The 503(B) Bulks List

The Food and Drug Administration (FDA) continues to recommend additions to the 503(B) Bulks List (https://www.fda.gov/media/94164/download). A component of the Drug Quality and Security Act of 2013, the list includes drug products that 503(B) outsourcing facilities can use in drug compounding, and which qualify for certain exemptions from the requirements of the Federal Food, Drug and Cosmetic Act (e.g., office use compounding). On March 24, 2021, FDA added quinacrine hydrochloride to the list, and considered four other bulk drugs (i.e., bromfenac sodium, mitomycin C, nepafenac and hydroxychloroquine sulfate) but chose not to include them on the list as they did not meet the requirement for clinical need (federalregister.gov/d/2021-06060). Hydroxychloroquine was proposed by the nominator to compound a suspension form for pediatric dosing. FDA’s basis for not including hydroxychloroquine was that the suspension may be compounded from existing FDA-approved commercially available 200 mg tablets. As a result, compounding of hydroxychloroquine can still occur as long as the compound is not identical to the commercially available product (e.g., 200 mg tablets). Some believe that in its review of nominated bulk substances, FDA favors use of FDA-approved products over bulk ingredients in compounding.

FDA has been evaluating bulk drug substances nominated for the list on a rolling basis and many additional bulk substances are still in need of evaluation. Comments on the list were due on May 24, 2021. Depending on the comments received, FDA may finalize its proposed determination without change, or it may finalize a modification to its proposal to reflect new evidence or analysis regarding clinical need. Additionally, FDA remains open for nominations of bulk substances for inclusion on the list via a Public Docket.

How Frier Levitt Can Help

Frier Levitt can prepare comments as well as prepare formal submissions to FDA for bulk substances for nomination to the 503(B) list and subsequent FDA evaluation. Contact us to speak to a FDC regulatory attorney.

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