chargeof this pharmacy. This individual must be requiredto keep an accurate record of receipts andexpenditures and to keep these substances under lockwhen not in use. Except as provided above, acustodial officer must not permit any of thesesubstances to be placed in the possession of anyperson in quantities other than that required forimmediate consumption by patients, or for use inemergency, such as combat. All drugs must be dis-pensed under the supervision of Medical Departmentrepresentatives at activities where there are no offi-cers of the Medical Department.

(5) Officers of the Medical Department are autho-rized to issue controlled substances, for medicinalpurposes only, to COs of ships and to pilots of aircraftto which no Medical Corps officer is attached.

(6) An officer of the Medical Department, or ifno such officer is available, then an officer designatedby the CO, must keep in a separate locked compart-ment, all controlled substances, and substances classi-fied as dangerous, or otherwise controlled. The CSIB


21-34 Change 121 7 Feb 2005

must conduct an inventory quarterly or morefrequently per article 21-24. The inventory will beunannounced. A report will be made to the CO. Thekeys must always be in the custody of an officer.Personnel of the Medical Department must assureall such substances under their charge are properlylabeled.

(7) The executive officer, or other designated offi-cer, must arrange for the care and safe custody of allkeys, and require strict compliance with instructionsconcerning the receipt, custody, and issue of con-trolled substances, and ethyl alcohol contained in thelaw, U.S. Navy Regulations, and this manual.

(8) Custodians, or their designated assistants,must retain the keys to the place of storage while onduty. When relieved, they must deliver the keys totheir relief, or to a responsible person designated bylocal instructions. A copy of the combination of asafe, if used, must be sealed in an envelope anddeposited with the CO or an officer designated bythe CO.

(9) The senior Medical Department representa-tive must take charge of the medical storeroom andmaintain custody of the key. However, the medicalofficer, if one is assigned, or such other officer orpetty officer designated by the CO, must be respon-sible for the security of the contents of the medicalstores kept therein. Controlled substances and ethylalcohol must be kept in separate lockers and the keysto these lockers must always be in the custody of anofficer.

(10) Directives issued by fleet force, type com-mander, CO, or other appropriate authority, mayauthorize the following deviations from the controlsestablished in this chapter:

(a) Physician assistants, privileged nurseproviders, or the senior hospital corps member at anactivity not having a medical officer may be autho-rized to deviate from the control procedures estab-lished by this chapter, but not the intent regardingreceipt, custody, and issuance of controlled sub-stances, and other dangerous and controlled drugs.This deviation in no way relieves a command of theresponsibility for controlled material.

(b) Physician assistants, privileged nurseproviders, or senior hospital corps members mayprescribe and administer only those controlled sub-stances listed in the activity’s authorized medicalallowance list (AMAL). Only type commanders,medical officers, or their higher authority may makeany revision or augmentation of controlled substancesin AMALs of activities without medical or dentalofficers. A DD 1289 must be prepared and filedfollowing this chapter. Prescriptions not signed by amedical officer, dental officer, podiatrist, physicianassistant, nurse provider, or civilian physicianemployed by the Armed Forces must be countersigned by the CO or a duly appointed officer repre-sentative. See article 21-5.

(11) Physician assistants, nurse providers, orhospital corpsmen on independent duty are notrequired to use the DOD Prescription (DD 1289) forprescribing drugs, other than controlled drugs, unlessdirected by the CO or higher authority. This doesnot relieve personnel on independent duty fromcomplying with article 21-5(9).

21-51 Operational orEmergency Situations

(Regulatory)

(1) If operational commitments call for deviationfrom the established controls of this chapter, specialinstructions shall be issued by appropriate authorityrelative to the receipt, custody, and issuance of con-trolled substances, ethyl alcohol, and dangerous andcontrolled drugs.


Documents

MANMED Change 121 - Chapter 21...21-4 Change 121 7 Feb 2005 (2) The number of pharmacists and technicians assigned to a facility is determined by the Bureau of Medicine and Surgery