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V CVSHealth Ms . Florido March 8, 2019 Page 6 During your inspection you observed two containers in the pharmacy, one of which was labeled "No Hazardous Waste Pharmaceutical Reverse Processor Product (Genco) ONLY" and also had a label reading "Non-Viable Hazardous Pharmaceutical Waste " affixed to the container . Chris Yerzy, Environmental Specialist for northern California, spoke with Pharmacy Manager Myrna Coronel about this container . Ms . Coronel explained that this container is not a hazardous waste container, but rather a temporary storage container for potentially creditable items being handled through CVS ' s reverse distribution process (this process is discussed in more detail below) . The label reading "Non-Viable Hazardous Pharmaceutical Waste " was affixed to the container when it had previously been used to store hazardous waste pharmaceuticals . This container is no longer used for this purpose , and is now used to temporarily store potentially creditable product. Ms . Coronel has confirmed that the unnecessary label has been removed . Reverse Distribution of Pharmaceuticals Items 118 , 201 , 203 , 601 and 605 relate to sending non- dispensable potentially creditworthy pharmaceuticals to Genco , a FedEx company ( " Genco " ) . The inspection report states , "It could not be determined if the warfarin sodium tablets were expired when sent to Genco . " Below we provide general background on CVS ' s process . We also provide U . S . EPA support for CVS ' s approach to reverse distribution, including that U . S . EPA allows expired pharmaceuticals to be sent to a reverse distributor (unless more than one year past the expiration date) and that U . S . EPA does not require that a retailer have knowledge that a pharmaceutical will receive credit . Further, we detail our reverse distribution discussions with Santa Clara County, as we discussed at the CUPA conference . Last, we mention language regarding reverse distribution from CVS ' s 2012 Final Judgement. Background . CVS manages its non- dispensable pharmaceuticals via reverse distribution to Genco to manage non-leaking, potentially creditworthy pharmaceuticals that can no longer be dispensed ("non-dispensable pharmaceuticals") . Where pharmaceuticals are potentially creditworthy — meaning they are in a condition where the reverse distributor may determine , based on manufacturer instruction, that the pharmaceutical will receive credit ( i . e . in manufacturer packaging, expired or nearing expiration, or on recall) — the retailer is properly relying upon the reverse distribution process by sending such pharmaceuticals to the reverse distributor for the credit determination and further processing in accordance with manufacturer direction . The CVS decision-making system is designed to ensure consistent criteria are followed to determine when a pharmaceutical is potentially creditworthy . Genco , an out-of-state reverse distributor licensed for the receipt of dangerous drugs by the California State Board of Pharmacy as provided under Health and Safety Code section 117690 (b) ( 3 ) (A) , uses an extensive and ever- changing database to evaluate the pharmaceuticals received to process credit. Once Genco makes a �/S pharmacy / caremark / minute clinic / specialty