Okla. Admin. Code § 535:15-10-4

Current through Vol. 42, No. 4, November 1, 2024

Section 535:15-10-4 - Drug compounding facilities

(a) Pharmacies engaging in compounding shall have a specifically designated and adequate space for the orderly compounding of prescriptions, including the placement and storage of equipment and materials.

(b) The area used for the compounding of non-sterile compounded preparations shall be in an area separate and distinct from the area used for the compounding and aseptic processing of sterile preparations.

(c) The area(s) used for the compounding of drugs shall be maintained in a good state of repair. These area(s) shall also be maintained in a clean and sanitary condition. Adequate washing facilities are to be provided and sewage, trash and other refuse in the compounding area is to be disposed of in a safe, sanitary, and timely manner.

(d) Hazardous drugs shall be prepared within a certified Biological Safety Cabinet (Powder Containment hood). Hazardous drug compounding shall be prepared in compliance with applicable USP standards. When asepsis is not required, a Class I BSC, powder containment hood or an isolator intended for containment applications may be sufficient. Do not use a ventilated cabinet that re-circulates air inside the cabinet or exhausts air back into the room environment unless the hazardous drug(s) in use will not volatize while they are being handled or after they are captured by the HEPA filter.

(e) Bulk drugs and other chemicals or materials used in the compounding of drugs must be stored as directed by the manufacturer, or according to USP monograph requirements, in a clean, dry area, under appropriate temperature conditions (controlled room temperature, refrigerator, or freezer in adequately labeled containers). Bulk drugs shall also be stored such that they are protected from contamination.

(f) Adequate lighting and ventilation shall be provided in all compounding areas.

(g) Potable water shall be supplied under continuous positive pressure in a plumbing system free of defects that could contribute contamination to any compounded drug preparation.

(h) Purified water must be used for compounding non-sterile drug preparations when formulations indicate the inclusion of water.

Okla. Admin. Code § 535:15-10-4

Added at 17 Ok Reg 2633, eff 7-1-00; Amended at 26 Ok Reg 2276, eff 7-1-09

Amended by Oklahoma Register, Volume 32, Issue 23, August 17, 2015, eff. 8/27/2015.