Md. Code Regs. 10.34.19.17

Current through Register Vol. 51, No. 12, June 14, 2024

Section 10.34.19.17 - Minimum Requirements for Inspections

A. The Board shall inspect pharmacies located in Maryland at least annually.

B. The pharmacy shall provide as part of the inspection process:

(1) Quality assurance testing reports;

(2) Documentation of reporting adverse events as required in Regulation .18 of this chapter;

(3) Microbial testing of a sampling of the sterile compounded preparations of the pharmacy if applicable according to USP 797 Standards; and

(4) Any other information requested to ensure compliance with USP 797 Standards.

C. Within 90 days before the date of application, inspections of nonresident pharmacies may be conducted by:

(1) A designee of the Board;

(2) The U.S. Food and Drug Administration; or

(3) Another appropriate state entity which indicates compliance with USP 797 Standards.

D. The Board or designee shall inspect nonresident pharmacies upon initial application and upon renewal.

E. The Board may inspect a pharmacy at any time to:

(1) Verify compliance with permit requirements; or

(2) Investigate a complaint.

Md. Code Regs. 10.34.19.17

Regulation .17 amended effective 41:13 Md. R. 752, eff.1/1/2015; amended effective 43:2 Md. R. 127, eff.2/1/2016