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IVCVSHealth <br /> Ms . Florido <br /> March 8, 2019 <br /> Page 8 <br /> • EPA recognizes that in some cases a healthcare facility may not know if the <br /> hazardous waste pharmaceuticals will be given credit . We do not want to deter <br /> healthcare facilities from sending their hazardous waste pharmaceuticals to a <br /> reverse distributor if there is a reasonable expectation of credit . Whether or not <br /> credit is actually given is not a defining factor and it is not within EPA ' s expertise <br /> to know how many times a potentially creditable hazardous waste pharmaceutical <br /> needs to be rejected before it is considered "non- creditable . " Each pharmaceutical <br /> is different and is or is not creditable for various reasons as dictated by the <br /> manufacturer . 84 Fed . Reg . 5847 . <br /> • EPA ' s intent is to prevent hazardous waste pharmaceuticals that are clearly <br /> ineligible for credit and are ready for disposal , due to their condition, previous use <br /> with a patient, or other reason, from being sent to the reverse distributor . 84 Fed . <br /> Reg . 5847 . <br /> EPA also allows expired hazardous waste pharmaceuticals to be sent to a reverse <br /> distributor, so long as the pharmaceutical is not more than one year past the expiration date . <br /> Importantly, the Pharm Rule does not allow a healthcare facility to send any and all hazardous <br /> waste pharmaceuticals to a reverse distributor. The definition of "potentially creditable <br /> hazardous waste pharmaceutical" includes parameters around which pharmaceuticals qualify, <br /> including that the pharmaceutical must be ( 1 ) in original manufacturer ' s packaging (except <br /> pharmaceuticals that were subject to recall) ; (2) undispensed ; and (3 ) unexpired or less than one <br /> year past expiration date . EPA specifically excludes (and defines as "noncreditable hazardous <br /> waste pharmaceutical") , as examples , pharmaceuticals that have been removed from the original <br /> manufacturer container and repackaged for dispensing purposes, a pharmaceutical refused by a <br /> patient after an attempt to administer it, hazardous waste pharmaceuticals generated during <br /> patient care , and pharmaceuticals that are more than one year past their expiration date . <br /> Credit Focus ; Santa Clara County <br /> Additionally, during our discussion at the CUPA Conference , you mentioned CVS had <br /> worked with other CUPAs to address concerns regarding reverse distribution of potentially <br /> creditable pharmaceuticals . This is a correct statement, as CVS Health worked with Santa Clara <br /> County in 2017 regarding reverse distribution issues . During our discussions with Santa Clara <br /> County , the County focused on whether CVS Health evaluated items using criteria based on <br /> potential for credit, not on whether pharmaceuticals sent to Genco were expired . We provided <br /> the attached March 13 , 2017 letter and flow diagram to Santa Clara County to provide additional <br /> information on the evaluation process utilized in CVS pharmacies to determine if an item is <br /> potentially creditable . The criteria used to evaluate potential credit includes whether an item is <br /> on recall , whether an item is contained in manufacturer packaging, and whether an item is <br /> leaking or reconstituted . The criteria do not include whether an item is past its expiration date . <br /> After meeting with Santa Clara County on August 15 , 2017 to further discuss their concerns , the <br /> County ultimately concluded they were comfortable with the documentation CVS provided and <br /> M pharmacy / caremark / minute clinic / specialty <br />