2006 Nebraska Revised Statutes - § 71-5402 — Terms, defined.

Section 71-5402
Terms, defined.

For purposes of the Nebraska Drug Product Selection Act, unless the context otherwise requires:

(1) Bioequivalent means drug products: (a) That are legally marketed under regulations promulgated by the federal Food and Drug Administration; (b) that are the same dosage form of the identical active ingredients in the identical amounts as the drug product prescribed; (c) that comply with compendial standards and are consistent from lot to lot with respect to (i) purity of ingredients, (ii) weight variation, (iii) uniformity of content, and (iv) stability; and (d) for which the federal Food and Drug Administration has established bioequivalent standards or has determined that no bioequivalence problems exist;

(2) Board means the Board of Pharmacy;

(3) Brand name means the proprietary or trade name selected by the manufacturer, distributor, or packager for a drug product and placed upon the labeling of such product at the time of packaging;

(4) Chemically equivalent means drug products that contain amounts of the identical therapeutically active ingredients in the identical strength, quantity, and dosage form and that meet present compendial standards;

(5) Department means the Department of Health and Human Services Regulation and Licensure;

(6) Drug product means any drug or device as defined in section 71-1,142;

(7) Drug product select means to dispense, without the practitioner's express authorization, an equivalent drug product in place of the brand-name drug product contained in a medical order of such practitioner;

(8) Equivalent means drug products that are both chemically equivalent and bioequivalent;

(9) Generic name means the official title of a drug or drug combination as determined by the United States Adopted Names Council and accepted by the federal Food and Drug Administration of those drug products having the same active chemical ingredients in the same strength and quantity;

(10) Medical order has the definition found in section 71-1,142;

(11) Pharmacist means a pharmacist licensed under the Uniform Licensing Law; and

(12) Practitioner has the definition found in section 71-1,142.

Source:

Laws 1977, LB 103, § 2

Laws 1983, LB 476, § 21

Laws 1989, LB 342, § 36

Laws 1996, LB 1044, § 720

Laws 1998, LB 1073, § 148

Laws 2001, LB 398, § 76

Laws 2003, LB 667, § 15

Laws 2005, LB 382, § 11

Cross References:

Uniform Licensing Law,see section 71-101.

~Revised Statutes Supplement, 2006