Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
Published Date: 1/7/2025
Notice
Summary
The FDA just released a new interim policy for pharmacies that mix medicines using bulk drug ingredients. This update affects outsourcing facilities by setting clearer rules while the FDA finishes a list of approved bulk drugs. Starting January 7, 2025, these changes help keep medicines safe without slowing down production or adding extra costs right now.
Analyzed Economic Effects
5 provisions identified: 4 benefits, 0 costs, 1 mixed.
End of Category 1–3 Nominations Rule
The guidance ends FDA's practice of categorizing bulk drug substances into Categories 1, 2, or 3 for substances nominated for the 503B bulks list on or after the publication date (January 7, 2025). Outsourcing facilities should note that new nominations submitted on or after that date will no longer receive a Category 1, 2, or 3 designation under this policy.
Category 1 Substances Retain Interim Scope
Bulk drug substances that appear in Category 1, including those nominated with adequate supporting information prior to January 7, 2025, may continue to be within the scope of the policy for Category 1 substances until FDA makes a final determination to place them on the 503B bulks list or removes them from Category 1. Facilities using Category 1 substances should follow the guidance until FDA acts on those substances.
Final FDA Interim Guidance Published
The FDA published a final guidance titled "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act" on January 7, 2025. The guidance describes FDA's interim regulatory policy for outsourcing facilities that compound using bulk drug substances while FDA develops the 503B bulks list.
Nominations Considered on Rolling Basis
FDA will evaluate bulk drug substances nominated for the 503B bulks list on a rolling basis and will consider such substances for inclusion in accordance with the process and clinical need standard in section 503B(a)(2)(A)(i) of the FD&C Act. Outsourcing facilities may expect nominations to be reviewed continuously rather than in a single batch process.
Guidance Is Nonbinding and Flexible
The guidance represents FDA's current thinking and does not establish any rights for any person; it is not binding on FDA or the public and alternative approaches that satisfy applicable statutes and regulations may be used. Outsourcing facilities may follow other approaches if they meet legal requirements.
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The FDA just released a new interim policy for pharmacies that mix medicines using bulk drug ingredients. This update affects compounders who aren’t big outsourcing facilities and sets clearer rules while the FDA finalizes an official list of allowed bulk drugs. The policy kicks in January 2025 and aims to keep medicine mixing safe without slowing down your prescriptions or adding extra costs.