Businesses engaged in human drug compounding, both traditional pharmacies and the more recently created outsourcing facilities, have been on quite a rollercoaster ride since congressional enactment of the Drug Quality and Security Act (DQSA) approximately four-and-a-half years ago. Federal and State inspectional mandates have changed, FDA guidance documents (and a few regulations) have been churned out, and some entities have been the target of aggressive enforcement actions and even criminal prosecutions by the FDA/Department of Justice. Suffice it to say, this blog post cannot capture everything that compounders have been grappling with or how their compliance policies have been evolving. So today, we are sharing one important and positive bit of news for health systems and other entities that may be considering whether and how to set up an outsourcing facility under Section 503B of the Food, Drug, and Cosmetic Act (as amended by the DQSA). Continue Reading FDA Alters Course on Definition of Compounding “Facility” in Final Guidance
Last month, FDA released three draft guidance documents that are expected to have significant implications for traditional pharmacy-based compounding and the distribution of those drug products.
First, however, a little bit of historical context might be helpful. As previously reported here and widely known in health care circles, in late 2013 Congress passed a law called the Drug Quality and Security Act (DQSA). Among other things, DQSA created a new class of federally regulated drug compounders called “outsourcing facilities” and also clarified requirements for compounding by licensed pharmacists and physicians in compliance with the Federal Food, Drug, and Cosmetic Act. In the 2.5 years that have elapsed since enactment of the law, FDA has been busy implementing its new authority over outsourcing facilities and issuing guidance for those entities, such as how current Good Manufacturing Practice (cGMP) regulations will apply to them and how they should go about registering and paying a required annual establishment fee. The three draft policies issued in mid-April address issues that affect both outsourcing facilities and State-licensed pharmacies that compound drugs on behalf of health care practitioners who need customized, non-commercially available products for specific patients. The policies address, for example, what constitutes a “prescription” for a compounded drug; how much product can be prepared in anticipation of receiving future prescription orders; and how large hospital or health system pharmacies may distribute compounds to other areas of the facility in advance of receiving a patient-specific order. Continue Reading New Compounding Policies from FDA May Affect Hospital and Health System Pharmacy Operations