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</o:shapelayout></xml><![endif]--></head><body lang=EN-US link=blue vlink=purple><div class=WordSection1><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Good afternoon Ed,<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Thank you for the clarification. I do have one point to make, you refer to metabolites in the excretion.<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>I am talking about the raw drug in its original form and with its original strength and its original dangers and its continuing liability to those involved including the Chief Pharmacist (WHO) and the Management team (USP 800). This liability and danger continues with the drug before, during and after administration including into the home and family members.<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>USP does issue guidance on how to handle the waste from Hazardous drugs, it does not exclude the hazardous drug after it has passed through the patient and specifically defines the post patient waste as a danger. Section 3 table 1<o:p></o:p></span></p><p class=Default><span style='font-size:7.5pt'>Patient-care activities • Handling body fluids (e.g., urine, feces, sweat, or vomit) or body-fluid-contaminated clothing, dressings, linens, and other materials <o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>The metabolites are another issue and sometimes more dangerous. The example I like to use Cyclophosphamide a U listed EPA hazardous waste (U058), the first metabolite is Acrolein a P listed EPA hazardous waste (P003) and Phosphamide mustard (gas). <o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>The battle of wording is for the lawyers, the dangers are the same to the Pharmacist as they are to the Nurse and the families, septic systems and water systems.<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>I would remind everyone that we are talking about non-dose dependent chemicals where there is no safe level of exposure, I have attached the OSHA, Niosh, Joint Commission letter.<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Section 7.6 of USP 800 <o:p></o:p></span></p><p class=Default><span style='font-size:9.0pt'>Chemotherapy gloves and sleeve covers (if used) worn during compounding must be carefully removed and discarded immediately into a waste container ap-proved for trace contaminated waste inside the C-PEC or contained in a sealable bag for discarding outside the C-PEC. <o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>That being said, Ed <o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>We need a meeting, thinking Mystic CT.<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Jim Mullowney, President<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Pharma-Cycle, LLC.<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Associate Member American Society of Clinical Oncology<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Member of the American Chemical Society<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'><a href="mailto:jmullowney@pharma-cycle.com"><span style='color:blue'>jmullowney@pharma-cycle.com</span></a><o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>(617) 755-0883<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'><o:p> </o:p></span></p><p class=MsoNormal><b><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif"'>From:</span></b><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif"'> Pharmwaste [mailto:pharmwaste-bounces@lists.dep.state.fl.us] <b>On Behalf Of </b>Edward Krisiunas<br><b>Sent:</b> Thursday, April 19, 2018 9:14 AM<br><b>To:</b> pharmwaste<br><b>Subject:</b> Re: [Pharmwaste] Pharmwaste Digest, Vol 147, Issue 7<o:p></o:p></span></p><p class=MsoNormal><o:p> </o:p></p><div><p class=MsoNormal>Good the day:<o:p></o:p></p><div><p class=MsoNormal><o:p> </o:p></p></div><div><p class=MsoNormal>Jim is addressing an issue - management of the excretions from patients which is a risk to staff and family members. The 1985 OSHA guidance does not address waste disposal of these items as much as protecting oneself from exposure as well as being aware that metabolites may be present. Musgrave et al published data in 1992 regarding the presence of metabolites in excretions - nothing new here but how should this waste be managed is the issue...