FDA Proposes New Compounding Pharmacy Guidelines

As part of the FDA’s continuing efforts to facilitate the certain provisions of the Drug Quality and Security Act (DQSA), federal health regulators have published new guidelines for all compounding pharmacies with the United States.  The DGSA was initially enacted in 2013 to provide guidance for the compounding industry in the hopes of reducing the rate of pharmacy errors.

On July 1, the U.S. Food and Drug Administration issued a news release announcing several policy documents regarding compounded drugs for human use. A draft short-term guidance, proposed rule, final guidance, and two revised requests for nominations are included among the documents.

“Providing clarity to the compounding industry on the agency’s expectations for these unapproved drug products is a priority for the agency… These actions are essential next steps in providing the compounding industry with the appropriate tools to comply with the law and advancing the FDA’s efforts to continue protecting patients,” said the director of the FDA’s Center for Drug Evaluation and Research, Janet Woodcock, M.D.

FDA defines expectations for compounding pharmacies

According to the FDA, the following policy documents are currently available:

• Draft Interim Guidance – outlines the FDA’s compliance expectations concerning good manufacturing practice (CGMP) requirements for pharmacies that compound drugs and register with the FDA as outsourcing facilities. These guidelines focus specifically on practices to maintain the safety and sterility of compounded drugs intended for human use.
• Proposed Rule – Amends the current list of drugs that may be compounded, removing all drugs that have been withdrawn or recalled due to safety or efficacy issues. The proposed rule would be in effect for both compounders and outsourcing facilities that compound drugs for human use under sections 503A and 503B.
• Final Guidance – includes a non-exhaustive list of potential enforcement actions against pharmacies or individuals that compound drug products in violation of the FD&C Act. The guidance also applies to all facilities that plan to continue compounding human drugs for individual patients, stipulating the regulations to which they must adhere.

Pharmacy errors triggers laws for compounding facilities

New legislation that regulates compounding pharmacies was prompted by a serious fungal outbreak in 2012 which was traced back to a compounding center that had distributed thousands of contaminated injections of epidural steroids. The fungal meningitis outbreak claimed the lives of more than 60 Americans, and sent more than 700 to the hospital.

The contaminated doses had been manufactured in the New England Compounding Center (NECC), which was found to have sold some 17,000 doses of steroid injections to pain centers, clinics and hospitals across the country.

The following year, the Drug Quality and Security Act was passed under the Obama administration in an effort to address a largely unregulated industry of drug compounding facilities. “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,” explained FDA Commissioner Margaret Hamburg, M.D. in 2013.

Under the DQSA, those compounding pharmacies that are making bulk drugs for human use are now under the direct supervision of the FDA.