February 9, 2024

New year, new guidance: FDA publishes 2024 Guidance Agenda

FDA recently released this year’s CDER Guidance Agenda, a list of new, revised draft, and immediately-in-effect guidance documents it plans to publish this year.

There are five listed in the compounding category:

  • Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Revised Draft
  • Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Revised Draft
  • Nomination of Bulk Drug Substances for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act
  • Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Revised Draft
  • Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors-Guidance for Outsourcing Facilities Under Section 503B of the FD&C Act

HHS’ semiannual regulatory agenda is also scheduled to be published today in the Federal Register. Proposed rules related to the 503A bulks list and the MOU are on the agenda. 

We’re keeping an eye out and will let you know when they’re published, what they say, and any comments we may offer FDA.