State Codes and Statutes

State Codes and Statutes

Statutes > North-carolina > Chapter_90 > GS_90-85_27

§ 90‑85.27.  Definitions.

As used in G.S. 90‑85.28 through G.S. 90‑85.31:

(1)        "Equivalent drug product" means a drug productwhich has the same established name, active ingredient, strength, quantity, anddosage form, and which is therapeutically equivalent to the drug productidentified in the prescription;

(2)        "Established name" has the meaning given insection 502(e)(3) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C.352(e)(3);

(3)        "Good manufacturing practice" has the meaninggiven it in Part 211 of Chapter 1 of Title 21 of the Code of FederalRegulations;

(4)        "Manufacturer" means the actual manufacturer ofthe finished dosage form of the drug;

(4a)      "Narrow therapeutic index drugs" means thosepharmaceuticals having a narrowly defined range between risk and benefit. Suchdrugs have less than a twofold difference in the minimum toxic concentrationand minimum effective concentration in the blood or are those drug productformulations that exhibit limited or erratic absorption, formulation‑dependentbioavailability, and wide intrapatient pharmacokinetic variability thatrequires blood‑level monitoring. Drugs identified as having narrowtherapeutic indices shall be designated by the North Carolina Secretary ofHealth and Human Services upon the advice of the State Health Director, NorthCarolina Board of Pharmacy, and North Carolina Medical Board, as narrowtherapeutic index drugs and shall be subject to the provisions of G.S. 90‑85.28(b1).The North Carolina Board of Pharmacy shall submit the list of narrowtherapeutic index drugs to the Codifier of Rules, in a timely fashion forpublication in January of each year in the North Carolina Register.

(5)        "Prescriber" means anyone authorized to prescribedrugs pursuant to the laws of this State. (1979, c. 1017, s. 1; 1981 (Reg. Sess., 1982), c. 1188, s. 3; 1983, c.196, s. 9; 1997‑76, s. 1; 1997‑443, s. 11A.118(b).)