<o:p></o:p></p></div><div><p class=MsoNormal><o:p> </o:p></p></div><div><p class=MsoNormal><800> does not specifically address this issue to Jim's point and his letter to USP - there is no definition for HD waste or trace in the glossary - it refers you to state and federal regulations. <o:p></o:p></p></div><div><p class=MsoNormal><o:p> </o:p></p></div><div><p class=MsoNormal>In the attached commentary/replies to questions in 2016, USP is asked to define trace and declines as they state it is beyond the purview if the committee ( search for the term "trace")..it comes up several times.<o:p></o:p></p></div><div><p class=MsoNormal><o:p> </o:p></p></div><div><p class=MsoNormal>Regards,<o:p></o:p></p></div><div><p class=MsoNormal><o:p> </o:p></p></div><div><p class=MsoNormal>Ed Krisiunas<o:p></o:p></p></div><div><p class=MsoNormal><o:p> </o:p></p><div><p class=MsoNormal>On Thu, Apr 19, 2018 at 8:54 AM, <<a href="mailto:pharmwaste-request@lists.dep.state.fl.us" target="_blank">pharmwaste-request@lists.dep.state.fl.us</a>> wrote:<o:p></o:p></p><p class=MsoNormal>Send Pharmwaste mailing list submissions to<br> <a href="mailto:pharmwaste@lists.dep.state.fl.us" target="_blank">pharmwaste@lists.dep.state.fl.us</a><br><br>To subscribe or unsubscribe via the World Wide Web, visit<br> <a href="http://lists.dep.state.fl.us/mailman/listinfo/pharmwaste" target="_blank">http://lists.dep.state.fl.us/mailman/listinfo/pharmwaste</a><br>or, via email, send a message with subject or body 'help' to<br> <a href="mailto:pharmwaste-request@lists.dep.state.fl.us" target="_blank">pharmwaste-request@lists.dep.state.fl.us</a><br><br>You can reach the person managing the list at<br> <a href="mailto:pharmwaste-owner@lists.dep.state.fl.us" target="_blank">pharmwaste-owner@lists.dep.state.fl.us</a><br><br>When replying, please edit your Subject line so it is more specific<br>than "Re: Contents of Pharmwaste digest..."<br><br>Today's Topics:<br><br> 1. Re: Chemo drugs (Jim Mullowney)<br> 2. FREE PSI webinar: "Global Best Practices for Drug Take-Back<br> Programs"? 6/7/2018 (Vivian Futran Fuhrman)<br><br><br>---------- Forwarded message ----------<br>From: Jim Mullowney <<a href="mailto:jmullowney@pharma-cycle.com" target="_blank">jmullowney@pharma-cycle.com</a>><br>To: "'Smith, Charlotte'" <<a href="mailto:csmith32@wm.com" target="_blank">csmith32@wm.com</a>>, "'Ed Gottlieb'" <<a href="mailto:EGottlieb@cityofithaca.org" target="_blank">EGottlieb@cityofithaca.org</a>>, <<a href="mailto:pharmwaste@lists.dep.state.fl.us" target="_blank">pharmwaste@lists.dep.state.fl.us</a>><br>Cc: <br>Bcc: <br>Date: Wed, 18 Apr 2018 16:26:54 -0400<br>Subject: Re: [Pharmwaste] Chemo drugs<o:p></o:p></p><div><div><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Sorry about that again, I looked up my email and I should have said Hazardous Drug, Section 3 Table 1 of USP 800 </span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'> </span><o:p></o:p></p><p class=m1524691813403853507m-4493243876213236349default><span style='font-size:7.5pt'>Patient-care activities ∙ Handling body fluids (e.g., urine, feces, sweat, or vomit) or body-fluid-contaminated clothing, dressings, linens, and other materials </span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'> </span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'> </span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'> </span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Jim Mullowney, President</span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Pharma-Cycle, LLC.</span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Associate Member American Society of Clinical Oncology</span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Member of the American Chemical Society</span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'><a href="mailto:jmullowney@pharma-cycle.com" target="_blank">jmullowney@pharma-cycle.com</a></span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>(617) 755-0883</span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'> </span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'> </span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'> </span><o:p></o:p></p><div><div style='border:none;border-top:solid #B5C4DF 1.0pt;padding:3.0pt 0in 0in 0in'><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><b><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif"'>From:</span></b><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif"'> Smith, Charlotte [mailto:<a href="mailto:csmith32@wm.com" target="_blank">csmith32@wm.com</a>] <br><b>Sent:</b> Wednesday, April 18, 2018 3:31 PM<br><b>To:</b> Jim Mullowney; 'Ed Gottlieb'; <a href="mailto:pharmwaste@lists.dep.state.fl.us" target="_blank">pharmwaste@lists.dep.state.fl.us</a><br><b>Subject:</b> RE: