DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Institute for Occupational Safety and Health 

# NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2010DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Institute for Occupational Safety and Health 

# NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2010This document is in the public domain and may be freely copied or reprinted.



# D isclaimer Mention of any company or product does not constitute endorsement by the National Institute for Occupational Safety and Health (NIOSH). In addition, citations to Web sites external to NIOSH do not constitute NIOSH endorsement of the sponsoring organizations or their programs or products. Furthermore, NIOSH is not responsible for the content of these Web sites. 

# O r d ering 

# I nf o rmati o n
To receive documents or other information about occupational safety and health topics, contact NIOSH at Telephone: 1–800–CDC–INFO (1–800–232–4636) TTY:1–888–232–6348 E-mail: cdcinfo@cdc.gov or visit the NIOSH Web site at www.cdc.gov/niosh For a monthly update on news at NIOSH, subscribe to NIOSH eNewsby visiting www.cdc.gov/niosh/eNews.

DHHS (NIOSH) Publication Number 2010−167
September 2010Preamble: The National Institute for Occupational Safety and Health (NIOSH) Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settingswas published in September 2004 (http://www.cdc.gov/niosh/docs/2004-165/). In Appendix A of theAlert, NIOSH identified a sample list of major hazardous drugs. The list was compiled from information provided by four institutions that have generated lists of hazardous drugs for their respective facilities and by the Pharmaceutical Research and Manufacturers of America (PhRMA) from the American Hospital Formulary Service Drug Information (AHFS DI) monographs [ASHP/ AHFS DI 2003]. This update adds 21 drugs to the original list in the 2004 Alert. These additions are new drugs or existing drugs that had new warnings from 2004 to 2007. The review process for the addition of the new listings is described in the Federal Register: http://www.cdc.gov/niosh/docket/ archive/ pdfs/NIOSH-105-A/0105-A-042909-FR_Notice.pdf


# A ppendix

# A • d rugs

# C onsidered

# H AzArdous

ASHP Definition of Hazardous DrugsIn this Alert, NIOSH presents a standard precautions or universal precautions approach to handling hazardous drugs safely: that is, NIOSH recommends that all hazardous drugs be handled as outlined in this Alert. Therefore, no attempt has been made to perform drug risk assessments or propose exposure limits. The area of new drug development is rapidly evolving as unique approaches are being taken to treat cancer and other serious diseases.



### General Approach to Handling Hazardous Drugs

Hazardous drugs include those used for cancer c h em otherapy, antiviral drugs, hormones,some bioengineered drugs, and other miscellaneous drugs. The definition of hazardous drugsused in this Alert is based on an ASHP definition that was originally developed in 1990[ASHP 1990]. Thus the definition may not accurately reflect the toxicity criteria associated with the newer generation of pharmaceuticals entering the health care setting. For example, bioengineered drugs target specific sites in the b o dy ; an d although they may or may not be toxic to the patient, some may not pose a risk to health care workers.NIOSH and other organizations are still gathering data on the potential toxicity and healtheffects related to highly potent drugs and bioengineered drugs. Therefore, when working with any hazardous drug, health care workers should follow a standard precautions approach along with any recommendations included in the manufacturer’s MSDSs.



### Defining Hazardous Drugs The ASHP defines hazardous drugs in their 1990 revision of Technical Assistance Bulletin on Handling Hazardous Drugs [ASHP 1990]. Thebulletin gives criteria for identifying potentially hazardous drugs that should be handledin accordance with an established safety program [McDiarmid et al. 1991; Arrington and McDiarmid 1993]. The criteria are prioritizedto reflect the hierarchy of potential toxicity described below. Since the hazardous drugs covered by this Alert were designed as therapeutic agents for humans, human toxicity profiles

1should be considered superior to any data from animal models or in vitro systems. Additionalguidance for defining hazardous drugs is available in the following citations: carcinogenicity [61 Fed. Reg. 17960–18011 (1996b); IARC 2010], teratogenicity [56 Fed. Reg. 63798–63826 (1991)], developmental toxicity [56 Fed. Reg.63798–63826 (1991)], and reproductive toxicity [61 Fed. Reg. 56274–56322 (1996a)]. Physical characteristics of the agents (such as liquid versus solid, or water versus lipid solubility) also need to be considered in determining the potential for occupational exposure.



