Medical Air Solutions, LLC

USP <797> Information

The United States Pharmacopoeia (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.  Generally, the State Boards of Pharmacy may elect to enforce this standard for compounding pharmacies but the FDA may elect to inspect for compliance.  USP has adopted and issued the standard with regard to the Webinar information held this past summer.  There are three areas that may be updated this coming summer involving the cleaning schedule, particle and pathogen testing and the compounding of radiopharmaceuticals.

MAS will issue, and post on this web site, the latest engineering and other selected requirements on January 2, 2008 after reviewing all pertinent information and consulting experts on this standard.  Some highlights of the standard to take effect on January 1, 2008, are in the pages listed below.

The intent of USP General Chapter <797> is to provide a uniform standard for the compounding of sterile preparations (CSP).

MAS has assembled the latest information in this section that will enable the compounding pharmacies to develop and enact a comprehensive program to upgrade their CSP areas to meet this new standard.  Select a document from the list below to learn more about USP <797> and how MAS can assist in renovating your CSP area.

USP Chapter <797> Present Requirements and Adopted Revisions (will be available in our "Current Comments" series which was issued 1/2/08)

USP Chapter <797> Present Standard Requirements (from our "Current Comments" series)

USP Chapter <797> Draft (a draft with proposed revisions)

NIOSH Alert - for Compounding of Hazardous Pharmaceuticals

NIOSH Alert - Appendix A - Defines and lists Hazardous Drugs (Note: NIOSH's "hazardous" = USP's "High Risk")

NIOSH Alert - Appendix B, C and Acknowledgements - Appendix B & C and Data Sources

IEST Article on USP  <797> (April 2007)

Consorta/HealthTrust Membership Contract Information - Consorta/HealthTrust Members thumbnail sketch of the current contract

Pressurized Rooms - Air Handing Units (AHU) generally cannot consistently maintain ACH

USP Chapter <797> Frequently Asked Questions (Updated from USP)

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