Just days after President Barack Obama signed legislation giving the FDA expanded power over compounding pharmacies, the agency released draft guidance directing those pharmacies on how the law should be interpreted and will likely be enforced. The agency is also encouraging hospitals to only use compounders registered and approved by the FDA.
The new law, the Drug Quality and Security Act (PDF), was signed late last month and includes provisions specifically aimed at addressing concerns over the lack of oversight for compounding pharmacies.
Compounding pharmacies are facilities that make, or compound, medications on a case-by-case basis. Traditionally, they mix drugs on a per-prescription basis for local hospitals when those drugs are not available from the manufacturer. However, in recent years, amid a lack of coordinated federal regulation, many facilities have essentially turned into underground drug manufacturers who distribute thousands of medications to medical providers throughout the United States.
The legislation was introduced to address concerns following a nationwide fungal meningitis outbreak late last year, which was linked to thousands of vials of contaminated steroid injections distributed by a single compounding pharmacy, the New England Compounding Center (NECC). More than 700 cases of meningitis nationwide were linked to the outbreak, including at least 60 deaths. Subsequent investigations confirmed a number of problems with the facility, and information suggested that the FDA was aware of the potential risks, but may have lacked the necessary regulatory authority to take any actions.
In a draft guidance (PDF) released this week by the FDA, the agency provided information on how the law will actually effect regulations. One core part of the FDA’s interpretation of the new law is that it will encourage hospitals to only buy compounded drugs from facilities that have registered with the agency and who been vetted by the FDA.
“If compounders register with FDA as outsourcers, hospitals and other health care providers will be able to provide their patients with drugs that were compounded in facilities that are subject to FDA oversight and federal requirements for current good manufacturing practice, among others,” FDA Commissioner Margaret Hamburg, M.D., said in a December 2 FDA Blog. “To that end, we will be encouraging healthcare providers and health networks to consider purchasing compounded products from facilities that are registered with FDA and subject to risk based inspections.”
In the case of NECC, the compounder distributed more than 17,000 of its potentially contaminated epidural steroid injections, and U.S. Centers for Disease Control and Prevention (CDC) experts estimate that 14,000 people were exposed at hospitals and pain management centers nationwide.
The new law allows compounders that operate in a traditional manner and who never ship drugs outside of state lines to be regulated by state boards and not the FDA. The agency’s guidance further states that those compounders who create drugs for an individual patient based on a prescription from a health care provider are also exempt from a number of provisions, including requirements for New Drug Applications and good manufacturing processes.
However, larger operations will be considered “outsourcing facilities” that are subject to current good manufacturing practice requirements and regular FDA inspections.
Critics of the new law worry that the “outsourcing facilities” classification represents a new kind of drug manufacturer that does not have to meet the stringent requirements leveled against pharmaceutical companies. Established drug manufacturers also complained about the creation of this new category, which they say is a hybrid of a compounding pharmacy and a drug manufacturer, because those outsourcing facilities may be unfairly competitive.