Section 503B of the FDCA (Drug Quality and Security Act of 2013) provides that a facility that compounds sterile drugs can elect to register with the FDA as an Outsourcing Facility (OF). Upon registering as an OF, the facility would be required to meet certain regulatory requirements including: providing FDA with information about the products they compound, complying with cGMPs, reporting adverse events and providing appropriate labeling for their products. In addition, the OF will undergo FDA inspection based upon the Agency’s risk-based approach.
As a preliminary step in implementing the requirements of the DQSA, FDA is taking steps to encourage hospitals and other purchasers of sterile compounded drugs (such as surgery centers) to source their sterile compounds from suppliers that register with the FDA as OF. FDA Commissioner Margaret Hamburg issued letters on January 8, 2014 to State health officials explaining the Agency’s current position and urged State officials to consider ways to encourage that compounding pharmacies located outside their states register as OFs, explaining that when a facility registers with the FDA as an OF, that facility would be held to the FDA’s regulatory oversight, including FDA risk-based inspections, cGMP requirements, adverse events reporting and labeling review. It appears that the FDA is pushing that these measures would become the “standard of care” for the compounding pharmacy industry, further pressuring compounders to register with the FDA.
Based upon the FDA’s advisory, it is important that compounding pharmacies seriously review their pharmacy business and determine whether to register as an OF. For certain pharmacies, it may be in their best interest (particularly if the FDA succeeds in making registered facilities a part of the medical standard of care). For others, the added costs and requirements of becoming registered could far outweigh the benefits, particularly if their pharmacy practices are limited to traditional compounding. Making the decision to register as OF depends on several factors, many of which are not entirely clear at this point in time and will be developed and clarified by regulations to be put out by the FDA. Contact Frier Levitt to speak to an attorney.