RE: Chemo drugs</span><o:p></o:p></p></div></div><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'> <o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif"'>Thank you, Jim, for your clarification. It’s important that we keep the definitions clear and concise so healthcare facilities can operationalize in compliance and still be cost-effective. </span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif"'> </span><o:p></o:p></p><div><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif"'>Best regards,</span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif"'> </span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto;text-autospace:none'><b><span style='font-size:11.0pt;font-family:"Trebuchet MS","sans-serif";color:#00693C'>Charlotte A. Smith, RPh, MS </span></b><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Trebuchet MS","sans-serif";color:black'>Senior Regulatory Advisor</span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Trebuchet MS","sans-serif"'>PharmEcology Services, WM Sustainability Services </span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Trebuchet MS","sans-serif"'><a href="mailto:csmith32@wm.com" target="_blank">csmith32@wm.com</a></span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><b><span style='font-family:"Trebuchet MS","sans-serif";color:black'> </span></b><span style='font-family:"Trebuchet MS","sans-serif";color:black'> </span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto;text-autospace:none'><b><span style='font-size:11.0pt;font-family:"Trebuchet MS","sans-serif";color:#00693C'>Waste Management </span></b><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Trebuchet MS","sans-serif";color:black'>P.O. Box 1654</span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Trebuchet MS","sans-serif";color:black'>Brookfield, WI 53008-1654</span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Trebuchet MS","sans-serif";color:black'>Cell 713-725-6363 </span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Trebuchet MS","sans-serif";color:black'> </span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-family:"Trebuchet MS","sans-serif";color:black'>Waste Management’s Sustainability Services </span><span style='font-family:"Trebuchet MS","sans-serif"'>teams <span style='color:black'>work with you to devise a strategy that will help achieve your environmental goals while benefitting your financial objectives. Find out more at </span></span><span style='font-size:11.0pt;font-family:"Calibri","sans-serif"'><a href="http://www.wmsustainabilityservices.com/" target="_blank"><span style='font-size:12.0pt;color:#0563C1'>www.wmsustainabilityservices.com</span></a></span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Trebuchet MS","sans-serif";color:#339933'> </span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><b><span style='font-family:"Trebuchet MS","sans-serif";color:black'> </span></b><span style='font-family:"Trebuchet MS","sans-serif";color:black'> </span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><b><span style='font-size:10.0pt;font-family:"Trebuchet MS","sans-serif";color:#525252'> </span></b><o:p></o:p></p></div><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif"'> </span><o:p></o:p></p><div><div style='border:none;border-top:solid #E1E1E1 1.0pt;padding:3.0pt 0in 0in 0in'><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><b><span style='font-size:11.0pt;font-family:"Calibri","sans-serif"'>From:</span></b><span style='font-size:11.0pt;font-family:"Calibri","sans-serif"'> Jim Mullowney [mailto:<a href="mailto:jmullowney@pharma-cycle.com" target="_blank">jmullowney@pharma-cycle.com</a>] <br><b>Sent:</b> Wednesday, April 18, 2018 1:33 PM<br><b>To:</b> Smith, Charlotte <<a href="mailto:csmith32@wm.com" target="_blank">csmith32@wm.com</a>>; 'Ed Gottlieb' <<a href="mailto:EGottlieb@cityofithaca.org" target="_blank">EGottlieb@cityofithaca.org</a>>; <a href="mailto:pharmwaste@lists.dep.state.fl.us" target="_blank">pharmwaste@lists.dep.state.fl.us</a><br><b>Subject:</b> [EXTERNAL] RE: Chemo drugs</span><o:p></o:p></p></div></div><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'> <o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Hello Charlotte, </span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Good to hear from you and I agree with you completely, trace chemotherapy waste is not a Hazardous waste and is treated as "Trace Chemotherapy waste", not general trash but not a hazardous waste. Not sure where the misunderstanding came from but it most likely was my fault. </span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>I am attaching a letter I wrote to the USP committee last week that may have been a source of the confusion. Very few Hazardous Drugs are Hazardous Wastes and unassimilated Hazardous Drugs contained in urine, sweat, vomit and feces are NOT hazardous wastes and USP 800 has little to do with the EPA, except for the handful or so that are regulated. The dangers still exist and don't go away because the EPA does not regulate them and those working with the Hazardous Drugs and the patient waste should be aware of the dangers. OSHA and FDA still apply.