On November 1, 2022 the United States Pharmacopeia (USP) published the final revision to General Chapter <797> Pharmaceutical Compounding of Sterile Preparations. Compounding pharmacies must clearly understand how the new standards affect their compounding operations and take proper steps to comply. Changes become official on Wednesday November 1, 2023.
Read MoreA new proposal for USP 797 was released in September of 2021 for stakeholder review and comment. Pharmacies wanting to apply extended BUDs to their CSPs will be particularly impacted. Stakeholders have argued that many of the additional requirements for extended BUDs closely resemble some GMP processes and controls that 503Bs have to abide by. Others have debated that the 250-unit cap is arbitrary, cost-prohibitive, and will decrease patient access.
Read MoreMedical clinics that prepare or manipulate a sterile compound for in-office patient administration will need to take a closer look at USP, State Board of Pharmacy requirements, and FDA Guidance on insanitary conditions to make sure they are compliant with the expectations. Otherwise these healthcare facilities could face an FDA observation, warning letter, or other regulatory action. To better understand how a medical practice can be affected, let’s examine two scenarios.
Read More
