COMMITTEE SUBSTITUTE

FOR

Senate Bill No. 324

(By Senators Stollings and Beach)

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[Originating in the Committee on Government Organization;

reported March 14, 2013.]

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A BILL to amend and reenact §30-5-1a and §30-5-16 of the Code of West Virginia, 1931, as amended; to amend said code by adding thereto a new section, designated §30-5-16c; to amend and reenact §60A-3-301 of said code; and to amend said code by adding thereto a new section, designated §60A-3-301a, all relating to permits for manufacturing, making, producing, packing, packaging or preparing drugs, medicines, toilet articles, dentifrices and cosmetics and registration of practitioners dispensing controlled substances; modifying fees associated with the permits; granting rule-making authority to the Board of Pharmacy to establish a fee schedule for obtaining and maintaining the permit; providing that statutory fee schedule will remain in effect until amended, modified, repealed or replaced by legislative rule; clarifying disciplinary action that may be taken if condition or rule relating to permit is violated; modifying registration fees for practitioners dispensing controlled substances; granting rule-making authority to boards, departments and agencies that license or register practitioners dispensing controlled substances; and providing that statutory fee schedule for registering practitioners dispensing controlled substances will remain in effect until amended, modified, repealed or replaced by legislative rule.

Be it enacted by the Legislature of West Virginia:

    That §30-5-1a and §30-5-16 of the Code of West Virginia, 1931, as amended, be amended and reenacted; that said code be amended by adding thereto a new section, designated §30-5-16c; that §60A-3-301 of said code be amended and reenacted; and that said code be amended by adding thereto a new section, designated §60A-3-301a, 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; 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 any 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 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 the person is 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 appropriate 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) The board may establish by legislative rule application and renewal fees for a permit required by this section: Provided, That the fee schedule in effect as of the first day of July, two thousand thirteen, will remain in effect until amended, modified, repealed or replaced by any legislative rule promulgated pursuant to this section.

    (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 shall not be Permits are not transferable, and shall 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 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 shall 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 violation continues shall constitute a separate and distinct offense. Upon conviction of a permittee, his or her permit shall also immediately be revoked and become null and void. Each day a violation continues constitutes a separate offense.

    (h) (g) Any 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, have such her or his permit permanently revoked and the Board of Pharmacy shall refuse to issue further permits to such the person, firm, corporation, partnership, company, cooperative society, organization or permittee.

§30-5-16c. Fee schedule.

    Until amended, modified, repealed or replaced by legislative rule, the board shall collect the following fees from any person, firm, corporation, partnership, company, cooperative society, organization seeking a permit pursuant to section sixteen of this article [§30-5-16]:

    (1) Distributor application fee: $150;

    (2) Manufacturer application fee: $500;

    (3) Distributor annual permit renewal fee: $150; and

    (4) Manufacturer annual permit renewal fee: $500.

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 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.

    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.

    (b) The fee schedule in effect as of the first day of July, two thousand thirteen, will remain in effect until amended, modified, repealed or replaced by any legislative rule promulgated pursuant to this section.

§60A-3-301a. Fee schedule.

    Until amended, modified, repealed or replaced by legislative rule, 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 respect to controlled substances:

    (1) $50 for registration of a manufacturer;

    (2) $50 for registration of a wholesaler;

    (3) $50 for registration of a hospital or clinic;

    (4) $25 for registration of a medical examiner;

    (5) $25 for registration of a teaching or research institution;

    (6) $25 for registration of a nursing home or an extended care facility; and

    (7) $15 for registration of a dispenser.