§ 11.66 What are potential legal consequences of not complying with the requirements of this part?

(a) Civil or criminal judicial actions. Failure to comply with the requirements of this part, issued under section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)), is a prohibited act under one or more provisions of section 301(jj) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(jj)):

(1) Failure to submit the certification required by section 402(j)(5)(B) of the Public Health Service (42 U.S.C. 282(j)(5)(B)) that all applicable requirements of section 402(j) have been met, or knowingly submitting a false certification under section 402(j)(5)(B), is a prohibited act under section 301(jj)(1) of the Federal Food, Drug, and Cosmetic Act.