Regulatory Focus™ > News Articles > FDA Considers Compounding Restrictions on Four Drugs, Including Acetaminophen

FDA Considers Compounding Restrictions on Four Drugs, Including Acetaminophen

Posted 21 May 2015 | By Alexander Gaffney, RAC

FDA Considers Compounding Restrictions on Four Drugs, Including Acetaminophen

The US Food and Drug Administration (FDA) is preparing to ask one of its newest advisory committees to decide if some compounding pharmacies should be allowed to make four drugs, including the widely used painkiller acetaminophen.


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 or GlaxoSmithKline, 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.

Under the DQSA, FDA now regulates two categories of compounding pharmacies: traditional compounding pharmacies, and "outsourcing facilities." Unlike the former category, outsourcing facilities may compound their products for as-yet unidentified patients. This permits them to compound drugs in bulk amounts.

However, federal law also prevents these outsourcing facilities from compounding any drug withdrawn or removed from the market by FDA for reasons of safety or efficacy.

In addition, they may not compound any drug contained on FDA's "difficult to compound" list.

'Do Not Compound' List

The former of those two criteria will be the focus of discussion for the PCAC at its next meeting on 17 June 2015, when it will decide whether to add four drugs to its “do-not compound” list.

FDA says it is considering adding aprotinin (Trasylol), ondansetron hydrochloride (Zofran), bromocriptine mesylate (Parlodel) and acetaminophen (Tylenol) to its list of drugs unable to be compounded in bulk by outsourcing facilities.

As explained by FDA in its Federal Register notice, the addition of the drugs to the list may cover all indications, or just a few.

"The list may specify that a drug may not be compounded in any form, or, alternatively, may expressly exclude a particular formulation, indication, dosage form, or route of administration from an entry on the list because an approved drug containing the same active ingredient(s) has not been withdrawn or removed from the market. Moreover, a drug may be listed only with regard to certain formulations, indications, routes of administration, or dosage forms because it has been found to be unsafe or not effective in those particular formulations, indications, routes of administration, or dosage forms. FDA plans to seek the committee’s advice concerning the inclusion of these drug products."

In the case of acetaminophen, for example, FDA may be concerned about pharmacies manufacturing high-dose versions of the drug. In July 2014, FDA removed all prescription drugs containing more than 325 mg of acetaminophen from the market following reports of liver injury in some patients. FDA may therefore be looking to restrict certain types of compounding.

Other topics set to be discussed at the meeting include the criteria for inclusion on FDA's "demonstrably difficult to compound" list, and the inclusion of four other drug substances onto a "bulk drug substances list": Brilliant Blue G, tranilast, Nacetyl-D-glucosamine and oxitriptan.


FDA Notice


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