Spring 2020 UM CE Marcie Bough Finalhealth.umt.edu/pharmacypractice/CPE/docs/March 2020 UM CE Boar… · – Contract management, governance and resources, security – Functionality,

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Board of Pharmacy Update

MARCIE BOUGH, PharmDEXECUTIVE OFFICER

JOHN DOUGLAS, RPhBOARD INSPECTOR Certification in Sterile Compounding for Inspectors (CISCI)

March 1 , 2020Recent Drug Developments and Law Update 2020University of Montana Skaggs School of Pharmacy

Disclosure

The presenters declare no actual or potential conflict of interest in relation to this presentation.

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Objectives

1. Understand laws and regulatory updates related to the Board of Pharmacy.

2. Discuss changes to USP <797> 2019 compared to the 2008 version.

QuestionsWhat are the 2019 legislative topics related to the Montana Prescription Drug Registry (MPDR)?

A. FundingB. Integration into electronic workflow systems in medical and pharmacy

practicesC. Mandatory registration D. Mandatory use by prescribers of opioids or benzodiazepines effective July

2021E. All of the above

One major change in the 2019 version of USP <797> relates to the required frequency of viable surface sampling in the certified area. How often must surface sampling be done in each certified area?

A. Every MonthB. QuarterlyC. Every six monthsD. AnnuallyE. At the time of PEC certification

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Board of Pharmacy Members

Tony King, Pharmacist, President

Starla Blank, Pharmacist, Vice-President

Marian Jensen, Public Member, Secretary

Courtney Bahny, Certified Pharmacy Technician

Mike Bertagnolli, Pharmacist

Paul Brand, Pharmacist

Charmell Owens, Public Member

General

Email: [email protected]

Website: www.pharmacy.mt.gov

Phone: 406-841-2300

Customer Service: 406-444-6880

2020 Board Meetings

March 13

June 12

September 18

2020 Subcommittee Meetings

March 12, Automated Dispensing Systems

April 16, Technicians

Marcie Bough, PharmD, Executive Officer406-841-2371, [email protected]

John Douglas, RPh, Board Inspector406-431-1952, [email protected]

Mark Klawitter, RPh, Board Inspector406-459-8847, [email protected]

[Vacant], Program Manager Montana Prescription Drug Registry (MPDR)406-841-2240, [email protected]

Board of Pharmacy Contact Information and Meetings

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Montana Prescription Drug Registry (MPDR)

www.MPDR.mt.gov

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MPDR Interstate Data Sharing• Map indicates states

connected to NABP’s hub (August 2019)

• MPDR is currently sharing with 25 other states: Alaska, Arizona, Arkansas, Colorado, Idaho, Illinois, Indiana, Iowa, Kansas, Louisiana, Michigan, Minnesota, Mississippi, Nevada, New Mexico, North Carolina, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Texas, Virginia, Washington, and Wisconsin.

• Additional states will be added in the future.

MPDR Legislative Audit

Information Systems Audit, The Montana Prescription Drug Registry, 18DP-01, Final Report June 2019

• 9 Recommendations– Contract management, governance and resources, security – Functionality, delegate access – Data destruction, data reporting and validation, data analysis– Utilization of MPDR Advisory Group

• Department of Labor and Industry’s Response Included in Final Report– Ongoing improvements since launched in 2012– Future migration to a new vendor platform to improve functionality – Tools and efficiencies in more advanced systems– Data integration, MPDR Advisory Group, staffing/resources

• Legislative Audit Committee Meeting June 25, 2019– Report: https://leg.mt.gov/content/Committees/Administration/audit/2019-

20/Meetings/June-2019/18DP-01.pdf

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MPDR Next Steps

• Hire new pharmacist position for MPDR Program Manager

• Issue Request for Proposal for a new MPDR system vendor and migrate to a new online platform

– Improve functionality, provide integration and new clinical tools for frontline users, increase use, and improve administrative procedures

• Continue to collect MPDR fees from all Montana licensed prescribers and pharmacists during license renewal

• Collaborate with boards, state agencies, associations, and other stakeholders on outreach/education

• Continue to implement recommendations from Legislative Audit and engage MPDR Advisory Group

