Posted 10 January 2014
By Alexander Gaffney, RAC
The US Food and Drug Administration (FDA) has announced the formation of an eagerly awaited advisory committee set to offer critical input in deciding which drug products will no longer be allowed to be compounded under the terms of a recent piece of legislation.
That legislation, the Drug Quality and Security Act (DQSA), was passed into law on 27 November 2013, and contained numerous provisions intended to regulate pharmaceutical products produced by so-called "compounding pharmacies."
Unlike more traditional pharmaceutical manufacturers-think Pfizer, for example-compounding pharmacies make custom versions of already-approved pharmaceuticals with the stated purpose of meeting unique patient needs. A compounding pharmacy might make a smaller dose of a drug than is commercially available, for example.
But as a massive outbreak of fungal meningitis in late 2012 illustrated, not all was well in the compounding sector. FDA investigators would later determine that deficient quality practices at a compounding pharmacy had resulted in patients being exposed to contaminated products, and a subsequent surge of inspections found dozens of compounders with similar deficiencies.
Those findings in hand, legislators passed the DQSA, which creates a new system in which some compounding pharmacies will register with FDA and consent to inspections. The hope, legislators said, is that this category of pharmacy will be sought after by consumers because of the quality assurances they offer relative to smaller pharmacies.
The Pharmacy Compounding Advisory Committee
But unlike their state-regulated counterparts, federally regulated "outsourcing pharmacies" will be subject to additional restrictions. Chief among those restrictions: not compounding any drug product present on a "difficult-to-compound" list. The theory is that certain drugs present unique challenges that make it difficult for companies to assure their potency, quality, consistency and bioavailability. Rather than risk patient safety, FDA will require those drugs to only be made by approved manufacturers.
So which drugs will be on that list? While the final determination will be up to FDA, it's due to receive help from an Advisory Committee created in 2012 and, as of 10 January 2014, seeking new members.
The Pharmacy Compounding Advisory Committee (PCAC) is now a standing committee intended to assist the Center for Drug Evaluation and Research (CDER), FDA wrote in a Federal Register notice announcing its re-creation. The PCAC had previously been formed in 1998, but was disbanded in 2002 after part of FDA's compounding authority was found to be unconstitutional.
FDA says the committee will include 12 voting members, including a chair. Members will be selected from the National Association of Boards of Pharmacy (NABP) and the United States Pharmacopoeia (USP), as well as representatives of patient and public health advocacy organizations. Members will serve four-year terms.
The committee will also include non-voting representatives from the pharmaceutical industry and a voting consumer representative, FDA said.
Once constituted, the committee will consider a list of drugs the public and industry wants to be on the list. Its final recommendations will then be sent to FDA for the agency's final consideration.
Responses are due to FDA by 13 February 2014.
Federal Register notice