Current through Register Vol. XLI, No. 25, June 21, 2024
Section 15-2-4 - Controlled Substance Registration4.1. Persons required to register. 4.1.1. A person who manufactures, distributes, reverse distributes, or dispenses any controlled substance or who proposes to engage in the manufacture, distribution or dispensing of any controlled substance shall obtain annually a controlled substance registration unless exempted by law or pursuant to Section 4.2 of this rule. Only persons actually engaged in these activities are required to obtain a registration; related or affiliated persons who are not engaged in these activities are not required to be registered. For example, a stockholder or parent corporation of a corporation manufacturing controlled substances is not required to obtain a registration. A person who has obtained a controlled substance registration from the Board is a "registrant".4.2. The Board shall exempt from payment of a fee for a controlled substance registration the following registrants: 4.2.1. An official or agency of the United States Army, Navy, Marine Corps, Air Force, Coast Guard, Veterans' Administration or Public Health Service who is authorized to procure or purchase controlled substances for official use; and4.2.2. An official, employee or other civil officer or agency of the United States, of any state or any political subdivision or agency thereof, who is authorized to purchase controlled substances, to obtain the substances from official stocks, to dispense or administer the substances, to conduct research, instructional activities, or chemical analysis with the substances, or any combination thereof, in the course of his or her official duties or employment.4.3. In order to claim exemption from payment of a fee, the applicant shall complete the certification on the appropriate application form, in which the registrant's superior certifies to the status and address of the registrant and to the authority of the registrant to acquire, possess or handle controlled substances.4.4. Exemption from payment of a fee does not relieve the registrant of any other requirements or duties prescribed by law or legislative rule.4.5. An applicant shall include all information called for in the form, unless the item is not applicable, in which case this fact shall be indicated.4.6. An individual applicant shall sign the application; the partners shall sign the application if the applicant is a partnership; by a partner of the applicant if a partnership; the officers shall sign the application if the applicant is a corporation, corporate division, association, trust or other entity. Another person may be authorized to sign for the applicant, if proof of authority accompanies the application.4.7. If an applicant is a pharmacy, the pharmacist in charge of the pharmacy shall sign the application. If the owner of the pharmacy is a person, other than the practicing pharmacist, the other person, partnership, or corporation, corporate division, association, trust or other entity, shall sign the application form as provided in subsection 4.6. of this rule in addition to any other persons required to sign the application.4.8. If the applicant is at a place requiring the use of pharmacist consultant or coordinators of pharmaceutical services, the consultant or coordinator shall sign the application in addition to any other persons required to sign the application.4.9. Filing of application; joint filings.4.9.1. An applicant for registration shall submit the application to the office of the Board for filing.4.9.2. A person required to obtain more than one registration may submit all applications in one package. An application must be complete and should not refer to an accompanying application for required information.4.10. Acceptance for filing; defective applications.4.10.1. Upon receipt, the Board shall date the application. If found to be complete, the Board will accept the application for filing. The Board does not accept an application failing to comply with the requirements of this rule. If an application has minor defects as to completeness, the Board may accept the application for filing with a request to the applicant for additional information. The Board shall return a defective application to the applicant within ten days following its receipt with a statement of the reason for not accepting the application for filing. An applicant may correct a defective application and resubmit the application for filing at any time.4.11. Additional information. 4.11.1. The Board may require an applicant to submit documents or written statements of fact relevant to the application as it considers necessary to determine whether the application should be granted. The failure of the applicant to provide the documents or statements within a reasonable time after being requested to do so is considered a waiver by the applicant of an opportunity to present the documents or facts for consideration by the Board in granting or denying the application.4.12. Amendments to and withdrawal of applications. 4.12.1. An applicant may amend or withdraw an application without permission of the Board at any time before the date on which the applicant receives an order to show cause, or before the date on which a notice of hearing on the application is published pursuant to W. Va. Code § 60A-3-305, whichever is sooner. An applicant may amend or withdraw an application with permission of the Board at any time where good cause is shown by the applicant or where the amendment or withdrawal is in the public interest.4.12.2. After an application has been accepted by the Board for filing, the Board shall consider a request by the applicant that it be returned or failure of the applicant to respond to official correspondence regarding the application, when sent by registered or certified mail, as withdrawal of the application.4.13. Administrative review generally. 4.13.1. The Board may inspect, or cause to be inspected, the establishment of an applicant or registrant, pursuant to W. Va. Code § 60A-5-501. The Board shall review the application for registration and other information gathered by the Board regarding an applicant in order to determine whether the applicable standards of W. Va. Code § 60A-3-303 have been met by the applicant.4.14. Applications for research in Schedule I substances. 4.14.1. In the case of an application for registration to conduct research with controlled substances in Schedule I, the Board shall determine the qualifications and competency of the applicant as well as the merits of the research protocol. The Board, in determining the merits of a research protocol, shall confer as to effective procedures to safeguard adequately against diversion of the controlled substances from legitimate medical or scientific use. If the Board finds the applicant qualified and competent and the research protocol meritorious and adequately safeguarded, it shall register the applicant unless it finds registration should be denied for reasons set forth in W. Va. Code § 60A-3-303.4.14.2. If the Board is unable to find the applicant qualified or the Board finds that grounds exist for the denial of the application, it shall issue an order to show cause and, if requested by the applicant, shall hold a hearing on the application.4.15. The controlled substance registration shall contain the name, address and registration number of the registrant, the activity authorized by the registration, the schedules of the controlled substances which the registrant is authorized to handle, and the expiration date of the registration. The registrant shall prominently display the controlled substance registration at the registered location.4.16. Registration or any authority conferred may not be assigned or otherwise transferred except upon conditions specifically designated by the Board and then only pursuant to its written consent.