Hi there,
I'm a longevity physician, and the number one thing I get asked about is probably...yes, peptides.
You may have seen some very interesting news on them over the last week, so here's what actually changed.
The short version
HHS says it won't go after pharmacies that compound six peptides, if they meet strict conditions.
It's a draft. It isn't FDA approval, and it isn't proof any of them work.
The quality bar is real, but a prescription can't make an unproven peptide safe.
Public comments are open until November 13.
What happened
On October 30, HHS published a draft policy in the Federal Register. It says HHS doesn't intend to take enforcement action against compounding pharmacies that make six peptides: BPC-157, TB-500, KPV, MOTS-c, epitalon and Semax.
What that means in plain terms: a regular compounding pharmacy normally can only make drugs from ingredients that are already approved for compounding. These six aren't on that approved list. While FDA decides whether to add them, HHS is saying it won't go after pharmacies that make them for individual patients, as long as they follow its conditions.
The stated goal is to move people away from the "research use only" peptides sold online, many of them from overseas suppliers.
I'm a fan of that mission, because people need safer and more regulated sources of these products.
The conditions to this new policy
A specific prescription for a specific patient.
One active ingredient per product. BPC-157 and TB-500 are both listed, but a vial with both in it together breaks the "rule."
The listed forms and routes only. Oral forms need evidence of human absorption (which is functionally very low - so unless you intend it for the gut lining it probably is not doing much).
Reporting of serious adverse events and quality problems.
Can you get them, and are they safe?
Access. Only with a prescription, through a state-licensed compounding pharmacy, made for one patient at a time. It isn't over the counter, and it doesn't cover large outsourcing facilities making batches.
Quality. The bar is real. The company that makes the raw ingredient (not just a distributor or relabeler) has to be registered with FDA and follow good manufacturing practice (GMP). Every lot needs a certificate of analysis showing identity, purity and potency, plus tests for contaminants like endotoxins, heavy metals and microbes.
The limits. That's a big step up from research-use vials. But FDA doesn't review compounded drugs before they're sold, so these checks rest on the pharmacy's paperwork. And being registered with FDA isn't the same as FDA approving a batch.
A sobering case from Australia
The same week, a coroner in Australia found that the death of actor and martial artist Richard Norton, 75, in March 2025 was "triggered by" an injection of two peptides, CJC-1295 and ipamorelin.
They aren't among the six in the HHS draft. But he got them the same way this policy works: a doctor's prescription and a licensed compounding pharmacy.
The coroner wrote that the injection caused an anaphylactic reaction, which led to cardiac arrest. Norton had told the clinic he'd been taking double the prescribed dose. But a severe allergic reaction doesn't need a big dose; it can happen at the prescribed one. The coroner has asked Australia's drug regulator to consider tighter limits on these peptides. (ABC News)
A prescription and a licensed pharmacy improve what's in the vial. They don't make an unproven peptide safe, and they can't predict who will react.
What this isn't
Not FDA approval, and not final. The six still aren't on the official list of ingredients pharmacies can compound with. Adding them takes rulemaking.
Not proof they work. Quality testing tells you what's in the vial, not whether it does anything. The human evidence varies a lot across the six. For TB-500, FDA staff said in July they hadn't found direct human studies of the fragment itself.
Not a green light for every launch. Some companies have announced launches or waitlists. Those are their statements, and the draft's conditions still apply.
If you're offered one
Ask three questions:
Is it a single ingredient?
Who made the raw ingredient?
Can I see the certificate of analysis for this lot?
What happens next
Public comments are open until November 13. Read the HHS notice, then comment on Regulations.gov under docket HHS-OASH-2026-0496.
Join my membership
If you want more, join my private membership on Curator. That's where I'll be releasing special members-only content and products. Join here.
Talk soon, Hillary Lin, MD
P.S. If you're building something in health and peptides are on your radar, I write about this and more for founders in The Curator Stack: the rules, the business side and what's changing. Join the Stack here.
From The Longevity Show
For more on peptides, I sat down with Dr. Mayoni Gooneratne to talk through them, including what I'm not seeing in my patients.
Where to find me
February 2027, Scottsdale: I'll join the faculty at the Science of Skin Longevity Summit for AI in diagnostics and the peptides panel.
March 5–6, 2027, San Francisco: I'll be back at the Livelong Women's Health Summit.
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Educational content only, not personal medical advice.
