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V CVSHealth Ms. Florido March 29, 2019 Page 2 As you may know, on November 4, 2011,U.S. EPA issued a memorandum titled Containers that Once Held P-Listed Pharmaceuticals, in which EPA clarified that"it is only the residue in the non-RCRA-empty container that is considered a P-listed hazardous waste;the container itself is not a hazardous waste. Accordingly, it is only the weight of residue in the container that needs to be counted toward generator status;the weight of the container does not need to be counted toward generator status." In accordance with this EPA memorandum, CVS counts only the weight of warfarin residue toward a facility's generator status. Federal Hazardous Waste Pharmaceuticals Rule. On February 22, 2019, EPA's final Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine ("Pharm Rule")was published in the Federal Register (84 Fed. Reg. 5816). The Pharm Rule codifies EPA's position regarding containers that once held acute and non-acute hazardous waste. With respect to dispensing bottles,vials, or ampules (not to exceed 1 liter or 1,000 pills) or unit-dose containers,the new 40 CFR 266.507 (effective at the federal level on August 21, 2019)indicates that these containers are"considered empty and the residues are not regulated as hazardous waste provided the pharmaceuticals have been removed from the stock bottle, dispensing bottle,vial, ampule, or the unit-dose container using the practices commonly employed to remove materials from that type of container." 40 CFR 266.507. Based on this provision, containers that previously held acute hazardous pharmaceuticals no longer require triple rinsing to be considered"RCRA empty." Also based on this provision, since containers are considered empty and the residues also do not have to be regulated as hazardous waste, neither the residue nor the container counts toward a facility's generator status at the federal level. We highlight several important considerations from the Pharm Rule preamble: 1. EPA reviewed data and confirmed that very little residue remains in containers after the pharmaceuticals have been removed. EPA then concluded that the containers (and the residue) do not require management as hazardous waste. Specifically, in the Pharm Rule,EPA references back to several studies that EPA discussed in the preamble to the proposed rule. Based on the studies, although some residues remain in containers, EPA concluded that the residues are minimal and that these containers are effectively empty once the pharmaceuticals have been dispensed. EPA ultimately determined that residue data for single-unit dose containers/packaging and dispensing bottles,vials and ampules that once held p-listed pharmaceuticals (warfarin) can be considered effectively"RCRA empty." Given the size of the containers and"nominal quantities of residues involved," EPA proposed(and ultimately finalized)to allow the residues in these containers to be managed as non-hazardous waste pharmaceuticals, so long as the pharmaceutical product has been fully dispensed. The specific studies—two from stakeholders; one from Riverside County, California; and one from EPA's Office of Research and Development —and EPA's conclusions regarding these studies are discussed at 80 Federal Register 58051 through 58054 of the proposed Pharmaceuticals Rule. These pages are attached. (; pharmacy / caremark / minute clinic / specialty