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 Massachusetts Board of Registration in Pharmacy 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 Massachusetts Board of Registration in Pharmacy 4
The provisional license may be extended beyond 1 year. A. False B. True Massachusetts Board of Registration in Pharmacy 5
What’s the difference? Legislation Regulation Massachusetts Board of Registration in Pharmacy 6
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 Massachusetts Board of Registration in Pharmacy 7
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 Massachusetts Board of Registration in Pharmacy 8
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 Massachusetts Board of Registration in Pharmacy 9
Promulgated and Pending Regulations Promulgated Pending 247 CMR 3.00 247 CMR 6.00 Pharmacist Licensure Pharmacy Licensure 247 CMR 4.00 247 CMR 9.00 License Renewal Professional Standards 247 CMR 8.00 247 CMR 17.00 Interns & Technicians Sterile Compounding 247 CMR 16.00 247 CMR 18.00 CDTM Non-Sterile Compounding 247 CMR 19.00 Hazardous Medications 247 CMR 20.00 Reporting Massachusetts Board of Registration in Pharmacy 10
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. Massachusetts Board of Registration in Pharmacy 11
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. Massachusetts Board of Registration in Pharmacy 12
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 Massachusetts Board of Registration in Pharmacy 13
Draft Application Checklist Massachusetts Board of Registration in Pharmacy 14
Draft Engineering Control and Environmental Monitoring Review Massachusetts Board of Registration in Pharmacy 15
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 Massachusetts Board of Registration in Pharmacy 16
Inspection Agenda • Introduction • Facility Observation • Records Review • Review Inspection Results • Wrap-Up Massachusetts Board of Registration in Pharmacy 17
Provisional Inspection • Demographic Information • Regulatory Requirements • Quality Requirements • Compounding Environment • Engineering Controls • Compounding Procedures • Records Management • USP <797> Criteria Massachusetts Board of Registration in Pharmacy 18
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 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 Massachusetts Board of Registration in Pharmacy 20
The provisional license may be extended beyond 1 year. A. True B. False Massachusetts Board of Registration in Pharmacy 21
Plans of Correction (POC) Identified deficiencies must have a plan of correction developed and submitted to the Board. Massachusetts Board of Registration in Pharmacy 22
Substantial Compliance Objective Data • Personnel licensure • Personnel training and competency documentation • Certification • Room(s) • Hood(s) • Environmental monitoring Massachusetts Board of Registration in Pharmacy 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 Massachusetts Board of Registration in Pharmacy 24
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 Massachusetts Board of Registration in Pharmacy 25
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! Massachusetts Board of Registration in Pharmacy 26
NABP Newsletter Massachusetts Board of Registration in Pharmacy 27
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 28
Contact Information Massachusetts Board of Registration in Pharmacy 239 Causeway Street – 5 th Floor Boston, MA 02114 (800) 414-0168 Website: www.mass.gov/dph/boards/pharmacy Email: pharmacy.admin@Massmail.state.ma.us Massachusetts Board of Registration in Pharmacy 29
Massachusetts Board of Registration in Pharmacy 30
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