• Continue to collaborate on MPDR data research with Department of Public Health and Human Services and other stakeholders

2019 Law Updates House Bill (HB)Senate Bill (SB)

Senate Resolution (SR)

Montana Code Annotated (MCA)Administrative Rules of Montana (ARM)

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Montana Legislature: https://leg.mt.gov

SB 61, Revise Prescription Drug Registry

Sponsor: Sen. MacDonald (D-Billings)Requestor: Board of Pharmacy/Department of Labor & Industry

• MPDR Funding– Permanent funding through fee collection– Fee set in rule commensurate with cost – All licensees authorized under Title 37, MCA, to prescribe or dispense

prescription drugs are required to pay the MPDR fee

• Mandatory MPDR Registration for Prescribers and Pharmacists

• MPDR Data Integration into Electronic Workflow Systems in Medical and Pharmacy Practices

– Electronic health records, health information exchange networks, and pharmacy dispensing systems

– Online service will continue to be available

• Effective 10/1/2019– 37-7-1503(1) and 1511(1), MCA, and ARM 24.174.1712

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HB 86, Generally Revise Prescription Drug Laws(1 of 2)

Sponsor: Rep. Ricci (R-Laurel)Requestor: Department of Justice/Attorney General Tim Fox

• Require Positive Identification of Recipient of Controlled Substance Prescription

– Statute: driver’s license, school district/postsecondary photo ID, tribal photo ID, by Board rule

– Rule: valid government-issued photo ID, including but not limited to passport, military, or state-issued ID

– Requires positive identification of recipient of controlled substance prescription, with exceptions, and documentation

– 37-7-410, MCA; ARM 24.174.842 as identified in MAR Notice No. 24-174-73

• Prescriber 7-day Supply Restrictions for Opioid-naïve Patient – Opioid-naïve defined as no opioid in past 90-days– Does not apply: professional judgement of prescriber for treatment of chronic

pain, cancer pain, palliative care pain; treatment of opioid abuse/dependence– 37-2-108, MCA; terminates 2025– Pharmacists responsible for DEA corresponding responsibility (21 CFR 1306.04)

and practice of pharmacy requirements (37-7-101(38), MCA)

• Effective 10/1/2019

HB 86, Generally Revise Prescription Drug Laws (2 of 2)

Sponsor: Rep. Ricci (R-Laurel)Requestor: Department of Justice/Attorney General Tim Fox

• Mandatory MPDR Use for Prescribers of Opioids and Benzodiazepines– Does not apply: hospice, 7-day supply or less/no refills, administration in health

care facility, or emergencies– Use for chronic pain patient required every 3 months – 37-7-1515, MCA; effective 7/1/2021

• Mandatory MPDR Registration for Prescribers and Pharmacist– 37-7-1503(1) and 1511(1), MCA, and ARM 24.174.1712

• Effective 10/1/2019 - Except MPDR Mandatory Use 7/1/2021

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Other New Laws of Interest (1 of 2)

• SB 274, Revise Drug Scheduling LawsSen. Olszewski (R-Kalispell)

– Listing of controlled substances updated to match recent DEA activity – Cannabis-related FDA approved drugs will match DEA schedule

• Changed dronabinol (Marinol) to Schedule III • Added cannabidiol (Epidiolex) to Schedule V

– 50-32-221 through 232, MCA; effective 4/12/2019

• HB 231, Revising Pharmacy Laws Regarding VaccinesRep. Knudsen (R-Malta)

– Amends 37-7-105, MCA, Administration of Immunizations– Adds pertussis vaccine to list of immunizations pharmacists can

prescribe/administer independently– Allows for age 7 and older through collaborative practice agreement per Centers for

Disease Control and Prevention (CDC) guidelines– Adds various documentation, communication, and notification requirements – 37-7-105, MCA; effective 7/1/2019

Other New Laws of Interest (2 of 2)

• HB 105, Revise Process for Out-of-State Licensure for Professional Licensing BoardsRep. Sullivan (D-Missoula)

– Effective 3/20/2019

• HB 137, Create a Statewide Drug Takeback DayRep. Dudik (D-Missoula)


