A House committee says the Food and Drug Administration's regulation of drug compounding is veering from the intent of the law passed in 2013 in the wake of a national meningitis outbreak tied to unsanitary practices at a compounding pharmacy.
The committee included the criticism in a draft report released Tuesday on a pending appropriations bill, just days after the FDA released a draft document clarifying its guidelines for compounding without a prescription.
In that document, the FDA details how much product pharmacists can compound in anticipation of a prescription and explains rules for “outsourcing facilities,” which are large-scale compounding operations that can fill orders that aren't specific to particular patients and are subject to strict FDA manufacturing standards and inspections like conventional drugmakers. The document advised pharmacists that they can keep up to a 30-day supply of drugs they anticipate will be needed by established patients, and notes that providers who want to keep more drugs in stock for non-specific patients can work with an outsourcing facility.
The Appropriations Committee says the FDA's prohibition of such “office stock” is not in line with the intent of Drug Quality and Security Act. Congress passed the legislation in 2013 to give the FDA more authority to regulate compounding and better track the pharmaceutical supply chain in response to a deadly meningitis outbreak tied to a Massachusetts compounding pharmacy.
The committee directed the FDA to issue further guidance, within 90 days of the enactment of the appropriations bill, on how pharmacists can continue to engage in office-use compounding before receiving a prescription.
The committee also said outsourcing facilities should not be required to conform to the FDA's stricter Good Manufacturing Practices and be subject to federal inspections, which the lawmakers said contradicts some state laws that allow compounding pharmacies to produce a limited inventory for physicians' offices without a prescription or an established relationship. Members argued that pharmacies are better served by adhering to the standards established by the United States Pharmacopeial Convention and state laws and regulations.
“The committee reminds the FDA that compounding pharmacies are not drug manufacturers, but rather, are state licensed and regulated healthcare providers that are inspected by state boards of pharmacy pursuant to state laws and regulations that establish sterility and other standards for the pharmacies operating within their states,” the report said.
The FDA did not immediately respond to a request for comment.
Elizabeth Jungman, director of public health at the Pew Charitable Trusts, said she wasn't entirely surprised by the committee's reaction but argued that its endorsement of office-use compounding is risky because drugs produced for office stock are made in larger batches and sit on provider shelves longer, increasing their potential to harm patients.
“It is somewhat shocking that this soon after the fungal meningitis outbreak that caused Congress to pass DQSA in the first place, we're seeing language that would make it very difficult to maintain that law,” Jungman said.
Pew has teamed up with a number of healthcare organizations in support the FDA's enforcement of compounding rules, including the American Public Health Association, Pharmaceutical Research and Manufacturers of America, the Biotechnology Industry Association, the Generic Pharmaceutical Association and Trust for America's Health.
The International Academy of Compounding Pharmacists, which was critical of the office-use prohibition, expressed support for the committee's interpretation, saying the FDA “continues to ignore clear Congressional intent … where the states have clearly indicated pathways” for office-use compounding.
The compounding pharmacists organization also agreed that outsourcing facilities should be subject to state law and state inspections and not the “undue pressure” of FDA inspection unless the state has proof the pharmacy violated federal law. “We look forward to working with lawmakers to ensure these various amendments or statements are fully recognized and adhered to by the agency,” the IACP said.
