Md. Code Regs. 10.34.19.01

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

Section 10.34.19.01 - Scope

This chapter applies to a licensed pharmacy, sterile compounding facility, or other person dispensing or distributing sterile compounded preparations or sterile drug products into, out of, or within Maryland engaging in:

A. Compounding or mixing sterile prescription solutions or suspensions to be administered parenterally or by irrigation, inhalation, or intraocular routes; and

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.

Md. Code Regs. 10.34.19.01

Regulations.01 adopted effective September 10, 2007 (34:18 Md. R. 1580)
Regulation .01 amended effective February 23, 2009 (36:4 Md. R. 354)
Regulation .01 amended effective 41:13 Md. R. 752, eff. 1/1/2015