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

Semaglutide Consent Form | Your Practice Name
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

Want This Form Automated?

Karpa Health turns static intake forms into a fully automated clinical workflow.

  • Branded patient intake embedded on your website
  • AI clinical review with contraindication screening
  • One-click prescribing to compounding pharmacies
  • Automated follow-up and refill management
  • E-signatures, HIPAA compliance, and audit trail
Book a Demo

Related Clinical Forms

Sources & References

  1. FDA Prescribing Information for Semaglutide (Wegovy)
  2. Federation of State Medical Boards (FSMB)
  3. Pharmacy Compounding Accreditation Board (PCAB)
  4. ESIGN Act (15 U.S.C. 7001)

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.