Medical Food and Exempt Infant Formula Definitions​

You may need to educate your insurer about severe food allergies, understand how to obtain coverage and why you may qualify to get reimbursement. Below are some tools that will help you. Remember, our Nutricia Navigator team is here to help you.

Exempt Infant Formula:

Title 21 Code of Federal Regulations Part 107-Infant Formula

Subpart C Exempt Infant Formulas [21 CFR 107.50(c)] (as of April 1, 2017)

“(c) Infant formulas not generally available at the retail level. (1) These exempt infant formulas are not generally found on retail shelves for general consumer purchase. Such formulas typically are prescribed by a physician and must be requested from a pharmacist, or are distributed directly to institutions such as hospitals, clinics, and state or federal agencies. Such formulas are also generally represented and labeled solely to provide dietary management for specific diseases or conditions that are clinically serious or life threatening and generally are required for prolonged periods of time….”

Medical Food:

Title 21 Code of Federal Regulations 101.9(j)(8)
(as of April 1, 2017)

“(8) Medical foods as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)). A medical food 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. A food is subject to this exemption only if:

(i) It is a specially formulated and processed product (as opposed to a naturally occurring foodstuff used in its natural state) for the partial or exclusive feeding of a patient by means of oral intake or feeding by tube;

(ii) It is intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone;

(iii) It provides nutritional support specifically modified for the management of the unique nutrient needs that result from the specific disease or condition, as determined by medical evaluation;

(iv) It is intended to be used under medical supervision; and

(v) It is intended 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….”


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