</span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'> </span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Hope this helps.</span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'> </span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Jim Mullowney, President</span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Pharma-Cycle, LLC.</span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Associate Member American Society of Clinical Oncology</span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Member of the American Chemical Society</span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'><a href="mailto:jmullowney@pharma-cycle.com" target="_blank">jmullowney@pharma-cycle.com</a></span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>(617) 755-0883</span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'> </span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'> </span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'> </span><o:p></o:p></p><div><div style='border:none;border-top:solid #B5C4DF 1.0pt;padding:3.0pt 0in 0in 0in'><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><b><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif"'>From:</span></b><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif"'> Smith, Charlotte [<a href="mailto:csmith32@wm.com" target="_blank">mailto:csmith32@wm.com</a>] <br><b>Sent:</b> Wednesday, April 18, 2018 2:10 PM<br><b>To:</b> Ed Gottlieb; <a href="mailto:pharmwaste@lists.dep.state.fl.us" target="_blank">pharmwaste@lists.dep.state.fl.us</a><br><b>Cc:</b> Mullowney, Jim<br><b>Subject:</b> RE: Chemo drugs</span><o:p></o:p></p></div></div><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'> <o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif"'>With all due respect, I have carefully re-read the final USP General Chapter <800> Handling Hazardous Drugs and I do not find any reference to the requirement to dispose of trace chemotherapy as a hazardous waste. The chapter repeatedly refers to the complying with EPA regulations, which do not currently address trace chemotherapy waste. There is one reference to disposal in a container appropriate for trace contaminated HD waste and also a reference to “HD containers” but that is a hazardous drug container, not necessarily a hazardous waste container. It is also my understanding that the current version available from USP is the final version with no additional drafts being contemplated. There is often confusion between a hazardous drug and a hazardous waste, but the definitions are very different. </span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif"'> </span><o:p></o:p></p><div><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif"'>Best regards,</span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif"'> </span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto;text-autospace:none'><b><span style='font-size:11.0pt;font-family:"Trebuchet MS","sans-serif";color:#00693C'>Charlotte A. Smith, RPh, MS </span></b><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Trebuchet MS","sans-serif";color:black'>Senior Regulatory Advisor</span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Trebuchet MS","sans-serif"'>PharmEcology Services, WM Sustainability Services </span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Trebuchet MS","sans-serif"'><a href="mailto:csmith32@wm.com" target="_blank">csmith32@wm.com</a></span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><b><span style='font-family:"Trebuchet MS","sans-serif";color:black'> </span></b><span style='font-family:"Trebuchet MS","sans-serif";color:black'> </span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto;text-autospace:none'><b><span style='font-size:11.0pt;font-family:"Trebuchet MS","sans-serif";color:#00693C'>Waste Management </span></b><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Trebuchet MS","sans-serif";color:black'>P.O. Box 