On June 1, 2019 the United States Pharmacopeia (USP) published revisions to USP Chapters 795 and 797, which were slated to become effective on December 1, 2019. USP also announced that USP Chapter 800 would become effective on December 1, 2019. Consequently, the Board amended rule 657—8.5(11) to require compliance with USP Chapter 800 effective December 1, 2019.
On September 23, 2019 USP announced that the effective date of the published revisions to USP Chapters 795 and 797 would be delayed, and would no longer become effective on December 1, 2019. USP maintained the December 1, 2019 effective date for USP Chapter 800.
USP is considering the following appeal topics for USP Chapters 795 and 797: (1) beyond-use date (BUD) provisions in both chapters, (2) removal of the alternative technology provision from USP Chapter 797, and (3) the applicability of both chapters to veterinary practitioners. The Board recognizes that if USP’s appointed appeals panel approves one or more appeals, the USP Expert Committee’s review of USP Chapters 795 and 797 is not necessarily limited to the sections under appeal. In accordance with rules 657—20.3 and 20.4, the proposed revisions will become effective, and enforceable by the Board, on the effective date established by USP.
The Board has received several inquiries as to how the Board intends to enforce USP Chapters 795, 797, and 800 in light of USP’s recent announcement. On October 3, 2019 the Board convened and made the following decisions regarding enforcement:
Enforcement of USP Chapter 800
All pharmacies are expected to be fully compliant with USP Chapter 800 beginning on December 1, 2019. This includes pharmacies that receive, store, handle, dispense, or compound hazardous drugs.
USP Chapters 795 and 797: Current Versions v. Proposed Revisions
A pharmacy that has made progress towards complying with the proposed revisions to USP Chapters 795 and 797 will not be penalized for doing so. A pharmacy that is already compliant or making progress towards compliance with the proposed revisions will have a head start at achieving compliance by the new effective date, which will be established by USP.
During this period of flux, a pharmacy may comply with either the current versions or the proposed revisions of USP Chapters 795 and 797. A pharmacy is expected to establish and follow standard operating procedures for sterile and nonsterile compounding which identify the version of USP Chapters 795 or 797 it intends to follow. Requirements specified by USP Chapter 800 must be followed for hazardous compounding even if not specified by current versions of USP Chapters 795 or 797, unless a delayed compliance petition has been granted.
All compounding pharmacies will be expected to comply with the proposed revisions to USP Chapters 795 and 797 by the effective date established by USP, which has yet to be determined.
Delayed Compliance Petitions
Board rule 657—8.5(11) establishes a process whereby a pharmacy engaged in compounding of hazardous drugs may request delayed compliance for specific requirements of USP Chapter 800 pertaining to compounding in accordance with rule 657—20.5. The Board has received and responded to several petitions filed under these provisions.
A compounding pharmacy that can comply with all requirements of USP Chapter 800 by December 1, 2019 does not need to submit a petition for delayed compliance. A pharmacy is not eligible to receive delayed compliance for any non-compounding requirements in USP Chapter 800.
A compounding pharmacy that has been granted a delay in compliance will retain the delay as specified in the approval letter. The granted delay will be valid through the end date referenced in the approval letter.