Compounders Escape Mandatory FDA Inspection Oversight

Congress rejected the FDA’s call for mandatory oversight of compounding pharmacies, passing legislation Nov. 18 that instead allows compounders to volunteer for agency oversight.

Under the Drug Quality and Security Act (H.R. 3204), which has passed both houses of Congress and which President Obama is expected to sign, compounders would be allowed to stay under state supervision or voluntarily register as an “outsourcing facility.”

An “outsourcing facility” that agrees to FDA scrutiny would have to:

• Be subject to risk-based inspections;

• Pay user fees, including a $15,000 establishment fee and a reinspection fee for each reinspection in a fiscal year; and

• Report adverse events.

FDA Commissioner Margaret Hamburg last year asked Congress to give the agency a clear, mandatory oversight role over high-volume compounders and those dealing with the most complex drugs. The FDA was disappointed with the compromise legislation, but glad for some authority over compounders.

“While this bill does not provide FDA with the additional authorities it sought, it provides a regulatory framework for certain compounders who register with the FDA,” the agency said.

Compounders will need to weigh the marketing benefits of being “FDA registered” against the higher costs of satisfying FDA standards.

Congress hopes that hospital and consumer pressure will prompt compounders to register with the agency. Hospitals need to insist on compounded drugs from FDA-regulated facilities, enticing compounders to register, Allan Coukell, senior director of drugs and medical devices for Pew Charitable Trusts, says.

“I think that all the other stakeholders in the supply chain and clinicians working with compounding pharmacies will make sure [the compounders] are regulated,” Michael Werner, a lawyer with Holland & Knight, who works on pharmaceutical cases, said. “Once there is a class of entity that is regulated, that puts pressure on everyone else to get to that bar of quality and public assurance.”

The International Academy of Compounding Pharmacists, which opposed any additional regulations for compounders, says it still believes states are the appropriate regulators for compounding pharmacies. Spokesman David Ball says the association will work with the FDA and its members to prepare for the new law.

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