Transcription of 795 PHARMACEUTICAL COMPOUNDING—NONSTERILE …
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795 PHARMACEUTICAL COMPOUNDING—NONSTERILE …
Revision BulletinOfficial January 1, 2014 795 pharmaceutical compounding nonsterile Preparations1 Preparation of drugs or devices for the purposes of, or 795 PHARMACEUTICALas an incident to, research (clinical or academic),teaching, or chemical analysisCOMPOUNDING nonsterile Preparation of drugs and devices for prescriber s officeuse where permitted by federal and state lawPREPARATIONSHAZARDOUS DRUG Any drug identified by at least one ofthe following six criteria: Carcinogenicity Teratogenicity or developmental toxicity Reproductive toxicity in humansINTRODUCTION Organ toxicity at low doses in humans or animals GenotoxicityThe purpose of this chapter is to provide compounders New drugs that mimic existing hazardous drugs inwith guidance on applying good compounding practicesstructure or toxicity [for examples see current Nationalfor the preparation of nonsterile compounded formulationsInstitute for Occupational Safety and Health (NIOSH)for dispensing and/or admini]
tive ingredient in that preparation and furnishing pharma-specified limits and throughout its period of storage and cological activity or other direct effect in the diagnosis, use, the same properties and characteristics that it pos-cure, mitigation, treatment, or prevention of disease in sessed at the time of compounding (see Stability Considera-
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