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

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

   1. (1) Quality assurance testing reports;
   2. (2) Documentation of reporting adverse events as required in Regulation .18 of this chapter;
   3. (3) Microbial testing of a sampling of the sterile compounded preparations of the pharmacy if applicable according to USP 797 Standards; and
   4. (4) Any other information requested to ensure compliance with USP 797 Standards.

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

   1. (1) A designee of the Board;
   2. (2) The U.S. Food and Drug Administration; or
   3. (3) Another appropriate state entity which indicates compliance with USP 797 Standards.
4. D. The Board or designee shall inspect nonresident pharmacies upon initial application and upon renewal.

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

   1. (1) Verify compliance with permit requirements; or
   2. (2) Investigate a complaint.

Authority: Health Occupations Article, §§12-205, 12-403, 12-503, 12-505, 12-6C-01, and 12-6C-03, Annotated Code of Maryland

Effective date: February 19, 1990 (17:3 Md. R. 299)

Regulation .04B amended effective July 20, 1992 (19:14 Md. R. 1284)

Regulation .05 amended effective July 20, 1992 (19:14 Md. R. 1284)

Regulations .01 — .06 repealed and new Regulations .01 — .16 adopted effective September 10, 2007 (34:18 Md. R. 1580)

Regulation .01 amended effective February 23, 2009 (36:4 Md. R. 354)

Regulation .02 amended effective February 23, 2009 (36:4 Md. R. 354)

Regulation .03B amended effective February 23, 2009 (36:4 Md. R. 354); February 1, 2016 (43:2 Md. R. 127)

Regulation .05A amended effective February 1, 2016 (43:2 Md. R. 127)

Regulation .06A amended effective February 1, 2016 (43:2 Md. R. 127)

Regulation .06A, D amended effective February 23, 2009 (36:4 Md. R. 354)

Regulation .07A amended effective February 1, 2016 (43:2 Md. R. 127)

Regulation .09 amended effective February 23, 2009 (36:4 Md. R. 354)

Regulation .09A amended effective February 1, 2016 (43:2 Md. R. 127)

Regulation .10 amended effective February 23, 2009 (36:4 Md. R. 354)

Regulation .11 amended effective February 23, 2009 (36:4 Md. R. 354)

Regulation .13 amended effective February 23, 2009 (36:4 Md. R. 354)

Regulation .14E amended effective February 23, 2009 (36:4 Md. R. 354)

Regulation .15C, E amended effective February 23, 2009 (36:4 Md. R. 354)

Regulation .16A amended effective February 23, 2009 (36:4 Md. R. 354)

Regulation .17 adopted effective February 1, 2016 (43:2 Md. R. 127)

Regulation .18 adopted effective February 1, 2016 (43:2 Md. R. 127)

Regulation .19 adopted effective February 1, 2016 (43:2 Md. R. 127)