### NIOSH Revision of ASHP Definition
The 1990 ASHP definition of hazardous drugs * was revised by the NIOSH Working Group onHazardous Drugs for this Alert. Drugs considered hazardous include those that exhibit one or more of the following six characteristics in humans or animals: 1. Carcinogenicity2. Teratogenicity or other developmental toxicity †

* ASHP [1990] definition of hazardous drugs: 1. Carcinogenicity 2. Teratogenicity or other developmental toxicity 3. Reproductive toxicity 4. Organ toxicity at low doses 5. Genotoxicity 6. Structure and toxicity profiles of new drugs that mimic existing drugs determined hazardous by the above criteria.

† All drugs have toxic side effects, but some exhibit toxicity at low doses. The level of toxicity reflects a continuum from relatively nontoxic to production of toxic effects in patients at low doses (for example, a few milligrams or less). For example, a daily therapeutic dose of 10 mg/day or a dose of 1 mg/kg per day inlaboratory animals that produces serious organ toxicity, developmental toxicity, or reproductive toxicity has been used by the pharmaceutical industry to develop occupational exposure limits (OELs) of less than 10 μg/m 3 after applying appropriate uncertainty 3. Reproductive toxicity† 4. Organ toxicity at low doses † 5. Genotoxicity‡ Structure and toxicity profiles of new drugsthat mimic existing drugs determined hazardous by the above criteria



### Determining Whether a Drug is Hazardous
Many hazardous drugs used to treat cancerbind to or damage DNA (for example, alkylating agents). Other antineoplastic drugs, some antivirals, antibiotics, and bioengineered drugs interfere with cell growth or proliferation, orwith DNA synthesis. In some cases, the nonselective actions of these drugs disrupt thegrowth and function of both healthy and diseased cells, resulting in toxic side effects for treated patients. These nonselective actions can also cause adverse effects in health careworkers who are inadvertently exposed to hazardous drugs. Early concerns about occupational exposure to antineoplastic drugs first appeared in the 1970s. Although the antineoplastic drugs remain the principal focus of this Alert, other drugs may also be considered hazardous because they arepotent (small quantities produce a physiological effect) or cause irreversible effects. As the use and number of these potent drugs increase,

factors [Sargent and Kirk 1988; Naumann and Sargent 1997; Sargent et al. 2002]. OELs in this range are typically established for potent or toxic drugs in the pharmaceutical industry. Under all circumstances, an evaluation of all available data should be conducted to protect health care workers.

‡ In evaluating mutagenicity for potentially hazardous

drugs, responses from multiple test systems are needed before precautions can be required for handling such agents. The EPA evaluations include the type of cells affected and in vitro versus in vivo testing [51 Fed. Reg. 34006–34012 (1986)].

23 so do opportunities for hazardous exposures among health care workers. For example, an

tineoplastic drugs such as cyclophosphamide have immunosuppressant effects that proved beneficial for treating nonmalignant diseas

es such as rheumatoid arthritis and multiple sclerosis [Baker et al. 1987; Moody et al. 1987; Chabner et al. 1996; Abel 2000]. This document presents criteria and sources of information for determining whether a drug is hazardous. When a drug has been judged to be hazardous, the various precautions outlined the Alert should be applied when handling that drug. Also included is a list of drugs that should be handled as hazardous. This list is based on a compilation of lists from four health care fa

cilities, one drug manufacturers’ organization, and NIOSH. In addition to using the list of hazardous drugs presented here, each organization should cre

ate its own list of drugs considered to be haz

ardous. This document presents guidance for making such a facility-specific list (see section entitled How to Generate your own List of Haz

