Applicability and status.

(a) The criteria and definitions in this part apply in determining whether a food is: (1) Adulterated within the meaning of: (i) Section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act in that the food has been manufactured under such conditions that it is unfit for food; or (ii) Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act in that the food has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; and (2) In violation of section 361 of the Public Health Service Act (42 U.S.C. 264). (b) The operation of a facility that manufactures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is required to comply with, and is not in compliance with, section 418 of the Federal Food, Drug, and Cosmetic Act or subpart C, D, E, F, or G of this part is a prohibited act under section 301(uu) of the Federal Food, Drug, and Cosmetic Act. (c) Food covered by specific current good manufacturing practice regulations also is subject to the requirements of those regulations. [80 FR 56145, Sept. 17, 2015, as amended at 81 FR 3715, Jan. 22, 2016]