FDA Issues Final Rule on Drugs that Cannot Be Compounded

“FDA is amending its regulations to revise the list of drug products that have been withdrawn or removed from the market because the drug products or components of such drug products have been found to be unsafe or not effective (referred to as ‘the withdrawn or removed list’ or ‘the list’) (§ 216.24 (21 CFR 216.24)). Drugs appearing on the withdrawn or removed list may not be compounded under the exemptions provided by sections 503A and 503B of the FD&C Act.”

FDA has decided to continue to make additions or removals from the list through comments and rulemaking provisions, since FDA’s action could have a significant impact on the compounding community.  In this Final Rule, the FDA is adding 24 entries to the list, modifies the list to permit one product to be compounded under certain circumstances, and “modifies the title of part 216 the introductory test to §216.24” (where the list is published).

There are pharmacy compounders under section 503A of the Act and outsourcing facilities identified under section 503B of the Act.  One condition to qualify for the exemptions under those sections of the Act is that the compounder does not use an ingredient identified on the list of products that the Secretary has determined have been withdrawn or removed for safety or efficacy reasons. This Final Rule (here) implements these provisions of the Act.

Expect updates to the list, but in a more formal manner, as FDA will employ both their Compounding Advisory Committee and will make its final decisions through its comment and rule-making procedures.  FDA notes that “[A]t this time, FDA is not finalizing the entry in the proposed rule for all extended-release drug products containing oxycodone hydrochloride that have not been determined by FDA to have abuse-deterrent properties. The addition of an entry to the withdrawn or removed list for oxycodone hydrochloride remains under consideration by FDA.”  This is an interesting development since FDA has taken the position that OxyContin that does not contain abuse-deterrent properties is no longer considered safe.  It appears that FDA is not ready to make the leap to all potential oxycodone single-entity products in extended-release form.

In the Final Rule, the FDA outlines 16 comments that were submitted to the proposed rule and provides their responses.  The process for adding or deleting drugs from the list is also discussed. The final list is also presented.