FDA yesterday issued three guidances in draft form that implement the newly signed Drug Quality and Safety Act (DQSA). FDA is taking an aggressive stance in regulating the industry and traditional pharmacies, including a surprising reliance on USP Chapters <795> and <797> in the pharmacy compounding guidance that has potentially far-reaching impact on practice.
“The pharmacy compounding guidance revokes the 1998 and 2002 current good manufacturing practices (cGMPs) from FDA that regulated traditional pharmacy compounding and replaces them with this document,” said Lee Rosebush, PharmD, JD, MBA, MS, Counsel at the Baker-Hostetler law firm in Washington, DC, in describing the impact of these regulations if they are adopted unchanged. “By doing so, FDA has provided 10 conditions that must be met before a compounded drug meets the exemption under Section 503A [of the Federal Food, Drug, and Cosmetic Act]. One condition references both USP chapter <795> and USP chapter <797>. These are the chapters for both nonsterile and sterile pharmacy compounding. In other words, all compounding—including mixing powder antibiotics with water—must be done under USP standards.”
“Drugs produced by compounders that are not registered as outsourcing facilities must meet certain other conditions described in the law, or they will be regulated by FDA as conventional drug manufacturers,” FDA Commissioner Margaret A. Hamburg, MD, wrote in a blog. “Generally, the state boards of pharmacy will continue to have primary responsibility for the day-to-day oversight of state-licensed pharmacies, including traditional pharmacy compounding. And FDA will continue to cooperate with state authorities to address pharmacy compounding activities that may be in violation of the Federal Food Drug and Cosmetic Act.”
The other two guidance documents cover outsourcing facilities—compounding pharmacies that voluntarily elect FDA regulation under DQSA. One provides interim product reporting details. The other covers registration of human drug compounding outsourcing facilities. All three guidances will likely be published in the Federal Register within a few days, starting a 60-day comment period. After that, FDA would likely develop a final rule with an effective date by which compliance is required.
APhA is evaluating the guidances and will keep members informed as the comment period begins and positions are developed.