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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
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
Massachusetts Board of Registration in Pharmacy
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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 3.00Pharmacist 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
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
Massachusetts Board of Registration in Pharmacy
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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
Massachusetts Board of Registration in Pharmacy
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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
Massachusetts Board of Registration in Pharmacy
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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:pharmacy.admin@Massmail.state.ma.us
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