FDA Revised Interim Policy on Compounding — End of Category System for New Nominations — VialBase News
FDA Revised Interim Policy — End of Category System for New Nominations
Summary
On January 7, 2025, the FDA published final interim guidances on compounding using bulk drug substances for both 503A pharmacies and 503B outsourcing facilities. The key change: the FDA will no longer place newly nominated bulk drug substances into interim categories (Category 1, 2, or 3). Substances already categorized retain their existing designations, but no new substances will enter the pipeline under the old framework.
Background
Since establishing the FDA-503A-Category-System, the FDA had been placing nominated bulk drug substances into three categories while they awaited full evaluation by the Pharmacy Compounding Advisory Committee (PCAC). This created a grey zone where Category 3 substances (under evaluation) could be compounded at the compounder’s risk.
The January 2025 guidance ends this practice. Newly nominated substances must now undergo the full FDA evaluation process — including PCAC consultation, USP review, and Federal Register notice-and-comment — before they can be used in compounding. No more interim permissions.
Key provisions:
- Existing Category 1 substances: Can continue to be compounded
- Existing Category 2 substances: Remain restricted (including BPC-157, TB-500, CJC-1295, Ipamorelin)
- New nominations: Will not receive interim categorization; must complete full evaluation before compounding is permitted
- 503B outsourcing facilities: Subject to parallel guidance with equivalent restrictions
Impact
- Closes the nomination loophole: Previously, nominating a substance could create a window where compounding was tolerated during review. That window is now shut.
- Raises the barrier to entry: New peptides and other substances face a longer, more rigorous path to legal compounding status.
- Preserves status quo for existing categories: This did not reclassify any existing substances — Category 2 peptides remain restricted.
- Sets the stage for enforcement: Combined with the semaglutide shortage resolution (February 2025), this guidance armed the FDA for the aggressive enforcement wave that followed throughout 2025.
What This Means for Researchers
- Research peptides sold as “for research use only” are not directly affected by compounding regulations, but this guidance signals the FDA’s intent to tighten the entire pipeline.
- The regulatory environment is narrowing. Substances that were once in a grey zone now face a clear binary: either they are on the approved list, or they are not.
- Compounding pharmacies that were using the nomination process as a shield can no longer do so.