Every time the FDA has discussed compounding pharmacies and the need to keep fake drugs out of the supply chain in recent years, one message has shone through--we need more power. Now, the FDA is being given some, but not all, of the powers it wants, and has begun to discuss how it plans to use its new authority.
The powers derive from the Drug Quality and Security Act that President Barack Obama signed into law just before Thanksgiving. On Monday, the FDA began detailing how it will implement the law, which calls for the adoption of a full track-and-trace system within 10 years and creates a new way to oversee compounders. While the traceability project is a long-term initiative, the pharmacy powers have immediate implications and the FDA has already posted draft guidance.
In the guidance documents, the agency outlines how compounding pharmacies can register as "outsourcers" and submit information about their products. The voluntary nature of registration could limit uptake, but the FDA is optimistic. If drug buyers favor registered facilities, they will quickly gain a competitive edge and account for a larger share of the compounding market. "Today's news really is an important step to having stronger drug quality and security laws," FDA Commissioner Margaret Hamburg told reporters.
The FDA plans to explain the benefits of buying from registered compounders to hospitals and other drug purchasers. If hospitals fail to make preference for registered facilities standard practice, the FDA's struggles to oversee compounding pharmacies could continue. "It will be difficult for us to identify compounding pharmacies that choose not to register with us. We will not be able to do proactive inspections and will have to wait until we have a complaint," FDA associate director for policy Jane Axelrad said.