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MarketSAN FRANCISCO · Event October 29, 2026

Hims opens Peptides+ waitlist a day after HHS notice

Planned offerings include sermorelin, glutathione, B12, NAD+ and L-carnitine via independent providers and licensed pharmacies. BPC-157 and TB-500 are listed to follow when allowable.

Document graphic of the Public record titled "Expanding Safe Access to Peptides" from Hims & Hers (newsroom; Andrew Dudum), dated October 29, 2026, and 1 more cited record listed below it.
The primary record: Expanding Safe Access to Peptides (Hims & Hers (newsroom; Andrew Dudum), October 29, 2026). Graphic: Amino Wire, from the public record

Hims & Hers Health on October 29, 2026 invited customers to preview Peptides+, a new specialty, and to join a waitlist ahead of launch. Co-founder and CEO Andrew Dudum published the announcement in the company’s newsroom, one day after the Department of Health and Human Services posted an enforcement-discretion policy for section 503A compounding of six peptide bulk drug substances (our report).

What Hims says it plans to offer

Dudum wrote that eligible Hims & Hers customers can access peptides and related therapies under a clinically guided protocol. The company plans to offer access to sermorelin, glutathione, B12, NAD+ and L-carnitine, with BPC-157 and TB-500 “to follow when allowable.” If a customer is eligible, he wrote, a personalized treatment plan will be prescribed and delivered by independent providers, with treatments supplied by licensed pharmacies and ongoing clinical support.

The post stresses infrastructure rather than an immediate nationwide catalog. Dudum said Hims has spent years building a U.S.-based peptide manufacturing facility, developing clinical protocols with experts and setting frameworks to study potential benefits and side effects. He also wrote that most of what is known about these compounds is still early, with limited published studies, and that provider-supervised use is how the company plans to proceed.

The announcement is a preview and waitlist, not a claim that every listed product is available to every customer today. The same post’s forward-looking statements warn about rollout timing, limited clinical data, the manufacturing facility, reliance on independent providers and pharmacies, and changes in HHS or FDA policy.

The HHS backdrop

On October 28, 2026, HHS posted “HHS Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances.” Until a final rule addresses each substance on the 503A bulks list, HHS said it does not intend to take enforcement action against State-licensed pharmacies, Federal facilities or licensed physicians compounding with Appendix A peptides — BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500 — when listed conditions are met. Compounded drugs under that policy remain not FDA-approved.

Dudum’s October 29 post frames the HHS draft interim policy as “meaningful progress toward a regulated, safer pathway to care” while arguing that gray-market channels lack clinician oversight, quality standards and transparency. He also pointed ahead to a future Pharmacy Compounding Advisory Committee review of additional peptides.

What secondary reporting adds

Yahoo Finance reported on October 28 that Hims shares rose about 6% that day after the HHS notice. Citing an August Reuters report, it said CEO Dudum has said Hims is waiting for “full and final rulemaking” from the FDA before selling peptides still under review, and that the October 28 notice “falls short of that.” Yahoo Finance also wrote that Hims plans to offer NAD+, sermorelin and glutathione by year-end under existing compounding pathways, and that third-quarter results are due November 9. We could not re-fetch the August Reuters piece (HTTP 401) or a Becker’s Hospital Review URL in our tip sheet (HTTP 403), so we rely on Yahoo Finance for those secondary points and do not use Becker’s for any fact.

Why it matters

Peptides+ is a public product roadmap from a large telehealth company that already owns peptide manufacturing capacity, posted the day after HHS opened a conditional 503A lane that includes BPC-157 and TB-500. That combination will be watched by compounders, state boards and competitors. It is not a substitute for FDA approval of any finished peptide drug, and Hims’ own language keeps BPC-157 and TB-500 behind an “when allowable” gate.

What is not known

  • When Peptides+ will leave the waitlist and which products will ship first in which states.
  • Whether Hims will use the HHS interim 503A conditions for Appendix A peptides before a final bulks rule, or wait for final rulemaking as Yahoo Finance described.
  • How state boards will handle telehealth peptide protocols on a national platform.

What to watch

Federal Register publication of the HHS notice (scheduled October 30); Hims’ November 9 earnings commentary on peptide timing; and any further PCAC agenda for additional peptides.

What changed: key dates

Dated timeline for this report
DateWhat happened
U.S. Department of Health and Human Services: HHS Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances
Yahoo Finance: Hims & Hers Jumped 6% as RFK Jr.'s HHS Uses "Enforcement Discretion" to Open Peptide Compounding
Hims & Hers (newsroom; Andrew Dudum): Expanding Safe Access to Peptides
Event date for this report
Amino Wire published this report

Frequently asked questions

What is Peptides+ according to Hims?

In an October 29, 2026 newsroom post, CEO Andrew Dudum described Peptides+ as a new specialty built around a clinically guided protocol. Eligible customers can join a waitlist. The company plans sermorelin, glutathione, B12, NAD+ and L-carnitine first, with BPC-157 and TB-500 to follow when allowable.

How does this relate to the HHS 503A peptide notice?

HHS posted an enforcement-discretion policy on October 28, 2026 covering six peptide bulks for 503A compounding under listed conditions, including BPC-157 and TB-500. Hims' Peptides+ preview was posted the next day and explicitly references that HHS move.

Is this an FDA approval of those peptides?

No. Hims' own post frames Peptides+ as provider-prescribed treatments supplied by licensed pharmacies. The HHS notice is interim enforcement discretion while rulemaking proceeds, not FDA approval of finished peptide drugs.

Sources

3 linked records
  1. [1]
    Expanding Safe Access to Peptides

    Hims & Hers co-founder and CEO Andrew Dudum on the Department of Health and Human Services (HHS) announcement to expand regulated access to peptide therapies, and a preview of our upcoming Peptides+ specialty.

    news.hims.com/newsroom/expanding-safe-access-to-peptides

    Hims & Hers (newsroom; Andrew Dudum) · Primary record

  2. [2]
    HHS Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances

    hhs.gov/sites/default/files/hhs-503a-peptide-enforceme…

    U.S. Department of Health and Human Services · Primary record

  3. [3]
    Hims & Hers Jumped 6% as RFK Jr.'s HHS Uses "Enforcement Discretion" to Open Peptide Compounding

    finance.yahoo.com/healthcare/articles/hims-hers-jumped-6-rfk-191…

    Yahoo Finance ·

Amino Wire reports regulatory and court records. Nothing here is medical or legal advice, and we do not provide dosing information. Named companies may respond; see right of reply.

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