§ 107.3Definitions.Link to an amendment published at 79 FR 8074, Feb. 10, 2014.
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]
Effective Date Note:
At 79 FR 8074, Feb. 10, 2014, § 107.3 was amended by revising the definition of “manufacturer”, effective July 10, 2014. For the convenience of the user, the revised text is set forth as follows:
Manufacturer. A person who prepares, reconstitutes, or otherwise changes the physical or chemical characteristics of an infant formula or packages or labels the product in a container for distribution. The term “manufacturer” does not include a person who prepares, reconstitutes, or mixes infant formula exclusively for an infant under his/her direct care or the direct care of the institution employing such person.
Title 21 published on 2014-04-01
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