knowingly and falsely makes, alters, forges, or counterfeits the labeling or documentation (including documentation relating to origination or shipping) of a pre-retail medical product;
if the value of the medical products involved in the offense is $5,000 or greater, shall be fined under this title, imprisoned for not more than 15 years, or both, but if the offense is an aggravated offense other than one under subsection (b)(2)(C), the maximum term of imprisonment is 20 years; and
in any other case, shall be fined under this title, imprisoned for not more than 3 years, or both, but if the offense is an aggravated offense other than one under subsection (b)(2)(C), the maximum term of imprisonment is 5 years.
the terms “device”, “drug”, “infant formula”, and “labeling” have, respectively, the meanings given those terms in section 201 of the Federal Food, Drug, and Cosmetic Act;
the term “supply chain” includes manufacturer, wholesaler, repacker, own-labeled distributor, private-label distributor, jobber, broker, drug trader, transportation company, hospital, pharmacy, or security company.
Section 201 of the Federal Food, Drug, and Cosmetic Act, referred to in subsec. (e)(3), is classified to section 321 of Title 21, Food and Drugs.
Section 351 of the Public Health Service Act, referred to in subsec. (e)(4), is classified to section 262 of Title 42, The Public Health and Welfare.
Section 5(b) of the Orphan Drug Act, referred to in subsec. (e)(5), is classified to section 360ee(b) of Title 21.
Statutory Notes and Related Subsidiaries
Priority Given to Certain Investigations and Prosecutions
Pub. L. 112–186, § 4(e), Oct. 5, 2012, 126 Stat. 1429, provided that: “The Attorney General shall give increased priority to efforts to investigate and prosecute offenses under section 670 of title 18, United States Code, that involve pre-retail medical products.”