The FDA removed 12 peptide substances from Category 2 following withdrawn nominations, according to an April 22, 2026, update. Further evaluation is planned through consultation with an advisory committee under section 503A of the Federal Food, Drug, and Cosmetic Act.
Bulk Drug Substances Nominated for Compounding Under Section 503A
On April 22, 2026, the U.S. Food and Drug Administration removed 12 peptide substances from Category 2 of its 503A bulk drug substances list, as reflected in an agency update. The agency states the removals were due to withdrawn nominations and that further evaluation will occur through advisory committee consultation. The change is relevant to Med Spa operators that offer peptide-based services involving compounded products.
FDA Removes 12 Peptides From Category 2 Following Withdrawn Nominations
In an April 22, 2026, update, the U.S. Food and Drug Administration removed 12 peptide substances from Category 2 of its 503A bulk drug substances list, which includes substances that previously raised significant safety concerns for compounding. The agency states that each removal occurred because the nominators withdrew their nominations, not because of a new safety determination.
The substances removed from Category 2 include BPC-157, Cathelicidin (LL-37), Dihexa acetate, Emideltide (DSIP), Epitalon, injectable GHK-Cu, KPV, PEG-MGF, Melanotan II, MOTs-C, Semax, and TB-500.
The FDA indicates that several of these substances will undergo further evaluation through consultation with the Pharmacy Compounding Advisory Committee (PCAC). According to the agency, specific substances—including BPC-157, KPV, MOTs-C, and TB-500—are scheduled for advisory committee review in July 2026, while others may be reviewed before the end of February 2027.
The Pharmacy Compounding Advisory Committee (PCAC) provides independent, non-binding recommendations to the FDA on whether nominated substances should be included on the 503A bulk drug substances list.
As of this reporting, these substances remain under evaluation, with final determinations pending advisory committee consultation and subsequent FDA action. Applicable statutes and current FDA regulations governing compounding under section 503A remain in effect.
Source Attribution
According to the U.S. Food and Drug Administration, the removal of the 12 peptide substances from Category 2 is documented in its April 22, 2026, update to the 503A bulk drug substances list.
Compounding Oversight and 503A Substance Classification
Section 503A of the Federal Food, Drug, and Cosmetic Act governs when pharmacies may compound medications using bulk drug substances, including requirements that substances meet FDA eligibility criteria. Category 2 identifies substances that previously raised significant safety or regulatory concerns for compounding.
The April 22, 2026, update removing peptide substances from Category 2 due to withdrawn nominations does not establish that these substances meet the criteria for compounding under section 503A. These substances remain under evaluation, with final determinations dependent on future FDA action informed by advisory committee review.
This development aligns with broader FDA oversight of prescribing practices involving compounded therapies. The FDA reported in March 2026 that it issued 30 warning letters targeting telehealth marketing of compounded GLP-1 drugs and identified prescriber practices related to false marketing claims and compounding violations.
In Med Spa settings, compounded products may be used in services such as weight-loss treatments, peptide-based protocols, hormone-related therapies, and certain injectable or IV-based wellness offerings.
For Med Spa operators, substance classification continues to affect sourcing through 503A-compliant pharmacies, as well as prescriber documentation and adherence to existing FDA requirements. FDA’s interim policy also addresses compounding by human drug compounders using bulk substances while the agency develops the 503A bulk substances list.
Practical Implications for Med Spa Operators
Based on the April 22, 2026, FDA update and existing section 503A compounding requirements, key compliance considerations for Med Spa operators include:
- Verify peptide ingredient eligibility under section 503A before sourcing or use in compounded products.
- Audit compounding pharmacy partners for compliance with 503A requirements and applicable standards.
- Align marketing with FDA requirements to avoid false or misleading claims related to compounded or peptide-based services.
- Capture prescriber documentation supporting patient-specific prescriptions and medical necessity for compounded therapies.
- Assess telehealth prescribing practices for compliance with FDA expectations and enforcement trends.
- Monitor FDA updates and advisory committee activity related to peptide substances currently under evaluation.
- Differentiate Category 2 removals from approved compounding substances when evaluating peptide-based treatment options.
What to Watch
FDA consultation with the Pharmacy Compounding Advisory Committee (PCAC) is scheduled for July 2026, with additional reviews expected before February 2027. Outcomes will inform whether these substances are included on the 503A bulk drug substances list. Further FDA action may affect the sourcing or use of compounded products in Med Spa settings.
About Spakinect
Spakinect provides compliance infrastructure and telehealth-supported supervision solutions for medical aesthetic practices. For additional information, see our website.
Image Attribution: “FDA Buildings 1 and 21 – Exterior with Flag Pole” by U.S. Food and Drug Administration, via Wikimedia Commons, public domain.
