Md. Code Regs. 10.34.22.04

Current through Register Vol. 51, No. 25, December 13, 2024

Section 10.34.22.04 - Personnel

A. The permit holder shall affirm in the initial application and subsequent renewal applications that personnel employed in wholesale distribution have appropriate education and experience to assume responsibilities related to compliance with State licensing requirements.

B. Registered Agent.

(1) Each licensed wholesale distributor located outside of this State that wholesale distributes prescription drugs or devices in this State shall designate a registered agent in this State for service of process.

(2) If any wholesale distributor is not licensed in this State, service on the Director of the State Department of Assessments and Taxation only shall be sufficient service.

C. Requirements and Responsibilities of the Designated Representative.

(1) The designated representative shall be aware of, and knowledgeable about, all policies and procedures pertaining to the operations of the wholesale distributor, including applicable State and federal laws.

(2) The designated representative shall have documented training sufficient to ensure that operations of the wholesale distributor are in compliance with applicable State and federal laws and are provided by qualified in-house specialists, outside counsel, or consulting specialists with capabilities to help ensure compliance with all applicable State and federal laws and regulations.

(3) The designated representative shall maintain current working knowledge of the requirements for wholesale distributor and assure ongoing training for personnel to ensure compliance.

(4) The designated representative shall be responsible for all record keeping requirements and make all records available for inspection.

Md. Code Regs. 10.34.22.04

Regulation .04 amended effective November 7, 1994 (21:22 Md. R. 1877)
Regulations .04 adopted effective March 28, 2005 (32:6 Md. R. 636)
Regulations .04 adopted effective April 7, 2008 (35:7 Md. R. 748)