Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 10 - Good Compounding Practices › Part 1 - GOOD COMPOUNDING PRACTICES FOR NON-STERILE PREPARATIONS › Section 535:15-10-14 - Compounding of non-sterile hazardous drugs

Current through Vol. 41, No. 20, July 1, 2024
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.
Added at 26 Ok Reg
					 2276, eff 7-1-09