[Pharmwaste] Chemo drugs

Jim Mullowney jmullowney at pharma-cycle.com
Wed Apr 18 14:32:41 EDT 2018

Hello Charlotte, 

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. 

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.


Hope this helps.


Jim Mullowney, President

Pharma-Cycle, LLC.

Associate Member American Society of Clinical Oncology

Member of the American Chemical Society

 <mailto:jmullowney at pharma-cycle.com> jmullowney at pharma-cycle.com

(617) 755-0883




From: Smith, Charlotte [mailto:csmith32 at wm.com] 
Sent: Wednesday, April 18, 2018 2:10 PM
To: Ed Gottlieb; pharmwaste at lists.dep.state.fl.us
Cc: Mullowney, Jim
Subject: RE: Chemo drugs


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


Best regards,


Charlotte A. Smith, RPh, MS 

Senior Regulatory Advisor

PharmEcology Services, WM Sustainability Services 

csmith32 at wm.com


Waste Management 

P.O. Box 1654

Brookfield, WI 53008-1654

Cell 713-725-6363 


Waste Management's Sustainability Services teams work with you to devise a
strategy that will help achieve your environmental goals while benefitting
your financial objectives. Find out more at
<http://www.wmsustainabilityservices.com/> www.wmsustainabilityservices.com





From: Pharmwaste [mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf
Of Ed Gottlieb
Sent: Monday, April 9, 2018 1:43 PM
To: pharmwaste at lists.dep.state.fl.us
Cc: Mullowney, Jim <jmullowney at pharma-cycle.com>
Subject: [EXTERNAL] [Pharmwaste] Chemo drugs


New info from Jim Mullowney below.  Contact him for more information:
jmullowney at pharma-cycle.com


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.  


Problem Chemotherapy Drugs That Are Excreted at High Concentrations & Can
Damage Others at Ultra-low Doses1

Generic Name        Other Names                            Excretion
Administered Dose

Danger Period    Dose/Weight      Amount

Actinomycin D     Dactinomycin, Cosmenogen     30%         7 Days         ?
50 ug/Kg          ? 4 mg
Bleomycin         Blenoxane                             60-70%     1 Day
? 50 units (mg)/Kg  ? 4000 mg
Carboplatin         Paraplatin                             65-75%     1 Day
? 12 mg/Kg         ? 960 mg
Cisplatin             Platin                                    13-17%     1
Day         ? 3.3 mg/Kg         ? 264 mg
Cyclophosphamide     Endoxan, Cytoxan, Neosar, Procytox, Revimmune 

1 Day         ? 50 mg/Kg     ? 4000 mg
Dacarbazine     DTIC, DTIC-Dome                     40%         1 Day
? 4.5 mg/Kg     ? 360 mg
Daunorubicin HCl     Cerubidine                         65%         3 Days
? 1.5 mg/Kg     ?120 mg
Doxorubicin     Adriamycin, Rubex, Doxil, Caelyx, Myocet 

5 Days         ? 2.5 mg/Kg     ? 200 mg
Epirubicin         Ellence, Pharmorubicin                 55%     4 Days
? 40 mg/Kg     ? 3200 mg
Etoposide     Eposin, Etopophos, Vepesid, VP-16     45%     5 Days         ?
3.3 mg/Kg     ? 264 mg
Floxuridine     Fdur                                             20%     1
Day             ? 0.6 mg/Kg     ? 48 mg
Fludarabine     Fludara                                     40-60%     1 Day
? 0.83 mg/Kg     ? 66.4 mg
Fluorouracil     5-FU, Adrucil, Carac, Efudix, Efudex, Fluoroplex

1 Day         ? 12 mg/Kg         ? 960 mg
Idarubicin     Zavedos, Idamycin                         20%         8 Days
? 0.4 mg/Kg     ? 32 mg
Ifosfamide     Mitoxana, Ifex                             12-18%     1 Day
? 40 mg/Kg     ? 3200 mg
Irinotecan     Camptosar, Campto                     25-50%     2 Days
? 11.7 mg/Kg     ? 936 mg
Mitomycin     Mitosol                                         10%         1
Day         ? 0.67 mg/Kg     ? 53.6 mg
Mitoxantrone                                                     24%
5 Days     ? 0.47 mg/Kg     ? 37.6 mg
Oxaliplatin     Eloxatin                                         35%
1 Day     ? 2.8 mg/Kg         ? 224 mg
Methotrexate     Trexall, MTX, Amethopterin         80-90%     1 Day     ?
15 mg/Kg         ? 1200 mg
Temozolomide     Temodar                                 18%         7 Days
? 50 mg/Kg     ? 4000 mg
Topotecan     Hycamtin                                     70 -75%     9
Days     ? 0.05 mg/Kg     ? 4 mg
Restricted use
Arsenic trioxide     Trisenox                                 15%         1
Day     ? 15 mg/Kg         ? 1200 mg
Clofarabine                                                     49-60%
1 Day     ? 1.7 mg/Kg         ? 138 mg
Melphalan     Alkeran                                     10-15%
1 Day     6 mg                 6 mg
Teniposide     Vumon                                         4-12%         5
Days     ? 8.3 mg/Kg     ? 666 mg
Valrubicin     Valstar                                             99%
1 Day         800 mg             800 mg
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.

2. Estimated percent of drug dose that exits patient's body as parental drug
or active metabolite as well as excretion period.

3. Doses will vary depending on disease and doctors' recommendations. See
individual Drug Inserts for more details.
4. Where needed, converted from mg/m2 to mg/Kg


Ed Gottlieb 
Industrial Pretreatment Coordinator
Ithaca Area Wastewater Treatment Facility
525 3rd Street
Ithaca, NY  14850
(607) 273-8381 <tel:(607)%20273-8381> 
fax:  <tel:(607)%20273-8433> (607) 273-8433



Recycling is a good thing. Please recycle any printed emails. 

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