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A live board of pending federal and state peptide-compounding legislation, FDA rule-makings, and scheduled votes — researched fresh on each visit.
Upcoming Votes & Pending Legislation
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Drug Products That Present Demonstrable Difficulties for Compounding under 503A/503B
Proposed rule establishing criteria for identifying drug products that are demonstrably difficult to compound, which would prohibit their compounding under sections 503A and 503B.
Official bill / rule pageProposed Rule to Exclude GLP-1s from 503B Bulks List
Proposed rule to formally exclude semaglutide, tirzepatide, and liraglutide from the 503B outsourcing facility bulk drug substances list, prohibiting their compounding from bulk substances.
Official bill / rule pagePCAC Recommendation for 503A Bulks List (Peptides)
The PCAC recommended adding BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax to the 503A Bulks List, pending final approval by the Secretary of Health and Human Services.
Official bill / rule pageThe current rules
Curated sections linking directly to the official pages — FDA compounding status, the shortage list, import alerts, DEA scheduling, and state board of pharmacy resources.
Compounding Pharmacies — 503A & 503B
Sections 503A and 503B of the FD&C Act set the federal framework for human drug compounding. 503A pharmacies compound patient-specific prescriptions; 503B facilities are registered as outsourcing facilities and may compound larger batches without patient-specific prescriptions, subject to cGMP requirements.
Official source →Drug Shortage List
Compounded drugs may appear on the FDA Drug Shortage list; a 503B outsourcing facility may compound a drug in shortage if it appears on the FDA's shortage list, under specific conditions. The list is updated continuously.
Official source →Import Alerts (e.g. BPC-157, TB-500)
FDA Import Alerts identify products that appear to be unapproved new drugs or misbranded and may be detained without physical examination. Some peptide compounds sold as 'research' have been the subject of import alerts.
Official source →Compounding Act / FDORA 2023
The Modernization of Compounding Act, part of the FY2023 Consolidated Appropriations Act, clarified oversight of office-use compounding and the 503A / 503B framework after the D.C. Circuit rulings.
Official source →Controlled Substance Scheduling
The DEA schedules substances under the Controlled Substances Act. Most peptide compounds are not scheduled, but any analog with pharmacological activity similar to a scheduled substance may be subject to review.
Official source →State Boards of Pharmacy
Compounding is also regulated at the state level. Each state board of pharmacy adopts its own rules for licensure, labeling, and patient-specific compounding. Use the search above to look up a specific state's pharmacy compounding rules.
Official source →FTC — Dietary Supplement & Health Claims
The FTC regulates advertising claims for dietary ingredients and supplements under the FTC Act. Investigational products marketed with disease-treatment claims may trigger FTC scrutiny.
Official source →Email me industry & legislation updates
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