ardous Drugs ). Once this list is made, newly purchased drugs should be evaluated against the organization’s hazardous drug criteria and added to the list if they are deemed hazardous. Some organizations may have inadequate resources for determining their own list of hazardous drugs. If so, the sample list of haz

ardous drugs in this document (current only to the printing date of this document) will help employers and workers to determine when precautions are needed. However, re

liance on such a published list is a concern because it quickly becomes outdated as new drugs continually enter the market or listed drugs are removed when additional infor

mation becomes available. To fill this knowl

edge gap, NIOSH will update an internet list periodically, adding new drugs considered to be hazardous and removing those that re

quire reclassification. This hazardous drug list will be posted on the NIOSH Web site at www.cdc.gov/niosh.



### How to Generate Your Own List of Hazardous Drugs

The OSHA hazard communication standard [29 CFR 1910.1200] requires employers to develop a hazard communication program appropriate for their unique workplace. An essential part of the program is the identifi

cation of all hazardous drugs a worker may encounter in the facility. Compliance with the OSHA hazard communication standard entails (1) evaluating whether these drugs meet one or more of the criteria for defining hazardous drugs and (2) posting a list of the hazardous drugs to ensure worker safety. In

stitutions may wish to compare their lists to the sample listing in this document or on the NIOSH Web site. It is not likely that every health care provider or facility will use all drugs that have received U.S. Food and Drug Administration (FDA) ap

proval, and the OSHA hazard communication standard does not mandate evaluation of every marketed drug. Instead, compliance requires practice-specific assessments for drugs used at any one time by a facility. However, hazardous drug evaluation is a continual process. Local hazard communication programs should pro

vide for assessment of new drugs as they enter the marketplace, and when appropriate, reas

sessment of their presence on hazardous drug lists as toxicological data become available to support recategorization. Toxicological data are often incomplete or unavailable for inves

tigational drugs. However, if the mechanism of action suggests that there may be a concern, it is prudent to handle them as hazardous drugs until adequate information becomes available to exclude them.4 Some drugs defined as hazardous may not pose a significant risk of direct occupational exposure because of their dosage formulation (for ex

ample, coated tablets or capsules—solid, intact medications that are administered to patients without modifying the formulation). However, they may pose a risk if solid drug formulations are altered, such as by crushing tablets or making solutions from them outside a ventilated cabinet.



### Where to Find Information Related to Drug Toxicity
Practice-specific lists of hazardous drugs (usu

ally developed by pharmacy or nursing depart

ments) should be comprehensive, including all hazardous medications routinely used or very likely to be used by a local practice. Some of the resources that employers can use to evalu

ate the hazard potential of a drug include, but are not limited to, the following:

 MSDSs

 Product labeling approved by the U.S. FDA (package inserts)

 Special health warnings from drug man

ufacturers, FDA, and other professional groups and organizations

 Reports and case studies published in medical and other health care profession journals

 Evidence-based recommendations from other facilities that meet the criteria defin

ing hazardous drugs



### Examples of Hazardous Drugs
The following list contains a sampling of major hazardous drugs. The list was compiled from information provided by (1) four institutions that have generated lists of hazardous drugs for their respective facilities, (2) the American Hospital Formulary Service Drug Informa

tion (AHFS DI) monographs [ASHP/AHFS DI 2003], and (3) a NIOSH review of new drug approvals and new drug warning from 2004 to 2007. This review resulted in the addition of 21 new entries to the list. The OSHA hazard com

munication standard requires hazardous drugs to be handled using special precautions. The mandate applies not only to health care profes

sionals who provide direct patient care but also to others who support patient care by partici

pating in product acquisition, storage, trans

portation, housekeeping, and waste disposal. Institutions may want to adopt this list or com

pare theirs with the list on the NIOSH Web site. Caution: Drugs purchased and used by a facil