1654</span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Trebuchet MS","sans-serif";color:black'>Brookfield, WI 53008-1654</span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Trebuchet MS","sans-serif";color:black'>Cell 713-725-6363 </span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Trebuchet MS","sans-serif";color:black'> </span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-family:"Trebuchet MS","sans-serif";color:black'>Waste Management’s Sustainability Services </span><span style='font-family:"Trebuchet MS","sans-serif"'>teams <span style='color:black'>work with you to devise a strategy that will help achieve your environmental goals while benefitting your financial objectives. Find out more at </span></span><span style='font-size:11.0pt;font-family:"Calibri","sans-serif"'><a href="http://www.wmsustainabilityservices.com/" target="_blank"><span style='font-size:12.0pt;color:#0563C1'>www.wmsustainabilityservices.com</span></a></span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Trebuchet MS","sans-serif";color:#339933'> </span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><b><span style='font-family:"Trebuchet MS","sans-serif";color:black'> </span></b><span style='font-family:"Trebuchet MS","sans-serif";color:black'> </span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><b><span style='font-size:10.0pt;font-family:"Trebuchet MS","sans-serif";color:#525252'> </span></b><o:p></o:p></p></div><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Calibri","sans-serif"'> </span><o:p></o:p></p><div><div style='border:none;border-top:solid #E1E1E1 1.0pt;padding:3.0pt 0in 0in 0in'><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><b><span style='font-size:11.0pt;font-family:"Calibri","sans-serif"'>From:</span></b><span style='font-size:11.0pt;font-family:"Calibri","sans-serif"'> Pharmwaste [<a href="mailto:pharmwaste-bounces@lists.dep.state.fl.us" target="_blank">mailto:pharmwaste-bounces@lists.dep.state.fl.us</a>] <b>On Behalf Of </b>Ed Gottlieb<br><b>Sent:</b> Monday, April 9, 2018 1:43 PM<br><b>To:</b> <a href="mailto:pharmwaste@lists.dep.state.fl.us" target="_blank">pharmwaste@lists.dep.state.fl.us</a><br><b>Cc:</b> Mullowney, Jim <<a href="mailto:jmullowney@pharma-cycle.com" target="_blank">jmullowney@pharma-cycle.com</a>><br><b>Subject:</b> [EXTERNAL] [Pharmwaste] Chemo drugs</span><o:p></o:p></p></div></div><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'> <o:p></o:p></p><div><div><p><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif";color:black'>New info from Jim Mullowney below. Contact him for more information: <span class=m1524691813403853507m-4493243876213236349rwrr> <a href="mailto:jmullowney@pharma-cycle.com" target="_blank">jmullowney@pharma-cycle.com</a></span></span><o:p></o:p></p><p><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif";color:black'> </span><o:p></o:p></p><p><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif";color:black'>Unofficial draft of the updated USP [set standards, publish International Pharmacopoeia] "General Chapter <800> on Hazardous Drugs, handling in healthcare settings" states that materials with trace amounts of Hazardous Drugs must be discarded as a Hazardous Waste. This includes items contaminated in the medical care facility and patient-care environment, which can include the home. </span><o:p></o:p></p><p><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif";color:black'> </span><o:p></o:p></p><p><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif";color:black'>Problem Chemotherapy Drugs That Are Excreted at High Concentrations & Can Damage Others at Ultra-low Doses1</span><o:p></o:p></p><p><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif";color:black'>Generic Name Other Names Excretion Administered Dose</span><o:p></o:p></p><p><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif";color:black'> % Danger Period Dose/Weight Amount</span><o:p></o:p></p><p><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif";color:black'>Actinomycin D Dactinomycin, Cosmenogen 30% 7 Days ≤ 50 ug/Kg ≤ 4 mg<br>Bleomycin Blenoxane 60-70% 1 Day ≤ 50 units (mg)/Kg ≤ 4000 mg<br>Carboplatin Paraplatin 65-75% 1 Day ≤ 12 mg/Kg ≤ 960 mg<br>Cisplatin Platin 13-17% 1 Day ≤ 3.3 mg/Kg ≤ 264 mg<br>Cyclophosphamide Endoxan, Cytoxan, Neosar, Procytox, Revimmune </span><o:p></o:p></p><p><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif";color:black'> 5-25% 1 Day ≤ 50 mg/Kg ≤ 4000 mg<br>Dacarbazine DTIC, DTIC-Dome 40% 1 Day ≤ 4.5 mg/Kg ≤ 360 mg<br>Daunorubicin HCl Cerubidine 65% 