United States Pharmacopeia (USP)
USP is the official public standards-setting authority for all prescription and over-the-counter medicines, dietary supplements, and other healthcare products manufactured and sold in the United States. USP is an independent, science-based public health organization that sets standards for the quality of these products.
General Chapter Pharmaceutical Compounding - Sterile Preparations
Commonly termed "USP 797" this standard provides guidance on achieving and maintaining sterility and overall freedom from contamination of compounded pharmaceutical products. A key element of this standard is the Environmental Quality and Control requirements which establish specific design, construction, operation, and testing requirements for pharmacy cleanrooms. The current edition of USP 797 was published in 2004. This standard is currently in the revision cycle. Public comments were accepted on the proposed revisions with a comment closing date of August 15, 2006.
- Visit the USP Website for the current status of USP 797 revision
- ASHE comments to USP
- Specific proposed revisions and ASHE recommendations
- ASHE Regulatory Advisory:
USP Proposes increased Air Purity Requirements for Pharmacy Cleanrooms (USP 797) – members encouraged to submit comments
- Select sections of the proposed revisions (Distilled down to environmental quality and control issues – including definitions and ISO Classification for particulate matter in room air)
- ASHE Regulatory Advisory: JCAHO Clarifies Their Expectations related to USP 797 in Perspectives
- USP 797 Status Map