ity may have entered the marketplace after the list below was assembled. Therefore, this list may not be all-inclusive. If you use a drug that is not included in the list of examples, check the available literature to see whether the unlisted drug should be treated as hazardous. Check the MSDS or the proper handling section of the package insert; or check with other institutions that might be using the same drug. If any of the documents mention carcinogenicity, genotoxicity, tera

togenicity, or reproductive or developmental toxicity, use the precautions stipulated in this Alert. If a drug meets one or more of the cri

teria for hazardous drugs listed in this Alert, handle it as hazardous. The listing below will be updated periodically on this website. The attached list of hazardous drugs super

sedes the 2004 list: http://www.cdc.gov/niosh/ docs/2004-165/5 

### Sample List of Drugs that Should be Handled as Hazardous*

Drug Source AHFS Pharmalocologic-therapeutic classification Aldesleukin 4,5 10:00 Antineoplastic agents Alefacept 6 84:92 Miscellaneous skin and mucous membrane agents Alemtuzumab 1,3,4,5 10:00 Antineoplastic agents Alitretinoin 3,4,5 84:36 Miscellaneous skin and mucous membrane agents (retinoid) Altretamine 1,2,3,4,5 10:00 Antineoplastic agents Amsacrine 3,5 Not in AHFS (antineoplastic agent) Anastrozole 1,5 10:00 Antineoplastic agents Arsenic trioxide 1,2,3,4,5 10:00 Antineoplastic agents Asparaginase 1,2,3,4,5 10:00 Antineoplastic agents Azacitidine 3,5 10:00 Antineoplastic agents Azathioprine 2,3,5 92:44 Unclassified therapeutic agents (immunosuppressant) Bacillus Calmette-Guerin (BCG) † 1,2,4 80:12 Vaccines

Bexarotene 2,3,4,5 10:00 Antineoplastic agents Bicalutamide 1,5 10:00 Antineoplastic agents Bleomycin 1,2,3,4,5 10:00 Antineoplastic agents Bort e zomib 6 10:00 Antineoplastic agents Bosentan 6 24:12.92 Vasodilating agents Busulfan 1,2,3,4,5 10:00 Antineoplastic agents Capecitabine 1,2,3,4,5 10:00 Antineoplastic agents Carboplatin 1,2,3,4,5 10:00 Antineoplastic agents Carmustine 1,2,3,4,5 10:00 Antineoplastic agents Cetrorelix acetate 5 92:40 Unclassified therapeutic agents (GnRH antagonist) Chlorambucil 1,2,3,4,5 10:00 Antineoplastic agents Chloramphenicol 1,5 8:12.08 Antibacterials Choriogonadotropin alfa 5 68:18 Gonadotropins Cidofovir 3,5 8:18.32 Antiviral nucleoside Cisplatin 1,2,3,4,5 10:00 Antineoplastic agents Cladribine 1,2,3,4,5 10:00 Antineoplastic agents Clofarabine 6 10:00 Antineoplastic agents

(Continued)6 

### Sample List of Drugs that Should be Handled as Hazardous (Continued)

Drug Source AHFS Pharmalocologic-therapeutic classification Colchicine 5 92:16 Unclassified therapeutic agents (antigout agents) Cyclophosphamide 1,2,3,4,5 10:00 Antineoplastic agents Cyclosporin 1 92:00 Immunosuppressive agents Cytarabine 1,2,3,4,5 10:00 Antineoplastic agents Dacarbazine 1,2,3,4,5 10:00 Antineoplastic agents Dactinomycin 1,2,3,4,5 10:00 Antineoplastic agents Dasatinib 6 10:00 Antineoplastic agents Daunorubicin HCl 1,2,3,4,5 10:00 Antineoplastic agents Decit a bine 6 10:00 Antineoplastic agents Denileukin 3,4,5 10:00 Antineoplastic agents Dienestrol 5 68:16.04 Estrogens Diethylstilbestrol 5 Not in AHFS (nonsteroidal synthetic estrogen) Dinoprostone 5 76:00 Oxytocics Docetaxel 1,2,3,4,5 10:00 Antineoplastic agents Doxorubicin 1,2,3,4,5 10:00 Antineoplastic agents Dutasteride 5 92:08 Unclassified therapeutic agents (5-alpha reductase inhibitor) Entecavir 6 8:18.32 Antiviral nucleoside Epirubicin 1,2,3,4,5 10:00 Antineoplastic agents Ergonovine/ methylergonovine 5 76:00 Oxytocics

