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21 CFR 107.3 - Definitions.

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§ 107.3
Definitions.
The following definitions shall apply, in addition to the definitions contained in section 201 of the Federal Food, Drug, and Cosmetic Act (the act):
Exempt formula. An exempt infant formula is an infant formula intended for commercial or charitable distribution that is represented and labeled for use by infants who have inborn errors of metabolism or low birth weight, or who otherwise have unusual medical or dietary problems.
Manufacturer. A manufacturer is a person who prepares, reconstitutes, or otherwise changes the physical or chemical characteristics of an infant formula or packages the infant formula in containers for distribution.
References. References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.
[50 FR 48186, Nov. 22, 1985]

Title 21 published on 2012-04-01

no entries appear in the Federal Register after this date.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code
USC : Title 21 - FOOD AND DRUGS

§ 343 - Misbranded food

§ 350a - Infant formulas

Title 21 published on 2012-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 107 after this date.

  • 2013-04-16; vol. 78 # 73 - Tuesday, April 16, 2013
    1. 78 FR 22442 - Infant Formula: The Addition of Minimum and Maximum Levels of Selenium to Infant Formula and Related Labeling Requirements
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed rule.
      Submit either electronic or written comments on the proposed rule by July 1, 2013. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by May 16, 2013, (see the “Paperwork Reduction Act of 1995” section of this document).
      21 CFR Part 107