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, 2014 

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Centers for Disease Control and Prevention 

National Institute for Occupational Safety and Health 
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Suggested Citation 

NIOSH [2014]. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2014. By 

Connor TH, MacKenzie BA, DeBord DG, Trout DB, O'Callaghan JP.. Cincinnati, OH: U.S. Department of 

Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2014-138 (Supersedes 2012-150). 

DHHS (NIOSH) Publication Number 2014-138 (Supersedes 2012-150) 

September 2014 

SAFER • HEALTHIER • PEOPLETM 
Preamble:. The National Institute for Occupational Safety and Health (NIOSH) Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings was published 

in September 2004, http://www.cdc.gov/niosh/docs/2004-165/ . In Appendix A of the Alert, NIOSH identified a sample list of major hazardous drugs. The list was compiled from information provided by four 

institutions that had generated lists of hazardous drugs for their respective institutions, as well as a list 

from the Pharmaceutical Research and Manufacturers of America (PhRMA). The 20041ist was updated 

in 2010 and 2012. The curreiit update (2014) adds 27 drugs and includes a review of the 20041ist and the 

consequent removal of 12 drugs that did not meet the NIOSH criteria for hazardous drugs. In addition, 

a new format has been developed for the list of hazardous drugs, as described below. 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--frn.pdf. 

Appendix A * Drugs Considered Hazardous 

In the Alert (NIOSH 2O04) and updates to the hazardous drug list (NIOSH 2O12), NIOSH has recommended standard precautions or universal precautions be taken in handling hazardous drugs. Given 

the addition of many non-antineoplastic drugs and 

drugs in tablet and/or capsule form to the list, no 

single approach can cover the diverse potential 

occupational exposures to the drugs. The current 

NIOSH approach involves three groups of drugs: 

■ Group l: Antineoplastic drugs (AHFS Classification 10:00) [ASHP/AHFS DI 20131. Note that 

many of these drugs may also pose a reproductive risk for susceptible populations (Table 1). 

■ Group 2: Non-antineoplastic drugs that meet 

one or more of the NIOSH criteria for a hazardous drug. Note that some of these drugs may 

also pose a reproductive risk for susceptible 

populations (Table 2). 

■ Group 3: Drugs that primarily pose a reproductive risk to men and women who are actively 

trying to conceive and women who are pregnant 

or breast feeding, because some of these drugs 

may be present in breast milk (Table 3). 

The majority of the reproductive risks associated with the drugs listed in Table 3 are focused on 

women, but some can apply to men only (such as reduced fertility or sperm count) or to both men and 

women. Although all hazardous drugs should be 

handled accordingly, especially if they must be prepared aseptically, some populations of workers may 

not be at serious risk from handling drugs in Group 

3. These include workers who are excluded from the 

susceptible populations for specific reasons such as 

age or infertility. In addition, drugs for which the 

manufacturer includes safe-handling guidance in 

the package insert are indicated. NIOSH carries 

out a hazard identification on each drug on the 

basis of the NIOSH criteria for a hazardous drug. 

No attempt has been made to perform risk assessments on each drug or to propose exposure limits. 

NIOSH has provided guidance for personal protective equipment and ventilated engineering controls 

for some of the various scenarios in which a drug 

may be handled in health care settings (Table 5). 

This guidance cannot cover all possible situations 

but provides general recommendations for the major handling events typically seen in health care. 

Hazardous drugs include those used for cancer chemotherapy, antiviral drugs, hormoiies, some bioengineered drugs, and other miscellaneous drugs. The 

deiinition of hazardous drugs used in the Alert is 

based on a definition originally developed in 1990 

by the American Society of Hospital Pharmacists 
[ASHP 1990], currently known as the American 

Society of Health-System Pharmacists. Thus, the 

definition may not accurately reflect the potential 

toxicity criteria associated with some of the newer-generation pharmaceuticals entering the health 

care setting. For example, bioengineered drugs target specific sites in the body, and although they may 

or may not pose a risk to health care workers, some 

may pose a risk to patients. 

NIOSH and other organizations are still gathering 

data on the potential toxicity and health effects related to highly potent drugs and bioengineered drugs. 

