§ 106-145.2. Definitions. - North Carolina Statutes

§ 106‑145.2. Definitions.

The following definitionsapply in this Article:

(1)        Blood. – Whole bloodcollected from a single donor and processed either for transfusion or furthermanufacturing.

(2)        Blood component. –That part of blood separated by physical or mechanical means.

(3)        Commissioner. – TheCommissioner of Agriculture.

(4)        Common control. –The power to direct or cause the direction of the management and policies of aperson, whether by ownership of stock, by voting rights, by contract, or otherwise.

(5)        Department. – TheDepartment of Agriculture and Consumer Services.

(6)        Drug sample. – Aunit of a prescription drug that is not intended to be sold and is intended topromote the sale of the drug.

(7)        Manufacturer. – Aperson who is engaged in manufacturing, preparing, propagating, compounding,processing, packaging, repackaging, or labeling a prescription drug.

(8)        Person. – Anindividual, a corporation, a partnership, or any other entity.

(9)        Prescription drug. –A human drug required by federal law or regulation to be dispensed only by aprescription, including finished dosage forms and active ingredients subject to21 U.S.C. § 353(b). Only for the purposes of the provisions of this Article,the term "prescription drug" shall include pseudoephedrine productsas defined in G.S. 90‑113.51 that may be dispensed without aprescription.

(10)      Wholesaledistribution. – Distribution of a prescription drug to a person who is not aconsumer or patient, other than any of the following types of distributions:

a.         Intracompany sales.An intracompany sale is a transaction or transfer between any divisions,subsidiary and parent companies, or affiliated companies under common controlof the same corporate entity.

b.         The purchase orother acquisition of a prescription drug by a hospital or other health careentity that is a member of a group purchasing organization for its own use fromthe group purchasing organization or from other hospitals or other health careentities that are members of these organizations.

c.         The sale, purchase,or trade of a prescription drug or an offer to sell, purchase, or trade aprescription drug by a charitable organization described in section 501(c)(3)of the Internal Revenue Code to a nonprofit affiliate of the organization tothe extent otherwise permitted by law.

d.         The sale, purchase,or trade of a prescription drug or an offer to sell, purchase, or trade aprescription drug among hospitals or other health care entities that are undercommon control.

e.         The sale, purchase,or trade of a prescription drug or an offer to sell, purchase, or trade aprescription drug for emergency medical reasons. Emergency medical reasonsinclude transfers of prescription drugs by a retail pharmacy to another retailpharmacy to alleviate a temporary shortage when the gross dollar value of thetransfers does not exceed five percent (5%) of the total prescription drugsales revenue of either the transferor or transferee pharmacy during any 12‑consecutive‑monthperiod.

f.          The sale, purchase,or trade of a prescription drug; an offer to sell, purchase, or trade aprescription drug; or the dispensing of a prescription drug pursuant to aprescription.

g.         The distribution ofdrug samples by a representative of a manufacturer or a wholesale distributor.

h.         The sale, purchase,or trade of blood and blood components intended for transfusion.

(11)      Wholesaledistributor. – A person who is engaged in the wholesale distribution ofprescription drugs. The term includes manufacturers, repackers, own‑labeldistributors, private‑label distributors, jobbers, brokers, warehouses,independent wholesale drug traders, and retail pharmacies that conductwholesale distributions. The term does not include a person who acquiresprescription drugs commingled with other goods as part of a recovery operationand who disposes of such drugs under the supervision of the Department. Awarehouse includes a warehouse of a manufacturer or wholesale distributor, achain drug warehouse, and a wholesale drug warehouse. (1991, c. 699, s. 2; 1997‑261,s. 35; 2005‑434, s. 2.)