The FDA has shared a compilation of regulatory information applicable to outsourcing facilities as well as a listing of drugs that registered outsourcing facilities have produced
FDA oversight of compounding is high priority because compounded drugs, while important to patients, can pose serious risks if not manufactured properly. Every year the FDA learns of cases of patient illnesses and deaths due to improperly compounded drugs; because such drugs are entering the bloodstream, the eye or the spine, they need to be sterile.
The multi-state outbreak of fungal meningitis in 2012, which led to more than 70 deaths due to drugs prepared in unsanitary conditions, led to a tightening of FDA oversight. For example outsourcing facilities must be registered with the FDA and fully comply with the provisions put in place by Congress to protect patients under the Drug Quality and Security Act (DQSA).
However, while there is a growing need for compounded drugs, the high production standards required under current good manufacturing practice (cGMP) makes drug compounding a complex area for new entrants.
The FDA is now posting a new report that provides a list of the drugs that entities registered as outsourcing facilities have produced. Under the DQSA, outsourcing facilities are required to report to the FDA, upon initial registration and each June and December, the drug products that they compounded during the previous six months.
In his statement last week, FDA Commissioner Scott Gottlieb said: “We are making the list public, among other reasons, to help the medical community in their efforts to identify and access specific compounded drug products from facilities that are required to follow current good manufacturing practice standards.”
The FDA is also sharing a new guide – Outsourcing Facility Information – which gives key regulatory information applicable to the outsourcing facilities. It includes information about the implications of becoming an outsourcing facility, the agency resources available to outsourcing facilities, registration and product listing, and FDA inspections and subsequent actions.
The guide will 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 and FDA policies and procedures.
“This guide is one step in our efforts to help more pharmacies become outsourcing facilities. We are committed to making this process as efficient as possible,” said Gottlieb.
“Toward these goals, we’ll be taking additional steps in the coming months to help more compounders register as outsourcing facilities – by continuing to streamline the process and appropriately calibrate the regulatory burden of operating as an outsourcing facility, “ he added.