Compliance
503A vs 503B: How to Source Compounded Peptides Compliantly
Published May 10, 2026 · 7 min read
If you prescribe or dispense compounded peptides, you need to know exactly which of these two pharmacy categories your product came from, because the rules around each are very different.
503A, patient-specific compounding
Traditional compounding pharmacies. They make medications for a specific patient pursuant to a valid prescription. They cannot ship office stock to clinics for general use.
- Requires a patient name on every order
- State-board regulated
- Most flexibility on custom formulations
503B, outsourcing facilities
FDA-registered facilities that can produce sterile compounded medications in bulk for office use, without patient-specific prescriptions. Higher manufacturing standards (cGMP).
- Can supply office stock for in-clinic administration
- FDA-registered and inspected
- Limited to a specific list of bulk substances
How clinics use both
Office-administered injectables (in-clinic IV, B12 shots, etc.) typically come from 503B. Patient take-home prescriptions (semaglutide pens, BPC-157 vials) typically come from 503A. A good wholesale partner gives you access to both.
FAQs
- Can I get 503B-style office stock of compounded semaglutide?
- Generally no, semaglutide is not on the 503B bulks list, so patient-specific 503A is the compliant path.
Request an independent partner introduction
DPS makes introductions only. The independent parties determine their own account requirements and timelines.
Get Started →