2021 FDA Science Forum
Evaluation of the U.S. Food and Drug Administration (FDA)’s 2020 Proposed 503B Bulk Drug Substances
- Authors:
- Center:
-
Contributing OfficeCenter for Drug Evaluation and Research
Abstract
For a subset of patients compounded drugs fill a clinical need that FDA-approved drug products cannot, this clinical need does not come without risks. To minimize risk and protect patients, while still providing for their clinical need, the Drug Quality and Security Act was signed into law and a new section was added under the Federal Food, Drug, and Cosmetic Act. This 503B section includes compounding regulations by outsourcing facilities. For outsourcing facilities to produce a compounded drug product the substance must appear on the 503B Bulks List or appear on FDA’s drug shortage list. Development of the 503B Bulks List has been underway with the FDA.
In July of 2020, proposals for inclusion and exclusion certain substances to the 503B Bulks List was published in the Federal Register. The substances proposed for inclusion are diphenylcyclopropenone (DPCP), glycolic acid, squaric acid dibutyl ester (SADBE), and trichloroacetic acid (TCA). Nineteen other substances were proposed to not be included on the list. Referenced evidence that was provided to the public from the July 2020 Federal Register Notice will be highlighted to illustrate the decision-making process involved in the review of the proposals. The FDA’s general progress with reviewing nominated bulk drug substances will also be discussed with the goal of educating the public on the 503B nomination review process.