• HB 555, Ensuring Transparency in Prior AuthorizationRep. Lenz (R-Butte)


• HB 654, Generally Revise Laws for Funding Treatment CourtsRep. Brown (D-Bozeman)

– Department of Revenue licensing of wholesale drug distributors selling opioids into Montana who are licensed by Board of Pharmacy

– $500 annual license fee to help fund treatment courts – Effective 5/6/19; license required after 6/30/2019

• SR 31, Confirm Governor’s Appointees to Health & Human Services Related BoardsSen. Howard (R-Park City)

– Adopted by Senate 3/12/19; filed with Secretary of State 3/18/2019

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Information on PBM Legislation• SB 83, Establishing Allowable and Prohibited Practices for Pharmacy Benefit Managers

Sen. Fitzpatrick (R-Great Falls)

– Montana Pharmacy Association effort – Effective 1/1/2020

• SB 270, Revise Reimbursement Conditions for Certain Pharmacies, PharmacistsSen. McNally (D-Billings)


• SB 71, Regulate Health Insurers’ Administration of Pharmacy Benefits for ConsumersSen. Olszewski (R-Kalispell)

– Requestor: State Auditor Matt Rosendale– Vetoed by Governor 5/9/2019; veto override vote failed

• HB 344, Require Transparency Reporting of Pharmacy Benefits ManagersRep. Kelker (D-Billings)

– Passed House, Failed Senate Floor vote

NOTE: PBM bills/laws relate to drug price transparency, reimbursement, and other pharmacy business issues that are not related to Board of Pharmacy activity or authority but are included as informational.

Contact the Montana Pharmacy Association for details.

Regulatory Updates

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Board Rulemaking MAR 71 (1 of 2)

• Pharmacist to Technician/Intern Ratio

– Expanded pharmacist to technician ratio from 3:1 to 4:1 and interns removed from counting against the ratio

– ARM 24.174.711

• Technician-in-Training (TTR) Licensing

– Changed how TTR are licensed; issue as temporary certified pharmacy technician (PTE) license valid for 1 year

– Must meet PTE requirements except for completion of certification exam– Logistics: license is still called TTR– ARM 24.174.701

• Internship and Preceptor Requirements

– Removed requirements for interns to report hours to the Board– Redirects intern paperwork, forms, documentation, and reporting of hours to pharmacy

school(s)– Removed intern limits for preceptors – Revised other related intern/preceptor requirements– ARM 24.174.602, 604, 612

Final Rule Montana Administrative Register (MAR) Notice No. 24-174-71Effective 9/21/2019

Board Rulemaking MAR 71 (2 of 2)

• Collaborative Practice Agreements

– Removed requirement to submit copy to Board office; must be available upon inspection– ARM 24.174.524

• Prescription Transfers

– Revised to better reflect current practice, remove limitations, and align with existing DEA requirements

– ARM 24.174.835

• Continuing Education Requirements

– Aligns with Department standards– ARM 24.174.2104

• Military Training and Experience for Licensure

– Aligns with Department standards– ARM 24.174.507

• Repeal unnecessary and duplicative rules to align with rule changes and the Department

Final Rule MAR Notice No. 24-174-71Effective 9/21/2019

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Board Rulemaking MAR 72

• Administration of Vaccines by Pharmacists

– Aligns with legislative changes to 37-7-105, MCA, pursuant to HB 231– Age 7 and older per CDC guidelines and collaborative practice agreement– Updated information about patient, product, pharmacist, and pharmacy to be maintained in

patient record– Removed language duplicative to statute– ARM 24.174.503

• MPDR Fee

– Aligns with legislative changes to 37-7-1511, MCA, pursuant to SB 61– All licensees authorized under Title 37, MCA, to prescribe or dispense prescription drugs are

required to pay the MPDR fee – Fee continues to be collected at time of license renewal– ARM 24.174.1712

Final Rule MAR Notice No. 24-174-72Effective December 7, 2019

Board Rulemaking MAR 73

• Positive Identification for Controlled Substance Prescriptions– Implements provisions of 37-7-410, MCA, pursuant to HB 86

– Requires positive identification of recipient of controlled substance prescription, with exceptions, and documentation

