Medical Foods

The classification and definition of Medical Foods came from the 1988 Orphan Drug Amendment. The FDAs intention was to encourage innovation in new products that used safe, natural ingredients in therapeutic doses. By doing so, Medical Foods were set apart from dietary supplements.

Medical Foods are used to meet the distinct nutritional requirements of patients with specifically diagnosed diseases or conditions. The active ingredient(s) must be found in a natural food source – but the dose amount is administered at a level higher than possible through normal diet. All Medical Foods ingredients must have GRAS status (Generally Recognized as Safe). Moreover, Medical Foods may only be under the supervision of a medical professional.

The regulatory body overseeing Medical Foods is the Center for Food Safety and Applied Nutrition (CFSAN). At Red River Pharma, we manufacture several state-of-the-art Medical Food products that are prescribed and dispensed nationwide. Thus far, our delivery formats include tablets, caplets and capsules. Our manufacturing processes follow the strictest cGMP guidelines.  We also follow the same FDA guidelines as used for prescription drug products. In this way, should the pharmaceutical company choose to submit their Medical Food as an NDA product (a distinct option), our manufacturing process will already be in compliance.

Red River Pharma has become one of the nation's preeminent Medical Foods manufacturing sites. Our expertise in this category is a clear advantage for any company considering Medical Food production.