(1) "Advertising or marketing" means any manner of communication of information, either directly or indirectly, that is paid for and usually persuasive in nature about products, services or ideas related to pharmaceuticals by identified sponsors through various media, persons or other forms as further defined by legislative rule.
(2) "AWP" or "average wholesale price" means the amount determined from the latest publication of the blue book, a universally subscribed pharmacist reference guide annually published by the Hearst Corporation. "AWP" or "average wholesale price" may also be derived electronically from the drug pricing database synonymous with the latest publication of the blue book and furnished in the national drug data file (NDDF) by first data bank (FDB), a service of the Hearst Corporation.
(3) "Dispensing fee" means the fee charged by a pharmacy to dispense pharmaceuticals.
(4) "Drug manufacturer" or "pharmaceutical manufacturer" means any entity which is engaged in: (A) The production, preparation, propagation, compounding, conversion or processing of prescription drug products, either directly or indirectly by extraction from substances of natural origin, or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis; or (B) in the packaging, repackaging, labeling, relabeling or distribution of prescription drug products. "Drug manufacturer" or "pharmaceutical manufacturer" does not include a wholesale distributor of drugs or a retail pharmacy licensed under state law.
(5) "Federal supply schedule" or "FSS" means the price available to all federal agencies for the purchase of pharmaceuticals authorized in the Veterans Health Care Act of 1992, PL 102-585. FSS prices are intended to equal or better the prices manufacturers charge their "most-favored" non-federal customers under comparable terms and conditions.
(6) "Multiple-source drug", "innovator drug" and "noninnovator drug" mean the following:
(A) The term "multiple-source drug" means, for which there are two or more drug products which are: Rated as therapeutically equivalent (under the food and drug administration's most recent publication of "Approved Drug Products with Therapeutic Equivalence Evaluations"), except as provided in paragraph (B) of this subdivision, are pharmaceutically equivalent and bioequivalent, as determined by the food and drug administration, and the term "innovator drug" shall hereinafter be referred to as "brand". The term "innovator drug" means a drug which is produced or distributed under an original new drug application approved by the food and drug administration, including a drug product marketed by any cross-licensed producers or distributors operating under the new drug application and any multiple-source drug that was originally marketed under an original new drug application approved by the food and drug administration. The term "noninnovator drug" shall hereinafter be referred to as "generic". The term "noninnovator drug" means a multiple-source drug that is not an "innovator drug".
(B) Paragraph (A) of this subdivision shall not apply if the food and drug administration changes by regulation the requirement that, for purposes of the publication described in paragraph (A) of this subdivision, in order for drug products to be rated as therapeutically equivalent, they must be pharmaceutically equivalent and bioequivalent.
(7) "Labeler" means an entity or person that receives prescription drugs from a manufacturer or wholesaler and repackages those drugs for later retail sale and that has a labeler code from the federal food and drug administration pursuant to 21 C.F.R. §207.20 (1999).
(8) "Person" means any natural person or persons or any corporation, partnership, company, trust or association of persons.
(9) "Pharmaceutical drug detailing" or "detailing" means the function performed by a sales representative who is employed by a pharmaceutical manufacturer for the purpose of: Promotion of pharmaceutical drugs or related products; education about pharmaceutical drugs or related products; or to provide samples of pharmaceutical drugs, related products or related materials, gifts, food or meals.
(10) "Savings" means the difference between the previous price of a prescription drug including any discounts, rebates or price containments and the current price after the effective date of this article for the public employees insurance agency, children's health insurance program, medicaid and workers' compensation programs or other programs which are payors for prescription drugs.
(11) "Sole source" means a pharmaceutical that provides a unique and powerful advantage available in the market to a broad group of patients established under federal law.
(12) "West Virginia Pharmaceutical Cost Management Council" or "council" means the council created pursuant to section eight of this article.
Note: WV Code updated with legislation passed through the 2016 Regular Session
The West Virginia Code Online is an unofficial copy of the annotated WV Code, provided as a convenience. It has NOT been edited for publication, and is not in any way official or authoritative.