Agency moving quickly, aggressively to implement DQSA
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.”
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