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</o:shapelayout></xml><![endif]--></head><body lang=EN-US link="#0563C1" vlink="#954F72"><div class=WordSection1><p class=MsoNormal>I am responding to your question regarding how to legally dispose of pharmaceutical waste generated by patient care operations and the EXP Cactus Sink. <o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>EPA and many states are disallowing the practice of flushing waste pharmaceuticals down the toilet or sink.<o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>Disposal facilities acceptance processes and operating permits require a detailed characterization and inventory describing the wastes that will be shipped <o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>EPA requires Generators to ensure Hazardous Waste are identified and disposed of properly. Mixing of just 1 warfarin tablet with unused patient controlled drugs, even if it is rendered Unrecoverable and Unusable, makes the mixture a Hazardous Waste. If the mixture weighs more than 1 Kg., the Generator is now considered a fully regulated Large Quantity Generator of Hazardous Waste. <o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>Since 2014, DEA rules requires patient owned waste to be managed by a DEA Registrant/Collector or law enforcement in specially designed collection systems that meet security requirements for placement, installation, operation and shipment to DEA Registrant/Collector Pharmaceutical Reverse Distributors. Waste must be stored in DEA Schedule II vault until waste is witness destroyed by incineration. Pharmaceutical wastes that do not belong to the end user (i.e patient) are prohibited. <o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>Over the past several years, the healthcare industry has shown interest in a product called the Cactus Sink. Marketed as the ultimate answer to disposal of pharmaceutical waste generated by hospitals, the Cactus Sink manufacturer accurately describes its product as securely capturing dispensed unused pharmaceutical waste and renders it "unrecoverable and unusable" <through chemical fixation> This is an effective collection system but it has serious side effects with disposal abilities:<o:p></o:p></p><ol style='margin-top:0in' start=1 type=1><li class=MsoListParagraphCxSpFirst style='margin-left:0in;mso-add-space:auto;mso-list:l0 level1 lfo1'>There is no inventory maintained as to the contents and after mixing, cannot be verified. This makes the filled canisters very difficult, if not impossible, to dispose of.<o:p></o:p></li><li class=MsoListParagraphCxSpMiddle style='margin-left:0in;mso-add-space:auto;mso-list:l0 level1 lfo1'>How does the Hospital totally ensure that the device is used only for controlled drugs and never contains any hazardous waste? If the canister and contents weigh more than 1 Kg. before being used, adding just 1 warfarin tablet (or other “P” Listed product dose) makes the hospital a Large Quantity Generator of Hazardous Waste<o:p></o:p></li><li class=MsoListParagraphCxSpMiddle style='margin-left:0in;mso-add-space:auto;mso-list:l0 level1 lfo1'>In 2014 DEA finalized rules for the collection of patient medications from households and Long Term Care Facilities. The collection system has strict DEA security specifications and the collectors DEA Registration must be amended prior to staring the collection. The Cactus Sink is intended to collect waste pharmaceuticals in a hospital setting where the waste does not necessarily belong to the patient, violating this DEA rule. <o:p></o:p></li><li class=MsoListParagraphCxSpLast style='margin-left:0in;mso-add-space:auto;mso-list:l0 level1 lfo1'>The canister can be used for liquids. Many pharmaceutical products, particularly liquid preparations, meet the definition of a DOT Hazardous Material in Transportation (e.g. Excelon - 6.1 Toxic and flammables, corrosives and oxidizers are quite common pharmaceutical wastes). While these may be shipped as a Consumer commodity ORMD as a medicine, there is no provision to mark those canisters that contain Hazardous Materials as ORMD. Incompatibility of hazards is an issue potentially causing a dangerous shipment of mixed flammables and oxidizers, etc. to occur in transit. <o:p></o:p></li></ol><p class=MsoNormal>The Cactus Sink is a great waste collection system but needs considerable effort to make it a viable solution for disposal of the wastes it collects. <o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>If you are interested in a truly better way to destroy your unwanted pharmaceuticals from the hospital/pharmacy or patient wastes collection and destruction please contact us about our WasteLink products and services<o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal><span style='font-size:12.0pt;font-family:"Arial",sans-serif'>William G. Speenburgh,<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:12.0pt;font-family:"Arial",sans-serif'>President<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:12.0pt;font-family:"Arial",sans-serif'>World Class Environmental Resources, LLC<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:12.0pt;font-family:"Arial",sans-serif'>(973) 219-5720<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:12.0pt;font-family:"Arial",sans-serif'><o:p> </o:p></span></p><p class=MsoNormal><u><span style='font-size:12.0pt;font-family:"Comic Sans MS"'>WasteLink: Connecting the Missing Link in Reverse Distribution <o:p></o:p></span></u></p><p class=MsoNormal><span style='font-size:12.0pt;font-family:"Arial",sans-serif'><o:p> </o:p></span></p><p class=MsoNormal><i><span style='font-size:12.0pt;font-family:"Arial",sans-serif'>A Service Connected Disabled Veteran Owned Business<o:p></o:p></span></i></p><p class=MsoNormal><i><span style='font-size:12.0pt;font-family:"Arial",sans-serif'>DUNS: </span></i><span style='font-size:12.0pt;font-family:"Arial",sans-serif;color:black'>012781816 CAGE Code: 62GD7</span><span style='color:black'><o:p></o:p></span></p><p class=MsoNormal><i><span style='font-size:12.0pt;font-family:"Arial",sans-serif'><o:p> </o:p></span></i></p><p class=MsoNormal><span style='font-size:12.0pt;font-family:"Arial",sans-serif'><o:p> </o:p></span></p><p class=MsoNormal><o:p> </o:p></p></div></body></html>