Estradiol 1,5 68:16.04 Estrogens Estramustine phosphate 1,2,3,4,5 10:00 Antineoplastic agents Estrogen-progestin combinations 5 68:12 Contraceptives
Estrogens, conjugated 5 68:16.04 Estrogens Estrogens, esterified 5 68:16.04 Estrogens Estrone 5 68:16.04 Estrogens Estropipate 5 68:16.04 Estrogens Etoposide 1,2,3,4,5 10:00 Antineoplastic agents Exemestane 1,5 10:00 Antineoplastic agents Finasteride 1,3,5 92:08 Unclassified therapeutic agents (5-alpha reductase inhibitor) (Continued)7 

### Sample List of Drugs that Should be Handled as Hazardous (Continued)

Drug Source AHFS Pharmalocologic-therapeutic classification Floxuridine 1,2,3,4,5 10:00 Antineoplastic agents Fludarabine 1,2,3,4,5 10:00 Antineoplastic agents Fluorouracil 1,2,3,4,5 10:00 Antineoplastic agents Fluoxymesterone 5 68:08 Androgens Flutamide 1,2,5 10:00 Antineoplastic agents Fulvestrant 5 10:00 Antineoplastic agents Ganciclovir 1,2,3,4,5 8:18.32 Antiviral nucleoside Ganirelix acetate 5 92:40 Unclassified therapeutic agents (GnRH antagonist) Gemcitabine 1,2,3,4,5 10:00 Antineoplastic agents Gemtuzumab ozogamicin 1,3,4,5 10:00 Antineoplastic agents Gonadotropin, chorionic 5 68:18 Gonadotropins Goserelin 1,2,5 10:00 Antineoplastic agents Hydroxyurea 1,2,3,4,5 10:00 Antineoplastic agents Ibritumomab tiuxetan 3 10:00 Antineoplastic agents Idarubicin 1,2,3,4,5 10:00 Antineoplastic agents Ifosfamide 1,2,3,4,5 10:00 Antineoplastic agents Imatinib mesylate 1,3,4,5 10:00 Antineoplastic agents Interferon alfa-2a 1,2,4,5 10:00 Antineoplastic agents Interferon alfa-2b 1,2,4,5 10:00 Antineoplastic agents Interferon alfa-n1 1,5 10:00 Antineoplastic agents Interferon alfa-n3 1,5 10:00 Antineoplastic agents Irinotecan HCl 1,2,3,4,5 10:00 Antineoplastic agents Leflunomide 3,5 92:36 Unclassified therapeutic agents (antineoplastic agent) Lenalidomide 6 92:20 Unclassified therapeutic agents (biologic response modifiers) Letrozole 1,5 10:00 Antineoplastic agents Leuprolide acetate 1,2,5 10:00 Antineoplastic agents Lomustine 1,2,3,4,5 10:00 Antineoplastic agents Mechlorethamine 1,2,3,4,5 10:00 Antineoplastic agents Medroxyprogesterone acetate 6 68:32 Progestins
Megestrol 1,5 10:00 Antineoplastic agents

