Md. Code Regs. 10.34.14.02

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

Section 10.34.14.02 - Opening a Pharmacy

A. To apply for a pharmacy permit, an applicant shall:

(1) Submit an application to the Board on the form that the Board requires;

(2) Pay to the Board an application fee set by the Board in COMAR 10.34.09; and

(3) Submit to an opening inspection, at which time the applicant shall have, at a minimum, the following:

(a) If applicable, a Class A prescription balance and weights, or a prescription balance with equivalent or superior sensitivity;

(b) A refrigerator, solely for the storage of medications requiring refrigeration, with a thermometer or a temperature monitoring device;

(c) Additional equipment to enable the pharmacy to prepare and dispense prescriptions properly consistent with the pharmacy's scope of practice;

(d) Hot and cold running water;

(e) A library of current reference sources, consistent with the pharmacy's scope of practice, that is accessible to appropriate personnel;

(f) A current edition of Maryland Pharmacy Laws;

(g) A security system in accordance with COMAR 10.34.05.02B ; and

(h) A pharmacist on the premises during the opening inspection, if prescription drugs are present.

B. A pharmacy may not be located in a residence.

C. A permit holder who has been issued a pharmacy permit by the Board shall, within 60 days following the initial issuance of the pharmacy permit, have and maintain an operational pharmacy.

D. The Board shall inspect a pharmacy after the initial issuance of a pharmacy permit to ensure that the pharmacy is an operational pharmacy.

E. If a pharmacy is not an operational pharmacy within 60 days following the initial issuance of a pharmacy permit, the Board shall notify the permit holder of the Board's intent to rescind the pharmacy permit.

F. A permit holder who has been notified of the Board's intent to rescind the pharmacy permit under this regulation shall return the permit to the Board within 10 days of notification, unless the permit holder submits documentation satisfactory to the Board to show that the pharmacy is an operational pharmacy.

G. If a pharmacy permit has been rescinded under this regulation, the permit holder may reapply if application requirements are met.

H. The Board may waive any of the requirements set forth in this regulation.

Md. Code Regs. 10.34.14.02

Regulations .02E amended effective February 19, 1990 (17:3 Md. R. 299)
Regulations .02 adopted effective April 16, 2001 (28:7 Md. R. 690)