Reed Smith Client Alerts

On October 31, 2019, the U.S. Food and Drug Administration (“FDA” or the “Agency”) moved ten bulk drug substances to Category 1 of the Agency’s list of categories of nominated substances for which there is a “clinical need” under section 503B of the Federal Food, Drug, & Cosmetic Act (FDCA).

The following bulk drug substances have been added or moved to Category 1:

  1. Amphotericin B
  2. Anastrazole
  3. Ciprofloxacin HCl
  4. Cocaine HCl
  5. Cyclosporine/Cyclosporine A
  6. DHEA (dehydroepiandosterone)
  7. Diphenhydramine HCl
  8. Dyclonine HCl
  9. Haloperidol
  10. Sodium thiosulfate

What does this categorization mean?

Over the past few years, FDA has been evaluating bulk drug substances on a rolling basis that have been nominated by industry stakeholders for inclusion on what is known as the “503B Bulks List”—that is, a formal list of bulk drug substances that FDA has approved for compounding by registered outsourcing facilities based on the Agency’s determination of whether there is a “clinical need” for the substance. While FDA works to develop the 503B Bulks List, FDA operates according to its Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug & Cosmetic Act (“Interim Policy”). The Interim Policy set out conditions under which the Agency will forgo action against outsourcing facilities that compound drug products from bulk drug substances that cannot otherwise be compounded under Section 503B of the FDCA.