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Frequently Asked Questions for Pharmacists on Compounding / USP <800> has FAQs concerning USP <800> found here:





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 is the NC Board of Pharmacy's position with respect to USP <800> standards and their application to non-compounding activities involving hazardous medications?

A:  The Board views compliance as a best practice for pharmacies who are doing non-compounding activities with hazardous medications. As pharmacists know, USP Chapter <800> standards are designed to protect pharmacists, pharmacy staff, patients, and the public from the harmful effects of exposure to hazardous medications.

As USP Chapter <800> standards for non-compounding activities become commonly followed, North Carolina law is likely to reflect that doing so is considered standard of practice.  In that case, failure to comply may be evidence of negligence.  Therefore, you are encouraged to evaluate (and to continue to re-evaluate) to what extent compliance reflects the appropriate standard of care.  Board staff will continue to make observations during inspections to help identify potential risk for handling Hazardous Medications, and will provide education on how to comply with USP Chapter  <800> standards to minimize risk to pharmacy staff, patients, and the public.  These observations regarding USP Chapter <800> compliance in non-compounding activities involving Hazardous Medications will not, by themselves, serve as a basis for disciplinary action by the Board. The Board's full position statement may be found here:

Board Staff have created helpful educational information that addresses identification of Hazardous Drugs, instructions on conducting an Assessment of Risk, and templates for non-compounding pharmacies to develop Standard Operating Procedures (SOPs) addressed in USP<800>. This informational material is for pharmacies that DO NOT compound with hazardous medications:

As a reminder Board issued a statement on September 29, 2017 statement regarding, pharmacies that perform any nonsterile or sterile compounding with Hazardous Medications must be in full compliance with USP <800> when the chapter becomes official December 1, 2019 in accordance to NCAC 46. 2801. That position statement may be found here:



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