FDA Disclaimers and Required Communication to Patients
“The FDA has not approved hCG Therapy to lose weight. “hCG HAS NOT BEEN DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF OBESITY. THERE IS NO SUBSTANTIAL EVIDENCE THAT IT INCREASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE ATTRACTIVE OR “NORMAL” DISTRIBUTION OF FAT, OR THAT IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH CALORIE-RESTRICTED DIETS.
This diet protocol includes “off-label” use of the FDA approved medication hCG Human Chorionic Gonadotropin. This medication has not been approved for the purpose of weight loss but is approved by the FDA for other medical treatments. These treatments are approved for young boys with a condition of Hyper-Gonadism and in women as an aid in achieving pregnancy.
FDA understands that sometimes approved products are used to treat conditions that the products were not approved for (i.e., “off-label” uses). The “off-label” use of products usually presents greater uncertainty about both the risks or benefits because less information is available on safety and effectiveness. Unexpected adverse events may occur in this context.
(“Off-label” use means the use of FDA approved drugs for purposes other than those for which the FDA has approved them.) “Off-label” prescribing is a legal and common practice by physicians in the United States.
Below are Standards for Telemedicine Practice in Florida (64B8-9.0141)and how B12 Miami remains in compliance with these standards.
B12 Injections Miami is in full compliance with Telemedicine laws, rules, and regulations. B12 Miami accepts and is in compliance with the requirements below:
* “Telemedicine” means the practice of medicine by a licensed Florida physician or physician assistant where patient care, treatment, or services are provided using medical information exchanged from one site to another via electronic communications.
* The standard of care, as defined in Section 456.50(1)(e), F.S., shall remain the same regardless of whether a Florida licensed physician or physician assistant provides health care services in person or by telemedicine.
* Controlled substances shall not be prescribed using telemedicine except for the treatment of psychiatric disorders. Please note that HCG, Sermorelin, B12, L-Carnitine, and all other injectable vitamins, used by B12 Miami partner physicians, are legend drugs and NOT classified as controlled substances.
Also note that a physician can prescribe a controlled substance via telemedicine for the treatment of psychiatric disorders such as anxiety, depression, or binge eating. These psychiatric disorders are often related to body weight issues and a proper diet is a justifiable treatment.
* Prescribing medications based solely on an electronic medical questionnaire constitutes the failure to practice medicine with that level of care, skill, and treatment which is recognized by reasonably prudent physicians as being acceptable under similar conditions and circumstances, as well as prescribing legend drugs other than in the course of a physician’s professional practice.
Physicians working with you will review a questionnaire as well as consult over the phone, skype, facetime, or another form of face to face electronic communication in order to fully understand the cause of weight gain and to skillfully treat the issue with the highest level of care.
* Physicians and physician assistants shall not provide treatment recommendations, including issuing a prescription, via electronic or other means, unless the following elements have been met:
- A documented patient evaluation, including history and physical examination to establish the diagnosis for which any legend drug is prescribed. (A STANDARD PHYSICAL EXAMINATION MUST BE OBTAINED)
- Discussion between the physician or the physician assistant and the patient regarding treatment options and the risks and benefits of treatment.
On our legal forms, you the patient designates B12 Miami to act as a coordinator between you and the physician. B12 Miami becomes a designee of the patient and we can discuss with the physician, on the patient’s behalf, the best possible treatment options.
- Maintenance of contemporaneous medical records meeting the requirements of Rule 64B8-9.003, F.A.C.
* The practice of medicine by telemedicine does not alter any obligation of the physician or the physician assistant regarding patient confidentiality or recordkeeping.
* A physician-patient relationship may be established through telemedicine.