Licensed practices source compounded peptides, such as sermorelin and oxytocin, from state-licensed 503A pharmacies and FDA-registered 503B outsourcing facilities, ordered by a licensed prescriber. Products sold "for research use only" are not intended for human use and are not a substitute.
What are peptides, in a clinical setting?
Peptides are short chains of amino acids. In a practice, the relevant products are compounded medications that a licensed prescriber orders from a licensed pharmacy. Examples include sermorelin and oxytocin.
Which peptides can be compounded
The FDA limits which bulk drug substances may be used in compounding, and that affects which peptides a pharmacy can legally supply. Eligibility also depends on the pharmacy type and your state. A licensed pharmacy confirms whether a product can be made before it fills the order. See the FDA's compounding questions and answers.
Research-use products are different
Products sold "for research use only" are not intended for human use, are not made by licensed compounding pharmacies, and do not come with the oversight that 503A and 503B pharmacies are subject to. Clinics should source products for patients from licensed pharmacies.
How a practice sources peptides
- The practitioner holds an active medical license and NPI.
- The practice opens an account and has its credentials verified.
- The practitioner orders from a licensed 503A pharmacy or a 503B outsourcing facility.
- The pharmacy collects payment and ships with documentation.
Aurum handles steps two and three of that process for practices in the consortium. See also the pharmacy checklist and the guide to compounding pharmacies for med spas.