Legal · Important safety information
Compounded preparations and what that means
Every product NPS dispenses is a compounded preparation. This page explains exactly what that means, what the FDA does and does not verify, and what we do instead.
These are not FDA-approved drugs
The FDA does not verify the safety, effectiveness or quality of compounded medications. Compounded preparations do not go through the new-drug approval process. The FDA regulates the pharmacies that compound them; it does not review each preparation.
We state that plainly because in a category built on unlabeled vials, the companies that are vague about it are the ones you should worry about.
What a 503A pharmacy is
Section 503A of the Federal Food, Drug, and Cosmetic Act permits a licensed pharmacy to compound a medication for an individual patient against a valid prescription. It is not manufacturing, and preparations may not be produced for general sale or in advance of a prescription.
A prescription is always required
Nothing on this site can be bought without a prescription from a licensed provider, issued after a real medical evaluation. Completing our form is a request for that evaluation. Approval is not guaranteed.
The July 2026 PCAC recommendation — precisely
In April 2026 the FDA published a Federal Register notice on peptide compounding. On 23–24 July 2026 the Pharmacy Compounding Advisory Committee voted to recommend several peptides for Category 1 compoundability.
An advisory-committee recommendation is not an approval, and it is not an endorsement of safety or efficacy. It is a recommendation about which substances may be compounded.
The recommendation covers some, but not all, of our catalog:
- Covered by the July 2026 recommendation: BPC-157, TB-500, KPV, MOTS-c.
- Not part of that recommendation: Epitalon, Semax.
We list both because saying “our peptides are FDA-recommended” would be false for a third of the catalog.
What we do instead
Because no regulator is verifying each preparation for you, we publish what we verify ourselves. Every lot is released against identity by LC-MS/MS, potency by HPLC against a 99.0% specification, endotoxin by LAL, sterility per USP <71> and particulates per USP <788>. Every vial carries a lot number you can look up.
Reporting a problem
If you experience a side effect or any other problem, please use our adverse event reporting page. You may also report directly to the FDA through MedWatch. If you are having a medical emergency, call 911.
[TBD-LEGAL] Final wording of this disclosure, and the identity of the specific licensed dispensing entity or entities, require counsel sign-off before launch.