Strive Pharmacy pre-sources peptide ingredients ahead of any FDA 503A bulks-list rule
A large compounding pharmacy is preparing to make peptides it cannot legally make yet, a sign of how the sector is positioning while federal and state rules stay unsettled.
Strive Pharmacy is buying peptide ingredients and running quality tests on them before the FDA has decided whether those peptides may be compounded, co-founder and CEO Nate Hill said in a Q&A published September 4, 2026 [1].
Hill said the company is pre-sourcing active pharmaceutical ingredients and running stability, potency and sterility testing on "a limited set of higher-demand SKUs," and is consulting legal counsel on where the agency's decision stands [1]. He drew a line between preparing and selling: "we're not going to produce them until it is moved over to category one" [1]. Which peptides Strive is testing, how much it has spent and when it expects to sell anything have not been disclosed [1].
The rule Hill referred to does not exist yet. At a July 23–24, 2026 meeting, the FDA's Pharmacy Compounding Advisory Committee recommended six peptides for the 503A Bulks List — BPC-157, KPV, TB-500, MOTS-c, Semax and Epitalon — and did not recommend emideltide (DSIP) [1]. That vote is advisory and nonbinding. No proposed rule has been published, none of the six is on the list, and none is lawfully compoundable today [1]. Formal rulemaking can take up to a year and runs through docket FDA-2018-N-4845 [1].
None of the six is a GLP-1. A separate April 15, 2026 FDA notice removed twelve other peptides — including BPC-157, TB-500, KPV, MOTS-c, Semax, Epitalon, DSIP and GHK-Cu — from Category 2, the agency's safety-risk flag. That step ended a de facto freeze on at-scale compounding but did not make any of them approved or compoundable [1]. As of the agency's April 22, 2026 list, the peptides still in Category 2 are GHRP-2, GHRP-6, ipamorelin acetate (503B) and kisspeptin-10 (503A) [1].
The GLP-1 track has moved in a different direction. On August 27, 2026, the Fifth Circuit upheld the FDA's removal of Ozempic and Wegovy (semaglutide) and Mounjaro and Zepbound (tirzepatide) from the drug shortage list in two unpublished opinions, Case 25-10600 and Case 25-10758 [1]. Bulk compounding of those molecules for general use is no longer allowed; patient-specific compounding for an individual with a documented medical need remains legal [1]. On August 19, Novo Nordisk asked the FDA to place semaglutide on the Demonstrable Difficulties for Compounding lists, a request first filed in October 2024 [1].
Enforcement is running at the same time. The FDA issued warning letters on August 24, 2026, to five online sellers — Peptide Partners LLC, Peak Performance Peptides, Royal Peptides LLC, NuScience Peptides LLC and TXP Innovations LLC (Tex Peptides) — over injectables sold under "research use only" labels, and posted the letters September 1 [1]. Those are unapproved-drug cases, not compounding cases, and no compounding pathway authorizes an unapproved injectable sold from a web storefront [1].
State boards are acting too. Warnings have gone out to licensees in Alabama, California, Connecticut, Louisiana, Mississippi, New Jersey, Ohio and South Carolina, according to a September 3, 2026 legal analysis [2]. Some are broad, treating peptides as unapproved substances; others target "research use only" products [2]. Licenses have been suspended and practices have lost licenses [2]. Mississippi's warning is a joint statement from its boards of nursing, pharmacy and medicine, and South Carolina's says in part that a practitioner buying or dispensing drugs from an unpermitted facility "is aiding and abetting unlicensed practices in violating state law involving drugs and may be disciplined for unprofessional conduct" [2].
Why it matters for patients
For anyone taking a compounded GLP-1 such as semaglutide or tirzepatide, the federal route to bulk compounding has closed, and state boards can add their own restrictions on top of the federal floor [1][2]. Patient-specific compounding for a documented medical need remains lawful under the Fifth Circuit ruling, but that is a narrower path than the earlier shortage-era supply [1].
The peptides Strive is preparing to test are not GLP-1s and cannot be prescribed as compounded products today [1]. Peptides sold online under "research use only" labels are treated by the FDA as unapproved new drugs, and buying from an unpermitted source can expose a prescriber or pharmacy to state discipline; waivers and disclaimers do not move that responsibility to the patient, according to the state-board analysis [1][2]. Preparation by a pharmacy is also not a signal that a product will reach the market — it reflects a bet on a decision the FDA has not made [1].
What happens next
The FDA has not set a timeline for a proposed or final 503A Bulks List rule, so the six recommended peptides remain not lawfully compoundable [1]. Dr. Heidi Overton, nominated August 19, 2026, to lead the FDA, has made no public statements on peptide compounding or the 503A and 503B lists, and no Senate hearing date has been set [1]. Sellers that received the August 24 warning letters face a 15-business-day response window, with possible escalation to seizure and injunction [1].
Sources
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