Oklahoma Administrative Code
Title 535 - Oklahoma State Board of Pharmacy
Chapter 15 - Pharmacies
Subchapter 10 - Good Compounding Practices
Part 3 - GOOD COMPOUNDING PRACTICES FOR STERILE PREPARATIONS
Section 535:15-10-65 - Compounding of sterile hazardous drugs

(a) Although the potential therapeutic benefits of compounded sterile and non-sterile hazardous drug preparations outweigh the risks of their adverse effects in ill patients, exposed healthcare workers risk similar adverse effects with no therapeutic benefit. Occupational exposure to hazardous drugs can result in:

(b) Hazardous drugs shall be any drug identified by at least one of the following six criteria: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity in humans, organ toxicity at low doses in humans or animals, or genotoxicity. A new or investigational drug that has no information on toxicity should be treated as a hazardous drug. At a minimum, the hazardous drug communication list shall be drugs received in the facility that are recognized as such by the National Institute for Occupational Safety and Health (NIOSH).

(c) Hazardous drugs shall be prepared for administration only under conditions that protect the healthcare workers and other personnel in the preparation and storage areas. Hazardous drugs shall be stored separately from other inventory in a manner to prevent contamination and personnel exposure. Many hazardous drugs have sufficient vapor pressures that allow volatilization at room temperature; thus storage is preferably within a containment area such as a negative pressure room. The storage area should have sufficient general exhaust ventilation, at least 12 air changes per hour (ACPH) to dilute and remove any airborne contaminants.

(d) Hazardous drugs shall be handled with caution at all times using appropriate chemotherapy gloves during receiving, distribution, stocking, inventorying, preparation for administration, and disposal.

(e) Hazardous sterile drugs shall be prepared in an ISO Class 5 environment with protective engineering controls in place as specified in 535.15-10-55(g). Hazardous drug compounding shall have negative pressure to adjacent positive pressure ISO Class 7 or better ante-areas, thus providing inward airflow to contain any airborne drug. All vented cabinets shall be vented through HEPA filtration, preferably to outside air or through use of suitable technology or equipment. Ventilation exhaust shall be placed as not to reenter the facility at any point.

(f) If a CACI that meets the requirements of this chapter is used outside of an ISO class 7 buffer area, the compounding area shall maintain negative pressure and have a minimum of 12 ACPHs. Manufacturer's guidelines or NSF/ANSI Standard 49 standards shall be followed for isolators, containment hoods and BSC. Quality control certification for proper function shall be performed every six months by NSF/ANSI Standard 49 certified personnel.

(g) When closed-system vial-transfer devices (CSTDs) (i.e., vial-transfer systems that allow no venting or exposure of hazardous substance to the environment, Add-Vantage and PhaSeal) are used, they shall be used within the vented cabinet.

(h) In facilities that prepare a low volume, an average of no more than two per day, of hazardous drugs, the use of two tiers of containment (e.g., CSTD within a BSC or CACI that is located in a non-negative pressure room) is acceptable.

(i) Appropriate PPE shall be worn when compounding hazardous drugs. PPE should include gowns, face masks, eye protection, hair covers, shoe covers or dedicated shoes, gloving with chemotherapy gloves; and compliance with manufacturers' recommendations when using a CACI.

(j) All personnel who compound hazardous drugs shall be fully trained in the storage, handling, and disposal of these drugs. This training shall occur prior to preparing or handling hazardous drugs, and its effectiveness shall be verified by testing specific hazardous drugs preparation techniques. Such verification shall be documented for each person at least annually. This training shall include didactic overview of hazardous drugs, including mutagenic, teratogenic, and carcinogenic properties, and it shall include ongoing training for each new hazardous drug that enters the marketplace. Compounding personnel of reproductive capability shall confirm in writing that they understand the risks of handling hazardous drugs. The training shall include at least the following:

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

(l) Disposal of all hazardous drug wastes shall comply with all applicable federal and state regulations. All personnel who perform routine custodial waste removal and cleaning activities in storage and preparation areas for hazardous drugs shall be trained in appropriate procedures to protect themselves and prevent contamination.

(m) Pharmacies engaging in compounding of hazardous drugs shall be responsible to manage hazardous drug spills according to policies and procedures for each workplace.

(n) Pharmacies engaging in compounding of hazardous drugs shall locate spill kits and other cleanup materials in the immediate area where exposures may occur.