# COMAR Title 10 — Maryland Department of Health

## Subtitle 34 — Board of Pharmacy

### Chapter 19 — Sterile Pharmaceutical Compounding

#### Regulation .13 Attire.

*COMAR 10.34.19.13*

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.