3 Days ≤ 1.5 mg/Kg ≤120 mg<br>Doxorubicin Adriamycin, Rubex, Doxil, Caelyx, Myocet </span><o:p></o:p></p><p><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif";color:black'> 45-55% 5 Days ≤ 2.5 mg/Kg ≤ 200 mg<br>Epirubicin Ellence, Pharmorubicin 55% 4 Days ≤ 40 mg/Kg ≤ 3200 mg<br>Etoposide Eposin, Etopophos, Vepesid, VP-16 45% 5 Days ≤ 3.3 mg/Kg ≤ 264 mg<br>Floxuridine Fdur 20% 1 Day ≤ 0.6 mg/Kg ≤ 48 mg<br>Fludarabine Fludara 40-60% 1 Day ≤ 0.83 mg/Kg ≤ 66.4 mg<br>Fluorouracil 5-FU, Adrucil, Carac, Efudix, Efudex, Fluoroplex</span><o:p></o:p></p><p><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif";color:black'> 7-20% 1 Day ≤ 12 mg/Kg ≤ 960 mg<br>Idarubicin Zavedos, Idamycin 20% 8 Days ≤ 0.4 mg/Kg ≤ 32 mg<br>Ifosfamide Mitoxana, Ifex 12-18% 1 Day ≤ 40 mg/Kg ≤ 3200 mg<br>Irinotecan Camptosar, Campto 25-50% 2 Days ≤ 11.7 mg/Kg ≤ 936 mg<br>Mitomycin Mitosol 10% 1 Day ≤ 0.67 mg/Kg ≤ 53.6 mg<br>Mitoxantrone 24% 5 Days ≤ 0.47 mg/Kg ≤ 37.6 mg<br>Oxaliplatin Eloxatin 35% 1 Day ≤ 2.8 mg/Kg ≤ 224 mg<br>Methotrexate Trexall, MTX, Amethopterin 80-90% 1 Day ≤ 15 mg/Kg ≤ 1200 mg<br>Temozolomide Temodar 18% 7 Days ≤ 50 mg/Kg ≤ 4000 mg<br>Topotecan Hycamtin 70 -75% 9 Days ≤ 0.05 mg/Kg ≤ 4 mg<br>Restricted use<br>Arsenic trioxide Trisenox 15% 1 Day ≤ 15 mg/Kg ≤ 1200 mg<br>Clofarabine 49-60% 1 Day ≤ 1.7 mg/Kg ≤ 138 mg<br>Melphalan Alkeran 10-15% 1 Day 6 mg 6 mg<br>Teniposide Vumon 4-12% 5 Days ≤ 8.3 mg/Kg ≤ 666 mg<br>Valrubicin Valstar 99% 1 Day 800 mg 800 mg<br>1. Information summarized from the Drug Package Inserts - information required by the FDA from pharmaceutical companies before each drug is approved for use in humans.</span><o:p></o:p></p><p><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif";color:black'>2. Estimated percent of drug dose that exits patient's body as parental drug or active metabolite as well as excretion period.</span><o:p></o:p></p><p><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif";color:black'>3. Doses will vary depending on disease and doctors' recommendations. See individual Drug Inserts for more details.<br>4. Where needed, converted from mg/m2 to mg/Kg</span><o:p></o:p></p><p><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif";color:black'> </span><o:p></o:p></p><div><div><div><div><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif";color:black'>Ed Gottlieb <br>Industrial Pretreatment Coordinator<br>Ithaca Area Wastewater Treatment Facility<br>525 3<sup>rd</sup> Street<br>Ithaca, NY 14850<br></span><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif";color:blue'><a href="tel:(607)%20273-8381" target="_blank">(607) 273-8381</a><br></span><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif";color:black'>fax: <a href="tel:(607)%20273-8433" target="_blank"><span style='color:#0066CC'>(607) 273-8433</span></a></span><o:p></o:p></p></div><div><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-family:"Tahoma","sans-serif";color:black'> </span><o:p></o:p></p></div></div></div></div></div></div><div class=MsoNormal align=center style='text-align:center'><hr size=2 width="100%" align=center></div><p><strong><span style='font-family:"Arial","sans-serif";color:green'>Recycling is a good thing. Please recycle any printed emails. </span></strong><o:p></o:p></p></div></div><p class=MsoNormal><br><br>---------- Forwarded message ----------<br>From: Vivian Futran Fuhrman <<a href="mailto:vivian@productstewardship.us" target="_blank">vivian@productstewardship.us</a>><br>To: "<a href="mailto:pharmwaste@lists.dep.state.fl.us" target="_blank">pharmwaste@lists.dep.state.fl.us</a>" <<a href="mailto:pharmwaste@lists.dep.state.fl.us" target="_blank">pharmwaste@lists.dep.state.fl.us</a>><br>Cc: <br>Bcc: <br>Date: Thu, 19 Apr 2018 12:54:11 +0000<br>Subject: [Pharmwaste] FREE PSI webinar: "Global Best Practices for Drug Take-Back Programs"– 6/7/2018<o:p></o:p></p><div><div><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'>Good Morning,<o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'> <o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'>PSI is holding a free webinar, <b><i>Global Best Practices for Drug Take-Back Programs</i></b>, on <b>June 7, 11am - 12:30pm EDT (8am PDT / 5pm CEST)</b>. This is the third in a four-webinar global series that will connect stakeholders worldwide and launch an ongoing dialogue about best practices for safely managing waste pharmaceuticals. <o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'> <o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'>The 90 minute webinar will feature speakers from Canada, the United States, France, and Sweden who will share their program best practices. The presentations will be followed by a 45 minute question/answer session. The entire webinar will be held in English.