Therefore, when working with any hazardous drug, 

health care workers should follow the approaches 

described in Table 5, along with any recommendations included in the manufacturer's Safety Data 

Sheet (SDS). 

The 1990 ASHP definition of hazardous drugs' was 

revised by the NIOSH Working Group on Hazardous Drugs for the Alert. Drugs considered hazardous include those that exhibit one or more of the 

following six characteristics in humans or animals: 

• Carcinogenicity 

• Teratogenicity or other developmental 

toxicityt 

• Reproductive toxicityt 

• Organ toxicity at low doses' 

• Genotoxicity$ 

• Structure and toxicity profiles of new drugs that 

nlinlic existing drugs determined hazardous by 

the above criteria 

ASHP defines hazardous drugs in its 1990 revision 

of the Technical Assistance Bulletin on Handling 

Hazardous Drugs [ASHP 1990]. The bulletin gives 

criteria for identifying potentially hazardous drugs 

that should be handled in accordance with an established safety program [McDiarmid et al. 1991; 

Arrington and McDiarmid 1993; ASHP 2006; Massoomi et al. 2008; Eisenberg 2009; ONS 2011]. The 

criteria are prioritized to reflect the hierarchy of 

potential toxicity described below. Since the hazardous drugs covered by the Alert were designed as 

therapeutic agents for humans, human toxicity profiles should be considered superior to any data from 

animal models or in vitro systems. Additional guidance for defining hazardous drugs is available in the 

following sources: carcinogenicity [61 Fed Regist 

17960-18011 (1996b); IARC 2014], teratogenicity 

[56 Fed Regist 63798-63826 (1991)], developmental toxicity [56 Fed Regist 63798-63826 (1991)], and 

reproductive toxicity [61 Fed Regist 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. 

*ASHP [1990] definition of hazardous drugs 

1. Genotoxicity (i.e., mutagenicity and clastogenicity in 

short-term test systems) 

2. Carcinogenicity in animal models, in the patient population, or both, as reported by the International Agency 

for Research on Cancer (IARC) 

3. Teratogenicity or fertility impairment in animal studies 

or in treated patients 

4. Evidence of serious organ or other toxicity at low doses 

in animal models or treated patients. 

'All drugs have toxic side effects, but some exhibit toxicity at 

low doses. 'Ihe level of toxicity reflects a continuum from relatively nontoxic to production of toxic efl'ects 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 in laboratory 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/m3after 

applying appropriate uncertainty 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. Regist. 34006-34012 (1986)]. 
NIOSH considers it to be highly relevailt. If doses producing an adverse effect are many tinles 

the MRHD, usually NIOSH does not consider 

them in its evaluation. 

Many hazardous drugs used to treat cancer (for example, alkylating agents) bind to or damage DNA. Other antineoplastic drugs, some antivirals, antibiotics, 

and bioengineered drugs interfere with cell growth or 

pl-oliferation, or with DNA synthesis. In some cases, 

the nonselective actions of these drugs disrupt the 

growth and function of both healthy and diseased 

cells, resulting in toxic side effects for treated patients 

and their offspring. These nonselective actions can 

also cause adverse effects in health care workers 

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 the Alert, other drugs may also be considered 

hazardous because they are potent (small quantities 

produce a physiological effect) or cause irreversible 

effects. As the use and number of these potent drugs 

increase, so do opportunities for hazardous exposures among health care workers. For example, antineoplastic drugs such as cyclophosphamide have 

immunosuppressant effects that proved beneficial 

for treating nonmalignant diseases such as rheumatoid arthritis and multiple sclerosis [Baker et a1.1987; 

Moody et al. 1987; Chabner et al. 1996; Abel 2000]. 

The lack of proper training for handling antineoplastic drugs in other specialty areas may be an issue that 

needs to be addressed [Polovich and Giesker 2011; 

Menonna-Quinn et al. 2013]. 

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 in the Alert 

should be applied when handling that drug. Also 

included is a list of drugs that should be handled as 

hazardous. When applying the criteria for a hazardous drug as outlined above, NIOSH takes the following approach. 

