The FDA has announced a two-day meeting of the Pharmacy Compounding Advisory Committee for the purpose of reviewing certain bulk drug substances nominated for inclusion in the Section 503A bulk drug substances list.  The meeting is scheduled for July 23-24, 2026, and it will be held at the FDA’s White Oak Campus.  The full notice from the pre-publication page of the Federal Register can be found here.

Section 503A of the Federal Food, Drug and Cosmetic Act “describes the conditions that must be satisfied for human drug products compounded by a licensed pharmacist in a state-licensed pharmacy or a federal facility, or a licensed physician, to be exempt from the following three sections of the FD&C Act: (1) section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice requirements); (2) section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use); and (3) section 505 (21 U.S.C. 355) (concerning the approval of human drug products under new drug applications (NDAs) or abbreviated new drug applications (ANDAs)).”

Following is one of the sets of conditions that must be satisfied to qualify for the exemptions for a product that is compounded using a bulk drug substance:

  • The drug substances must comply with the standards of an applicable United States Pharmacopoeia (USP) or National Formulary monograph, if a monograph exists, and the USP chapter on pharmacy compounding;
  • If an applicable monograph does not exist, are drug substances that are components of drugs approved by the Secretary of Health and Human Services (the Secretary); or
  • If such a monograph does not exist and the drug substance is not a component of a drug approved by the Secretary, that appear on a list developed by the Secretary through regulations issued by the Secretary under section 503A(c) of the FD&C Act (the 503A Bulks List).

The current permitted bulk drug substances that fall under the third category above can be found here; as you can see from this list, not many drug substances that fall under category 3 have been approved for inclusion.  I get a general sense that many 503A compounders are not pleased with the slow speed of the process and the low number of bulk drug substances that have been approved for inclusion on the list.  However, the process is moving forward and the FDA will be discussing the following bulk drugs substances, which have been nominated for inclusion on the list, at the July 23rd meeting:

The following bulk drug substances and their uses are to be discussed at the July 24th meeting:

The process for registering to attend is outlined in the Federal Register notice cited above.  The process for those wishing to present data, information, or views, either in person or by written comment, is also delineated in the notice.