We posted a blog earlier today (here) regarding the FDA’s announcement that it plans to review a number of drug substances at a two-day meeting, in July, of the Pharmacy Compounding Advisory Committee. Later in the day, the FDA released a document outlining additional plans to reclassify other drug substances, including several peptide drug substances, onto the list of drug substances permitted to be used by 503A compounders to allow wider availability.
The document released by the Agency this afternoon, titled Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic (FD&C) Act, can be found here; it provides notice of updates to section 503A categories of drug substances that may change and be permitted after the Pharmacy Compounding Advisory Committee meetings in July 2026 and in February 2027.
Max Bayer of Endpoints News reports here (subscription required) that the decision for the proposed changes “was announced by HHS Secretary Robert F. Kennedy Jr. in a post on X, who wrote that ‘this action begins to restore regulated access and will immediately begin shifting demand away from the black market.’”
The wording I find most interesting in the FDA-released document (see link above) is regarding the proposed category shifts, stating that certain products “will be removed from category 2 after seven calendar days because the nominations were withdrawn by the nominators.” The FDA then refers to the relevant dates of the Pharmacy Compounding Advisory Committee meetings and notes that the Agency will place the products on the okay-to-compound list after the meeting, seemingly saying that the FDA’s intentions may already have been signaled. We’ll need to watch the results of the two ADCOM meetings to see the final outcomes. With the FDA’s previously expressed concerns about some of these drug substances, the question is, what may have changed so dramatically?
