Source: http://www.wvlegislature.gov/Bill_Status/bills_text.cfm?billdoc=sb588%20intr.htm&yr=2012&sesstype=RS&i=588
Timestamp: 2018-02-24 20:44:25
Document Index: 264583651

Matched Legal Cases: ['§60', '§60', '§60', '§60', '§60', '§60', '§60', '§321', '§353', 'art 205', '§60', '§60', '§60']

Introduced Version Senate Bill 588 History
A BILL to repeal §60A-8-4 of the Code of West Virginia, 1931, as amended; to amend and reenact §60A-8-3, §60A-8-5 and §60A-8-7 of said code; and to amend said code by adding thereto three new sections, designated §60A-8-14, §60A-8-15 and §60A-8-16, all relating generally to wholesale drug distributors licensed by Board of Pharmacy; specifying purpose of article; defining terms; specifying wholesale drug distributor licensing requirements; specifying powers of Board of Pharmacy; authorizing board to take certain disciplinary action against licensees, including civil penalties; providing for register of wholesale and pharmacy distributors of prescription drugs; and providing for the disposition of fees.
The purpose of this article is to protect the health, safety and general welfare of residents of this state and to implement the federal prescription drug marketing act of one thousand nine hundred eighty-seven ("PDMA"), U.S. Pubic Law 100-293, 102 Stat. 95, codified at 21 U.S. Code §321; and particularly PDMA requirements that no person or entity may engage in the wholesale distribution of human prescription drugs in any state unless such person or entity is licensed by such state in accordance with federally-prescribed minimum standards, terms and conditions as set forth in guidelines issued by United States food and drug administration (FDA) regulations pursuant to 21 U.S. Code §353(e)(2)(A) and (B); and such regulations as are set forth in 21 C.F.R. Part 205.
(1) Intracompany sales, being defined as any transaction or transfer between any division, subsidiary, parent and/or affiliated or related company under the common ownership and control of a corporate entity;
(4) The type of ownership or operation (i.e., partnership, corporation, or sole proprietorship);
(f) An agent or employee of any licensed wholesale drug distributor need not seek licensure under this section and may lawfully possess pharmaceutical drugs when the agent or employee is acting in the usual course of business or employment.
(g) The issuance of a license pursuant to this article does not change or affect tax liability imposed by this state's department of tax and revenue on any wholesale drug distributor.
(g) An applicant who is awarded a license or renewal of a license shall give the board written notification of any material change in the information previously submitted in, or with the application for the license or for renewal thereof, whichever is the most recent document filed with the board, within thirty days after the material change occurs or the licensee becomes aware of the material change, whichever event occurs last. Material changes include, but are not limited to:
(1) A change of the physical and mailing, or both, address;
(4) A change in the location where the records of the licensee that are retained;
(h) The board may deny a license to an applicant for a license or for renewal of a license if the board determines that the granting of the license would not be in the public interest.
(i) The licensing of any person as a wholesale drug distributor subjects the person and the person’s agents and employees to the jurisdiction of the board and to the laws of this state for the purpose of the enforcement of this article, article five, chapter thirty of this code and the rules of the board. However, the filing of an application for a license as a wholesale drug distributor by, or on behalf of, any person or the licensing of any person as a wholesale drug distributor may not, of itself, constitute evidence that the person is doing business within this state.
(h) (j) The board of pharmacy may adopt rules pursuant to section nine of this article which permit out-of-state wholesale drug distributors to obtain any license required by this article on the basis of reciprocity to the extent that: (i) An out-of-state wholesale drug distributor possesses a valid license granted by another state pursuant to legal standards comparable to those which must be met by a wholesale drug distributor of this state as prerequisites for obtaining a license under the laws of this state; and (ii) such other state would extend reciprocal treatment under its own laws to a wholesale drug distributor of this state.
(k) Notwithstanding the provisions of section four, article thirteen, chapter eight of this code to the contrary, municipalities may not impose the license fees imposed by this article on manufacturers of prescription drugs, wholesale distributors of prescription drugs or pharmacy distributors of prescription drugs.
(2) Violating any federal, state or local drug law; any provision of this article or any rule of the board;
(b) The roster shall set forth the names and addresses of:
(2) Those persons whose licenses have been suspended, revoked, or surrendered during the current license year or during the two preceding license years; and
(c) In lieu of annually publishing a typed or printed roster providing the information required by this subsection, the board may make the information required to be published available at its website.
NOTE: The purpose of this bill is to update the Wholesale Drug Distribution Act of 1991, including specifying additional purpose of article and definition of terms. The bill specifies wholesale drug distributor licensing requirements and powers of the Board of Pharmacy. It authorizes the board to take certain disciplinary action against licensees, including civil penalty fines. It provides for the register of wholesale and pharmacy distributors of prescription drugs. And, it provides for the disposition of fees.
§60A-8-14, §60A-8-15 and §60A-8-16 are new; therefore, strike-throughs and underscoring have been omitted.