Source: http://www.wvlegislature.gov/WVCODE/Code.cfm?chap=60A&art=8
Timestamp: 2019-04-20 20:10:53+00:00

Document:
ARTICLE 3. REGULATION OF MANUFACTURE, DISTRIBUTION AND DISPENSING OF CONTROLLED SUBSTANCES.
ARTICLE 7. WEST VIRGINIA CONTRABAND FORFEITURE ACT.
ARTICLE 8. WHOLESALE DRUG DISTRIBUTION LICENSING ACT OF 1991.
§60A-8-6. Prohibited drug purchases or receipt; penalties.
§60A-8-7. Wholesale drug distributor licensing requirements.
§60A-8-8. License renewal application procedures.
§60A-8-9. West Virginia Board of Pharmacy powers to promulgate rules.
§60A-8-10. West Virginia Board of Pharmacy complaint provisions.
§60A-8-11. The West Virginia Board of Pharmacy inspection powers and access to wholesale drug distributor records.
§60A-8-12. Judicial enforcement of the article.
§60A-8-14. Disciplinary actions - wholesale drug distributor.
§60A-8-15. Maintenance of register and roster of wholesale and pharmacy distributors.
ARTICLE 11. CLANDESTINE DRUG LABORATORY REMEDIATION ACT.
This article applies to any person, partnership, corporation or business firm engaging in the wholesale distribution of human prescription drugs within this state.
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 1987 ("PDMA"), U. S. Public 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.
Acts, 2012 Reg. Sess., Ch. 203.
(9) The sale, purchase or trade of blood and blood components intended for transfusion.
(b) "Wholesale drug distributor" or "wholesale distributor" means any person or entity engaged in wholesale distribution of prescription drugs, including, but not limited to, manufacturers, repackers, own-label distributors, jobbers, private-label distributors, brokers, warehouses, including manufacturers' and distributors' warehouses, chain drug warehouses and wholesale drug warehouses, independent wholesale drug traders, prescription drug repackagers, physicians, dentists, veterinarians, birth control and other clinics, individuals, hospitals, nursing homes and/or their providers, health maintenance organizations and other health care providers, and retail and hospital pharmacies that conduct wholesale distributions, including, but not limited to, any pharmacy distributor as defined in this section. A wholesale drug distributor shall not include any for hire carrier or person or entity hired solely to transport prescription drugs.
(c) "Pharmacy distributor" means any pharmacy licensed in this state or hospital pharmacy which is engaged in the delivery or distribution of prescription drugs either to any other pharmacy licensed in this state or to any other person or entity, including, but not limited to, a wholesale drug distributor as defined in subdivision (b) of this section engaged in the delivery or distribution of prescription drugs and who is involved in the actual, constructive or attempted transfer of a drug in this state to other than the ultimate consumer except as otherwise provided for by law.
(d) "Manufacturer" means any person who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging or labeling of a prescription drug, whether within or outside this state.
(e) "West Virginia Board of Pharmacy", "Board of Pharmacy" or "board" means the agency of this state authorized to license wholesale drug distribution except where otherwise provided.
(f) "Prescription drug" means any human drug required by federal law or regulation to be dispensed only by prescription, including finished dosage forms and active ingredients subject to section 503(b) of the federal food, drug and cosmetic act.
(g) "Blood" means whole blood collected from a single donor and processed either for transfusion or further manufacturing.
(h) "Blood component" means that part of blood separated by physical or mechanical means.
(i) "Drug sample" means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.
(j) "Person" means any individual, partnership, association, limited liability company, corporation or other entity.
(1) An officer, director, trustee, partner, principal or proprietor of a person that has applied for or holds a license issued under this article or an affiliate or holding company that has control of a person that has applied for or holds a license under this article.
(5) A managerial employee of a person that has applied for or holds a license under this article or a managerial employee of an affiliate or holding company that has control of a person that has applied for or holds a license under this article who will perform or performs the function of an operations manager or will exercise or exercises management, supervisory or policy-making authority over the distribution of prescription drugs.
(l) "Third-party logistics provider" means a person who contracts with a prescription drug manufacturer to provide or coordinate warehousing, distribution or other services on behalf of a manufacturer, but does not take title to the prescription drug or have general responsibility to direct the prescription drug's sale or disposition. A third-party logistics provider must be licensed as a wholesale distributor under this article and, in order to be considered part of the normal distribution channel, must also be an authorized distributor of record.
It is unlawful for any person or entity to knowingly purchase or receive any prescription drug from any source other than a person or entity licensed pursuant to the laws of this state except where otherwise provided, such person or entity to include, but not be limited to, a wholesale distributor, manufacturer, pharmacy distributor or pharmacy. Any person violating the provisions of this section is guilty of a misdemeanor, and, upon conviction thereof, shall be fined not more than $1,000. Any person who violates this section shall for a second offense be guilty of a misdemeanor, and, upon conviction thereof, shall be fined not less than $1,000 nor more than $5,000.
(6) Any other information or documentation that the board may require.
