Quality & regulatory
Every lot on this site is compounded by a licensed 503A or 503B pharmacy partner. Here is how they test it, how it ships, and how we vet them.
503A & 503B sourcing
Partners hold current state pharmacy licenses; 503B outsourcing facilities are FDA-registered and inspected.
USP-aligned compounding
Sterile compounding aligned with USP <797> and non-sterile with USP <795>; potency and sterility testing per lot.
CoA on every lot
Identity (ESI-MS), purity (RP-HPLC), endotoxin where applicable, sterility, and beyond-use dating documented per lot.
Cold-chain handling
Temperature-controlled packaging with monitored transit. Sterile injectables ship with appropriate qualified shippers.
Reading a partner CoA
- Pharmacy of record. Name, state license number, and (for 503B) FDA establishment registration.
- Identity. Confirmed by ESI-MS against theoretical monoisotopic mass.
- Purity & potency. Area-% by RP-HPLC at 215 nm with assay vs. label claim.
- Sterility & endotoxin. USP <71> and <85> results for sterile injectables.
- Beyond-use dating & storage. Assigned BUD and the storage conditions it depends on.