(Continued)8 

### Sample List of Drugs that Should be Handled as Hazardous (Continued)

Drug Source AHFS Pharmalocologic-therapeutic classification Melphalan 1,2,3,4,5 10:00 Antineoplastic agents Menotropins 5 68:18 Gonadotropins Mercaptopurine 1,2,3,4,5 10:00 Antineoplastic agents Methotrexate 1,2,3,4,5 10:00 Antineoplastic agents Methyltestosterone 5 68:08 Androgens Mifepristone 5 76:00 Oxytocics Mitomycin 1,2,3,4,5 10:00 Antineoplastic agents Mitotane 1,4,5 10:00 Antineoplastic agents Mitoxantrone HCl 1,2,3,4,5 10:00 Antineoplastic agents Mycophenolate mofetil 1,3,5 92:44 Unclassified therapeutic agents (immunosuppressive agents) Nafarelin 5 68:18 Gonadotropins Nelarabine 6 10:00 Antineoplastic agents Nilutamide 1,5 10:00 Antineoplastic agents Oxaliplatin 1,3,4,5 10:00 Antineoplastic agents Oxytocin 5 76:00 Oxytocics Paclitaxel 1,2,3,4,5 10:00 Antineoplastic agents Palifermin 6 84:16 Cell stimulants Paroxetine HCl 6 28:16.04.20 Selective seretonin uptake inhibitors Pegaspargase 1,2,3,4,5 10:00 Antineoplastic agents Pemetrexed 6 10:00 Antineoplastic agents Pentamidine isethionate 1,2,3,5 8:40 Miscellaneous anti-infectives Pentetate calcium trisodium 6 Not in AHFS Pentostatin 1,2,3,4,5 10:00 Antineoplastic agents Perphosphamide 3,5 Not in AHFS (antineoplastic agent) Pipobroman 3,5 Not in AHFS (antineoplastic agent) Piritrexim isethionate 3,5 Not in AHFS (antineoplastic agent) Plicamycin 1,2,3,5 Not in AHFS (antineoplastic agent) Podofilox 5 84:92 Miscellaneous skin and mucous membrane agents (mitotic inhibitor) Podophyllum resin 5 84:92 Miscellaneous skin and mucousmembrane agents (mitotic inhibitor) (Continued)9 

### Sample List of Drugs that Should be Handled as Hazardous (Continued)

Drug Source AHFS Pharmalocologic-therapeutic classification Prednimustine 3,5 Not in AHFS (antineoplastic agent) Procarbazine 1,2,3,4,5 10:00 Antineoplastic agents Progesterone 5 68:32 Progestins Progestins 5 68:12 Contraceptives Raloxifene 5 68:16.12 Estrogen agonists-antagonists Raltitrexed 5 Not in AHFS (antineoplastic agent) Rasagiline mesylate 6 28:36 Antiparkinsonian agents Ribavirin 1,2,5 8:18.32 Antiviral nucleoside Risperidone 6 28:16.08.04 Atypical antipsychotics Sirolimus 6 92:00 I mm u n osuppressive agents Sorafenib 6 10:00 Antineoplastic agents Streptozocin 1,2,3,4,5 10:00 Antineoplastic agents Sunitinib malate 6 10:00 Antineoplastic agents Tacrolimus 1,5 92:44 Unclassified therapeutic agents (immunosuppressant) Tamoxifen 1,2,5 10:00 Antineoplastic agents Temozolomide 3,4,5 10:00 Antineoplastic agents Teniposide 1,2,3,4,5 10:00 Antineoplastic agents Testolactone 5 10:00 Antineoplastic agents Testosterone 5 68:08 Androgens Thalidomide 1,3,5 92:20 Unclassified therapeutic agents (biologic response modifier) Thioguanine 1,2,3,4,5 10:00 Antineoplastic agents Thiotepa 1,2,3,4,5 10:00 Antineoplastic agents Topotecan 1,2,3,4,5 10:00 Antineoplastic agents Toremifene citrate 1,5 10:00 Antineoplastic agents Tositumomab 3,5 10:00 Antineoplastic agents Tretinoin 1,2,3,5 84:16 Cell stimulants and proliferants (retinoid) Trifluridine 1,2,5 52:04.06 Antivirals Trimetrexate glucuronate 5 8:30.92 Miscellaneous antiprotozoals Triptorelin 5 10:00 Antineoplastic agents Uracil mustard 3,5 Not in AHFS (antineoplastic agent) Valganciclovir 1,3,5 8:18.32 Antiviral nucleoside

