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Introduced Version House Bill 2573 History

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Key: Green = existing Code. Red = new code to be enacted
H. B. 2573


          (By Delegates Morgan, Stephens, Hartman and Paxton)
          [Introduced February 20, 2013; referred to the
          Committee on Government Organization then the Judiciary.]




A BILL to amend and reenact §30-5-1a of the Code of West Virginia, 1931, as amended; to amend and reenact §30-5-16 of said code; and to amend and reenact §60A-3-301 of said code, all relating to authorizing boards that issue licenses to engage in the manufacture, distribution or dispensing of controlled substances to set fees by legislative rulemaking.
Be it enacted by the Legislature of West Virginia:
     That §30-5-1a of the Code of West Virginia, 1931, as amended, be amended and reenacted; that §30-5-16 of said code be amended and reenacted; and that §60A-3-301 of said code be amended and reenacted, all to read as follows:
CHAPTER 30. PROFESSIONS AND OCCUPATIONS.

ARTICLE 5. PHARMACISTS, PHARMACY TECHNICIANS, PHARMACY INTERNS AND PHARMACIES.

§30-5-1a. Statement of purpose.
     
(a) It is the purpose of this article to promote, preserve and protect the public health, safety and welfare by the effective regulation of the practice of pharmacy, the licensure of pharmacists and the licensure and regulation of all sites or persons who distribute, manufacture or sell drugs or devices used in the dispensing and administration of drugs or devices within this state.
     (b) A person, firm, corporation, partnership, company, cooperative society or organization who offers for sale, sells, offers or exposes for sale through the method of distribution legend drugs are subject to this article.
§30-5-16. Permit for manufacture and packaging of drugs, medicines, cosmetics; distribution of legend drugs; regulations as to sanitation and equipment; penalties; revocation of permit.
     (a) No drugs, or medicines, or toilet articles, dentifrices or cosmetics shall may be manufactured, made, produced, packed, packaged or prepared within the state except under the personal supervision of a pharmacist as defined by section one-b of this article or such other person as may be approved by the Board of Pharmacy, after an investigation and determination by the board that they are qualified by scientific or technical training and/or experience to perform such the duties of supervision as may be necessary to protect the public health and safety.
     (b) No person shall manufacture, make, produce, pack, package or prepare any such articles without first obtaining a permit to do so from the Board of Pharmacy. The permit shall be is subject to such rules with respect to sanitation and/or equipment as the Board of Pharmacy may from time to time adopt for the protection of the public health and safety promulgate.
     (c) Any person, firm, corporation, partnership, company, cooperative society or organization who offers for sale, sells, offers or exposes for sale through the method of distribution any legend drugs shall be subject to this article.
     
(d) (c) The application for any a permit required by this section shall be made on a form to be prescribed in legislative rule, and furnished by the Board of Pharmacy and shall be accompanied by the following fees: For a distributor, $150, for a manufacturer, $500, which amounts shall also be are also paid as the fees for each annual renewal of such the permits. Separate applications shall be made and separate permits issued for each separate place of manufacture, distribution, making, producing, packing, packaging or preparation.
     (d) On and after the effective date of the reenactment of this section during the Regular Session of the Legislature in 2013, the Board of Pharmacy and each department, board or agency may establish by legislative rule annual fees for a permit required in subsection (c) of this section. The fees set forth in subsection (c) of this section remain in effect until modified by a legislative rule promulgated pursuant to this subsection.
     (e) The following fees shall be charged for a permit to handle controlled substances: For a hospital or clinic, $50; for extended care facilities, $25; for a nursing home, $25; for a teaching institution, $25; for a researcher, $25; for a medical examiner, $25; and for a pharmacy or drugstore, $15, which amounts shall also be paid for each annual renewal of such permits.
     
(f) (e) Permits issued under the provisions of pursuant to this section shall be posted in a conspicuous place in the factory or place for which issued. such permits Permits shall not be transferable, and shall Permits are not transferable, expire on June 30 following the day of issue and shall be renewed annually. Nothing in this section shall be construed to apply applies to those operating registered pharmacies.
     (g) (f) Any A person, firm, corporation, partnership, company, cooperative society or organization violating any of the provisions a provision of this section and any permittee hereunder who shall violate any of the conditions a permittee who violates a condition of this permit or any of the rules adopted a rule promulgated by the Board of Pharmacy shall upon conviction, be deemed be guilty of a misdemeanor and, upon conviction, be fined not more than $50 for each offense and shall have his or her permit immediately revoked. Each and every day such a violation continues shall constitute constitutes a separate and distinct offense. Upon conviction of a permittee, his or her permit shall also immediately be revoked and become null and void.
     
(h) Any (g) A person, firm, corporation, partnership, company, cooperative society, organization or any a permittee who is convicted of two or more successive violations of the provisions of this section or of the rules adopted promulgated by the Board of Pharmacy shall, at the discretion of the Board of Pharmacy:
     (1) Have such the permit permanently revoked; and,
     (2) The Board of Pharmacy shall refuse to issue further permits to such person, firm, corporation, partnership, company, cooperative society, organization or permittee Have the issuance of further permits refused.
CHAPTER 60A. UNIFORM CONTROLLED SUBSTANCE ACT.

ARTICLE 3. REGULATION OF MANUFACTURE, DISTRIBUTION AND DISPENSING OF CONTROLLED SUBSTANCES.
§60A-3-301. Rules; fees.
     
(a) The State Board of Pharmacy shall promulgate rules and charge fees relating to the registration and control of the manufacture and distribution of controlled substances within this state. and each Each department, board or agency of this state which licenses or registers practitioners authorized to dispense any a controlled substance shall promulgate rules and charge fees relating to the registration and control of the dispensing of controlled substances within this state by those practitioners licensed or registered by such the department, board or agency.
     (b) The State Board of Pharmacy or the department, board or agency shall collect the following annual registration fees from persons who manufacture, distribute, dispense or conduct research with controlled substances: For registration of a manufacturer, $50; for registration of a wholesaler, $50; for registration of a retailer $15; for registration of a hospital or clinic, $15; and for registration of a research institution, $5. for registration of a dispenser, $15; for registration of a hospital or clinic, $50; for registration of a medical examiner, $25; for registration of a teaching or research institution, $25; and for registration of nursing home or an extended care facility, $25.___
_____(c) On and after the effective date of the reenactment of this section during the Regular Session of the Legislature in 2013, the Board of Pharmacy and each department, board or agency may establish by legislative rule annual fees for any registration as set forth in this section. The fees set forth in subsection (b) of this section remain in effect until modified by legislative rule promulgated pursuant to this subsection.



     NOTE: The purpose of this bill is to authorize boards that issue licenses to engage in the manufacture, distribution or dispensing of controlled substances to set fees by legislative rulemaking.

     Strike-throughs indicate language that would be stricken from the present law and underscoring indicates new language that would be added.
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