NIOSH takes into account the dose for animal 

testing, for reproductive and developmental toxicity, and for carcinogenicity testing. If adverse 

effects are observed near, at, or below the maximum recommended human dose (MRHD), 

• In addition to dose, for carcinogenicity testing 

NIOSH looks for tumors in more than one species 

and sex. It looks for tumors in multiple organs and 

for tumors that are not rodent-specific. Any available huiilan data are considered significant. 

• For effects of genotoxicity, NIOSH looks at ifr 

vivo testing over in vitro testing. However, adverse outcomes in several in vitro tests will be 

considered in its evaluation. 

For reproductive and developmental effects, 

NIOSH notes if there was maternal toxicity, in 

addition to the dose. Effects on the fetus in the 

absence of maternal toxicity are considered relevant. Drugs with an FDA pregnancy category X 

rating are typically listed as hazardous. Drugs in 

Category D are often listed as hazardous, but it 

will depend on the individual drug. Any available human data are considered significant. 

• For organ toxicity, the low dose criterion in the 

definition (a daily therapeutic dose of 10 mg/day 

or a dose of 1 mg/kg per day in laboratory animals) is used as a benchmark. 

• Drugs with safe-handling guidelines from the 

manufacturer are automatically put on the list 

because the manufacturer has decided their 

properties warrant special handling. 

In addition to using the list of hazardous drugs presented here, each organization should create its own 

list of drugs considered to be hazardous. This document presents guidance for making such a facility-specific list (see section entitled How to Generate 

Your Own List of Hazardous Drugs). Subsequently, 

newly purchased drugs should be evaluated against 

the organization's hazardous drug criteria and added to the list if they are deemed hazardous. Organizations have developed various approaches to identifying and classifying hazardous drugs [Chaffee et 

al. 2010; Badry et al. 2013; Kaestli et al. 2013]. Although the classification schemes may differ somewhat >the drugs listed as hazardous are quite similar. 

Individual organizations may not have adequate resources for determining their own list of hazardous 
drugs. If so, the list of hazardous drugs in t his document will help employers and workers to determine 

when precautions are needed. However, reliance 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 information becomes available. NIOSH will 

update this list periodically, adding new drugs considered to be hazardous and removing those that require reclassification. This hazardous drug list will 

be posted on the NIOSH website at www.cdc.gov/ 

niosh/topics/hazdrug/. 

'Ihe OSHA hazard communication standard [29 

CFR 1910.1200] requires eniployers to develop a 

hazard communication program appropriate for 

their unique workplaces. An essential part of the 

program is the identification 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. Institutions may wish to compare their lists to the listing in this document or on 

the NIOSH website. 

It is not l i kely that every health care provider or facility wi I I use all drugs that have received U.S. Food 

and Drug Administration (FDA) approval, 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 provide for assessment of new drugs as they 

enter the marketplace and, when appropriate, reassessment of their presence on hazardous drug lists 

as toxicological data become available to support 

re-categorization. Toxicological data are often incomplete or unavailable for investigational 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. 

With the increased availability of oral antineoplastic 

and other hazardous drugs, additional precautions are 

required in order to prevent worker exposure to these 

formulations. Some drugs defined as hazardous may 

not pose a significant risk of direct occupational exposure because of their dosage formulation (for example, 

coated tablets or capsules—solid, intact medications 

that are administered to patients without modifying 

the formulation). However, they may pose a risk if the 

formulations are altered, such as by crushing tablets or 

making solutions from them outside a ventilated cabinet [Simmons 2010; Goodin et al. 2011]. Uncoated tablets may present a risk of exposure from dust by skin 

contact and/or inhalation Nvhen the tablets are counted 

[Shahsavarani et a1.1993]. 

All hazardous drugs, regardless of the formulation, 

should be labeled as such to prevent improper handling. Tablet and capsule forms of hazardous drugs 

should not be placed in automated counting machines, which subject them to stress and may introduce powdered contaminants into the work area. 

