FDA Makes Temporary Rules While Writing The Real Rules
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 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.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Enforcement Safe Harbor for Compounders
If you are a State-licensed pharmacy, Federal facility, or licensed physician who compounds human drugs, FDA says it does not intend to take action against certain compounding using bulk drug substances while it develops the 503A bulks list. The guidance describing this interim policy was published on January 7, 2025.
End of Category 1–3 Nominations Categorization
For bulk drug substances nominated on or after January 7, 2025, FDA will no longer place those nominations into Categories 1, 2, or 3. Instead, FDA will consider such nominations for inclusion on the statutory 503A bulks list according to the FD&C Act and its regulations.
Transitional Protection for Prior Category 1 Substances
Bulk drug substances that were in Category 1, including those nominated with adequate supporting information before January 7, 2025, may remain within the scope of the Category 1 interim policy until FDA issues a final rule placing them on the 503A bulks list or removes them from Category 1. This allows existing Category 1 substances to continue under the prior interim policy while FDA completes rulemaking or reevaluation.
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Previous / Next Documents
Previous: 2024-31545, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
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.
Next: 2024-31547, Notifying the Food and Drug Administration of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry and Food and Drug Administration Staff; Availability
The FDA has released updated rules for medical device makers about telling the agency if they stop or pause making certain devices. This new guidance lists which devices need mandatory notifications and lets companies share supply problems anytime, even without a health emergency. These changes help keep important medical devices available and give manufacturers clear deadlines to avoid surprises.