<o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'> <o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'>More details and a link to register can be found online: <a href="https://productstewardship.site-ym.com/events/EventDetails.aspx?id=1096126" target="_blank">https://productstewardship.site-ym.com/events/EventDetails.aspx?id=1096126</a>. <o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'>We hope to see you there!<o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'> <o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'>Best,<o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'>Vivian<o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><b><span style='font-size:10.0pt;color:#333333'>______________________________<br>Vivian Fuhrman, Ph.D.</span></b><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:10.0pt;color:#404040'>Sr. Associate for Policy and Programs</span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><i><span style='font-size:10.0pt;color:#333333'>Product Stewardship Institute, Inc.<br></span></i><span style='font-size:10.0pt;color:#333333'>29 Stanhope St., 3rd Floor, Boston, MA 02116<br>P: (617) 236-4771 F: (617) 236-4766<br></span><span style='font-size:10.0pt;color:#1F497D'><a href="http://www.productstewardship.us/" target="_blank"><span style='color:#333333'>www.productstewardship.us</span></a><br><a href="mailto:vivian@productstewardship.us" target="_blank"><span style='color:#333333'>vivian@productstewardship.us</span></a></span><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><i><span style='font-size:10.0pt;color:#333333'>The Product Stewardship Institute, Inc. is an equal opportunity provider and employer.</span></i><o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'> <o:p></o:p></p></div></div><p class=MsoNormal><br>---<br>Note: As a courtesy to other listserv subscribers, please post messages to the listserv in plain text format to avoid the garbling of messages received by digest recipients.<br>---<br>TO SUBSCRIBE, go to: <a href="http://lists.dep.state.fl.us/cgi-bin/mailman/listinfo/pharmwaste" target="_blank">http://lists.dep.state.fl.us/cgi-bin/mailman/listinfo/pharmwaste</a><br>TO UNSUBSCRIBE, DO NOT REPLY TO THE LISTSERV. Please send an e-mail to <a href="mailto:pharmwaste-unsubscribe@lists.dep.state.fl.us" target="_blank">pharmwaste-unsubscribe@lists.dep.state.fl.us</a> -- the subject line and body of the e-mail should be blank.<br>If you believe you may be subscribed with a different email address, please visit the subscriber listing at <a href="http://lists.dep.state.fl.us/cgi-bin/mailman/roster/pharmwaste" target="_blank">http://lists.dep.state.fl.us/cgi-bin/mailman/roster/pharmwaste</a><br>FOR PROBLEMS: Contact List Administrator glen.perrigan@dep.state.fl.usSEND MAIL to the list server at: <a href="mailto:pharmwaste@lists.dep.state.fl.us" target="_blank">pharmwaste@lists.dep.state.fl.us</a><o:p></o:p></p></div><p class=MsoNormal><br><br clear=all><o:p></o:p></p><div><p class=MsoNormal><o:p> </o:p></p></div><p class=MsoNormal>-- <o:p></o:p></p><div><div><div><p class=MsoNormal> <o:p></o:p></p></div><div><p class=MsoNormal> <o:p></o:p></p></div><div><p class=MsoNormal><span style='font-size:10.0pt;font-family:"Arial","sans-serif"'>Ed Krisiunas, MT(ASCP), MPH<br>President<br>WNWN International<br>PO Box 1164<br>Burlington, Connecticut<br>06013<br>1-860-675-1217 (O)<br>1-860-675-1311 (F)<br>1-860-839-3993 (M)<br>SKYPE - Boutiquewaste<br><br></span><b><u><span style='font-size:7.5pt;font-family:"Verdana","sans-serif";color:black'>PRIVACY NOTICE:</span></u></b><span style='font-size:7.5pt;font-family:"Verdana","sans-serif";color:black'> This information is intended only for the use of the individual or entity to which it is addressed and may contain information that is privileged, confidential or exempt from disclosure under applicable federal or state law. If the reader of this message is not the intended recipient or the employee or agent responsible for delivering the message to the intended recipient, you are hereby notified that any dissemination, distribution or copying of this communication is strictly prohibited. If you have received this communication in error, contact the sender and delete the material from any computer.</span><o:p></o:p></p></div></div></div></div></div></div></body></html>