Institutional Sterile Compounding Pharmacy David Sencabaugh, RPh, - - PowerPoint PPT Presentation

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Institutional Sterile Compounding Pharmacy David Sencabaugh, RPh, - - PowerPoint PPT Presentation

Oct 13, 2023 157 likes •460 views

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

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Institutional Sterile Compounding Pharmacy

David Sencabaugh, RPh, Executive Director William Frisch, Jr., RPh, Director of Pharmacy Compliance Nathan Van Allen, RPh, Pharmacy Investigator

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Objectives

  • 1. Summarize the licensure process for sterile

compounding.

  • 2. Describe the requirements for licensure

inspections.

Massachusetts Board of Registration in Pharmacy

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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

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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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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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Promulgated and Pending Regulations

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Promulgated Pending 247 CMR 3.00 Pharmacist Licensure 247 CMR 6.00 Pharmacy Licensure 247 CMR 4.00 License Renewal 247 CMR 9.00 Professional Standards 247 CMR 8.00 Interns & Technicians 247 CMR 17.00 Sterile Compounding 247 CMR 16.00 CDTM 247 CMR 18.00 Non-Sterile Compounding 247 CMR 19.00 Hazardous Medications 247 CMR 20.00 Reporting

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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

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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

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The provisional license may be extended beyond 1 year.

  • A. True
  • B. False

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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

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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: nathan.vanallen@massmail.state.ma.us

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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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Contact Information

Massachusetts Board of Registration in Pharmacy

239 Causeway Street – 5th Floor Boston, MA 02114 (800) 414-0168

Website: www.mass.gov/dph/boards/pharmacy Email: pharmacy.admin@Massmail.state.ma.us

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