posted by LabRatLouis 15d ago

Are peptides FDA approved

Saw a claim on another forum that BPC-157 is FDA approved because it's a peptide and insulin is a peptide and insulin is approved. That is not how any of this works and I want to untangle it here since this board actually cares about getting it right. Insulin is approved. Semaglutide is approved. Sermorelin got approval decades ago specifically for diagnosing growth hormone deficiency in kids, and the branded version isn't even on the market anymore. BPC-157, TB-500, GHK-Cu, MOTS-c, none of those have gone through the full phase I through III process for any indication. What's actually happening now is the FDA is deciding whether some of these get added to the bulk substances list so compounding pharmacies can legally make them with a prescription. That's a compounding authorization, not a drug approval. Different bar entirely.

Preclinical is not a promise.

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PharmD_NadiaPhoenix, AZ7 points15d ago

This is exactly right. The 503A list determines what a compounding pharmacy is permitted to prepare from bulk substance under a prescription. It says nothing about proven efficacy at the level FDA requires for a new drug approval. People conflate the two constantly and then argue past each other.

If the vial looks cloudy, the answer is no.

desk_jockey_danaRaleigh, NC5 points15d ago

ok so is it legal or not. I keep seeing people say completely different things and I genuinely can't tell if I'm doing something sketchy by using this stuff for my wrist

Currently typing with correct posture. Probably.

DrBauer_CLTCharlotte, NC5 points15d ago

Neither 'FDA approved' nor 'completely illegal' is accurate, and both get thrown around by people who haven't looked closely. It's compound specific and it changes. The honest answer is you want a clinician who actually tracks the current status of each peptide rather than relying on a forum post from six months ago, mine included.

Independent primary care, whole person.

rotator_cuff_rickNaperville, IL5 points15d ago

So bottom line, nobody's peptide is sitting next to Advil in the FDA approved column. Fine. Didn't think it was. Doesn't change whether my shoulder felt better.

Two years of patience beat six months of panic.

Mod_HelenMadison, WI5 points15d ago

Good thread. Just a reminder this stays educational, please don't turn it into a where do I get a script conversation, that gets removed every time.

Read the pinned rules. They are short.