FDA Extends Oversight of Large Compounders

Moving fast to bolster its authority over compounding pharmacies that operate as manufacturers of prescription drugs, FDA is urging “outsourcers” to register, seeking state support, and moving to issue more rules and guidance. The agency is pleased that 14 outsourcers registered through mid-January. The number is small, considering that an estimated 3000 compounding pharmacies make sterile injectible drugs, but this initial activity reflects FDA’s fast action in implementing the Drug Quality and Security Act (DQSA), which was enacted less than three months ago.

One strategy to spur registration is to urge hospitals to exert their purchasing power to compel compounders to embrace the new regulatory system. FDA commissioner Margaret Hamburg sent letters in early January to hundreds of hospitals urging them to pressure the compounding pharmacies they buy from to sign up as outsourcing facilities. Support for this approach was recently voiced by executives at the Premier hospital system, which purchases drugs for hundreds of hospitals.

Commissioner Hamburg also has written state governors, members of state boards of pharmacy and state health officials outlining the benefits of DQSA and asking them to encourage outsourcer registration. FDA is looking for state assistance moreover in dealing with distant compounders that ship into a state.

Even this relatively low level of compliance is notable because registration is not that attractive for compounders:  pharmacies have to submit to FDA inspections and pay hefty user fees. Thus the prospect of commercial benefit and protection from legal action is key to convincing firms to sign up. Many outsources on the registration list were inspected by FDA last year, and most were cited by the agency for quality problems.

To help craft further regulations on outsourcing facilities, FDA is re-establishing its Pharmacy Compounding Advisory Committee (AC), which was disbanded some years ago when the agency’s authority over compounders came under legal fire. FDA recently issued requests for nominations to the AC of leading experts in the field, plus nonvoting representatives of pharmaceutical manufacturers and of pharmacy compounders. FDA published notices on the AC nominating process in the Jan. 13, 2013 Federal Register, noting that information on prospective candidates should be sent in by Feb. 12, 2014.

One important task for FDA is to develop lists of drugs that may not be compounded and lists of bulk drug substances that comply with established standards and thus may be used in compounding. FDA plans to issue new regulations to update these lists. The agency also will continue proactive and for-cause inspections of compounding pharmacies and will “take aggressive action” when necessary to protect the public health.