Key takeaways
- After many years of deliberation, FDA has crafted a proposed rule for drug products that present demonstrable difficulties for compounding
- FDA has proposed a set of six criteria to consider when determining whether a drug product should be included on FDA’s demonstrably difficult-to-compound lists
- FDA has identified three categories of drug products for inclusion on the lists
On March 20, 2024, the United States Food and Drug Administration (FDA or Agency) published its proposed rule on “Drug Products or Categories of Drug Products that Present Demonstrable Difficulties for Compounding Under sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act” (the Proposed Rule). The FDA is proposing to establish criteria for the list of drug products or categories of drug products that present demonstrable difficulties for compounding (DDC Lists) under certain sections of the federal Food, Drug, and Cosmetic Act (FDCA). Additionally, the Agency is proposing to identify the first three categories of drug products on both DDC Lists. Drug products or categories of drug products that appear on the DDC Lists cannot qualify for certain statutory exemptions and therefore may not be compounded under either section 503A or section 503B, respectively.
1. Why is the FDA doing this?
Under sections 503A and 503B of the FDCA, specified conditions must be satisfied for compounded drug products to qualify for certain exemptions from the FDCA’s new drug approval process. One such condition concerns whether the compounded drug product is one identified by the FDA as presenting demonstrable difficulties for compounding. A drug product that the FDA has identified as presenting demonstrable difficulties for compounding pursuant to section 503A or section 503B may not be compounded under either section 503A or section 503B, respectively.
Both sections 503A and 503B of the FDCA contemplate that, before a drug product is identified by the FDA through regulation as one that is difficult to compound, the FDA must convene and consult an advisory committee on compounding unless the FDA determines that the issuance of such regulations before consultation is necessary to protect the public health. Beginning in 2013, the FDA established a docket and invited industry stakeholders to nominate drug products or categories of drug products to be identified as ones that present demonstrable difficulties for compounding. Approximately 70 unique drug products or categories of drug products were nominated.
In July 2017, the FDA established another public docket so that interested parties could nominate drug products or categories of drug products that were not previously nominated, resubmit previous nominations with additional supporting information, or submit comments. Since establishing the new public docket, several new unique drug products or categories of drug products have been nominated, and additional information regarding previous nominations and general comments has been submitted. In addition, between June 2015 and November 2017, the FDA consulted with the Pharmacy Compounding Advisory Committee (PCAC) regarding criteria for evaluating whether drug products and categories of drug products present demonstrable difficulties for compounding and certain categories of drug products that qualify as demonstrably difficult to compound.
Those deliberations have led to the Proposed Rule published today.