(1)if the offense is an aggravated offense under subsection (b)(2)(C), shall be fined under this title or imprisoned not more than 30 years, or both;
(2)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
(3)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.
(d) Civil Penalties.— Whoever violates subsection (a) is subject to a civil penalty in an amount not more than the greater of—
(1)three times the economic loss attributable to the violation; or
(e) Definitions.— In this section—
(1)the term “pre-retail medical product” means a medical product that has not yet been made available for retail purchase by a consumer;
(2)the term “medical product” means a drug, biological product, device, medical food, or infant formula;
(3)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;
(4)the term “biological product” has the meaning given the term in section 351 of the Public Health Service Act;
(5)the term “medical food” has the meaning given the term in section 5(b) of the Orphan Drug Act; and
(6)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
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.”
The table below lists the classification updates, since Jan. 3, 2012, for this section. Updates to a broader range of sections may be found at the update page for containing chapter, title, etc.
The most recent Classification Table update that we have noticed was Tuesday, August 13, 2013
An empty table indicates that we see no relevant changes listed in the classification tables. If you suspect that our system may be missing something, please double-check with the Office of the Law Revision Counsel.