Peptide Therapy Informed Consent Form Template
Informed consent for peptide therapy requires additional disclosures beyond standard medication consent. Most therapeutic peptides are prescribed off-label and dispensed through compounding pharmacies, which means patients must understand that these medications have not undergone FDA approval for their prescribed indication. This template covers the specific consent elements required for peptide therapy programs, including off-label use disclosures, compounding pharmacy information, potential side effects by peptide category, and patient acknowledgments. Designed for integrative medicine practices, functional medicine clinics, anti-aging practices, and med spas offering peptide protocols.
Form Preview
Section 1 of 5
Patient Identification
Please confirm your information.
Patient Full Name *
Jane Smith
Date of Birth *
...
Date *
...
Section 2 of 5
Treatment Information
Your provider will fill in your prescribed treatment details.
Peptide(s) Prescribed *
Filled in by your provider
Dose and Frequency *
Filled in by your provider
Section 3 of 5
Benefits & Alternatives
Your provider wants you to understand what to expect and what other options are available.
Expected benefits discussed with me include:
Alternatives were discussed, including:
Section 4 of 5
Acknowledgments & Consent Disclosures
Please review and confirm your understanding.
I acknowledge and understand that:
Section 5 of 5
Consent Signature
Please review and sign below.
I have read, understand, and agree to the above disclosures. I voluntarily consent to the prescribed peptide therapy. I understand I may withdraw my consent and stop treatment at any time.
Patient Signature *
Electronic signature
Date Signed *
...
Provider Name *
...
Provider Signature *
Electronic signature
This is a preview. Actual form will be customized with your practice branding.
Compliance & Regulatory Notes
Most therapeutic peptides are prescribed off-label. Off-label prescribing is legal but requires documented informed consent explaining the off-label nature of the treatment. The FSMB recommends specific off-label consent documentation. See FSMB: https://www.fsmb.org
Following the FDA's 2024 reclassification actions, some peptides (including certain forms of BPC-157) may face regulatory changes. Practices should monitor FDA announcements and update consent forms accordingly. See FDA peptide guidance: https://www.fda.gov/drugs/human-drug-compounding
Compounding pharmacies dispensing peptides must hold appropriate state licensure. 503A pharmacies compound for individual prescriptions; 503B outsourcing facilities can produce larger batches. Verify your pharmacy's status. See FDA 503A/503B guidance: https://www.fda.gov/drugs/human-drug-compounding
Peptide consent forms should be stored per state medical record retention requirements. Consider maintaining a separate peptide therapy chart section for liability documentation.
Practices should maintain documentation of the compounding pharmacy's licensure, accreditation, and certificate of analysis (COA) for each peptide dispensed.
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Frequently Asked Questions
Why is a separate consent form needed for peptide therapy?
Peptide therapy involves off-label use and compounded medications, both of which require specific informed consent disclosures beyond standard medication consent. This protects both the patient and the provider.
Which peptides require the most detailed consent?
Growth hormone secretagogues (CJC-1295, Ipamorelin, Sermorelin) and any peptide with recent FDA regulatory attention (BPC-157, certain research peptides) should have the most comprehensive consent documentation due to evolving regulatory landscape.
Do I need a separate consent for each peptide prescribed?
A single consent form can cover multiple peptides if each is listed individually. However, if you add a new peptide to a patient's protocol later, you should obtain updated consent documenting the additional medication.
What changed with FDA peptide regulations in 2024-2025?
The FDA took action on several peptides through the bulk drug substance nomination process and 503A/503B compounding framework. Some previously available peptides now face additional restrictions. Practices should monitor FDA.gov for current guidance and update forms accordingly.