– Authorized identification in statute: • Valid driver’s license; a school district/postsecondary photo ID; tribal photo ID

– Authorized identification in rule: • Valid government-issued photo ID, including but not limited to passport, military, or

state-issued ID

– Current reference: ARM 24.174.842 as identified in MAR Notice No. 24-174-73• Effective but not yet updated in rules listed online

New Rule MAR Notice No. 24-174-73Effective January 18, 2020

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Future TopicsNext Proposed Rule • Continuing education programs: remove Board from pre-approval of non-ACPE

programs; revise requirements and audit information

• Prescription transfer: add reference to quantity remaining

• Device license type: new non-pharmacy license for device/DME/medical gas supplier to separate from other facilities; allow for person-in-charge

• Drug kits: combine contingency/emergency drug kits into one rule

Future Rule Topics • Wholesale drug distributors, third-party logistics providers, repackagers, and

manufacturers

• Facility general requirements

• Facility endorsements for compounding, outsourcing facility, and others

• Compounding information and references

• Collaborative practice, inspections, documentation/record keeping, limited service pharmacy, and others

Current Subcommittee Rule Discussions• Automated Dispensing Systems/Machines

• Technicians

Question

What are the 2019 legislative topics related to the Montana Prescription Drug Registry (MPDR)?

A. FundingB. Integration into electronic workflow systems in medical and

pharmacy practicesC. Mandatory registration D. Mandatory use by prescribers of opioids or benzodiazepines

effective July 2021E. All of the above

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Question

What are the 2019 legislative topics related to the Montana Prescription Drug Registry (MPDR)?

A. FundingB. Integration into electronic workflow systems in medical and

pharmacy practicesC. Mandatory registration D. Mandatory use by prescribers of opioids or benzodiazepines

effective July 2021

E. All of the above

THANK YOU

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2019 USP Sterile Compounding Chapter <797> Overview

JOHN DOUGLAS, RPhBOARD INSPECTOR MONTANA BOARD OF PHARMACY Certification in Sterile Compounding for Inspectors (CISCI)

March 1, 2020Recent Drug Developments and Law Update 2020 University of Montana Skaggs School of Pharmacy

United States Pharmacopeia

(USP)

General Chapter <795> Pharmaceutical Compounding—Nonsterile Preparations

General Chapter <797> Pharmaceutical Compounding – Sterile Preparations

General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings

General Chapter <825> Radiopharmaceuticals— Preparation, Compounding, Dispensing, and Repackaging

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Reference:• www.usp.org• www.usp.org/compounding/general-chapter-797

USP TimelineGeneral

Chapter <797> Pharmaceutical Compounding

2019 Revisions

Public comment period July 27, 2018 through November 30, 2018

Open microphone session September 5, 2018

Intended publication date June 1, 2019

Intended official date of December 1, 2019

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Important USP Updates:

• June 1, 2019 – Publication date of revised Chapter <797> (last revised 2008)

• September 23, 2019 – Revised Chapter <797> postponed until further notice

Per USP: “The currently official version of General Chapter <797> (last revised 2008) remains official until further notice”

https://www.usp.org/compounding/general-chapter-797

2019 USP <797> Overview: Sections

1. Introduction and Scope 2. Personnel Qualifications—Training,

Evaluation, and Requalification 3. Personal Hygiene and Garbing 4. Facilities and Engineering Controls 5. Microbiological Air and Surface Monitoring 6. Cleaning and Disinfecting Compounding

Areas 7. Equipment, Supplies, and Components 8. Sterilization and Depyrogenation

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2019 USP <797> Overview: Sections

9. SOPs and Master Formulation and Compounding Records

10. Release Testing 11. Labeling 12. Establishing Beyond-Use Dates 13. Use of Conventionally Manufactured Products 14. Use of CSPs As Components 15. Quality Assurance and Quality Control 16. CSP Storage, Handling, Packaging, Shipping, And

Transport 17. Documentation 18. Compounding Allergenic Extracts

USP <797> Section 1.

Introduction and Scope

This chapter describes the minimum standards to be followed when preparing compounded sterile human and animal drugs based on current scientific information and best practices for sterile compounding.

