FDA Provides Guidance for Compounders


The Drug Quality and Security Act (DQSA) provides a framework for working with outsourcing facilities to meet federal regulatory standards.

The FDA understands the importance of access to compounded drugs, and is committed to supporting access to these drugs under "high production standards," according to a recently-released statement from FDA Commissioner Scott Gottlieb, MD.

The Drug Quality and Security Act (DQSA) provides a pivotal foundation for achieving these goals, by working with outsourcing facilities to meet regulatory standards, Gottlieb explained in the statement. The FDA has posted a new report that provides a list of the drugs that entities registered as outsourcing facilities have produced. The first report list includes compounded drug products that outsourcing facilities reportedly produced between December 2016 and May 2017.

"FDA oversight of compounding continues to remain essential, because compounded drugs, while important to patients who need them, pose ongoing and serious risks if they are not manufactured properly," Gottlieb wrote. "Every year, the FDA learns of cases of patient illnesses and deaths due to improperly compounded drugs and caused by issues like contamination in drugs that need to be sterile because they are entering the bloodstream, the eye, or the spine or because the drugs are not made at the right strength and are super-potent."

FDA officials have also shared a guide, "Outsourcing Facility Information," which is a compilation of key regulatory information applicable to the outsourcing facilities designed to assist compounders in deciding whether to register with the FDA as outsourcing facilities and provide existing outsourcing facilities with a helpful resource on applicable provisions of federal law.

"The guide that the FDA is posting today is one part of a larger effort to make the process for becoming an outsourcing facility more transparent and efficient," Gottlieb wrote in the statement. "Appropriately compounded drugs can provide important alternatives for patients who need them. Our ultimate goal is to make it more feasible for compounding pharmacies to register as outsourcing facilities, enabling them to grow their businesses under a legally approved framework, and increase access to better quality compounded drugs in the process."


FDA. Outsourcing facilities. FDA website. https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm393571.htm#reporting. Published September 2017. Accessed Oct. 1, 2017.

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