Fla. Admin. Code Ann. R. 64B8ER23-11 - Mandatory Standardized Informed Consent for Sex-reassignment Prescriptions or Procedures in Adults

Pursuant to Section 456.52, Florida Statutes, when sex-reassignment prescriptions or procedures are prescribed for or administered or performed on patients 18 years of age or older, the physician is required to obtain voluntary, informed consent while physically present in the same room as the patient. Consent is not required for renewal of such prescriptions if a physician and the physician's patient have met the requirements for consent for the initial prescription or renewal; however, a separate consent is required for any new prescription for a pharmaceutical product not previously prescribed to the patient.

(1) Informed Consent. The Board has approved the following mandatory informed consent forms for sex-reassignment prescriptions or procedures for patients 18 years of age or older:

(a) For patients prescribed sex-reassignment feminizing medication, form DH5082-MQA, (Rev. 08/23), entitled "Feminizing Medications for Patients with Gender Dysphoria, Patient Information and Informed Consent," which is hereby incorporated by reference and available from the Board's website at https://flboardofmedicine.gov/forms/Feminizing-Medications-for-Patients-with-Gender-Dysphoria-Patient-Information-and-Informed-Consent.pdf.

(b) For patients prescribed sex-reassignment masculinizing medications, form DH5083-MQA, (Rev. 08/23), entitled "Masculinizing Medications for Patients with Gender Dysphoria, Patient Information and Informed Consent," which is hereby incorporated by reference and available from the Board's website at https://flboardofmedicine.gov/forms/Masculinizing-Medications-for-Patients-with-Gender-Dysphoria-Patient-Information-and-Informed-Consent.pdf.

(c) For patients undergoing surgical treatment, form DH5084-MQA, (06/23), entitled "Surgical Treatment for Adults with Gender Dysphoria, Patient Information and Informed Consent," which is hereby incorporated by reference and available from the Board's website at https://flboardofmedicine.gov/forms/Surgical-Treatment-for-Adults-with-Gender-Dysphoria-Patients-Information-and-Informed-Consent.pdf.

(2) A Board-approved informed consent form is not executed until:

(a) The physician issuing the prescription or performing the procedure, while physically present in the same room as the patient, has informed the patient of the nature and risks of the prescription or procedure and has provided and received the patient's written acknowledgement before the prescription is prescribed, administered, or performed. The physician is prohibited from delegating this responsibility to another person. The physician is also required to sign the informed consent form.

(b) The patient is required to sign the informed consent form.

(c) A competent witness is also required to sign the informed consent form.

Notes

Fla. Admin. Code Ann. R. 64B8ER23-11

Rulemaking Authority 456.52 FS. Law Implemented 456.52 FS.

Adopted by Florida Register Volume 49, Number 163, August 22, 2023 effective 8/18/2023 (EMERGENCY).