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Sterile Compounding is the process of combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug or bulk drug substance to create a sterile medication.

Preparing a conventionally manufactured sterile product in accordance with the directions contained in approved labeling provided by the product’s manufacturer is not compounding as long as the product is prepared for an individual patient and follows the provisions for administration.

Administration means the direct and immediate application of a conventionally manufactured product or CSP to a patient. • It is out of the scope of this chapter



• Reconstitution: The process of adding a diluent to a solid conventionally manufactured product to prepare a sterile solution or suspension.

• Repackaging: The act of removing a sterile product or preparation from its original primary container and placing it into another primary container, usually of smaller size without further manipulation.

• Proprietary bag and vial systems (e.g., ADD-Vantage, Mini Bag plus, addEASE):

– Docking and activation in accordance with the manufacturer’s instructions for immediate administration to an individual patient is not considered compounding.

Docking for future activation and administration is considered compounding.

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Category is based on the conditions under which CSPs are made, the probability for microbial growth, and the time period within which they must be used.

Category 1: • All PECs may be placed in an unclassified segregated

compounding area (SCA)

• Beyond use date (BUD):– Controlled room temperature: < 12 hours – Refrigerated: < 24 hours

Category 2: • PECs (LAFS and RABS) must be placed in an ISO 7 positive

pressure buffer room with an ISO 8 positive pressure ante-room.

• BUD: – Controlled room temperature: > 12 hours – Refrigerated > 24 hours

USP <797> Section 2. Personnel

Qualifications Training,

Evaluation, andRequalification

Personnel Qualifications:• Visual observation of hand hygiene and garbing: every 6

months • Gloved fingertip and thumb sampling: every 6 months,

after media fill test • Media fill testing: every 6 months

Core Competencies 12 months (written and hands-on proficiency): • Cleaning and disinfection • Calculations, measuring, and mixing • Aseptic technique • Achieving and/or maintaining sterility and apyrogenicity • Use of equipment • Documentation of the compounding process (e.g.,

master formulation and compounding records) • Principles of HEPA-filtered unidirectional airflow within

the ISO Class 5 area • Proper use of PECs • Principles of movement of materials and personnel

within the compounding area

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USP <797> Section 2. Personnel

Qualifications Training,

Evaluation, and Requalification

Gloved fingertip and thumb sampling: Direct touch contamination is the most likely source of microorganisms.

• Initial gloved fingertip and thumb sampling – before being allowed to compound. – Evaluates a compounder’s competency in correctly

performing hand hygiene and garbing.– No fewer than 3 separate times. – Must be performed on donned sterile gloves in the ISO 7

buffer room or SCA. – Action level ≥1cfu (colony forming units) on both hands.

• Then every 6 months after completing the media-fill test. – Must be performed on donned sterile gloves inside of an

ISO 5 PEC. – Action level >3 cfu (colony forming units) on both hands.

USP <797> Section 3.Personal

Hygiene and Garbing

Before entering a compounding area, at a minimum, individuals must:

• Remove personal outer garments.

• Remove all cosmetics.

• Remove all hand, wrist, and other exposed jewelry including piercings that could interfere with the effectiveness of garbing.

• Not wear ear buds or headphones.

• Not bring electronic devices that are not necessary for compounding or other required tasks into the compounding area.

• Keep nails clean and neatly trimmed to minimize particle shedding and avoid glove punctures. Nail polish, artificial nails, and extenders must not be worn.

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USP <797> Section 3. Personal

Hygiene and Garbing

Hand Hygiene: • Must be performed before entering a

compounding area • Alcohol hand sanitizers alone are not

sufficient • Brushes must not be used for hand hygiene

(potential skin irritation) • Hand driers must not be used (air

turbulence and contamination) • Perform after donning shoe covers, head

and facial hair covers, and a face mask. • The order of garbing must be determined by

the facility • After hands are washed and dried, don

remaining garb except sterile gloves, and then perform hand antisepsis using an alcohol-based hand rub with persistent antimicrobial activity immediately before donning sterile gloves.

USP <797> Section 3. Personal

Hygiene and Garbing

To enter a buffer room or SCA must be properlygarbed.

Garbing Requirements:• Gown (non-cotton, low-lint, sleeves that

snugly fit, enclosed at the neck) • Disposable covers for shoes (low-lint) • Disposable covers for head and facial hair

(low-lint) • Face mask • Sterile gloves (powder free) • If using RABS (CAI or CACI) → disposable

gloves (either nonsterile or sterile) inside of gauntlet gloves, and sterile gloves over gauntlet gloves.

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Facilities and Engineering

Controls

Cleanroom Suite: • All surfaces must be smooth, non-shedding,

resistant to damage. • HEPA filters must be located in the ceiling of the

buffer and ante-rooms. • Returns must be low on the wall. • Pressure –differential monitoring systems must

continuously monitor the pressure differentials. A minimum differential positive pressure of 0.02-inch water column is required between each ISO classified area.

• Line of demarcation in the ante-room. • No tacky surfaces. • Access doors should be hands-free. • Sink may be placed inside or outside of ante-room. • Buffer room must not contain water sources. • Microbiological incubator (if used) must be placed

outside of the classified areas. • Temperature of 20° (68 F) or cooler and a relative

humidity below 60%.



Controls

SCA: • All surfaces must be smooth, non-shedding,

resistant to damage.

• Must be located away from: – Unsealed windows, doors that connect to

the outdoors, and traffic flow. – Environmental control challenges

(restrooms, warehouses, cafeterias, etc.)

• A visible perimeter must establish the boundaries.

• Sink at least 1 meter from the PEC, outside of the perimeter.

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Controls

PECs:

• Placement must allow for cleaning around all PECs.

• Smoke pattern test (under dynamic operating conditions) must be performed initially and every 6 months.

• LAFS (Laminar Airflow Systems) -must be located out of traffic patters and away from room air currents that could disrupt airflow patter inside the PEC.

• RABS (Restricted – Access Barrier System) (CAI and CACI) – the recovery time after opening to achieve ISO 5 air must be documented and followed.



Controls

Added clarifications on Air Exchange Requirements

Compounding Area ACPH Requirement Unclassified SCA No requirement ISO Class 7 room(s) ≥ 30 ACPH (at least 15 from HVAC)ISO Class 8 room(s) ≥ 20 ACPH

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Controls

Certification: • During dynamic operating conditions • Required every 6 months

Certification needs to include: • Airflow testing (air velocity/volume, ACPH (from

HVAC/PEC) • HEPA filter integrity testing (PEC and SEC) • Total particle count testing (all classified areas) • Smoke visualization studies

Recertification:• When changes to the area such as redesign,

construction, or replacement or relocation of any PEC, or alteration in the configuration of the room that could affect airflow or air quality.


Microbiological Air and Surface

Monitoring

Microbiological Air and Surface Monitoring:

• Under dynamic operating conditions • Viable air sampling (each classified area): – Initially and Every 6 months

• Surface sampling (each classified area):– Initially and Monthly

And when: • New facility and equipment certification • After any servicing of facilities or equipment • Identified problems/trends

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https://www.usp.org/


Cleaning and Disinfecting

Compounding Areas

• Must be performed by trained and appropriately garbed personnel using facility-approved agents and procedures, which must be described in written SOPs.

• Minimum Contact Time -the manufacturer’s directions or published data for the minimum contact time must be followed for the cleaning, disinfecting, and sporicidal agents used.

• 70 % IPA (Isopropyl Alcohol) must be sterile.

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Compounding Areas

Table 8 of the proposed revised chapter provides the details the minimum frequency for cleaning and disinfecting surfaces and apply sporicidals in classified areas within the perimeter of the SCA.



Compounding Areas

Cleaning Supplies(e.g., wipers, sponges, mop heads)• Must be low-linting

• Should be disposable

• If reusable must be made of cleanable material and cleaned before and after each use.

• Must be dedicated for use in the classified areas or SCA, and must not be removed except for disposal.

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Equipment, Supplies, and Components

Restricted-access barrier system (RABS): enclosure that provides HEPA-filtered ISO Class 5 unidirectional air that allows for the ingress and/or egress of materials through defined openings that have been designed and validated to preclude the transfer of contamination, and that generally are not to be opened during operations. Examples of RABS include CAIs and CACIs.

