64B8-9.012. Standards for the Prescription of Drugs to Treat Obesity

The prescribing of anti-obesity drugs should only be performed by physicians qualified by training and experience to treat obesity. All licensees are expected to abide by the following guidelines and standards in the utilization of any drug, synthetic compound, nutritional supplement, or herbal treatment, for the purpose of providing medically assisted weight loss. For purposes of this rule, “anti-obesity drugs” means any drug, synthetic compound, nutritional supplement, or herbal treatment used for the purpose of providing medically assisted weight loss.

(1) To justify the use of anti-obesity drugs as set forth above, the patient must have an initial Body Mass Index (BMI) of 30 or above, or an initial BMI of greater than 27 with at least one comorbidity factor, or an initial measurable body fat content equal to or greater than 25% of total body weight for male patients or 30% of total body weight for women. The treating physician may also take into account other factors such as ethnicity-specific values and markers such as waist circumference when justifying the use of anti-obesity drugs. BMI is calculated by use of the formula BMI = weight(kg)/height(m2).

(2) Physicians in Florida are prohibited from prescribing, ordering, dispensing, or administering any anti-obesity drug that is both a serotonergic and anorexic agent unless the drug has been approved by the Food and Drug Administration (FDA) specifically for use in weight loss management. Selective serotonin re-uptake inhibitors (SSRIs) that have not been approved by the FDA for weight loss may not be prescribed, ordered, dispensed, or administered for such purposes.

(3) Physicians may only prescribe anti-obesity drugs to children with an initial BMI greater than 120th percent of the 95th percentile with significant comorbidity or an initial BMI greater than 140th percent of the 95th percentile.

(4) An initial evaluation of the patient shall be conducted prior to the prescribing, ordering, dispensing, or administering of any drug, synthetic compound, nutritional supplement or herbal treatment and such evaluation shall include physical and complete history; tests related to medical treatment for weight loss; medical referrals as indicated by the physical examination, history, and testing; all in accordance with general medical standards of care. The initial evaluation may be delegated to physician’s assistant licensed pursuant to Chapter 458 or 459, F.S., or an advanced practice registered nurse licensed pursuant to Chapter 464, F.S.

(5) Prior to prescribing, ordering, dispensing, or administering anti-obesity drugs the prescribing physician must obtain written informed consent from the patient. Such consent shall discuss potential benefits versus potential risks of weight loss treatments. A copy of the signed informed consent shall be included in the patient’s medical record.

(6) Each physician who is prescribing, ordering, or providing anti-obesity drugs to patients must assure that such patients undergo re-evaluation at least once every 3 months. The re-evaluation shall include the elements consistent with the standard of care and an assessment of the medical effects of the treatment being provided.

(7) Each physician who prescribes, orders, dispenses, or administers anti-obesity drugs for the purpose of providing medically assisted weight loss shall provide to each patient a legible copy of the Weight-Loss Consumer Bill of Rights as set forth in Sections 501.0575(1)(a) through (e)3., F.S.

(8) Any physician who advertises practice relating to weight loss that includes the prescribing of anti-obesity drugs or whose services are advertised by another person or entity shall be responsible for assuring that such advertising meets the requirements of Rule 64B8-11.001, F.A.C. Advertising weight loss treatment shall be considered false, deceptive, or misleading if it contains representations that:

(a) Promise specific results;

(b) Raise unreasonable expectations;

(c) Claim rapid, dramatic, incredible, or safe weight loss;

(d) State or suggest that diets or exercise are not required, or

(e) Suggest that weight loss is effortless or magical.

Rulemaking Authority 458.336 FS. Law Implemented 458.336 FS. History–New 12-4-97, Amended 2-17-98, 8-8-22.