DRUG REGISTRATION INFORMATION FOR RESEARCHERS - Update October 2006
Researchers who will use controlled substances in their research are required to be licensed by the State and by the Federal Government, DEA. The type or schedule of drug(s) to be used will determine license requirements. Most PI's will be using Schedule III, which requires both a State and Federal License. Each PI is reponsible for drug security and maintaining a record of drug inventory. Appropriate drugs used for anesthesia or euthanasia will be described in the Animal Use Statement (AUS) Protocol for IACUC review. Drugs used in aquatic research (therapeutic or anesthesia) are considered separately from drugs used with experimental animals for biomedical research. Aquatic-use drugs are in various stages of registration; many are only available under an INAD (Investigational New Animal Drug) status - see information on this website - "Announcements". Some commonly used chemicals for aquatic use are not approved, nor in review for approval - frequently these are "generally regarded as safe" (GRAS) and are used with the understanding that "violations" will not be processed. Common salt, Sodium Chloride, is a GRAS drug; it is important as a prophylactic dip treatment for ectoparasites of fishes, and it is also a practical and effective means of stress reduction for fishes through osmotic regulation.
For Registration Application, contact the Oklahoma DEA office, 405-475-7552/7553, or visit the website (http://www.deadiversion.usdoj.gov/drugreg/reg_apps/index.html). For current registrants, pay particular attention to inventory requirements; biannual record verification is required for compliance (http://www.deadiversion.usdoj.gov/21cfr/cfr/index.html).
BEGINNING IN 2006, VERIFICATION OF BIANNUAL DRUG INVENTORY WILL BE REQUESTED ON THE ANNUAL REPORT FOR ACTIVE PROTOCOLS.
ANNOUNCEMENT 26 SEPTEMBER 2006
USDA Policy number 3 - has been revised and updated - published 18 August 2006. Visit the USDA Animal Care Home Page (see links on the iacuc.ou.edu Home Page), or open the following URL (http://www.aphis.usda.gov/animal_welfare/Policy. shtml). The update discusses expired medical materials, surgery, pre- and post- procedural care, euthanasia, and veterinary care.
Health Workers exposure to Hazardous Drugs - August 2009
Health workers and or researchers may be exposed to hazardous drugs during the course of their duties. Precautions, including the use of appropriate protective equipment, is necessary to avoid exposure. See OU-EHSO newsletter for more information (http://www.ou.edu/ehso/); this site also accesses a newsletter (SAF-T-GRAM) with other pertinent updates. See a list of hazardous drugs provided by the OUHSC. Also visit the website of the National Institute for Occupational Safety and Health (www.cdc/niosh/eNews).
APPENDIX A HAZARDOUS DRUGS
AGENT
TRADE NAME
Aldesleukin (rIL-2)
Proleukin
Alemtuzumab
Campath
Alitretinoin
Panretin
Altretamine
Hexalen
Aminoglutethimide
Amsacrine
Anastrozole
Arimidex
Arsenic Trioxide
Trisenox
Asparaginase/L-Asparaginase
Elspar
Azacytidine
Azacytidine
Azathioprime
Azathioprine
Bexarotene
Targretin
Bicalutamide
Casodex
Bleomycin/Bleomycin Sulfate
Blenoxane
Busulfan
Myleran
Capecitabine
Xeloda
Carboplatin
Paraplatin
Carmustine (BCNU)
BiCNU
CCNU
Belustine
Chlorambucil*
Leukeran
Chloramphenicol
Chlornaphazin
Chlorotrianisene
Chlorozotocin
Cisplatin/Cis-Platin
Platinol
Cladribine (2-chlorode-oxyadenosine, 2CdA)
Leustatin
Cyclophosphamide*
