Md. Code Regs. 10.34.19.13

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

Section 10.34.19.13 - Attire

A. When compounding sterile preparations, individuals shall comply with the following standards:

(1) Sequencing of garbing that complies with USP 797 Standards;

(2) Thorough hand-washing before gowning;

(3) Wearing clean room garb inside the designated area at all times, which consists of:

(a) A non-shedding coverall or gown;

(b) Head and facial hair covers;

(c) A face mask; and

(d) Shoe covers;

(4) Clean room garb, with the exception of sterile gloves, shall be donned and removed outside the designated clean room area;

(5) All jewelry shall be removed;

(6) Sterile gloves are required; and

(7) Make-up may not be worn in the clean room.

B. The requirements of this regulation are not applicable if a compounding aseptic isolator is used to compound sterile preparations in accordance with USP 797 Standards and isolator vendor/manufacturer specifications.

Md. Code Regs. 10.34.19.13

Regulations .13 adopted effective September 10, 2007 (34:18 Md. R. 1580)
Regulation .13 amended effective February 23, 2009 (36:4 Md. R. 354)