MarketSAN FRANCISCO · Event October 30, 2026
Superpower opens compounded peptide pre-orders after HHS notice
The San Francisco health startup targets late-November shipping for BPC-157, TB-500 and MOTS-c. Epitalon, an oral BPC product and a Semax nasal spray are on a waitlist. Membership and a 40-plus biomarker panel are included; availability is not nationwide.
Superpower on October 30, 2026 opened clinical eligibility assessments and pre-orders for clinician-prescribed compounded BPC-157, TB-500 and MOTS-c, according to the company’s approach page and product listings. The move came two days 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), and one day after Hims & Hers previewed a Peptides+ waitlist (our report).
What Superpower says it is offering
Superpower’s approach page names an initial launch of three peptides its clinical team has aligned on: BPC-157, TB-500 and MOTS-c. Product pages for those compounds say medication is charged up front as a pre-order, with a target ship date of late November. If a clinician does not approve a prescription, Superpower says the buyer gets a full refund. Membership and a blood panel of 40-plus biomarkers are described as included. Charges after approval are described as recurring on a monthly cycle.
The same product pages state that the compounds are not available in all 50 states and are not HSA/FSA eligible. A patient-specific prescription is required, and eligibility is determined by a licensed clinician after reviewing intake and labs. Signing up or paying, Superpower writes, does not guarantee a prescription.
On Superpower’s peptides hub, Epitalon, an oral BPC product and a Semax nasal spray appear with join waitlist calls to action, separate from the three launch pre-orders.
How Superpower frames the HHS notice
The approach page cites HHS’s October 28, 2026 notice covering six peptides — BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500 — and summarizes draft 503A compounding conditions. It states that the notice is not FDA approval and does not cover every form or use of a peptide. Conditions Superpower lists include:
- a prescription for a specific patient;
- one active ingredient per product, rather than peptide blends;
- checks on the original ingredient maker and test records; and
- for products taken by mouth, human data showing adequate absorption of that exact product.
The Federal Register published the notice of availability on October 30, 2026, at 91 FR 68526-68527 (FR Doc. 2026-22192, Docket No. HHS-OASH-2026-0496). Written comments run for two weeks after publication; Foley & Lardner’s analysis, cited in our earlier HHS coverage, puts the deadline at November 13, 2026.
What HHS Appendix B says about FDA’s drug center
HHS’s policy Appendix B, for each of BPC-157, TB-500 and MOTS-c, states that FDA’s Center for Drug Evaluation and Research (CDER) recommended against listing those substances on the 503A bulks list, while the Pharmacy Compounding Advisory Committee voted in favor. The interim policy is enforcement discretion under listed conditions, not a bulks-list final rule and not FDA approval of finished drugs. Compounded drugs, HHS repeats, are not FDA-approved.
Why it matters
Superpower’s launch is a second high-profile telehealth response in the same window as Hims’ Peptides+ waitlist, and it puts three of the six HHS Appendix A peptides into a paid pre-order path with clinician review, membership and baseline labs. It does not settle 503A rulemaking, state-by-state availability or how pharmacies will meet the policy’s sourcing and reporting conditions.
What is not known
- Whether Superpower will ship on the late-November target in every state where it says it can operate.
- How state boards will treat telehealth peptide protocols tied to the interim HHS policy.
- When waitlisted products (Epitalon, oral BPC, Semax nasal spray) might move to pre-order or how oral bioavailability documentation will be handled for any oral form.
What to watch
Docket comments on HHS-OASH-2026-0496 through November 13; Superpower’s first shipments; Hims Peptides+ timing; and any FDA rulemaking under RIN 0910-ZD94.
What changed: key dates
Frequently asked questions
What did Superpower open on October 30, 2026?
According to Superpower, clinical eligibility assessments and pre-orders for clinician-prescribed compounded BPC-157, TB-500 and MOTS-c, with a target ship date of late November. Epitalon, an oral BPC product and a Semax nasal spray are on a waitlist.
How does this relate to the HHS 503A peptide notice?
Superpower's approach page cites HHS's October 28, 2026 enforcement-discretion notice for 503A compounding of six peptide bulks. The Federal Register published that notice on October 30 at 91 FR 68526. The policy is not FDA approval of finished peptide drugs.
Is this FDA approval of BPC-157, TB-500 or MOTS-c?
No. Superpower's product pages say the compounded products are not FDA-approved and require a patient-specific prescription after clinician review. HHS's notice is interim enforcement discretion while 503A bulks rulemaking continues.
Sources
6 linked records- [1] Superpower's approach to peptides
Superpower · Primary record
- [2] MOTS-c (injection)
Superpower · Primary record
- [3] BPC-157 (injection)
Superpower · Primary record
- [4] Superpower Peptides
Superpower · Primary record
- [5] Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances (91 FR 68526, FR Doc. 2026-22192)
Federal Register · Primary record
- [6] HHS Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances (policy text and Appendix B)
U.S. Department of Health and Human Services · Primary record
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.