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On November 1, 2023, revisions to USP Chapter 795 and Chapter 797 became official and made USP 800 compendially applicable and potentially enforceable. However, other regulatory agencies — including state boards of pharmacy and the FDA — may impact whether USP 800 is enforceable in your pharmacy.
On November 1, 2023, revised USP Chapters 795 and 797 are official. If adopted by your state board of pharmacy, the requirements listed within these Chapters must be met. All PCCA formulations in our formula database now contain updated language and beyond-use dates (BUDs) in compliance with USP Chapters 795 and 797.
Due to pending USP updates that are effective on November 1, 2023, we’re reposting our January Blog, which reviews how a modular compounding cleanroom can meet evolving regulatory requirements and standards.
Read what we’re doing to ensure PCCA Formulas for compounding nonsterile preparations — specifically beyond-use dates — comply with USP Chapter 795 revisions.
PCCA's Matt Martin and Melissa Merrell Rhoads provide guidance and examples to help you determine API calculations in your compounding pharmacy.
A modular compounding cleanroom is a great way to meet evolving regulatory requirements and standards. Learn the basics of a modular cleanroom in the first in a series of articles on Modular Compounding Cleanrooms.
Matt Martin points out the most significant change in the newly proposed version of USP Chapter 797 as well as the cascading effects it has on the guidelines. He also explains the process for the proposed version to become official and what compounding pharmacies and other stakeholders should do about it now.
Matt Martin highlights four key changes in the newly proposed version of USP Chapter 795 that may have significant implications for compounding pharmacies. He also explains what the process will look like for the proposed version to become official and suggests what compounders should do about it now.
Maria Carvalho discusses the latest versions of the USP (43rd edition) and NF (38th edition), as well as the corresponding USP Compounding Compendium, recognizing the importance of several proprietary PCCA bases
Melissa Merrell Rhoads and Suki Pramar of PCCA discuss selecting the right antimicrobial preservative when compounding medication for patient health challenges.