institutional sterile compounding pharmacy · institutional sterile compounding pharmacy david...

Institutional Sterile Compounding Pharmacy

David Sencabaugh, RPh, Executive Director

William Frisch, Jr., RPh, Director of Pharmacy Compliance

Nathan Van Allen, RPh, Pharmacy Investigator

Objectives

1. Summarize the licensure process for sterile compounding.

2. Describe the requirements for licensure inspections.

Massachusetts Board of Registration in Pharmacy

2

Which of the following regulations is closest to finalization?

A. 247 CMR 6.00: Licensure of Pharmacies

B. 247 CMR 17.00: Sterile Compounding

C. 247 CMR 18.00: Non-Sterile Compounding

D. 247 CMR 19.00: Hazardous Drugs


3

On what criteria will institutional sterile compounders be inspected for provisional

licensure?

A. USP <797> current

B. USP <797> draft

C. Draft 247 CMR 17.00: Sterile Compounding

D. A and C

E. All of the above


4

The provisional license may be extended beyond 1 year.

A. False

B. True


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What’s the difference?

Legislation

Regulation


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Legislation vs. Regulations

Legislation (statute, laws, M.G.L.)• Refers to a law enacted by the legislature• Provides framework • Cannot be waived

Regulation (CMR)• Authorized by statutes and have the effect of law• Provide details of “how to” carry out the law• May be waived


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Institutional Sterile Compounding Licensure

M.G.L. c.112 Section 39I• Board to establish licensure

• Manager of record must be designated

• Annual license renewal

• LEAN concepts

• Adhere to all of USP and Board regulations

• Yearly unannounced inspections

• Reports


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Reporting Requirements

• Above Action Level Environmental Monitoring Reports (Air/Surface/Bacterial/Fungal)

• Sterile Compounding Reporting Form (Number of CSPs and Risk Level Association)

• Failed Certification

• Serious Reportable Events (SREs)

• Defective Drug Preparation

https://www.mass.gov/lists/reporting-forms-for-the-board-of-registration-in-pharmacy


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https://www.mass.gov/lists/reporting-forms-for-the-board-of-registration-in-pharmacy

Promulgated and Pending Regulations


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Promulgated Pending

247 CMR 3.00Pharmacist Licensure

247 CMR 6.00Pharmacy Licensure

247 CMR 4.00License Renewal

247 CMR 9.00Professional Standards

247 CMR 8.00Interns & Technicians

247 CMR 17.00Sterile Compounding

247 CMR 16.00CDTM

247 CMR 18.00Non-Sterile Compounding

247 CMR 19.00Hazardous Medications

247 CMR 20.00 Reporting

Regulation Status Update

• 247 CMR 6.00: Licensure of Pharmacies • The Board has voted on the final draft and is awaiting executive office

approval for final promulgation.

• 247 CMR 9.00: Professional Practice Standards• The Board has voted on the final draft and is awaiting executive office

approval for final promulgation.


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Regulation Status Update

• 247 CMR 17.00: Sterile Compounding• The Board has voted on the final draft and is under administrative

review.

• 247 CMR 19.00: Hazardous Drugs• The proposed regulation has not yet been offered for public

hearing/comment.

• 247 CMR 20.00: Reporting • The Board has voted on the final draft

and is awaiting executive office approval

for final promulgation.


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Licensing Process

• Step 1: Application• Fee (TBD)

• Manager of Record

• Pharmacist in charge of each cleanroom (as applicable)

• Certified blueprints / architectural drawings

• HVAC design details

• Pharmacy related license(s) and registration(s)

• Attestation of intent to engage in sterile compounding

• “Engineering Control and Environmental Monitoring Review” document

• List of compounding personnel


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Draft Application Checklist


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Draft Engineering Control and Environmental Monitoring Review


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Licensing Process

• Step 2: Provisional Inspection• USP <797> criteria

• Scheduled

• Plan of correction (POC)

• Step 3: Licensure• Provisional License:

• Substantial compliance after inspection

• 1-time provisional license for a maximum of 1 year

• Standard License: • Fully compliant

• If minor issues without safety concerns, issue license with POC


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Inspection Agenda

• Introduction

• Facility Observation

• Records Review

• Review Inspection Results

• Wrap-Up


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Provisional Inspection

• Demographic Information

• Regulatory Requirements

• Quality Requirements

• Compounding Environment

• Engineering Controls

• Compounding Procedures

• Records Management

• USP <797> Criteria


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Records

• Employee licensure and certifications

• Facility certification, EM monitoring

• Cleaning, pressure differential, temperature logs

• Personnel training/competency

• Product testing (if applicable)

• RCA/CAPA

• Standard Operating Procedures


19

Which of the following regulations is closest to finalization?

A. 247 CMR 6.00: Licensure of Pharmacies

B. 247 CMR 17.00: Sterile Compounding

C. 247 CMR 18.00: Non-Sterile Compounding

D. 247 CMR 19.00: Hazardous Drugs


20

The provisional license may be extended beyond 1 year.

A. True

B. False


21

Plans of Correction (POC)

Identified deficiencies must have a plan of correction developed and submitted to the Board.


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Substantial Compliance

Objective Data

• Personnel licensure

• Personnel training and competency documentation

• Certification

• Room(s)

• Hood(s)

• Environmental monitoring


23

On what criteria will institutional sterile compounders be inspected for provisional

licensure?

A. USP <797> current

B. USP <797> draft

C. Draft 247 CMR 17.00: Sterile Compounding

D. A and C

E. All of the above


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Voluntary Inspections• Voluntary inspections are available prior to promulgation of

licensing regulation.

• Purpose: • education

• informal feedback

• collaborative working relationship

• If compliant, may be issued license upon final promulgation

• Date / time would be mutually agreed upon

• Looking for 15-20 volunteers

• First come, first served

• Contact Nathan if interested: [email protected]


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mailto:[email protected]

Final thoughts…

• Board staff available to help with questions or provide guidance on clean room renovation projects

• Have been actively engaged with some hospitals to discuss challenges and suggest pathways to comply with draft regulations

• Can meet with pharmacy directors and architects / engineers in person or by phone

We are here to help Don’t hesitate to reach out!


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NABP Newsletter


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References

• 247 CMR:• http://www.mass.gov/courts/case-legal-res/law-lib/laws-by-

source/cmr/200-299cmr/247cmr.html

• Draft Regulations:• http://www.mass.gov/eohhs/gov/departments/dph/programs/hcq/d

hpl/pharmacy/draft-regulations.html

• Law / Regulation Review:• https://www.mass.gov/files/documents/2016/07/nc/pharmacy-mpje-

packet.pdf


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http://www.mass.gov/courts/case-legal-res/law-lib/laws-by-source/cmr/200-299cmr/247cmr.html

http://www.mass.gov/eohhs/gov/departments/dph/programs/hcq/dhpl/pharmacy/draft-regulations.html

https://www.mass.gov/files/documents/2016/07/nc/pharmacy-mpje-packet.pdf

Contact Information

Massachusetts Board of Registration in Pharmacy239 Causeway Street – 5th FloorBoston, MA 02114(800) 414-0168

Website:www.mass.gov/dph/boards/pharmacy

Email:[email protected]


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http://www.mass.gov/dph/boards/pharmacy

mailto:[email protected]


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