The Update Continues: FDA’s List of Drugs that May Not Be Compounded Under 503A and 503B

October 27, 2016

By James E. Valentine & Karla L. Palmer

We reported earlier this month that the Food and Drug Administration (FDA) amended its regulations to update the list of drugs that may not used in compounding under the exceptions set forth in sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FDCA). This list reflects those drugs that have been withdrawn or removed from the market because the drugs or components of such drugs have been found to be unsafe or not effective. See 21 C.F.R. § 216.24.  FDA is at it again with another proposed rule that would further amend this list.

In alignment with the votes of the June 2015 Pharmacy Compounding Advisory Committee (see meeting transcript here), the proposed rulemaking would add the following three drugs to the current list of 83 drugs: 

Aprotinin: all drug products

Bromocriptine mesylate: all drug products for the prevention of physiological lactation

Ondansetron hydrochloride: all intravenous drug products container > 16 mg single dose

The notice provides a brief summary of the reasons why each drug is being proposed for inclusion. While the Pharmacy Compounding Advisory Committee also voted to include all drug products containing more than 325 mg of acetaminophen per dosage unit, FDA is still considering whether to propose adding it to the list.

Comments on the proposed rule can be submitted until January 3, 2017 here.