W. Va. Code R. § 15-5-5

Current through Register Vol. XLI, No. 50, December 13, 2024

Section 15-5-5 - Minimum Qualifications

5.1. The Board shall consider, at a minimum the following factors in reviewing the qualifications of persons who engage in wholesale distribution of prescription drugs, act as a third-party logistics provider, or manufacturer prescription drugs within or into the state:

5.1.1. Any convictions of the applicant under any Federal, State, or local laws relating to drug samples, drug manufacturing, wholesale or retail drug distribution, or distribution of controlled substances;

5.1.2. Any felony convictions of the applicant under Federal, State, or local laws;

5.1.3. The applicant's past experience in the manufacture or distribution of prescription drugs, including controlled substances;

5.1.4. The furnishing by the applicant of false or fraudulent material in any application made in connection with drug manufacturing or distribution or acting as a third-party logistics provider;

5.1.5. Suspension or revocation by Federal, State, or local government of any license, permit, or other authorization currently or previously held by the applicant for the manufacture or distribution of, or acting as a third-party logistics provider related to, any drugs, including controlled substances;

5.1.6. Compliance with licensing requirements under previously granted licenses, if any;

5.1.7. Compliance with requirements to maintain and/or make available to the Board or to Federal, State, or local law enforcement officials those records required under this section;

5.18. An outsourcing facility must complete an initial inspection satisfactory to the board; and

5.1.9. Any other factors or qualifications the Board considers relevant to and consistent with the public health and safety.

5.2. The Board may deny a license to any applicant if it determines that the granting of a license would not be in the public interest. The Board shall base public interest considerations upon factors and qualifications that are directly related to the protection of the public health and safety.

W. Va. Code R. § 15-5-5