Regulation .11 Minimum Requirements for Supplies.
Regulation .11 Minimum Requirements for Supplies.LinkCopy Citation
A pharmacy 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.