New Jersey Administrative Code › Title 8 - HEALTH › Chapter 21 - FOOD AND DRUGS › Subchapter 3A - REGISTRATION OF WHOLESALE DISTRIBUTORS OF DRUGS › Section 8:21-3A.3 - Definitions

Current through Register Vol. 56, No. 14, July 15, 2024
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.