The following bulk drug substances have been added or moved to Category 1:
- Amphotericin B
- Anastrazole
- Ciprofloxacin HCl
- Cocaine HCl
- Cyclosporine/Cyclosporine A
- DHEA (dehydroepiandosterone)
- Diphenhydramine HCl
- Dyclonine HCl
- Haloperidol
- 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.
One of these conditions involves placement of the bulk drug substance on Category 1, which indicates that the Agency believes the substances (1) may be eligible for inclusion on the 503B Bulks List, (2) were nominated with sufficient supporting information for FDA to evaluate them, and (3) do not appear on any other list. FDA indicated in its Interim Policy that bulk drug substances nominated for inclusion on the 503B Bulks List and not placed in Category 1 (i.e., they were placed in Category 2 or 3) may be eligible for inclusion in the future but currently cannot be compounded without sufficient supporting information.
Current status of the 503B Bulks List
FDA has not yet placed any bulk drug substances on the 503B Bulks List but it has decided not to include two substances: Nicardipine Hydrochloride and Vasopressin. FDA published a Notice in the Federal Register on September 3, 2019, proposing to exclude nine more bulk drug substances from the 503B Bulks List: dipyridamole, ephedrine sulfate, famotidine, hydralazine hydrochloride, methacholine chloride, sodium bicarbonate, sodium tetradecyl sulfate, trypan blue, and vecuronium bromide (all substances that are currently in Category 1). Stakeholders interested in submitting comments to this Notice on the 503B Bulks List had until November 4, 2019, to comment. For more information on this notice, please see our prior alert here.
Moving forward
FDA’s recent placement of Amphotericin B, Anastrazole, Ciprofloxacin HCl, Cocaine HCl, Cyclosporine/Cyclosporine A, DHEA, Diphenhydramine HCl, Dyclonine HCl, Haloperidol, and Sodium thiosulfate in Category 1 is further indication that the Agency is actively engaged in the implementation of the Drug Quality and Security Act, which is the federal law that regulates human health compounding practices. We therefore encourage stakeholders to remain apprised of FDA’s ongoing evaluation and placement of bulk drug substances on the 503B Bulks List, especially those stakeholders that compound with bulk drug substances currently placed in Category 1, 2, or 3.
Should you have any questions regarding the categorization or any of the issues raised in this alert, please do not hesitate to reach out to Rachael Pontikes, Emily Hussey, or Kelly Kearney for further discussion.
Client Alert 2019-267
