Md. Code Regs. 10.34.22.11

Current through Register Vol. 51, No. 24, December 2, 2024

Section 10.34.22.11 - Relocation

A. At least 30 days before relocation, a permit holder shall submit an application to the Board.

B. If relocation is due to a catastrophic event or State of Emergency, the relocation applicant shall:

(1) Notify the Board within 48 hours; and

(2) Submit an application to the Board within 30 days.

C. A relocation applicant:

(1) If the applicant holds products, shall comply with Regulation .07 of this chapter;

(2) Shall submit a surety bond or other equivalent means of security acceptable to the State specific to the permit holder's relocation, in accordance with Regulation .03 if this chapter; and

(3) Shall indicate on the application changes in product or personnel from the original application to the Board.

D. A new or different designated representative or immediate supervisor of a designated representative functioning at the relocated facility shall be required to undergo a criminal history records check as set forth in Regulation .03 of this chapter.

E. As part of the application process, a relocation applicant located in this State shall submit to and pass an opening inspection conducted by the Board, which shall include:

(1) Documentation of the permit holder's notification to suppliers of prescription drugs and devices of the permit holder's relocation; and

(2) Documentation from the permit holder evidencing the appropriate transfer, return, or disposal of any prescription drugs or devices not transferred to the facility's relocation.

F. A relocation applicant located in another state shall provide to the Board:

(1) Evidence of approval of the permit holder's relocation from the accreditation organization that accredited the permit holder's original location; or

(2) If the relocation applicant is not required to be accredited by an accreditation organization in accordance with Maryland law, inspection reports from the state in which the relocation applicant is located pertaining to the permit holder's relocation.

Md. Code Regs. 10.34.22.11

Regulations .11, adopted effective 41:10 Md. R. 561, eff.7/1/2014