Counting and pouring of hazardous drugs should be 

done carefully, and clean equipment should be dedicated for use with these drugs. Crushing tablets or 

opening capsules should be avoided and liquid formulations should be used whenever possible. During 

the compounding of hazardous drugs (e.g., crushing, 

dissolving, or preparing a solution or an ointment), 

workers should wear non-permeable gowns and 

double gloves (Table 5). Guidelines for the safe compounding, administration, and disposal of hazardous 

drugs have been developed by several organizations 

[NIOSH 2O04; ASHP 2006; ONS 2011; USP 2014]. 

Practice-specific lists of hazardous drugs (usually 

developed by pharmacy or nursing departments) 

should be comprehensive, including all hazardous 

medications routinely used or very likely to be used 
by a local practice. Here are some of the resources 

that employers can use to evaluate the hazard potential of a drug: 

• Safety Data Sheets (SDSs, formally Material 

Safety Data Sheets) 

• Product labeling approved by the U.S. FDA 

(drug package inserts) 

• International Agency for Research on Cancer 

(IARC) http://www.iarc.fr 

• Drugbank: http://www.drugbank.ca/ 

• DailyMed: http://dailymed.nlm.nih.gov/dailymed/ 

• Special health warnings from drug ilianlli -acturers, FDA, and other professional groups and 

organizations 

• Reports and case studies published in medical 

and other health care profession journals 

• Evidence-based recommendations fronm other 

facilities that meet the criteria defining hazardous drugs 

'Ihe following list (Tables 1-3) contains those drugs 

that NIOSH has reviewed according to the criteria 

in the NIOSH definition of a hazardous drug. The 

list was compiled from the following: 

• the original list published in 2004 (NIOSH 

2004), which was a compilation of five lists available to NIOSH at the time (subsequently, the list 

was re-evaluated against the NIOSH criteria and 

several drugs were removed; Table 4a) 

• the 2012 NIOSH update to the list 

• the NIOSH 2O14 update to the list, for which 27 

drugs were added (including five with manufacturers' safe-handling warnings) and one drug, 

tetracycline, was deleted on the basis of re-evaluation and feedback from stakeholders (Table 4b). 

The OSHA hazard communication standard requires hazardous drugs to be handled with use of 

special precautions. The mandate applies not only to 

health care professionals who provide direct patient 

care but also to others who support patient care by 

participating in product acquisition, storage, transportation, housekeeping, and waste disposal. Institutions may want to adopt this list or compare theirs 

with the list on the NIOSH website. 

CAUTION: Drugs purchased and used by a facility 

may have entered the marketplace after the list below was assembled. Therefore, this list may not be 

all-inclusive. 

I f you use a drug that is not included in the list of 

hazardous drugs, check the available literature to 

see whether the unlisted drug should be treated as 

hazardous. Check the SDS from the manufacturer or the drug package insert. You lnay also check 

with other institutions that might be using the same 

drug. If any of the documents mention carcinogenicity, genotoxicity, teratogenicity (Section 13 in 

package insert), or reproductive or developmental 

toxicity (Section 8), or if the package insert contains 

safe-handling warnings (Section 16), use the precautions stipulated in the Alert. If the drug meets 

one or more of the criteria for hazardous drugs in 

the NIOSH definition, handle it as hazardous. 

The list of hazardous drugs will be updated periodically on the website, hpp://www.cdc.gov/niosh/topics/hazdrug/. 

This list supersedes both the 20041ist, http://www. 

cdc.gov/niosh/docs/2004-165/and the 2012 list 

http://www.cdc.gov/niosh/docs/2012-150. 

Abel EA [2000]. Immunosuppressant and cytotoxic 

drugs: unapproved uses or indications. Clin Dermatol 18:95-101. 

Arrington DM, McDiarmid MA [1993]. Comprehensive 

program for handling hazardous drugs. Am J Hosp 

Pharm 50:1170-1174. 

ASHP (American Society of Hospital Pharmacists) 

[1990]. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp 

Pharm 47:1033-1049. 

ASHP (American Society of Health-System Pharmacists) 

[2006]. ASHP guidelines on handling hazardous 

drugs. Am J Health-Syst Pharm 63:1172-1193. 

ASHP/AHFS DI (American Hospital Formulary Service 

Drug Information) [2013]. AHFS drug information 

online updates, www.ahfsdruginformation.com . 
Baker GL, Kahl LE, Zee BC, Stolzer BL, Agarwal AK, 

Medsger TA Jr [1987]. Malignancy following treatment of rheumatoid arthritis with cyclophosphamide. Long-term case-control follow-up study. Am J 

Med 83(1):1-9. 

