Strive Pharmacy says it is pre-sourcing peptide ingredients ahead of any 503A rule

Strive Pharmacy, a major 503A/503B compounder, is pre-sourcing active pharmaceutical ingredients and running stability, potency, and sterility testing on a limited set of higher-demand peptide products, co-founder and CEO Nate Hill told Pharmaceutical Executive in a Q&A published September 4 ^[1]. Hill said the pharmacy is consulting legal counsel on where the FDA's decision stands, but was direct about the limits of the work: "we're not going to produce them until it is moved over to category one" ^[1].

The preparation follows a July 23–24 meeting of the FDA's Pharmacy Compounding Advisory Committee, which recommended six peptides — BPC-157, KPV, TB-500, MOTS-c, Semax, and Epitalon — for the 503A Bulks List, and declined to recommend a seventh, emideltide (DSIP) ^[1]. That vote is advisory and nonbinding. No proposed rule has been published, none of the six peptides is currently on the 503A Bulks List, and none is lawfully compoundable today ^[1]. Formal rulemaking, including a proposed rule and public comment period, can take up to a year ^[1].

The regulatory picture around peptides has shifted several times in 2026. On April 15, the FDA removed twelve peptides, including the six later recommended by PCAC, from Category 2 of its bulk drug substance framework — the flag used for substances that "may present significant safety risks" ^[1]. That removal ended a de facto freeze on at-scale compounding of those twelve substances but did not approve them; as of the FDA's April 22 list, GHRP-2, GHRP-6, ipamorelin acetate, and kisspeptin-10 remain on Category 2 ^[1].

The peptide-compounding track is separate from the GLP-1 track, though both sit inside the same enforcement environment. A separate April 30 proposal would exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list, and on August 27 the Fifth Circuit upheld the FDA's removal of Ozempic, Wegovy, Mounjaro, and Zepbound from the drug shortage list, ending bulk compounding of those molecules for general use while leaving patient-specific compounding for an individual with a documented medical need lawful ^[1]. Separately, on August 24, CDER issued warning letters — posted September 1 — to five online sellers over unapproved injectable products including semaglutide, tirzepatide, retatrutide, tesamorelin, elamipretide, and bremelanotide sold under "research use only" labels ^[1].

Why it matters for patients

For consumers, the practical bottom line has not changed: none of the six PCAC-recommended peptides is legal to buy as a compounded product today, and no timeline exists for when, or whether, that will change ^[1]. Strive's pre-sourcing and testing work is a business preparation step, not a signal that any product is closer to market. Buying peptides marketed as "research use only" from online sellers carries separate legal exposure that the recent warning letters make explicit — those products are being treated as unapproved new drugs regardless of labeling ^[1].

State-level rules add another layer. Health Law Alliance reports that medical, nursing, and pharmacy boards in at least eight states — Alabama, California, Connecticut, Louisiana, Mississippi, New Jersey, Ohio, and South Carolina — have issued warning notices to licensees about peptide use, with some boards suspending licenses ^[2]. Mississippi's warning is a joint statement from its nursing, pharmacy, and medicine boards, and South Carolina's guidance states that a practitioner obtaining drugs from an unpermitted facility may be disciplined for unprofessional conduct ^[2]. Several state warnings also say that routing prescriptions through nurse practitioners or physician assistants does not remove a physician's underlying legal responsibility ^[2].

What happens next

The FDA has not set a timeline for a proposed or final rule on the 503A Bulks List ^[1]. Until a final rule is published in the Federal Register, none of the six PCAC-recommended peptides can be lawfully compounded, and the leadership vacancy at FDA — with nominee Heidi Overton awaiting a Senate hearing — leaves the rulemaking and a related 503B GLP-1 exclusion proposal on the desk of whoever becomes the next commissioner ^[1].