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Hims & Hers names BPC-157 and TB-500 in its peptide plans as HHS's draft policy opens a compounding lane

By Peptide Policy Watch staff · Published November 3, 2026 · 7 min read · 10 sources, 9 checked at the source

One day after HHS released a draft policy letting state-licensed pharmacies compound six peptides, a major telehealth company, Hims & Hers, put two of them, BPC-157 and TB-500, into a written product plan. Compounded sermorelin and GLP-1 drugs have moved through pharmacies and online clinics for years. Named plans for the six-peptide group are new, and they show how quickly the compounding and telehealth world is lining up behind the policy.

Facts are as of November 3, 2026. Sources, with retrieval dates, are at the bottom.

What's actually new

Peptides in compounding aren't new. Sermorelin acetate sits in category 1 of FDA's 503BSection of federal drug law for outsourcing facilities: larger compounders that register with FDA and must follow drug-manufacturing quality rules. Glossary entry list for outsourcing facilities, with FDA's note that it is a component of a drug the agency once approved (list updated March 21, 2025). [V] Semaglutide and tirzepatide were on FDA's drug shortage list from 2022, and during those shortages compounders were allowed to make copies of them; FDA declared the tirzepatide shortage resolved on December 19, 2024, and the semaglutide shortage resolved on February 21, 2025. [V] Online clinics became a major channel in that period. In a KFF poll fielded October 27 to November 2, 2025, 17% of people who had taken a GLP-1 drug said they got it from an online provider or website. [V]

The six-peptide group is a different story. HHS's draft is the first federal enforcement policy aimed at compounding these six from bulk ingredients, and it followed FDA's July 2026 advisory committee review of each one. [V] Hims & Hers' October 29 newsroom release is, as far as we could find, the first time a large, publicly traded telehealth company has put BPC-157 and TB-500 by name into a written plan. [U] The release said the company has built a US-based peptide manufacturing facility and that treatments would be "supplied by licensed pharmacies." [S]

Note what it didn't say. The release doesn't list KPV, MOTS-c, epitalon or semax, and it ties BPC-157 and TB-500 to "when allowable," which reads as waiting on the policy becoming final. [S] The company also wrote that "most of what we know about these compounds is still early." [S]

• 6peptides in HHS's draft policy [V]
• 10conditions a 503A compounder must meet under it [V]
• Nov 13last day for public comments [V]

What the draft policy allows, and what it doesn't

The Federal Register notice describes the policy as HHS's enforcement approach "while the list of bulk drug substances that can be used in compounding under section 503A" is developed through rulemaking. [V] In plain terms, HHS says it won't bring federal enforcement action against state-licensed pharmacies and physicians that compound these six peptides from bulk ingredients for individual patients, as long as they meet the policy's ten conditions. [V]

Three limits matter for anyone reading a company announcement:

That last row is why company timelines carry caveats. Hims & Hers' own post lists "changes in HHS's draft interim policy or the final outcome of rulemaking" among its risk factors. [S]

Why telehealth is moving now

The GLP-1 years built the machinery: online prescribing, licensed pharmacy partners and shipping to patients' homes. When the semaglutide and tirzepatide shortages ended, FDA's 503A enforcement discretion for copies of those drugs ended too, and in an April 1, 2026 update FDA reminded compounders that semaglutide and tirzepatide appear on neither the 503B bulks list nor the shortage list. [V] FDA's February 6, 2026 statement said the agency intends to restrict GLP-1 ingredients in non-approved compounded drugs marketed at scale, naming Hims & Hers. [V]

A new, policy-backed peptide lane gives that infrastructure somewhere to go. That is our reading of the timing, not something the company or HHS stated. [U] The company's post does point to the next step: an FDA advisory committee meeting to "weigh five more peptides for compounding." [S]

Common misreadings

Limits and unknowns

We haven't seen the final policy, because there isn't one yet; HHS could change it after comments close. [V] We found no FDA or HHS data on how many pharmacies compound these six peptides today, so we don't estimate it. [U] Other telehealth companies and compounders may have plans they haven't announced; we cover company statements only when they're published and dated. [U] This page doesn't evaluate any company, product or service, and the evidence for each peptide is in our six-peptide evidence check.

Why it matters

The six-peptide policy moved peptide compounding from the margins toward the regulated pharmacy system, and the companies that built the GLP-1 telehealth model are now saying so out loud. That makes the November 13 comment deadline, and the final rule after it, the dates that decide how big this lane gets. Our compounding categories explainer and telehealth rules page cover the background.

What to watch next

• The comment docket, HHS-OASH-2026-0496, which closes November 13, 2026. [V]
• Whether HHS finalizes, changes or withdraws the interim policy, and the 503A bulks list rulemaking behind it. [U]
• FDA's next Pharmacy Compounding Advisory Committee meeting and the five peptides on its agenda. [U]
• Further dated statements from telehealth companies and pharmacy groups. [U]

Sources (retrieved November 3, 2026 unless noted)

1. Federal Register, notice of availability, "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances," 91 FR 68526-68527, FR Doc. 2026-22192, published October 30, 2026 (retrieved November 1, 2026) [V] — https://www.federalregister.gov/documents/2026/10/30/2026-22192/enforcement-discretion-policy-regarding-503a-compounding-using-certain-peptide-bulk-drug-substances
2. HHS, draft enforcement discretion policy, Appendix B (retrieved October 30, 2026) [V] — https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf
3. Regulations.gov, docket HHS-OASH-2026-0496, comment end date November 13, 2026, 11:59 PM ET (retrieved November 1, 2026) [V] — https://www.regulations.gov/docket/HHS-OASH-2026-0496
4. Hims & Hers newsroom, Andrew Dudum, "Expanding Safe Access to Peptides," October 29, 2026 (company statement) [S] — https://news.hims.com/newsroom/expanding-safe-access-to-peptides
5. FDA, "FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize," updates from October 2, 2024 to April 1, 2026 [V] — https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize
6. FDA, statement on non-FDA-approved GLP-1 drugs, February 6, 2026 [V] — https://www.fda.gov/news-events/press-announcements/fda-intends-take-action-against-non-fda-approved-glp-1-drugs
7. FDA, "Bulk Drug Substances Nominated for Use in Compounding Under Section 503B" category list, updated March 21, 2025 (retrieved October 26, 2026) [V] — https://www.fda.gov/media/94164/download
8. FDA, "Compounding and the FDA: Questions and Answers" [V] — https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers
9. FDA, Pharmacy Compounding Advisory Committee meeting page (retrieved November 1, 2026) [V] — https://www.fda.gov/advisory-committees/pharmacy-compounding-advisory-committee/meeting-pharmacy-compounding-advisory-committee
10. KFF, Health Tracking Poll on GLP-1 drug use, November 14, 2025 [V] — https://www.kff.org/public-opinion/poll-1-in-8-adults-say-they-are-currently-taking-a-glp-1-drug-for-weight-loss-diabetes-or-another-condition-even-as-half-say-the-drugs-are-difficult-to-afford/

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