Licensed 503a and 503b partners.
P3X Labs supplies through both 503a compounding pharmacies and 503b outsourcing facilities. Understanding the distinction helps partners choose the right supply path.
Two pathways, one standard
The distinction between 503a and 503b facilities comes from Sections 503A and 503B of the US Federal Food, Drug, and Cosmetic Act. Each serves a different need and carries different documentation requirements.
We match partners to the appropriate pathway based on their setting, prescription model, and volume requirements.
Right-sized supply
Patient-specific compounding through 503a partners, or bulk office-use supply through 503b partners.
Verified licensing
We confirm partner licensing and registration before supplying material.
Documentation to match
Each pathway carries the records its regulatory framework requires.
503a Compounding Pharmacy
A pharmacy licensed by its state board that compounds medications for a specific patient based on a valid prescription.
- Standards
- USP <795>, USP <797>, state pharmacy law
- Documentation
- Patient-specific prescriptions, compounding records, beyond-use dating
503b Outsourcing Facility
An FDA-registered facility that compounds sterile and non-sterile preparations in bulk for healthcare providers without patient-specific prescriptions.
- Standards
- cGMP, USP <795>, USP <797>, FDA oversight
- Documentation
- Batch records, validation studies, stability data, release testing
More on Science & Quality
Not sure which pathway fits?
Our team can help you map your setting to the right compounding partner.
Talk to our team