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Frequently Asked Questions for Pharmacists on Compounding / USP <797>


USP has developed very detailed FAQs on <797>:





IMPORTANT INFORMATION CONCERNING UNITED STATES PHARMACOPEIA’S ANNOUNCEMENT POSTPONING THE EFFECTIVE DATE OF REVISED CHAPTERS <795> AND <797>.  The United States Pharmacopeia (“USP”)  announced today, September 23, 2019, that – as required by USP by-laws – it is postponing the effective date of USP chapters <795> and <797> while appeals for review of these revised chapters are resolved.  These chapters were previously scheduled to go into effect on December 1, 2019.  More detail is found here:

How does USP’s announcement affect North Carolina-permitted pharmacists and pharmacies?

1.            Existing USP chapters <795> and <797> will continue to be enforced.  Board inspections and investigative staff will continue to use the inspection forms and tools mapped to existing USP chapter requirements (found here:  As pharmacists know, under both federal law (the Drug Quality and Security Act) and Board rule (21 NCAC 46.2801), compounding activities must conform with the standards in these chapters.   The revised chapters will be enforced when they go into effect.  USP did not set a new effective date in its announcement today.

2.            Board staff will not begin inspecting for compliance with USP chapter <800> standards in compounding activities on December 1, 2019.  USP’s announcement notes that chapter <800> is not subject to an appeal and will go into effect on December 1, 2019.  Nonetheless, both the DQSA and Board rule .2801 require compliance with chapters <795> and <797> and other chapters incorporated into them.  Existing chapters <795> and <797> do not incorporate chapter <800>.  Revised chapters <795> and <797> do.  Accordingly, Board staff will begin inspecting for compliance with chapter <800> standards at such time as the revised chapters go into effect.  Again, USP did not set a new effective date in its announcement today.  Pharmacies that have already implemented changes to comply with chapter <800> are commended for doing so.  And pharmacies working toward chapter <800> compliance are strongly encouraged to take the time afforded by this delay to finalize those preparations.  For a review of prior Board statements concerning USP <800>, see and




Q: What are the USP<797> certification requirements for Sterile compounding facilities?

A: All certification testing and documentation must be compliance with USP Chapter <797> in accordance with Rule 21 NCAC 46.2801. The Pharmacy Manager and/or Designated Compounding Pharmacist should review certification and environmental sampling reports to ensure that appropriate tests are performed and are in compliance with USP Chapter <797> and that the results are compliant with the action levels set forth in USP Chapter <797>. The link below provides guidance on Certification tests and documentation that is required for a sterile compounding facility and sterile compounding equipment. It also provides guidance on environmental sampling and documentation requirements that meet USP Chapter <797> and Rule 21 NCAC 46.2801:




Q:  What are the compounding record and master formulation record requirements for sterile compounded products?

A:  USP Chapter <797> requires that a compounding record be created and maintained.  USP Chapter <797> does not define the specific elements to be included in the compounding record.  North Carolina Board of Pharmacy rules have always required a compounding record and did so well before implementation and enforcement of USP standards for compounding.  The following link is a Guidance Document for compounding record and master formulation record requirements:




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