(Continued)10 

### Sample List of Drugs that Should be Handled as Hazardous (Continued)

Drug Source AHFS Pharmalocologic-therapeutic classification Valrubicin 1,2,3,5 10:00 Antineoplastic agents Vidarabine 1,2,5 Not in AHFS Vinblastine sulfate 1,2,3,4,5 10:00 Antineoplastic agents Vincristine sulfate 1,2,3,4,5 10:00 Antineoplastic agents Vindesine 1,5 Not in AHFS (antineoplastic agent) Vinorelbine tartrate 1,2,3,4,5 10:00 Antineoplastic agents Vorinostat 6 10:00 Antineoplastic agents Zidovudine 1,2,5 8:18:08 Antiretroviral agents Zonisamide 6 28:12.92 Anticonvulsant
*These lists of hazardous drugs were used with the permission of the institutions that provided them and were

adapted for use by NIOSH. The sample lists are intended to guide health care providers in diverse practice set

tings and should not be construed as complete representations of all of the hazardous drugs used at the referenced institutions. Some drugs defined as hazardous may not pose a significant risk of direct occupational exposure because of their dosage formulation (for example, intact medications such as coated tablets or capsules that are administered to patients without modifying the formulation). However, they may pose a risk if solid drug formu

lations are altered outside a ventilated cabinet (for example, if tablets are crushed or dissolved, or if capsules are pierced or opened).

† BCG preparation should be done using aseptic techniques. To avoid cross-contamination, parenteral drugs should

not be prepared in areas where BCG has been prepared. A separate area for the preparation of BCG suspension is recommended. All equipment, supplies, and receptacles in contact with BCG should be handled and disposed of as biohazardous. If preparation cannot be performed in a containment device, then respiratory protection, gloves and a gown should be worn to avoid inhalation or contact with BCG organisms.

1. The NIH Clinical Center, Bethesda, MD (Revised 8/2002). The NIH Health Clinical Center Hazardous Drug (HD) List is part of the NIH Clinical Center’s hazard communication program. It was developed in compli

ance with the OSHA hazard communication standard [29 CFR 1910.1200] as it applies to hazardous drugs used in the workplace. The list is continually revised and represents the diversity of medical practice at the NIH Clinical Center; however, its content does not reflect an exhaustive review of all FDA-approved medica

tions that may be considered hazardous, and it is not intended for use outside the NIH. 2. The Johns Hopkins Hospital, Baltimore, MD (Revised 9/2002). 3. The Northside Hospital, Atlanta, GA (Revised 8/2002). 4. The University of Michigan Hospitals and Health Centers, Ann Arbor, MI (Revised 2/2003) 5. This sample listing of hazardous drugs was compiled by the Pharmaceutical Research and Manufacturers of America (PhRMA) using information from the AHFS DI monographs published by ASHP in selected AHFS Pharmacologic-Therapeutic Classification categories [ASHP/AHFS DI 2003] and applying the definition for hazardous drugs. The list also includes drugs from other sources that satisfy the definition for hazard

ous drugs [PDR 2004; Sweetman 2002; Shepard 2001; Schardein 2000; REPROTOX 2003]. Newly approved drugs that have structures or toxicological profiles that mimic the drugs on this list should also be included. This list was revised in June 2004. 6. NIOSH addition 2010 updated using ASHP/AHFS DI 2010.11 

