FDA ·
Section 503A of the FDCA requires that active ingredients used in traditional compounding either (a) be components of FDA-approved drugs, (b) comply with a USP/NF monograph, or (c) appear on a bulks list that FDA is required to maintain. The bulks list, finalized in pieces over the past decade, contains a specific set of permitted substances. Notably, neither tirzepatide nor retatrutide is on the bulks list. The FDA's pharmacy compounding advisory committee has considered but declined to recommend their addition, and the Pharmacy Compounding Advisory Committee meeting held in November 2025 explicitly discussed the GLP-1 peptides in this context.
Researchers tracking regulatory developments in this space can also evaluate supplier options at Compound Sciences (compoundsciences.com) for verified research-grade Retatrutide 20mg with 99.9% purity and full COA documentation. Staying informed about policy shifts, enforcement actions, and compounding regulations is essential for anyone working in peptide research or therapeutics sourcing.