PRIA, Government Policy, Made Personal

Summary

Makes it a crime to use interstate or foreign trade to steal, fraudulently get, fake labels or shipping papers for, hide, move, buy, or sell pre-retail medical products, or to try or plan any of those acts. The offense is worse if the person works in the supply chain, uses or threatens violence, uses a deadly weapon, causes serious injury or death (including from the bad product), or has a prior conviction. Punishments can include fines and prison: up to 30 years if the act causes serious injury or death; if the products are worth $5,000 or more, up to 15 years (or up to 20 years for other aggravated cases); otherwise up to 3 years (or up to 5 years for other aggravated cases). Civil fines can be up to three times the economic loss or $1,000,000, whichever is greater. Definitions: pre-retail medical product = a medical product not yet sold at retail. medical product = a drug, biological product, device, medical food, or infant formula. device, drug, infant formula, and labeling = terms as defined in the Federal Food, Drug, and Cosmetic Act. biological product = defined in the Public Health Service Act. medical food = defined in the Orphan Drug Act. supply chain = includes makers, wholesalers, repackers, various distributors, brokers, transporters, hospitals, pharmacies, and security companies.

Title 18, §670

Crimes and Criminal Procedure, Source: USLM XML via OLRC

(a)Prohibited Conduct.—

Whoever, in, or using any means or facility of, interstate or foreign commerce—

(1)embezzles, steals, or by fraud or deception obtains, or knowingly and unlawfully takes, carries away, or conceals a pre-retail medical product;

(2)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;

(3)knowingly possesses, transports, or traffics in a pre-retail medical product that was involved in a violation of paragraph (1) or (2);

(4)with intent to defraud, buys, or otherwise obtains, a pre-retail medical product that has expired or been stolen;

(5)with intent to defraud, sells, or distributes, a pre-retail medical product that is expired or stolen; or

(6)attempts or conspires to violate any of paragraphs (1) through (5);

shall be punished as provided in subsection (c) and subject to the other sanctions provided in this section.

(b)Aggravated Offenses.—

An offense under this section is an aggravated offense if—

(1)the defendant is employed by, or is an agent of, an organization in the supply chain for the pre-retail medical product; or

(2)the violation—

(A)involves the use of violence, force, or a threat of violence or force;

(B)involves the use of a deadly weapon;

(C)results in serious bodily injury or death, including serious bodily injury or death resulting from the use of the medical product involved; or

(D)is subsequent to a prior conviction for an offense under this section.

(c)Criminal Penalties.—

Whoever violates subsection (a)—

(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)

(2)$1,000,000.

(e)Definitions.—

In this section

(1)

(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.

Notes & Related Subsidiaries

Editorial Notes

References in Text

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.”

§670 Theft of Medical Products