Compounding aseptic containment isolator (CACI): A type of RABS that uses HEPA filtration to provide an ISO Class 5 unidirectional air environment designed for the compounding of sterile HDs.

Compounding aseptic isolator (CAI): A type of RABS that uses HEPA filtration to provide an ISO Class 5 unidirectional air environment designed for compounding of sterile non-HDs.

USP <797>Section 7.


Components: Any ingredient used in the compounding of a preparation, including any active ingredient, added substance, and the container–closure system used to package the preparation.

• Conventionally manufactured sterile products should be used when available and appropriate for the intended CSP.

• Facility must establish the identity, strength, purity, and quality of the ingredients obtained.

• Each lot of commercially available sterile, depyrogenated containers and container–closure systems must be accompanied by a COA .

• Any ingredient lacking an expiration date shall not to exceed 1 year after receipt by the compounding facility. Date of receipt must be clearly marked.

• Must be evaluated when received and before use.

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USP <797>Section 7.


API (Active Pharmaceutical Ingredient): • Must be obtained from an FDA-registered

facility

• Must comply with USP-NF monograph if one exists.

• Must be accompanied by a COA: – Includes the specifications and test

results and shows the API meets the specifications of the USPNF monograph, if one exists.


Sterilization and Depyrogenation

Sterilization Methods

Aseptic Preparation • Compounding with only sterile

ingredients • Sterilization by filtration (not for a

suspension)

Terminal Sterilization is preferred, unless the CSP or container cannot tolerate (can achieve Sterility Assurance Level of 10-6 ). • Dry heat • Steam autoclaving (not if moisture,

pressure or temp would degrade CSP) • Irradiation

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SOPs and Master Formulation and

Compounding Records

Facilities that prepare CSPs, must develop SOPs • Must be reviewed every 12 months

• Any revisions must be communicated to all personnel

• Master Formulation Record; required if: – CSP prepared in a batch for > 1

patient – CSPs prepared from nonsterile

ingredient(s)


SOPs and Master Formulation and

Compounding Records

Compounding Record required for all CSPs • May be in the form of prescription

or medication order, compounding log, or label

• May be stored electronically (must be retrievable)

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Release Testing

Visual Inspection required at the completion of compounding and before release

• Check the physical appearance

• Check that the CSP, its label and the prescription match

• Container closure integrity (leakage, cracks, etc.)

Sterility Testing (CAT 2 as required)


Release Testing

Bacterial Endotoxin Testing

Excludes: • Inhalations • Topical ophthalmics

Required for Category 2 CSPs: • If made from one or more nonsterile

ingredient(s) or component(s)• AND if assigned a BUD that requires

sterility testing

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USP <797> Section 11. Labeling

Label: A display of written, printed, or graphic matter on the immediate container of any article.

Labeling: All labels and other written, printed, or graphic matter that are 1) on any article or any of its containers or wrappers, or 2) accompanying such an article.

The label on the immediate container of the CSP must, at a minimum, display prominently and legibly the following information: • Assigned internal identification number (e.g., prescription,

order, or lot number) • Active ingredient(s) and their amounts, activities, or

concentrations • Storage conditions if other than controlled room temperature • Date prepared • BUD • Indication that the preparation is compounded


Labeling

The label on the immediate container of the CSP must additionally display prominently the following information:

• Route of administration if it is not obvious from the container, or when necessary for the safe use of the CSP.

• Total amount or volume if it is not obvious from the container.

• If it is a multiple-dose container, a statement stating such.

• Contact information of the compounding facility if the CSP is to be sent outside of the facility in which it was compounded.

• The labeling of the CSP must provide any applicable special handling instructions or warning statements.

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USP <797> Section 12. Establishing

Beyond-Use Dates

Beyond-Use Date (BUD): Either the date or hour and date after which a CSP must not be used or administration must not begin. • Is determined from the date/time

that preparation of the CSP is initiated.

• Not intended to limit the time during which the CSP is administered (e.g., infused).


