N.J. Admin. Code § 8:21-3A.3
The words and terms used in this subchapter shall have the following meanings, unless the context clearly indicates otherwise:
"Authorized distributor" or "authorized distributor of record" means a wholesale distributor with whom a manufacturer has established an ongoing relationship to distribute the manufacturer's product. An ongoing relationship is deemed to exist when the wholesale distributor, or any member of its affiliated group, as defined in section 1504 of the Internal Revenue Code of 1986 ( 26 U.S.C. § 1504 ):
1. Is listed on the manufacturer's list of authorized distributors;
2. Has a written agreement currently in effect with the manufacturer; or
3. Has a verifiable account with the manufacturer and meets or exceeds the following transaction or volume requirement thresholds:
i. Five thousand sales units per company within 12 months; or
ii. Twelve purchases by invoice at the manufacturer's minimum purchasing requirement per invoice within 12 months.
"Blood" means whole blood collected from a single donor and processed either for transfusion or further manufacturing.
"Blood component" means that part of blood separated by physical or mechanical means.
"Broker" means a person participating in the wholesale distribution of a drug that buys and sells the drug but does not take physical possession such that the drug is "sold to" the broker and "shipped to" a third party. A "broker only" cannot take possession of drugs under any circumstances.
"Contraband drug" means a drug which is counterfeit, stolen, misbranded, obtained by fraud, purchased by a non-profit institution for its own use and placed in commerce in violation of the own use agreement for that drug.
"Counterfeit drug" means a controlled substance, or other drug which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, number, or device, or any likeness thereof, of a manufacturer, distributor, or dispenser other than the person or persons who in fact manufactured distributed, or dispensed such substance and which thereby is falsely purported or represented to be the product of, or to have been distributed by, such other manufacturer, distributor, or dispenser. A counterfeit drug shall include any counterfeit substance.
"Department" means the New Jersey Department of Health.
"Designated representative" means an individual who is designated by a wholesale prescription drug distributor to serve as the primary contact person for the wholesale distributor with the Department, and who is responsible for managing the company's operations at that licensed location.
"Drug" shall have the meaning set forth at 24:1-1 and as used throughout this subchapter shall include both non-prescription and prescription drugs.
"Drug sample" means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.
"Manufacturer" means anyone who is engaged in the manufacturing of drugs or devices, as defined in 24:6B-12, or engaged in the manufacturing, preparing, propagating, compounding, processing, packaging, repackaging, or labeling of a drug.
"Misbranded drug" shall be deemed to be misbranded if the label is false or misleading in any particular; or the label 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 in case of a drug; or do not show an accurate monograph for legend drugs; or other considerations as noted under 24:5-18 and in the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§ 301 et seq.
"Non-prescription" or "Non-legend" or "O.T.C." drugs mean drugs directly available to the consumer over the counter, without a physician's prescription.
"Prescription drug" means any human drug required by Federal law or regulation to be dispensed only by a prescription, including dosage forms and active ingredients subject to section 503(b) of the Federal Food, Drug and Cosmetic Act.
"Readily available" and "readily retrievable" mean that records, either hard copy or computerized, are organized in such a manner that they can be quickly and easily retrieved during an inspection; individual records can be produced within minutes of the request. Required records that are kept by automatic data processing systems or other electronic or mechanized recordkeeping systems are kept in such a manner so that they can be separated out from all other records in a reasonable time.
"Repackage" includes repacking or otherwise changing the container, wrapper, quantity, or labeling of a drug to further the distribution of the drug.
"Wholesale distribution" means the distribution of drugs or devices to persons other than a consumer or patient, but does not include:
1. Intracompany sales;
2. The purchase or other acquisition by a hospital or other health care entity that is a member of a group purchasing organization, of a drug or device for its own use from the group purchasing organization or from other hospitals or health care entities that are members of such organizations;
3. The sale, purchase, or trade of a drug or device or an offer to sell, purchase, or trade a drug or device by a charitable organization described in section 501(c)(3) of the Internal Revenue Code of 1954 to a nonprofit affiliate of the organization to the extent otherwise permitted by law;
4. The sale, purchase, or trade of a drug or device or an offer to sell, purchase, or trade a drug or device among hospitals or other health care entities that are under common control; for purposes of this definition "common control" means the power to direct or cause the direction of the management and policies of a person or an organization, whether by ownership of stock, voting rights, by contract, or otherwise;
5. The sale, purchase or trade of a drug or device or an offer to sell, purchase, or trade a drug or device for emergency medical reasons; for purposes of this definition, "emergency medical reasons" includes transfers of prescription drugs by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage;
6. The sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or the dispensing of a drug pursuant to a prescription;
7. The distribution of drug or device samples by manufacturers' representatives or distributors' representatives; or
8. The sale, purchase, or trade of blood and blood components intended for transfusion.
"Wholesale distributor" means anyone engaged in wholesale distribution of drugs including, but not limited to, manufacturers; repackagers; own-label distributors; private label distributors; jobbers; brokers; warehouses, including manufacturers' and distributors' warehouses, chain drug warehouses, and wholesale drug warehouses; and independent wholesale drug traders, but does not include a retail pharmacy whose sales of prescription drugs to other than the ultimate user, including physicians for office use, nursing homes, institutions, etc. does not exceed five percent of the total gross annual sales of prescription drugs of the pharmacy.
N.J. Admin. Code § 8:21-3A.3
See: 37 N.J.R. 3899(a), 38 N.J.R. 4857(b).
Inserted definitions "Authorized distributor", "Broker", "Contraband drug", "Counterfeit drug", "Designated representative", "Drug", "Misbranded drug", "Readily available" and "Repackage"; in definition "Manufacturer", deleted "prescription" preceding "drug"; and in definition "Wholesale distributor", deleted "prescription" following "distribution of".