Okla. Admin. Code § 535:15-10-14

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

Section 535:15-10-14 - Compounding of non-sterile hazardous drugs

Pharmacies engaging in compounding of hazardous drugs shall be responsible for meeting the following criteria:

(1) Non-sterile hazardous drugs shall include the NIOSH list of hazardous drugs as well as any individual products named per each individual pharmacy by referencing MSDS sheets or any other reference relating to above definition.

(2) Exposure control shall begin when hazardous drugs enter the facility. The PIC shall be responsible to confirm that medical products have labeling on the outer container that can be understood by all workers who will be separating hazardous from nonhazardous drugs.

(3) All individuals must wear PPE when opening containers to unpack hazardous drugs. Individuals must also wear chemotherapy gloves to prevent contamination when transporting the drug to the work area.

(4) Hazardous drugs must be stored separately from other drugs, as recommended by current ASHP guidelines on handling hazardous drugs. Hazardous drugs must be stored and transported in closed containers that minimize the risk of breakage.

(5) Pharmacies and pharmacist shall make sure the storage area has sufficient general exhaust ventilation to dilute and remove any airborne contaminants. Use a ventilated cabinet designed to reduce worker exposures while preparing hazardous drugs. 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.

(6) Staff should be fully trained and procedures established for their particular equipment and unique workplace setting.

(7) All staff shall wear PPE while working with hazardous drugs.

(8) Mix, prepare, and otherwise manipulate, count, crush, compound powders, or pour liquid hazardous drugs inside a ventilated cabinet designed to prevent hazardous drugs from being released into the work environment.

(9) Do not use supplemental engineering or process controls (such as needleless systems, glove bags and closed-system drug transfer devices) as a substitution for ventilated cabinets, even though such controls may reduce the potential for exposure when preparing and administering hazardous drugs.

(10) Use a high-efficiency particulate air filter (HEPA filter) for the exhaust from these controls.

(11) When drug preparation is complete, seal the final product in a plastic bag or other sealable container for transport before taking it out of the ventilated cabinet.

(12) Wash hands with soap and water immediately before donning and after removing gloves.

(13) Develop a written safety plan for all routine maintenance activities performed on equipment that could be contaminated with hazardous drugs.

(14) Manage hazardous drug spills according to policies and procedures for each workplace according to size of spill, possible spreading etc. Locate spill kits and other cleanup materials in the immediate area where exposures may occur.

(15) Consider a medical surveillance program or allow workers to have routine medical care.

Okla. Admin. Code § 535:15-10-14

Added at 26 Ok Reg 2276, eff 7-1-09

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