Food and Drug Administration, HHS

21 CFR Ch. 1 (4-1-97 Edition)

§ 107.50

Subpart C - Exempt Infant Formulas

(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.