The United States Pharmacopeia ("USP") announced on September 23, 2019, that – as required by USP by-laws – it is postponing the official dates of the revised USP chapters <795> and <797> and new chapter <825> while appeals for review of these chapters are resolved. These chapters were previously scheduled to go into effect on December 1, 2019.
Existing USP chapters <795> and <797> will continue to be enforced. The GA Drugs & Narcotics Agency (GDNA) will continue to use the inspection forms and tools to existing USP chapter <795> and <797> requirements. As pharmacists know, under GA Law, 26-4-86, and GA Board of Pharmacy Rule, 480-11-.02, compounding activities must comply with USP-NF standards. This includes chapters <795> and <797>. The revised chapters, as well as the new chapter <825>, will be enforced when they go into effect. USP did not set a new effective date in its announcement.
Since USP has announced that as of December 1, 2019, chapter <800> is to be simply informational and not [compendially] applicable, GDNA will not be inspecting for compliance with chapter <800>, until such time that the revised versions of chapters <795> and <797> are made effective by USP.
Again, USP did not set a new effective date in its announcement. Pharmacies working toward chapter <800> compliance are strongly encouraged to take the time afforded by this delay to finalize those preparations.
**A link to the 09/23/19 USP announcement is provided here: