Targeted Medical Pharma Inc. Products
Regulatory Information
Targeted Medical Pharma Inc.'s products are developed and marketed according to FDA guidelines. "The term medical food, as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3) is "a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation. The term "medical foods" does not pertain to all foods fed to sick patients. Medical foods are foods that are specially formulated and processed (as opposed to a naturally occurring foodstuff used in a natural state) for the patient who is seriously ill or who requires the product as a major treatment modality. Medical foods are only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food."
According to the FDA, "Medical foods must comply with all applicable requirements for the manufacture of foods, including the Current Good Manufacturing Practices regulations (21 CFR part 110), Registration of Food Facilities requirements (21 CFR part 1 Subpart H) and, if applicable, the Low Acid Canned Food regulations (21 CFR part 113) and Emergency Permit Control regulations (21 CFR part 108). Ingredients used in medical foods must be approved food additives or a food additive that is the subject of an exemption for investigational use (21 U.S.C. 321 and 348), if the ingredients are not Generally Recognized as Safe (GRAS).