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Pharmacy Compounding Advisory Committee · FDA White Oak Campus, Silver Spring, MD
The Pharmacy Compounding Advisory Committee (PCAC) advises FDA on which substances may be used in compounding under Section 503A and 503B of the FDCA. The July 2026 meeting is expected to issue updated recommendations on peptide substances currently in Category 1 and 2 review — including BPC-157, TB-500, ipamorelin, CJC-1295, and sermorelin. Recommendations from this meeting will shape compounding policy for the next decade, directly determining which peptides remain accessible through 503A pharmacies and which face prohibition. Clinics operating in this space should plan now, not after the ruling.
Regulatory Record
Chronological record of material regulatory decisions affecting compounding clinics.
FDA removed semaglutide from the drug shortage list, ending the shortage declaration that had permitted 503A/503B compounding. Compounders had a 90-day wind-down period ending May 22, 2025. After that date, compounding semaglutide without a shortage basis became unlawful under Section 503A/503B unless the compound differs meaningfully from the approved product.
Source: FDA Drug Shortage Database · FDA Compounding Q&A: Semaglutide
FDA determined that the tirzepatide shortage was resolved as of October 2, 2024. 503B outsourcing facilities lost the shortage-based compounding authorization first; 503A pharmacies received a staggered wind-down. Compounding based solely on the shortage designation is no longer permissible for tirzepatide.
Source: FDA Drug Shortage Database · FDA Compounding Q&A: Tirzepatide
FDA placed BPC-157 (Body Protection Compound 157) in Category 2 of the 503A Bulks List evaluation process, indicating that there are significant safety concerns that must be resolved before it may be nominated for inclusion on the 503A bulk substances list. Category 2 placement effectively prevents its lawful use in 503A compounding absent additional data.
Source: FDA 503A Bulk Substances List
Thymosin β4 / TB-500 received Category 2 placement on the 503A Bulks List evaluation. FDA cited concerns regarding safety information and lack of adequate clinical data to support inclusion. Like BPC-157, 503A compounding is not permissible under the bulk substances pathway until resolved.
Source: FDA 503A Bulk Substances List
Multiple peptides — including ipamorelin, CJC-1295, and AOD-9604 — remain under active PCAC/FDA review as part of the 503A Bulks List evaluation. None of these substances appear on FDA's affirmative list of approved bulk substances. Clinical use via compounding currently occupies a legal gray zone that the July 2026 PCAC meeting is expected to clarify.
Source: FDA 503A Bulk Substances List
Retatrutide (LY3437943) is an investigational triple GIP/GLP-1/glucagon receptor agonist developed by Eli Lilly. As of 2025, it remains in Phase 3 clinical trials. Compounding of investigational drugs without IND authorization is not permissible under current FDA regulations. Clinics should monitor NDA submissions, which could accelerate or foreclose compounding pathways.
Source: ClinicalTrials.gov — Retatrutide
Sermorelin acetate was previously an FDA-approved drug (Geref). Although discontinued, it remains on FDA's list of bulk substances that may be used in 503A compounding (Category 1 / Nominated). It is one of the more defensible peptides for clinic use, though FDA's ongoing PCAC review means this status remains subject to change.
Source: FDA 503A Bulk Substances List
Status Board
Current risk profile for clinic operators and compliance officers. Not legal advice.
| Substance | 503A Status | FDA Category | Clinic Risk | Notes |
|---|---|---|---|---|
| SemaglutideOzempic, Wegovy | Compounding Ended | Shortage Resolved | ● Critical | Shortage-basis compounding window closed May 22, 2025. Ongoing compounding creates significant legal exposure. |
| TirzepatideMounjaro, Zepbound | Compounding Ended | Shortage Resolved | ● Critical | Shortage resolved Oct 2, 2024. 503A wind-down completed. No shortage basis remains. |
| BPC-157Body Protection Compound | Not Permissible | Category 2 (503A) | ● High | Category 2 placement blocks 503A bulk substance pathway. PCAC may revisit in July 2026. |
| TB-500Thymosin β4 | Not Permissible | Category 2 (503A) | ● High | Same Category 2 designation as BPC-157. Safety data insufficient for approval to date. |
| IpamorelinGHRP / Growth Hormone Secretagogue | Under Review | Nominated, Not Listed | ● Medium | Not yet on the affirmative 503A bulk list. Legal status unresolved pending July 2026 PCAC. |
| CJC-1295Growth Hormone Releasing Factor | Under Review | Nominated, Not Listed | ● Medium | Frequently co-administered with ipamorelin. Regulatory fate likely mirrors ipamorelin at July 2026 meeting. |
| SermorelinGHRH Analog (fmr. Geref) | Permissible | Nominated (Cat. 1) | ● Lower | Previously FDA-approved; most defensible peptide for 503A use. Monitor for PCAC revision. |
| GHK-CuCopper Peptide | Cosmetic / Research | Not Formally Evaluated | ● Lower | Primarily topical/cosmetic use. Not a compounding priority for systemic clinic applications. |
| PT-141Bremelanotide (Vyleesi) | Restricted | Approved Drug — Limited Compounding | ● High | Vyleesi (bremelanotide) is FDA-approved; compounding approved drugs is restricted under 503A unless specific conditions met. |
| Melanotan IIMT-II | Unapproved Drug | No Investigational Pathway | ● Critical | Unapproved, no NDA or IND pathway. Distribution for human use carries significant FDA enforcement risk. |
| RetatrutideLY3437943 (Investigational) | Investigational Only | Phase 3 Clinical Trial | ● High | Not approved, not available for compounding. Monitor Eli Lilly NDA timeline; approval could create shortage-basis window. |
Status current as of May 2026. FDA regulatory positions change without notice. This board is updated on a best-effort basis. This is not legal advice — clinic operators must consult qualified regulatory counsel for their specific situation.
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