Cytoxan, Neosar
Cyclosporin
Cytarabine (ara-C)/Cytosine Arabinoside
Cytosar-U
Dacarbazine
DTIC, DIC, DTIC-Dome
Dactinomycin (Actinomycin-D)
Cosmegen
Daunomycin*
Daunorubicin/Daunorubicin Hydrochloride
Cerubidine
Daunorubicin (Liposomal)
DaunoXome
Denileukin Diftitox
Ontak
Diethylstilbesterol
Docetaxel
Taxotere
Doxorubicin
Adriamycin
Doxorubicin Hydrochloride Liposomal Injection
Doxil
Epirubicin/Epirubicin Hydrochloride
Ellence
Estradiol
Estramustine
Emcyt
Ethinyl Estradiol
Etoposide (VP-16-213)
VePesid
Exemestane
Aromasin
Floxuridine
Fludarabine/Fludarabine Phosphate
Fludara
Fluorouracil/5-Fluorouracil
Adrucil
Flutamide
Eulexin
Fulvestrant
Ganciclovir
Gemcitabine
Gemzar
Gemtuzumab Ozogamicin
Mylotarg
Goserelin/Goserelin Acetate
Zoladex
Hydroxyurea
Droxia, Mylocel
Ibritumomab Tiuetan
Zevalin
Idarubicin
Idamycin
Ifosfamide
Ifex
Imatinib Mesylate
Gleevec
Interferon-A/Interferon Alfa (2a, 2b)
Roferon-A, Intron-A
Interleukin-2 (IL-2)
Irinotecan (CPT-11)
Camposar
Isotretrinoin
Letrozole
Femara
Leuprolide/Leuprolide Acetate Lupron,
Lupron Depot
Levamisole
Ergamisol
Lomustine (CCNU)
CeeNu
Mechlorethamine (Nitrogen Mustard)
Mustargen
Mechlorethamine Hydrochloride
Medroxyprogesterone/Medroxyprogesterone Acetate
Provera
Megestrol/Megestrol Acetate
Megace
Melphalan*
Alkeran
Mercaptopurine (6-MP)
Purinethol
Methotrexate (MTX)
Mexate, Folex
Methyl-CCNU
Semustine
Mithramycin
Mithracin
Mitomycin
Mitomycin C*
Mutamycin
Mitotane
Mitoxantrone
Novantrone
Myleran
Nafarelin
Nilutamide
Nllandron
Nitrogen Mustard Mustargen
Oprelvekin
Neumega
Oxaliplatin
Paclitaxel
Taxol
Pegaspargase
Pentostatin (2-deoxycoformycin, DCF)
Nipent
Pipobroman
Plicamycin
Procarbazine/Procarbazine Hydrochloride
Matulane
Ribavirin
Rituximab
Rituxan
Streptozocin (Streptozoticin)*
Zanosar
Tamoxifen/Tamoxifen Citrate
Nolvadex
Temozolomide
Temodar
Teniposide
Vumon
Teosulfan
Testolactone
Thioguanine
Thiotepa
Thioplex
Topotecan
Hycamtin
Toremifene/Toremifene Citrate
Fareston
Trastuzumab
Herceptin
Tretinoin (ATRA)
Vesanoid
Triethylene Thiophosphoramide
Thiotepa
Triptorelin Pamoate
Trelstar
Depot
Uracil Mustard*
Uramustine
Valrubicin
Vidarabine
Vinblastine/Vinblastine Sulfate
Velban
Vincristine/Vincristine Sulfate
Oncovin
Vindesine
Vinorelbine/Vinorelbine Tartrate
Navelbine
VM-26
Zidovudine
Retrovir
_______________________________________________________________________________________
*These agents are listed by the Environmental Protection Agency as hazardous
wastes and must be disposed of as such.
Sources: American Hospital Formulary Service Drug Information
1995
American Hospital Formulary Service Drug Information 2002
Occupational Safety and Health Administration (OSHA) Instruction
PUB 8-1.1 Appendix A, Work
Practice Guidelines for Personnel Dealing with Cytotoxic (Antineoplastic)
Drugs, January 29, 1986
OSHA Instruction CPL 2-2.20B CH-4, Chapter 21, Controlling Occupational
Exposure to Hazardous
Drugs, April 14, 1995
OSHA Technical Manual Section VI, Chapter 2 Appendix VI:2-1, Some Common
Drugs that are
Considered Hazardous
Environmental Protection Agency Regulation 40 CFR 261.33
Oklahoma Department of Environmental Quality Instructions for Disposal
of Antineoplastic
(Chemotherapy) Agents at Permitted Biomedical
Waste Incinerators
Adams, Val R., “Guide to Cancer Chemotherapeutic Regimens,”
Pharmacy Practice News, October
2002 Supplement, pp. 29-46.
Adams, Val R., “Guide for the Administration and Use of Cancer
Chemotherapeutic Agents 2003,”
Oncology Special Edition, Vol 6, 2003, pp. 123-138.