Title: USP’s Update to Compounding Rules Could Affect Cleanroom Design

For facilities with cleanrooms, the guidance from the United States Pharmacopeia (USP) is likely already quite familiar. Rules for cleanroom design are covered at length in USP General Chapter <800> (“Hazardous Drugs — Handling in Healthcare Settings”), as well as General Chapters <795> (“Pharmaceutical Compounding — Nonsterile Preparations”) and <797> (“Pharmaceutical Compounding — Sterile Preparations”). This past spring, USP announced plans to better align the two compounding chapters (<795> and <797>) with USP <800>, which was published in 2016 and is expected to become official Dec. 1, 2019. As the first step in this effort, USP recently unveiled its Proposed Revision to GC <795>, and a period for public comment and review is now open, until July 31, 2018. In advance of this deadline, facilities that perform any compounding need to understand the proposed changes, and determine how they might be impacted, if <795> goes into effect as currently written. Potential impact on cleanrooms …

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   Person Information
   Application Sequencing
 325412 - Pharmaceutical Preparation Manufacturing                
Company  Product  Process  Other  Subjects  Event  Event  Date  Location  Publication  Publication  Date Text  Descriptor

  • Compound Sterile Preparation

  • Regulating


  • Design Standards

  • Regulation / Standard




  • Pharmaceutical Technology


  • 7/1/2018


  • Abstract