# R eferences Abel EA [2000]. Immunosuppressant and cyto

toxic drugs: unapproved uses or indications. Clin Dermatol 18 :95–101. Arrington DM, McDiarmid MA [1993]. Compre

hensive program for handling hazardous drugs. Am J Hosp Pharm 50 :1170–1174. ASHP (American Society of Hospital Pharma

cists) [1990]. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm 47:1033–1049. ASHP/AHFS DI (American Hospital Formulary Service Drug Information) [2003]. AHFS drug in

formation online updates [www.ahfsdruginforma

tion.com]. ASHP/AHFS DI (American Hospital Formulary Service Drug Information) [2010]. AHFS drug in

formation online updates [www.ahfsdruginforma

tion.com]. Baker GL, Kahl LE, Zee BC, Stolzer BL, Agarwal AK, Medsger TA Jr [1987]. Malignancy following treatment of rheumatoid arthritis with cyclophos

phamide. Long-term case-control follow-up study. Am J Med 83 (1):1–9. CFR. Code of Federal regulations. Washington, DC: U.S. Government Printing Office, Office of the Federal Register. Chabner BA, Allegra CJ, Curt GA, Calabresi P [1996]. Antineoplastic agents. In: Hardman JG, Lim

bird LE, eds. Goodman and Gilman’s the pharma

cological basis of therapeutics. 9th ed. New York: McGraw-Hill, pp. 1233–1287. IARC [2010]. IARC monographs on the evaluation of the carcinogenic risk of chemicals to humans. Lyons, France: World Health Organization, Inter

national Agency for Research on Cancer. [www. iarc.fr]. Date accessed: March 2010. McDiarmid MA, Gurley HT, Arrington D [1991]. Pharmaceuticals as hospital hazards: managing the risks. J Occup Med 33 (2):155–158. Moody DJ, Kagan J, Liao D, Ellison GW, Myers LW [1987]. Administration of monthly-pulse cy

clophosphamide in multiple sclerosis patients. Effects of long-term treatment on immunologic parameters. J Neuroimmunol 14 (2):161–173. Naumann BD, Sargent EV [1997]. Setting occupa

tional exposure limits for pharmaceuticals. Occup Med: State of the Art Rev 12 (1):67–80. NIOSH [2004]. NIOSH alert: preventing occu

pational exposure to antineoplastic and other hazardous drugs in health care settings. U.S. De

partment of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004–165. PDR [2004]. Physician’s desk reference for drug interactions. Montvale, NJ: Thomson Healthcare [www.pdr.net/]. Date accessed: March 2004. REPROTOX [2003]. An information system on environmental hazards to human reproduction and development. Washington, DC: Columbia Hospital for Women Medical Center, Reproductive Toxicol

ogy Center [http://reprotox.org]. Date accessed: February 2004. Sargent EV, Kirk GD [1988]. Establishing airborne exposure control limits in the pharmaceutical in

dustry. Am Ind Hyg Assoc J 49 (6):309–313. Sargent EV, Naumann BD, Dolan DG, Faria EC, Schulman L [2002]. The importance of human data in the establishment of occupational expo

sure limits. Hum Ecol Risk Assess 8 (4):805–822. Schardein, JL [2000]. Chemically induced birth defects. 3rd ed., rev. New York: Marcel Deckker, Inc. Shepard TH [2001]. Catalog of teratogenic agents. 10th ed. Baltimore, MD: Johns Hopkins Univer

sity Press [www.depts.washington.edu/~terisweb]. Date accessed: Feb. 2004. Sweetman SC [2003]. Martindale: the complete drug reference. 33rd ed. London: Pharmaceutical Press.To receive NIOSH documents or more information aboutoccupational safety and health topics, contact NIOSH at1–800–CDC–INFO(1–800–232–4636)TTY: 1–888–232–6348E-mail: cdcinfo@cdc.govor visit the NIOSH Web site at www.cdc.gov/niosh.For a monthly update on news at NIOSH, subscribe toNIOSH eNewsby visitingwww.cdc.gov/niosh/eNews.DHHS (NIOSH) Publication No. 2010–167safer • healthier • peopletmDelivering on the Nation’s promise:safety and health at work for all peoplethrough research and prevention

DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Institute for Occupational Safety and Health 4676 Columbia Parkway Cincinnati, Ohio 45226–1998

Offi cial Business Penalty for Private Use $300