On February 15, 2019, the Federal Food and Drug Administration (FDA) issued a final rule specific to section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) regarding the list of bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act. The rule becomes effective March 21, 2019.
Under Section 503A of the FD&C Act in order to compound a drug product with a bulk drug substance, such bulk drug substance must be the subject of a USP or NF monograph (if a monograph exists) or a component of an FDA approved drug, and if neither of those scenarios apply, then the bulk drug substance must be listed on the 503A bulks list.
The recently released final 503A rule issued by the FDA addresses drug substances that have been placed on the 503A bulks list. The FDA has placed six bulk drug substances on the 503A list, including: Brilliant Blue G, also known as Coomassie Brilliant Blue G-250; cantharidin (for topical use only); diphenylcyclopropenone (for topical use only); N-acetyl-D-glucosamine NAG) for topical use only) squaric acid dibutyl ester (for topical use only); and thymol iodide (for topical use only). The FDA has also identified four other bulk drug substances that will not be included on the list, including: Oxitriptan, piracetam, silver protein mild, and tranilast.
In addition to taking action regarding 503A compounding, the FDA has also recently taken action regarding 503B compounding. On March 1, 2019, the FDA issued a final guidance document, entitled, Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act. This guidance document, issued by the FDA, finalizes the draft version of the guidance document that the FDA previously issued in March 2018. A total of 67 public comments were posted on the Federal Register in response to the March 2018 draft guidance.
In accordance with section 503B of the FD&C Act, an outsourcing facility may compound drug products utilizing bulk drug substances as starting materials if such drug products are in shortage or appear on the 503B bulks list, which is a list of bulk drug substances developed by the FDA for which there is a clinical need. This recently finalized guidance document addresses the FDA’s interpretation of “bulk drug substance for which there is a clinical need” and also highlights criteria the FDA generally intends to use to evaluate whether a bulk drug substance should be used by outsourcing facilities to compound drugs. In addition to issuing the final guidance document, on March 4, 2019, the FDA also published a notice in the Federal Register announcing that the FDA has chosen not to include nicardipine hydrochloride and vasopressin on the 503B bulks list.
If you are compounder under section 503A or an outsourcing facility with questions regarding what these recent actions by the FDA may mean for your business and potential actions available, contact Frier Levitt today to speak to an attorney.