ASHP Guidelines on Handling Hazardous Drugs
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Chemicaldegradation of wastes of antineoplastic agents: cyclo-phosphamide, ifosfamide, and melphalan. Int Arch Occup Environ Health.1997; 69:109–14.104. Polovich M, Belcher C, Glynn-Tucker EM et al. Safehandling of hazardous drugs. Pittsburgh: Oncology Nursing Society; 2003.105. 40 C.F.R. 261.33.106. Resource Conservation and Recovery Act of 1976. 42 U.S.C. 82 §6901-92.107. 40 C.F.R. 261.20-24C.108. 40 C.F.R. 261.3.38D. 109. 40 C.F.R. 261.7.110. Vaccari PL, Tonat K, DeChristoforo R et al. Disposalof antineoplastic wastes at the National Institutes of Health. Am J Hosp Pharm. 1984; 41:87–93.111. 40 C.F.R. 261.7(b)(1)-(3).112. 49 C.F.R. 172.0-.123,173,178,179. 113. 29 C.F.R. 1910.120(e)(3)(i).114. 29 C.F.R. 1910.120(q)(1-6).115. 40 C.F.R. 260-8,270. 48 Drug Distribution and Control: Preparation and Handling–Guidelines Appendix A—Recommendationsfor Use of Class II BSCs 1. The use of a Class II BSC must be accompanied by astringent program of work practices, including train-ing, demonstrated competence, contamination reduc-tion, and decontamination.2. Only a Class II BSC with outside exhaust should beused for compounding hazardous drugs; type B2 totalexhaust is preferred. Total exhaust is required if thehazardous drug is known to be volatile.3. Without special design considerations, Class II BSCsare not recommended in traditional, positive-pressurecleanrooms, where contamination from hazardous drugs may result in airborne contamination that may spread from the open front to surrounding areas.4. Consider using closed-system drug-transfer deviceswhile compounding hazardous drugs in a Class II BSC;evidence documents a decrease in drug contaminantsinside a Class II BSC when such devices are used.5. Reduce the hazardous drug contamination burden inthe Class II BSC by wiping down hazardous drug vials before placing them in the BSC. Appendix B—Recommendations forUse of Class III BSCs and Isolators 1. Only a ventilated cabinet designed to protect workersand adjacent personnel from exposure and to providean aseptic environment may be used to compound ster-ile hazardous drugs.2. Only ventilated cabinets that are designed to containaerosolized drug product within the cabinet should be used to compound hazardous drugs.3. The use of a Class III BSC or isolator must be accom-panied by a stringent program of work practices, in-cluding operator training and demonstrated compe-tence, contamination reduction, and decontamination.4. Decontamination of the Class III BSC or isolator mustbe done in a way that contains any hazardous drug sur-face contamination during the cleaning process.5. Appropriate decontamination within the cabinet mustbe completed before the cabinet is accessed via pass-throughs or removable front panels.6. Gloves or gauntlets must not be replaced before com-pletion of appropriate decontamination within the cabinet.7. Surface decontamination of final preparations mustbe done before labeling and placing into the passthrough.8. Final preparations must be placed into a transport bagwhile in the pass-through for removal from the cabi-
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Drug Distribution and Control: Preparation and Handling–Guidelines 71 ASHP Guidelines on Handling Hazardous Drugs
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