Regulation .13 Attire.
Regulation .13 Attire.LinkCopy Citation
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.