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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'>Hello Charlotte, <o:p></o:p></span></p><p class=MsoNormal><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. <o:p></o:p></span></p><p class=MsoNormal><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.<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'>Hope this helps.<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><div><div style='border:none;border-top:solid #B5C4DF 1.0pt;padding:3.0pt 0in 0in 0in'><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"'> Smith, Charlotte [mailto:csmith32@wm.com] <br><b>Sent:</b> Wednesday, April 18, 2018 2:10 PM<br><b>To:</b> Ed Gottlieb; pharmwaste@lists.dep.state.fl.us<br><b>Cc:</b> Mullowney, Jim<br><b>Subject:</b> RE: Chemo drugs<o:p></o:p></span></p></div></div><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal><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. <o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif"'><o:p> </o:p></span></p><div><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif"'>Best regards,<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif"'><o:p> </o:p></span></p><p class=MsoNormal style='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><span style='font-size:11.0pt;font-family:"Trebuchet MS","sans-serif";color:#00693C'><o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Trebuchet MS","sans-serif";color:black'>Senior Regulatory Advisor</span><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:black'><o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Trebuchet MS","sans-serif"'>PharmEcology Services, WM Sustainability Services <o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Trebuchet MS","sans-serif"'><a href="mailto:csmith32@wm.com">csmith32@wm.com</a><span style='color:black'><o:p></o:p></span></span></p><p class=MsoNormal><b><span style='font-family:"Trebuchet MS","sans-serif";color:black'> </span></b><span style='font-family:"Trebuchet MS","sans-serif";color:black'> </span><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:black'><o:p></o:p></span></p><p class=MsoNormal style='text-autospace:none'><b><span style='font-size:11.0pt;font-family:"Trebuchet MS","sans-serif";color:#00693C'>Waste Management </span></b><span style='font-size:11.0pt;font-family:"Trebuchet MS","sans-serif";color:#00693C'><o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Trebuchet MS","sans-serif";color:black'>P.O. Box 1654<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Trebuchet MS","sans-serif";color:black'>Brookfield, WI 53008-1654</span><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:black'><o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Trebuchet MS","sans-serif";color:black'>Cell 713-725-6363 <o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Trebuchet MS","sans-serif";color:black'><o:p> </o:p></span></p><p class=MsoNormal><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 style='color:black'><o:p></o:p></span></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Trebuchet MS","sans-serif";color:#339933'><o:p> </o:p></span></p><p class=MsoNormal><b><span style='font-family:"Trebuchet MS","sans-serif";color:black'> </span></b><span style='font-family:"Trebuchet MS","sans-serif";color:black'> </span><span style='font-size:11.0pt;font-family:"Trebuchet MS","sans-serif";color:black'><o:p></o:p></span></p><p class=MsoNormal><b><span style='font-size:10.0pt;font-family:"Trebuchet MS","sans-serif";color:#525252'><o:p> </o:p></span></b></p></div><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif"'><o:p> </o:p></span></p><div><div style='border:none;border-top:solid #E1E1E1 1.0pt;padding:3.0pt 0in 0in 0in'><p class=MsoNormal><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 [mailto:pharmwaste-bounces@lists.dep.state.fl.us] <b>On Behalf Of </b>Ed Gottlieb<br><b>Sent:</b> Monday, April 9, 2018 1:43 PM<br><b>To:</b> pharmwaste@lists.dep.state.fl.us<br><b>Cc:</b> Mullowney, Jim <jmullowney@pharma-cycle.com><br><b>Subject:</b> [EXTERNAL] [Pharmwaste] Chemo drugs<o:p></o:p></span></p></div></div><p class=MsoNormal><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=rwrr> <a href="mailto:jmullowney@pharma-cycle.com">jmullowney@pharma-cycle.com</a></span><o:p></o:p></span></p><p><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif";color:black'> <o:p></o:p></span></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. <o:p></o:p></span></p><p><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif";color:black'> <o:p></o:p></span></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<o:p></o:p></span></p><p><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif";color:black'>Generic Name Other Names Excretion Administered Dose<o:p></o:p></span></p><p><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif";color:black'> % Danger Period Dose/Weight Amount<o:p></o:p></span></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 <o:p></o:p></span></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 <o:p></o:p></span></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<o:p></o:p></span></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.<o:p></o:p></span></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.<o:p></o:p></span></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<o:p></o:p></span></p><p><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif";color:black'> <o:p></o:p></span></p><div><div><div><div><p class=MsoNormal><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><span style='font-family:"Tahoma","sans-serif";color:black'><o:p></o:p></span></p></div><div><p class=MsoNormal><span style='font-family:"Tahoma","sans-serif";color:black'> <o:p></o:p></span></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. <o:p></o:p></span></strong></p></div></body></html>