(1) No person or distribution outlet may act as a wholesale drug distributor without first obtaining a license to do so from the Board of Pharmacy and paying any reasonable fee required by the Board of Pharmacy, such fee not to exceed four hundred dollars per year: Provided, That for licenses that are effective on and after July 1, 2012, the annual fee shall be $750 per license until modified by legislative rule. All fees collected pursuant to this section shall be used for the operation and implementation of the West Virginia Controlled Substances Monitoring Program database or in the same manner as those fees governed by article five, chapter thirty of this code.
(2) The Board of Pharmacy may grant a temporary license when a wholesale drug distributor first applies to the board for a wholesale drug distributor's license and the temporary license shall remain valid until the Board of Pharmacy finds that the applicant meets or fails to meet the requirements for regular licensure, except that no temporary license shall be valid for more than ninety days from the date of issuance. Any temporary license issued pursuant to this subdivision shall be renewable for a similar period of time not to exceed ninety days pursuant to policies and procedures to be prescribed by the Board of Pharmacy.
(3) No license may be issued or renewed for a wholesale drug distributor to operate unless the distributor operates in a manner prescribed by law and according to the rules promulgated by the Board of Pharmacy with respect thereto.
(4) The Board of Pharmacy may require a separate license for each facility directly or indirectly owned or operated by the same business entity within this state, or for a parent entity with divisions, subsidiaries, or affiliate companies within this state when operations are conducted at more than one location and there exists joint ownership and control among all the entities.
(I) Operations in compliance with all federal legal requirements applicable to wholesale drug distribution.
(I) Any other factors or qualifications the Board of Pharmacy considers relevant to and consistent with the public health and safety, including whether the granting of the license would not be in the public interest.
(3) All requirements set forth in this subsection shall conform to wholesale drug distributor licensing guidelines formally adopted by the United States Food and Drug Administration (FDA); and in case of conflict between any wholesale drug distributor licensing requirement imposed by the Board of Pharmacy pursuant to this subsection and any food and drug administration wholesale drug distributor licensing guideline, the latter shall control.
(d) An employee of any licensed wholesale drug distributor need not seek licensure under this section and may lawfully possess pharmaceutical drugs when the employee is acting in the usual course of business or employment.
(e) 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.
(6) Any other material change that the board may specify by rule.
(g) Before denial of a license or application for renewal of a license, the applicant shall be entitled to a hearing in accordance with subsection (h), section eight, article one, chapter thirty of this code.
(h) 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.
(i) 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: (1) 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 (2) such other state would extend reciprocal treatment under its own laws to a wholesale drug distributor of this state.
Application blanks for renewal of any license required by this article shall be mailed to each licensee at least thirty days before July 1, of each calendar year by the board. All licenses issued under this section are not transferable and expire on June 30 of each calendar year. If application for renewal of such license with required fee is not made before the expiration date of the license, the existing license, or renewal thereof, shall lapse and become null and void upon the last day of June of each calendar year.
The Board of Pharmacy shall promulgate rules not inconsistent with law, as may be necessary to carry out the purposes and enforce the provisions of this article pursuant to chapter twenty-nine-a of this code. Rules which incorporate and set detailed standards for meeting each of the license prerequisites set forth in section seven of this article shall be promulgated in final form by no later than September 14, 1992. All rules promulgated pursuant to this section shall conform to wholesale drug distributor licensing guidelines formally adopted by the food and drug administration at 21 C.F.R. Part 205; and in case of conflict between any rule adopted by the Board of Pharmacy and any food and drug administration wholesale drug distributor guideline, the latter shall control.
(a) The Board of Pharmacy is hereby authorized and empowered, when complaints or examinations or inspections of a wholesale drug distributor disclose that a wholesale drug distributor is not operating or conducting business according to the state and federal laws, to file a written complaint with the board charging the holder of a license to operate a wholesale drug distributorship operation with violations of this article which are grounds for restriction, suspension or revocation of the wholesale drug distributor's license.
(b) If the Board of Pharmacy concludes that a wholesale drug distributor has committed an act or is engaging in a course of conduct which constitutes a clear and present danger to the public health and safety in this state, the Board of Pharmacy may hold an expedited hearing. Within fifteen days after service of the complaint on a wholesale drug distributor, the West Virginia Board of Pharmacy shall conduct a preliminary hearing to determine whether the alleged activities of the wholesale drug distributor appear to constitute a clear and present danger to the public health and safety which justify that the wholesale drug distributor's license be immediately restricted or suspended. The burden of proving that a wholesale drug distributor is a clear and present danger to the public health and safety shall be upon the board. The board shall issue its decision immediately after the hearing and shall dismiss the action or suspend, restrict or revoke the license. The board shall require any wholesale drug distributor found in violation of this article to take all necessary measures for compliance.
