Exempt infant formula definition

Exempt infant formula means an infant formula that meets the requirements for an exempt infant formula under Section 412(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(h)) and the regulations at 21 CFR Parts 106 and 107.
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Exempt infant formula means an infant formula that meets the exempt specifications under section 412(h) of the federal Food, Drug and Cosmetic Act (21 U.S.C. 350 a(h)) and the regulations of 21 CFR parts 106 and 107.
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Examples of Exempt infant formula in a sentence

  • Columns G and H: The monthly average number of infants in the Participating Entities by formula type and physical form, excluding exclusively breastfed infants and infants using Exempt infant formula.

  • Separate Exempt infant formula carve-out adjustment factors were developed for each of the Medallion 3.0 aid categories.

  • One of the Company’s most important assets is its Confidential Information.[8] Officers, directors and employees who have received, or have access to, Confidential Information should take those steps necessary to keep such information confidential.

  • Exempt infant formula is infant formula intended for commercial or charitable distribution that is represented and labeled for use by infants with inborn errors of metabolism, low birth weight, or other unusual medical or dietary problems (21 CFR 107.3).• WIC-eligible nutritionals refers to certain enteral products that are specifically formulated to provide nutritional support for individuals with a qualifying condition, when the use of conventional foods is precluded, restricted, or inadequate.

  • Exempt infant formula is intended as a food substitute for human milk for use by infants who have inborn errors of metabolism, prematurity, low birth weight, or who otherwise have an unusual medical or dietary condition.

  • For powdered only, value in this column is carried over from data enter on page #1, column G, Reconstituted Ounce per Unit.• Columns D, E and F: The information in these cells is from 7 CFR 246.10(e) (9)(Table 1).• Columns G and H: The monthly average number of infants in the Participating Entities by formula type and physical form, excluding exclusively breastfed infants and infants using Exempt infant formula.

  • Exempt infant formula may only be issued for infants in Food Package III.5 The maximum monthly allowance is specified in reconstituted fluid ounces for liquid concentrate, RTF liquid, and powder forms of infant formula and exempt infant formula.

  • Exempt infant formula – Any infant formula which is represented and labeled for use by an infant (1) who has an inborn error of metabolism or a low birth weight, or (2) who otherwise has an unusual medical or dietary problem, in accordance with 21 U.S.C. 350a(h).

  • Exempt infant formula carve-out adjustment This adjustment removes the amount that the health plans pay for selected formulas after children up to age 19 have met the Women, Infants, and Children (WIC) benefit cap.

Related to Exempt infant formula

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  • Exempt compound means the same as defined in Rule 2.

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  • Example 2 An employee works his/her regular work shift of 7:00 a.m. to 3:30 p.m. on Tuesday. The employee is called back to work at midnight and works until 5:00