Sec. 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.