Md. Code Regs. 10.34.19.11

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

Section 10.34.19.11 - Minimum Requirements for Supplies

A sterile compounding facility engaging in compounding sterile preparations shall maintain adequate stock levels of the following supplies according to USP 797 Standards, including but not limited to:

A. Personal protective equipment:

(1) Sterile gloves;

(2) Masks;

(3) Non-shedding gowns;

(4) Shoe covers;

(5) Hair covers;

(6) Beard covers; and

(7) Other personal protective equipment;

B. Disposable syringes and needles in necessary sizes;

C. Disinfectant cleaning agents as specified in USP 797 Standards, including 70 percent sterile isopropyl alcohol;

D. Disposable lint free towels;

E. Hand washing materials, including antimicrobial skin cleanser;

F. Adequate equipment and materials for antineoplastic or cytotoxic agent spills;

G. Supplies necessary for the aseptic preparation of compounded sterile preparations; and

H. Closed system vial transfer devices (CSTD), as required for cytotoxic compounding, if applicable.

Md. Code Regs. 10.34.19.11

Regulations .11 adopted effective September 10, 2007 (34:18 Md. R. 1580)
Regulation .11 amended effective February 23, 2009 (36:4 Md. R. 354)
Regulation .11 amended effective 41:13 Md. R. 752, eff.1/1/2015