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Regulatory Focus™ > News Articles > FDA Committee Prepares to Decide if Six Drugs Can be Made by Compounding Pharmacies

FDA Committee Prepares to Decide if Six Drugs Can be Made by Compounding Pharmacies

Posted 23 January 2015 | By Alexander Gaffney, RAC

FDA Committee Prepares to Decide if Six Drugs Can be Made by Compounding Pharmacies

The US Food and Drug Administration (FDA) has announced it will soon hold the first meeting of a new and influential advisory committee that is set to make recommendations about which drugs will not be allowed to be made by compounding pharmacies in the US.


The advisory committee, known as the Pharmacy Compounding Advisory Committee (PCAC), was re-created under a piece of 2013 legislation known as the Drug Quality and Security Act (DQSA). The law, passed in the wake of a major drug safety scandal that left more than 60 people dead, sought to update the way in which FDA oversees and regulates pharmaceutical products made by 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.

An Important Mission

The PCAC is set to play a central role in helping FDA to more tightly regulate the pharmaceutical compounding sector.

For example, the PCAC will be advising FDA regarding a list of drugs known as the "difficult-to-compound" list, which compounders will not be allowed to make. As Regulatory Focus has previously reported, this list will potentially be a source of controversy as brand-name pharmaceutical manufacturers try to argue their products are "difficult to compound" in order to stave off compounded competition.

Read about how manufacturers are trying to add their drugs to the "difficult-to-compound" list to stave off potential competition here.

While FDA is drafting a list of candidates for the difficult-to-compound list, it will consult with the PCAC before issuing a final difficult-to-compound list by regulation.

First Meeting

In December 2014, FDA announced the names of the 16 members who will serve on the PCAC.

Now, in a Federal Register announcement made on 23 January 2015, FDA has announced it will soon hold its first meeting of the new PCAC.

The 23 February 2015 meeting will see the PCAC "discuss proposed criteria for developing the list of bulk drug substances that may be used to compound drug products in accordance with section 503A of the FD&C Act and will discuss six substances nominated for inclusion on the list."

Those six drug substances are: Cantharidin, diphenylcyclopropenone, piracetam, silver protein mild, squaric acid dibutyl ester and thymol iodide.

The committee also said it plans to discuss "proposed revisions to the list of drug products that may not be compounded under the exemptions provided by the Federal Food, Drug and Cosmetic Act because the drug products have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective."


Federal Register Notice

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