§ 54.1-3435.1

Denial, revocation, and suspension of license as wholesale distributor, registration as a nonresident wholesale distributor, or permit as a third-party logistics provider, manufacturer, or nonresident manufacturer

A. The Board may deny, revoke, suspend, or take other disciplinary actions against a wholesale distributor license, nonresident wholesale distributor registration, third-party logistics provider permit, manufacturer permit, or nonresident manufacturer permit as provided for in § 54.1-3316 or the following:

1. Any conviction of the applicant, licensee, or registrant under federal or state laws relating to controlled substances, including, but not limited to, drug samples and wholesale or retail prescription drug distribution;

2. Violations of licensing requirements under previously held licenses;

3. Failure to maintain and make available to the Board or to federal regulatory officials those records required to be maintained by wholesale distributors of prescription drugs; or

4. Violations of the minimum requirements for qualifications, personnel, storage, and handling of prescription drugs and maintenance of prescription drug records as set forth in the federal Drug Supply Chain Security Act of 2013, Title II of P. L. 113-54, and the requirements of Chapter 21 of the Code of Federal Regulations.

B. Wholesale drug distributors, nonresident wholesale drug distributors, third-party logistics providers, manufacturers, and nonresident manufacturers shall allow the Board or its authorized agents to enter and inspect, at reasonable times and in a reasonable manner, their premises and delivery vehicles, and to audit their records and written operating procedures. Such agents shall be required to show appropriate identification prior to being permitted access to wholesale drug distributors’ premises and delivery vehicles.

History

1992, c. 737; 1994, c. 300; 2007, c. 662; 2016, c. 221.

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