This chapter applies to a licensed pharmacy in Maryland engaging in:

1. A. Compounding or mixing sterile prescription solutions or suspensions to be administered parenterally or by irrigation, inhalation, or intraocular routes; and
2. B. Compounding of radiopharmaceuticals, except where U.S. Pharmacopeia (USP) General Chapter 797 Pharmaceutical Compounding — Sterile Preparations addresses radiopharmaceuticals, U.S. Pharmacopeia (USP) Chapter 821 Radioactivity, and U.S. Pharmacopeia (USP) Chapter 823 Radiopharmaceuticals for Positron Emission Tomography — Compounding would apply.

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Regulations .01 — .06 repealed and new Regulations .01 — .16 adopted effective September 10, 2007 (34:18 Md.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