(c) If the board restricts, revokes or suspends the wholesale drug distributor's license, such temporary restriction, revocation or suspension shall become a final restriction or suspension if there is no request by the wholesale drug distributor for a final hearing within thirty days of the preliminary hearing. The board shall, if requested by the wholesale drug distributor named in the complaint, set a date to hold a final hearing which shall be held pursuant to the provisions of chapter twenty-nine-a of this code.
(a) A person authorized by the board may inspect during normal business hours any premises being used by a wholesale drug distributor in this state in the course of its business. Any wholesale drug distributor providing adequate documentation of the most recent satisfactory inspection less than three years old of such distributor's wholesale drug distribution activities and facilities by either the food and drug administration or a state agency, or any person or entity lawfully designated by a state agency to perform such inspection, determined to be comparable by the board shall be exempt from further inspection for a period of time to be determined by the Board of Pharmacy. Such exemption shall not bar the board from initiating an investigation pursuant to a public or governmental complaint received by the board regarding a wholesale drug distributor.
(b) Wholesale drug distributors may keep records regarding purchase and sales transactions at a central location apart from the principal office of the wholesale drug distributor or the location at which the drugs were stored and from which they were shipped: Provided, That such records shall be made available for inspection within two working days after a request to inspect by the board is made. Such records may be kept in any form permissible under federal law applicable to prescription drugs record keeping.
(a) Upon proper application by the board, a court of competent jurisdiction may grant an injunction, restraining order or other order as may be appropriate to enjoin a person from offering to engage or engaging in the performance of any acts or practices for which a certificate of registration or authority, permit or license is required by any applicable federal or state law, including, but not limited to, this act upon a showing that such acts or practices were or are likely to be performed or offered to be performed without a certificate of registration or authority, permit or license.
(b) Any such judicial actions shall be commenced either in the county in which such conduct occurred or in the county in which defendant resides.
(c) Any action brought under this section shall be in addition to and not in lieu of any other penalty provided by law and may be brought concurrently with other actions to enforce this article.
Every person who violates any provision of section seven of this article shall be guilty of a misdemeanor, and, upon conviction thereof, shall be fined not less than $200 nor more than $1,000.
(6) Any reason for which the board may impose disciplinary sanctions under the provisions of chapter thirty of this code.
(b) Upon the suspension or revocation of the license of any wholesale distributor of prescription drugs, the distributor shall immediately surrender the license to the board.
(c) If the board suspends, revokes or refuses to renew any license issued to a wholesale distributor of prescription drugs and determines that there is clear and convincing evidence of a danger of immediate and serious harm to any person, the board may place under seal all drugs owned by or in the possession, custody or control of the affected wholesale distributor. Except as provided in this article, the board may not dispose of the drugs sealed under this subsection until the distributor exhausts all of his or her appeal rights under this article or article five, chapter thirty of this code. The court involved in the appeal may order the board, during the pendency of the appeal, to sell sealed dangerous drugs that are perishable. The board shall deposit the proceeds of the sale with the court.
(a) The Executive Director of the Board of Pharmacy shall maintain a register of the names, addresses and the date the current license was issued or renewed pursuant to this article for license years beginning on and after July 1, 2013. The register shall be the property of the board and shall be open for public examination and inspection at all reasonable times, as the board may direct.
(3) Those persons whose licenses have not been renewed for the current license year.
(c) In lieu of annually publishing a typed or printed register providing the information required by this subsection, the board may make the information required to be published available at its website.
(d) A written statement signed and verified by the executive director of the board, in which it is stated that after diligent search of the register no record or entry of the issuance of a license or registration certificate to a person is found, is admissible in evidence and constitutes presumptive evidence of the fact that the person is not a licensed as a wholesale drug distributor under this article.
The board shall pay all fees it collects under this article into the separate fund created in the State Treasury for the board pursuant to section ten, article one, chapter thirty of this code. The money in this fund shall be used exclusively by the board for the purposes of administering and enforcement of its duties pursuant to this article, articles one and five, chapter thirty of this code, or any other duty of the board prescribed by any other provision of this code.

References: §60

§60

§60

§60

§60

§60

§60

§60

§60
 §321
 §353