Badry N, Fabbro J, de Lemos ML [2013]. Hazards in 

determining whether a drug is hazardous. J Oncol 

Pharm Pract. doi: 10.1177/1078155213496675 (published online 20 August). 

CFR. Code of Federal regulations. NNashington, 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, Limbird LE, 

eds. Goodman and Gilman's the pharmacological basis of therapeutics. 9th ed. New York: McGraw-Hill, 

pp. 1233-1287. 

Chaffee BW, Armistead JA, Benjamin BE, Cotugno MC, 

Forrey RA, Hintzen BL, Pfeiffenberger T, Stevenson 

JG [2010]. Guidelines for the safe handling of hazardous drugs: consensus recommendations. Am J 

Health-Syst Pharm 67:1545-1546. 

Eisenberg S[2009]. Safe handling and administration of 

antineoplastic chemotherapy. J Infus Nurs 32(1):23- 

32. 

Goodin S, Griffith N, Chen B, Chuk K, Daouphars M, 

Doreau C, 1'atel RA, Schwartz R, Tames MJ, Terkola 

R, Vadnais B, Wright D, Meier K[2011]. Safe handling of oral chemotherapeutic agents in clinical 

practice: recommendations from an international 

pharmacy panel. J Oncol Pract 7(1):7-8. 

IARC [2014]. IARC monographs on the evaluation of 

the carcinogenic risk of chemicals to humans. Lyon, 

France: World Health Organization, International 

Agency for Research on Cancer. www. iarc.fr . Date 

accessed: March 2014. 

Kaestli L-Z, Fonzo-Christe C, Bonfillon C, Desmueles 

J, Bonnabry P[2013]. Development of a standardized 

method to recommend protective measures to handle hazardous drugs in hospitals. Eur J Hosp Pharm 

20:100-105. 

Massoomi F, Neff B, Rick A, Denekas P[2008]. Implementation of a safety program for handling hazardous drugs in a community hospital. Am J Heath-Sys 

Pharm 65:861-865. 

McDiarmid MA, Gurley HT, Arrington D[1991]. Pharmaceuticals as hospital hazards: managing the risks. J 

Occup Med 33(2):155-158. 

Menonna-Quinn D[2013]. Safe handling of chemotherapeutic agents in the treatment of nonmalignant diseases. J Infus Nurs 36(3):198-204. 

Moody DJ, Kagan J, Liao D, Ellison GW, Myers LW 

[1987]. Administration of monthly-pulse cyclophosphamide in multiple sclerosis patients. Effects of 

long-term treatment on immunologic parameters. J 

Neuroimmuno114(2):161-173. 

Naumann BD, Sargent EV [1997]. Setting occupational exposure limits for pharmaceuticals. Occup Med: 

State of the Art Rev 12(1):67-80. 

NIOSH [2004]. NIOSH alert: preventing occupational exposure to antineoplastic and other hazardous 

drugs in health care settings. U.S. Department 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. 

NIOSH [2012]. NIOSH list of antineoplastic and other 

hazardous drugs in healthcare settings. Cincinnati, 

OH: U.S. Department of Health and Human Services, 

Centers for Disease Control and Prevention, National 

Institute for Occupational Safety and Health, DHHS 

(NIOSH) Publication No. 2012-150 (September). 

http:// nioshdev.cdc.gov/niosh/docs/2012-150. 

ONS (Oncology Nursing Society) [2011]. Safe handling 

of hazardous drugs. 2nd Ed. M. Polovich, ed. Pittsburgh, PA: Oncology Nursing Society. 

Polovich M, Giesker KE [2011]. Occupational hazardous 

drug exposure among non-oncology nurses. Medsurg 

Nurs 20(2):79-85,97. 

Sargent EV, Kirk GD [19881. Establishing aii - borne exposure control limits in the pharmaceutical industry. 

Am Ind Hyg Assoc J 49(6):309-313. 

