New Jersey Administrative Code
Title 13 - LAW AND PUBLIC SAFETY
Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES
Subchapter 3 - LABELING AND PACKAGING REQUIREMENTS
Section 13:45H-3.2 - Definitions

Current through Register Vol. 56, No. 6, March 18, 2024

"Commercial container" means any bottle, jar, tube, ampule or other receptacle in which a substance is held for distribution or dispensing to an ultimate user, and in addition, any box or package in which the receptacle is held for distribution or dispensing to an ultimate user. The term "commercial container" does not include any package liner, package insert or other material kept with or within a commercial container, nor any carton, crate, drum or other package in which commercial containers are stored or used for shipment of controlled substances.

"Label" means any display of written, printed or graphic matter placed upon the commercial container of any controlled substance by any manufacturer of such substance.

"Labeling" means all labels and other written, printed or graphic matter upon any controlled substance or any of its commercial containers or wrappers, or accompanying such controlled substance.

"Manufacture" means the producing, preparation, propagation, compounding or processing of a drug or other substance or the packaging or repackaging of such substance, or the labeling or relabeling of the commercial container of such substance, but does not include the activities of a practitioner who, as an incident to his administration or dispensing such substance in the course of his professional practice, prepares, compounds, packages or labels such substance. The term "manufacture" means a person who manufactures a drug or other substance, whether under a registration or as a manufacturer or under authority of registration as a research or chemical analyst.

Any term not defined in this section shall have the definition set forth in Section 102 of the Act ( 21 U.S.C. 802 ) or 301.02 of 21 CFR.