Peptides Are Legal—But Regulated
Peptides used in clinical settings are prescription-only compounds. Most are not FDA-approved branded drugs, but they are legally available through compounding pharmacies under federal and state pharmacy guidelines. Understanding how peptide prescribing works—who can prescribe, how sourcing must be handled, and what your clinic is responsible for—is critical for compliant implementation.
This page walks you through the key regulatory facts, clarifies common misconceptions, and explains how ShineRx helps keep your practice aligned.
Key Distinction: FDA-Approved vs. Compounded Peptides
The FDA has not approved most peptides as branded medications. However, peptides can still be legally compounded and prescribed by licensed medical providers.
ShineRx partners only with licensed 503A and 503B pharmacies that meet rigorous quality and documentation standards. This is similar to how many hormone, IV, and dermatology compounds are prescribed in functional medicine and aesthetic practices.
503A vs. 503B Compounding Explained
| 503A Pharmacies | 503B Outsourcing Facilities |
| Traditional compounding for specific patients | Larger-scale, FDA-registered outsourcing sites |
| Requires individual patient prescription | Can compound in advance for office use (if allowed) |
| Regulated by state boards + USP standards | Regulated by FDA and state pharmacy boards |
| Most common for peptides at ShineRX | ShineRX uses both for flexibility + safety |
ShineRX only partners with U.S.-based, licensed facilities that provide lot testing, sterility reports, potency assays, and full traceability.
Who Can Prescribe Peptides?
Peptides must be prescribed by a licensed healthcare provider. That includes:
- Physicians (MD/DO)
- Nurse Practitioners (NPs)
- Physician Assistants (PAs)
Clinic owners or managers may not prescribe unless they hold one of the above credentials. Prescriptions must be written under a valid patient-provider relationship (PPR), which includes an intake review, clinical evaluation (virtual or in person), and charted rationale.
What About State Licensure?
The provider prescribing the peptide must hold an active license in the state where the patient resides. For multi-state telehealth models, you may need:
- Individual state licenses
- A supervising MD with a medical group model
- A third-party collaborative care structure
ShineRX can refer you to partners for expanded telehealth licensing if needed.
What You’re Responsible for as a Clinic
Even if ShineRX handles the sourcing and fulfillment, your clinic is still responsible for:
- Patient intake and eligibility review
- Valid provider license and PPR documentation
- Signed consent forms that explain peptide use and risks
- Proper EMR documentation of prescriptions, protocols, and follow-up plans
- Adverse event monitoring and reporting if necessary
How ShineRx Simplifies Compliance
- Provides pharmacy documentation for every order (lot, sterility, compounding info)
- Partners only with licensed 503A/503B facilities in the U.S.
- Offers consent form templates and patient education materials
- Helps you determine prescribing eligibility and setup structures
- Supports both telehealth and in-person models
You remain the clinical authority—but ShineRx helps you stay aligned, protected, and organized.
Common Compliance Questions
Can I delegate peptide injections to an RN or MA?
Yes, if your state allows and you’ve established appropriate protocols under your license.
Can my front desk staff explain peptides?
They can explain basics, but must avoid offering clinical advice or making medical claims.
What if I’m not sure what my state allows?
We recommend consulting your legal counsel or compliance consultant. ShineRX can connect you to industry partners if needed.
Up Next: Prescribing & Provider Structures
Now that you know the rules, let’s walk through how to set up your clinic with the right medical oversight and prescribing workflows.