Compliance Is Protection—for Your Patients and Your Practice
Offering peptides isn’t just about selecting the right compound—it’s about doing it safely, ethically, and legally. Whether you operate a brick-and-mortar medspa or a multi-state telehealth platform, your clinic must have proper consent language, documentation workflows, and oversight structures in place.
This page outlines what you need to stay compliant, how to explain risks and responsibilities to patients, and how ShineRx supports you with tools and templates.
What You Must Have in Place Before Prescribing
To remain compliant, your practice must meet all five of the following requirements:
1. Valid Provider-Patient Relationship (PPR)
You must establish a clinical relationship through:
- Intake form and medical history review
- A real-time consult (in-person or HIPAA-compliant telehealth)
- Documentation of the assessment and treatment plan
This must be completed before any peptide prescription is issued.
2. Provider Licensure in the Patient’s State
The prescribing provider must hold an active license in the state where the patient lives. This applies to:
- MDs / DOs
- Nurse Practitioners (NPs)
- Physician Assistants (PAs)
Telehealth models may require multi-state licensure or medical group structures.
3. Signed Informed Consent
Each patient must sign a peptide-specific informed consent form that includes:
- The fact that peptides are compounded and not FDA-approved
- Expected outcomes and realistic timelines
- Common risks, administration requirements, and follow-up expectations
- Acknowledgement that the patient understands off-label use
4. Clear Documentation in Your EMR
Every peptide prescription should be supported by:
- Intake summary and provider notes
- The rationale for treatment selection
- Dosing instructions and administration details
- Patient consent upload or notation
- Scheduled follow-up plan
We recommend using prebuilt EMR templates or macros to standardize documentation across your team.
5. Defined Delegation & Role Clarity
Providers must clearly outline which tasks are delegated to:
- RNs or MAs for administration (in states where allowed)
- Admin staff for scheduling, communication, and order tracking
- Patient educators or coaches for follow-up support
A supervising provider must review any clinical protocols delegated to non-prescribing staff.
→ Learn more: How to Navigate Peptides as a Medical Director
Explaining Risk and Use to Patients
You don’t need to over-explain the pharmacology—but you do need to set proper expectations. Here’s language your team can use:
“Peptides are compounded medications that signal your body to regulate or restore certain functions. They’re not FDA-approved, but they are safely prescribed and prepared by licensed compounding pharmacies. We’ll monitor your results closely and adjust your plan as needed.”
Avoid making medical claims like:
- “This will definitely help you lose weight faster”
- “Peptides will cure your hormone issues”
- “You’ll feel a difference in 2 days”
Instead, emphasize:
- Supportive function
- Consistency and gradual results
- Individual response variability
- Ongoing provider oversight
→ For team training: Educating Your Clinical Team
→ For patient communication: How to Educate Your Patients
Common Mistakes to Avoid
- Prescribing without a documented consult
- Letting non-licensed staff suggest or sell peptides
- Using hormone therapy consent forms for peptides
- Failing to schedule or document follow-up
- Offering peptides as “cash and carry” without a prescription
Build It Right from the Start
Consent and compliance should never be an afterthought. With ShineRx, your clinic gets:
- Tools to simplify documentation
- Clinical protocols that meet medical board standards
- Peace of mind that you’re prescribing safely and professionally
Related Pages to Explore
→ Ready to build protocols? Explore Integrating Peptides Into Your Workflow
→ Need to train your team? Start with Educating Your Clinical Team