Semaglutide Informed Consent Form Template
Informed consent is a legal and ethical requirement before prescribing semaglutide for weight management. This template covers the essential elements of valid informed consent: the nature of the treatment, expected benefits, known risks and side effects, alternative treatments, and the patient's right to withdraw. For practices prescribing compounded semaglutide, this form includes additional disclosures required by state pharmacy boards regarding the compounded nature of the medication. The template is designed to meet FSMB and AMA informed consent standards while remaining accessible to patients.
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 Details
Your provider will fill in your prescribed treatment details.
Medication Prescribed *
Filled in by your provider
Starting Dose *
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 of this treatment include:
Alternatives to this medication were discussed, including:
Section 4 of 5
Acknowledgments & Disclosures
Please review and confirm your understanding.
I understand and acknowledge that:
Section 5 of 5
Consent Signature
Please review and sign below.
I have read and understand this consent form. I have had the opportunity to ask questions and have received satisfactory answers. I voluntarily consent to treatment. I understand I may withdraw my consent and stop treatment at any time.
Patient Signature *
Electronic signature
Date Signed *
...
Witness / Provider Name *
...
Witness / Provider Signature *
Electronic signature
This is a preview. Actual form will be customized with your practice branding.
Compliance & Regulatory Notes
Informed consent for semaglutide must include disclosure of the FDA boxed warning regarding thyroid C-cell tumors. Failure to disclose this risk may constitute a violation of informed consent requirements. See FDA labeling: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215256s007lbl.pdf
For compounded semaglutide, the Federation of State Medical Boards (FSMB) and most state medical boards require additional disclosure that the medication is not FDA-approved in its compounded form. See FSMB policy: https://www.fsmb.org
Electronic signatures on consent forms must comply with the ESIGN Act (15 U.S.C. 7001) and applicable state electronic signature laws (e.g., UETA).
Consent forms must be retained as part of the patient medical record per applicable state medical record retention requirements (typically 7-10 years for adults).
Practices prescribing compounded semaglutide should verify their compounding pharmacy holds PCAB accreditation or state 503A/503B licensure. See PCAB: https://www.pcab.org
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Frequently Asked Questions
Is a consent form legally required before prescribing semaglutide?
Yes. Informed consent is a legal and ethical requirement before prescribing any medication. For semaglutide specifically, the FDA boxed warning regarding thyroid C-cell tumors makes documented informed consent especially important for liability protection.
What additional disclosures are needed for compounded semaglutide?
When prescribing compounded semaglutide, you must disclose that the medication is not an FDA-approved product, has not undergone FDA review for safety or efficacy, and explain why a compounded version is being prescribed. Most state boards require this disclosure in writing.
Can patients sign the consent form electronically?
Yes, electronic signatures are legally valid under the federal ESIGN Act and most state UETA laws. Ensure your electronic signature platform creates a tamper-evident record that can be stored as part of the patient's medical chart.
How often should patients re-sign the consent form?
Best practice is to obtain a new consent when changing medications, adjusting dosage beyond the initial titration plan, switching from brand to compounded (or vice versa), or annually for ongoing treatment. Document any material changes in treatment.