Sargent EV, Naumann BD, Dolan DG, Faria EC, Schulman L[2002]. The importance of huilian data in the 

establishment of occupational exposure limits. Hum 

Ecol Risk Assess 8(4):805-822. 

Shahsavarani S, Godefroid RJ, Harrison BR [1993]. Evaluation of occupational exposure to tablet trituration 

dust [abstract]. ASHP Midyear Clinical Meeting. 

Document No. P-59(E). 

Simmons CC [2010]. Oral chemotherapeutic drugs: handle with care. Nursing 40(7):44-47. 

U.S. Pharmacopeia (USP) [2014]. Pharmaceutical Compounding: Sterile Preparations. Revised chapter 797 

(USP 37-NF 32). 

This document was written by 'Ihomas H. Connor, 

PhD; Barbara A. MacKenzie, BS; D. Gayle DeBord, 

PhD; Douglas B. Trout, MD, MHS; and James P. 

O'Callaghan, PhD, all of NIOSH. 

Seleen Collins provided editorial services. Ryan 

Dufour, Nicole Romero, and Vanessa Williams provided graphic design and production services. 
NIOSH List of Antineoplastic and Other Hazardous Drugs 

in Healthcare Settings 2014 

NIOSH performs a hazard identification on each of 

the drugs in the following tables. The actual risk to 

health care workers depends on what is done with 

the drugs—how they are manipulated, how often 

they are handled, and what type of engineering controls and personal protective equipment (PPE) are 

used (see Table 5). For example, 

• Dispensing a single tablet to a patient poses little 

to no risk to the healthcare worker. A single pair 

of gloves would be adequate. 

• Repeatedly counting, cutting, or crushing tablets may pose a higher risk of worker exposure 

and contamination to the workplace if proper 

precautions are not in place. If a containment 

device such as a BSC (Class II biological safety 

cabinet) or CACI (compounding aseptic containment isolator) is not available, then double 

gloves, a protective gown, respiratory protection, and a disposable pad to protect the work 

surface should be used. 

Preparing a number of intravenous doses of an 

antineoplastic drug typically poses a higher potential risk to the worker. In addition to double 

gloving and a protective gown, an engineering 

control such as a BSC or CACI, possibly supplemented with a CSTD (closed system drug transfer device), is required to protect the drug, environment, and health care worker. 
The drugs in Table 1 meet one or more of the NIOSH criteria for a hazardous drug. These drugs represent an 

occupational hazard to health care workers and should always be handled ivith use of reconimended engineering controls and personal protective equipment (PPE), regardless of their formulation (IV [intravenous], 

SC [subcutaneous], topical, tablet, or capsule). Unopened, intact tablets and capsules may not pose the same 

degree of occupational exposure risk as injectable drugs, which usually require extensive preparation. Cutting, crushing or otherwise manipulating tablets and capsules will increase the risk of exposure to workers. 

In addition to many of these drugs being cytotoxic, the niajority are hazardous to males or females who are 

actively trying to conceive, women who are pregnant or may become pregnant, or women who are breast feeding, because they may be present in breast milk. Manufacturers' safe-handling guidance (MSHG) is typically 

in Sectioii 16 of the drug package insert. See Table 5 for safe-handling recommendations. AHFS = American 

Hospital Formulary Service; MHRD = maximum recommended human dose. 

'Drugs in red font were added in 2014. 

"International Agency for Research on Cancei -(www.iarc.fr). 

"'BCG, although classified as a vaccine, is used in the treatment of certain cancers. BCG should be prepared 

with 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 reconiinended. All 

equipmeiit, supplies, and receptacles in contact with BCG should be liandled and disposed of as biohazardous. 

If preparation cannot be performed in a containment device, then respiratory protection, gloves, and a gown 

should be woi- n to avoid inhalation or contact with BCG organisms. 