Beyond-Use Dates

Stability Factors (not address in the BUD tables)

Sterility Factors (related to the BUD tables) • Environment in which the CSP is

prepared (Cleanroom suite or SCA)• Aseptic preparation method and

sterilization method • Components used: sterile or

nonsterile starting ingredients• Sterility Testing • Storage conditions (e.g., packaging

and temperature)

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Beyond-Use Dates

Category 1 CSP: • PEC in a SCA

• Table 11 provided Beyond Use Dates for Category 1 CSPs


Beyond-Use Dates

Category 2 CSP: • Cleanroom suite

• Based on the following factors: – Aseptic preparation and

sterilization method – Starting components – Sterility testing – Storage conditions

Table 12 of the proposed revised chapter provides Beyond Use Dates for Category 2 CSPs

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Beyond-Use Dates

Multiple-Dose Container: A container of sterile medication for parenteral administration that is designed to contain more than one dose of the medication. A multiple-dose container is usually required to meet the antimicrobial effectiveness testing criteria. Intended to be entered or penetrated multiple times.

Must be prepared as a Category 2 CSP.


Beyond-Use Dates

Multiple-Dose Container: After initially entered or punctured, must not be used for longer than the assigned BUD or 28 days if supported by antimicrobial effectiveness testing results (see ⟨51⟩) on the CSP, whichever is shorter.

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https://www.usp.org/


Quality Assurance and Quality

Control

Recall SOP Must Contain Procedures: • To determine the severity and the urgency • To determine the distribution of any affected

CSP • To identify patients who have received the

CSP • For disposition and reconciliation of the

recalled CSP

Complaint Handling: • Designated person must review all

complaints

Adverse Event Reporting: • Must be reported

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CSP Storage, Handling,

Packaging, Shipping and Transport

Handling and Storing • CSPs must be handled to maintain quality

and package integrity. • Personnel must monitor conditions in the

storage areas. • Temperature excursions must be detected

and minimized.

Packaging• Packaging materials should protect CSPs

from damage, leakage, contamination, degradation, and adsorption.

Appropriate shipping containers and packaging materials must be selected.


CSP Storage, Handling,

Packaging, Shipping and

Transport

Shipping and Transporting CSPs

• Must select modes of transport that are expected to deliver properly packed CSPs in an undamaged, sterile and stable condition.

• Consider exposure to heat, cold, light, physical shaking.

• If special handling is required, instructions must be included on the exterior of the container.

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Documentation

The documentation must include, but is not limited to the following: • Personnel training, competency assessments, and

qualification records including corrective actions for any failures

• Certification reports, including corrective actions for any failures

• Environmental air and surface monitoring procedures and results

• Equipment records (e.g., calibration, verification, and maintenance reports)

• Receipt of components • SOPs, Master Formulation Records (when used), and

Compounding Records • Release testing records • Information related to complaints and adverse events • Investigations and corrective actions


Documentation

All required compounding records for a particular CSP (e.g., Master Formulation Record, Compounding Record, and release testing results) must be readily retrievable for at least 3 years after preparation or as required by jurisdictional laws and regulations, whichever is longer.

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Resources: • U.S. Pharmacopeia (USP)

• www.usp.org• www.usp.org/compounding/general-chapter-797

• Board of Pharmacy Rules• ARM 24.174.301 Definitions• ARM 24.174.407 Quality Assurance Program Requirements• ARM 24.174.841 Sterile Products• http://www.mtrules.org/gateway/ChapterHome.asp?Chapter=24%2E174

• Food and Drug Administration/Human Drug Compounding• Compounding: Laws and Policies; Regulatory Policy Information; Oversight; Research; Risk Alerts;

Inspections, Recalls, and other Actions• Compounding Quality Center of Excellence• Information for Outsourcing Facilities; Bulk Drug Substances Used in Compounding; Registered

Outsourcing Facilities• Consumer and Health Care Professional Information • Human Drug Compounding Information for States • https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding

Question



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Question



THANK YOU

Contact: JOHN DOUGLAS, RPh, Board Inspector

Montana Board of Pharmacy406-431-1952, [email protected]

Documents

Spring 2020 UM CE Marcie Bough Finalhealth.umt.edu/pharmacypractice/CPE/docs/March 2020 UM CE Boar… · – Contract management, governance and resources, security – Functionality,