USP says it will revise General Chapter <797> Pharmaceutical Compounding – Sterile Preparations. General Chapter <797> will be published in the Pharmacopeial Forum 44(5) Sept./Oct. 2018 for a second round of public comment before it is official.
The revised USP General Chapter <797> is expected to be published in USP 42-NF 37 Second Supplement on June 1, 2019, and become official on Dec. 1, 2019. Some sections may have longer implementation dates to allow for adoption of the standard. While <797> is under revision, the published version remains official and enforceable.
USP also has postponed the official start date of General Chapter <800>, which deals with the compounding of hazardous drugs, to Dec. 1, 2019. This postponement will align the official date of General Chapter <800> with the official revision of General Chapter <797>.
At Microbiology Research Associates (MRA), our expertise is in DQSA 503A and 503B facilities. For more than 20 years, MRA has served clients ranging from hospitals to national compounding pharmacies to 503B outsourcing manufacturers. We have become their USP <797>, <800> and cGMP compliance experts. MRA offers full-service compliance capabilities for pharmacists who need to ensure and/or restore a state of environmental control for their products and processes. To learn more, contact an MRA representative.