2C:35-11.1 Counterfeit drugs, medical devices; degree of crime; definitions.

1. a. A person who knowingly creates, distributes, dispenses. administers, installs, implants, possesses, or has under the person's control with intent to distribute a counterfeit drug or medical device, adulterated drug or medical device, or misbranded drug or medical device:

(1) in an amount of four or fewer dosage units; one container or labeling of a counterfeit drug, adulterated drug, or misbranded drug is guilty of a crime of the fourth degree;

(2) in an amount of at least five but fewer than 100 dosage units; at least two but fewer than five containers or labelings of a counterfeit drug, adulterated drug, or misbranded drug; or one counterfeit medical device, adulterated medical device, or misbranded medical device is guilty of a crime of the third degree; and

(3) in an amount of 100 or more dosage units; five or more containers or labelings of a counterfeit drug, adulterated drug, or misbranded drug; or two or more counterfeit medical devices, adulterated medical devices, or misbranded medical devices is guilty of a crime of the second degree.

b. In addition to penalties that may be imposed under subsection a. of this section or N.J.S.2C:35-15, a violation of this section shall be punishable by a penalty of not less than $1,000 and not more than $10,000 for each violation

c. Notwithstanding the definitions set forth in N.J.S.2C:35-2, as used in this section:

"Adulterated" means a drug or medical device that is adulterated pursuant to R.S.24:5-10.

"Container" means vial, bottle, can, jar, tube, package, or any other receptacle.

"Counterfeit" means a drug or medical device or the container or labeling of a drug or medical device that, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device or any likeness thereof of a drug or medical device manufacturer, processor, packer, or distributor other than the person who in fact manufactured, processed, packed, or distributed the medical device and that falsely purports or is represented to be the product of, or to have been packed or distributed by, the drug or medical device manufacturer, processor, packer, or distributor whose trademark, trade name, or other identifying mark, imprint, or device or likeness thereof appears on the drug or medical device or its container or labeling.

"Drug" means any medication approved by the federal Food and Drug Administration.

"Label" means a display of written, printed, or graphic matter upon the immediate container of any drug.

"Labeling" means all labels and other written, printed or graphic matter (1) upon a drug or any of its containers or wrappers, or (2) accompanying such drug or container.

"Medical device" means any device approved by the federal Food and Drug Administration.

"Misbranded" means a drug or medical device with respect to which the label is: false or misleading in any particular; does not bear the name and address of the manufacturer, packer, or distributor and does not have an accurate statement of the quantities of the active ingredients; or does not show an accurate monograph for legend drugs; or is misbranded based upon other considerations as provided in the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. s.301 et seq.

L.2019, c.339, s.1.