Wyoming § 33-24-147 Definitions

Wyoming Statutes

§ 33-24-147 — Definitions

Wyoming·Title 33 Professions and Occupations·Ch. 24 PHARMACY·Art. 1 IN GENERAL

(a)As used in this act:

(i)"Brand name" means the proprietary or trade name selected by the manufacturer and placed upon a drug, its container, label or wrapping at the time of packaging;

(ii)"Generically equivalent drug" means a drug that contains identical active ingredients in the identical dosage forms, but not necessarily containing the same inactive ingredients, that meet the identical compendial or other applicable standards of identity, strength, quality and purity, including potency, and, where applicable, content uniformity, disintegration times or dissolution rates, as the prescribed brand name drug, and, if applicable, the manufacturer or distributor holds either an approved new drug application or an approved abbreviated new drug application unless other approval by law or

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(a) As used in this act:
(i) "Brand name" means the proprietary or trade name
selected by the manufacturer and placed upon a drug, its
container, label or wrapping at the time of packaging;
(ii) "Generically equivalent drug" means a drug that
contains identical active ingredients in the identical dosage
forms, but not necessarily containing the same inactive
ingredients, that meet the identical compendial or other
applicable standards of identity, strength, quality and purity,
including potency, and, where applicable, content uniformity,
disintegration times or dissolution rates, as the prescribed
brand name drug, and, if applicable, the manufacturer or
distributor holds either an approved new drug application or an
approved abbreviated new drug application unless other approval
by law or from the Federal Food and Drug Administration is
required. A generically equivalent drug shall bear an "AB" or
higher rating in the Federal Food and Drug Administration
Approved Drug Products with Therapeutic Equivalence Evaluations;
(iii) "Generic name" means the chemical or generic
name, as determined by the United States Adopted Names (USAN)
and accepted by the Federal Food and Drug Administration (FDA),
of those drug products having the same active chemical
ingredients;
(iv) "Substitute" means to dispense a generically
equivalent drug or interchangeable biological product in place
of the prescription ordered or prescribed;
(v) "Therapeutically equivalent" means drugs that
will provide the same bioavailability or bioequivalence when
administered to an individual in the same dosage regimen;
(vi) "Biological product" means as defined in 42
U.S.C. 262(i)(1);
(vii) "Interchangeable biological product" means a
biological product that the United States food and drug
administration has:
(A) Licensed and determined meets the standards
for interchangeability under 42 U.S.C. 262(k)(4); or
(B) Determined is therapeutically equivalent to
the prescription ordered or prescribed, as set forth in the
latest edition or supplement to the Approved Drug Products with
Therapeutic Equivalence Evaluations (Orange Book) issued by the
United States food and drug administration.
(viii) "This act" means W.S. 33-24-146 through