Compounding Pharmacy Guidance, Proposed Rule Issued By FDA

Federal drug regulators have issued new guidelines for compounding pharmacies, as well as a proposed rule that lists which drugs have been banned from compounding because they are unsafe and ineffective. 

The FDA announced the new compounding pharmacy policies on July 1, as part of the agency’s efforts to implement the Drug Quality and Security Act, which was enacted in November 2013 and laid down new laws for how compounding pharmacies should be regulated.

The documents released by the FDA include a draft interim guidance (PDF), which lays out the current good manufacturing practice (CGMP) requirements for registered compounding pharmacies. The guidance focuses specifically on sterility and the safety of compounded drugs.

The FDA also issued a proposed rule (PDF), which lists drugs that may not be compounded because they have been found to be unsafe and ineffective regardless of who makes them. Drugs on the list have already been withdrawn or removed from the market.

There is also a final guidance (PDF) for compounding pharmacies that intend to continue to only compound drugs for individual patients, which will exempt them from a number of new FDA regulations. The guidance includes potential enforcement actions for those who violate federal law.

In addition, the FDA issued two federal register notices reopening the nomination process for bulk drug substances that can be used to compound drug products.

Fungal Meningitis Outbreak Sparked New Laws

The actions and the new compounding drug laws came as a result of Congress’s response to a deadly fungal meningitis outbreak that killed more than 60 people and sickened more than 700 beginning in the summer of 2012.

The outbreak was tracked back to the New England Compounding Center (NECC), which was found to have distributed more than 17,000 potentially contaminated doses of epidural steroid injections to hospitals and pain centers nationwide.

Before the new law, compounding pharmacies were supposed to be restricted to making small amounts of drugs for individual patients that were not available from a drug company. Instead, investigators discovered an entire underworld of mass drug manufacturing that was occurring without FDA oversight and which was rife with sterility and other quality control problems.

The DQSA created a new class of compounding pharmacy that could make bulk drugs, but which had to be under the direct oversight of the FDA to do so, leaving small individual compounding businesses out from under the FDA’s auspices.

Many critics disagreed with the law, saying that all compounding pharmacies should be under the oversight of the FDA, and that creation of a new class of pseudo-drug manufacturer was overly complicated, inefficient, and unfair to drug companies who had to jump through all of the FDA’s regulatory hoops to get drugs on the market safely.

In May, the owners of NECC agreed to a fungal meningitis lawsuit settlement that established a $100 million victim’s compensation fund.