Table 1. Antineoplastic drugs including those with 

manufacturers" safe handling guidance (MSHG) 

Drug AHFS classification MSHG Reason for listing Links 

abiraterone* 10:00 antineoplastic agents 

ado- 10:00 antineoplastic agents yes 

trastuzumab 

emtansine 

altretamine 10:00 antineoplastic agents yes 

amsacrine NA antineoplastic agents yes 

anastrozole 10:00 antineoplastic agents 

arsenic trioxide 10:00 antineoplastic agents yes 

azacitidine 10:00 antineoplastic agents yes 

bacillus 80:12 vaccines yes 

calmette Guerin 

(BCG)*** 

bendamustine 10:00 antineoplastic agents yes 

bexarotene 10:00 antineoplastic agents 

FDA Pregnancy Category X DailyMed; DrugBank 

Conjugated monoclonal DailyMed; DrugBank 

antibody; FDA Pregnancy 

Category D 

FDA Pregnancy category D DailyMed; DrugBank 

IARC Group 2B DrugBank 

FDA Pregnancy category X DailyMed; DrugBank 

IARC Group 1 carcinogen**; DailyMed; DrugBank 

FDA Pregnancy Category D 

IARC Group 2A carcinogen; DailyMed; DrugBank 

FDA Pregnancy Category D 

See special handling DailyMed 

requirements**; FDA Pregnancy Category C 

FDA Pregnancy Category D DailyMed; 

FDA Pregnancy Category X DailyMed; DrugBank 

(continued) 

8 
Table 1(Contintued). Antineoplastic drugs including those with 

manufacturers' safe handling guidance (MSHG) 

Drug AHFS classification MSHG Reason for listing Links 

bicalutimide 10:00 antineoplastic agents FDA Pregnancy Category X DailyMed; DrugBank 

bleomycin 10:00 antineoplastic agents yes IARC Group 213; FDA Preg- DailyMed; DrugBank 

nancy Category D 

bortezomib 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

brentuximab 10:00 antineoplastic agents yes Conjugated monoclonal DailyMed; DrugBank 

vedotin antibody; FDA Pregnancy 

Category D 

busulfan 10:00 antineoplastic agents yes IARC Group 1 carcinogen; DailyMed; DrugBank 

FDA Pregnancy Category D 

cabazitaxel 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

capecitabine 10:00 antineoplastic agents yes Metabolized to 5-fluoro- DailyMed; DrugBank 

uracil; FDA Pregnancy Category D 

carboplatin 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

carmustine 10:00 antineoplastic agents yes IARC Group 2A carcinogen; DailyMed; DrugBank 

FDA Pregnancy Category D 

chlorambucil 10:00 antineoplastic agents yes IARC Group 1 carcinogen; DailyMed; DrugBank 

FDA Pregnancy Category D 

cisplatin 10:00 antineoplastic agents yes IARC Group 2A carcinogen; DailyMed; DrugBank 

FDA Pregnancy Category D 

cladribine 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

clofarabine 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

crizotinib 10:00 antineoplastic agents FDA Pregnancy Category D DailyMed 

cyclophospha- 10:00 antineoplastic agents yes IARC Group 1 carcinogen; DailyMed; Drugbank 

mide FDA Pregnancy Category D 

cytarabine 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

dacarbazine 10:00 antineoplastic agents yes FDA Pregnancy Category C DailyMed; Drugbank 

dactinomycin 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

dasatinib 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; Drugbank 

daunorubicin 10:00 antineoplastic agents yes IARC Group 213, AKA dauno- DailyMed; Drugbank 

mycin; FDA Pregnancy Category D 

(continued) 

9 
Table 1(Contintued). Antineoplastic drugs including those with 

manufacturers' safe handling guidance (MSHG) 

Drug AHFS classification MSHG Reason for listing Links 

decitabine 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; Drugbank 

degarelix 10:00 antineoplastic agents FDA Pregnancy Category X DailyMed; Drugbank 

docetaxel 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

doxorubicin 10:00 antineoplastic agents yes IARC Group 2A carcinogen; DailyMed; DrugBank 

FDA Pregnancy Category D 

epirubicin 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; Drugbank 

eribulin 10:00 antineoplastic agents FDA Pregnancy Category D DailyMed; DrugBank 

erlotinib 10:00 antineoplastic agents FDA Pregnancy Category D DailyMed; DrugBank 

estramustine 10:00 antineoplastic agents yes FDA Pregnancy Category X DailyMed; Drugbank 

etoposide 10:00 antineoplastic agents yes IARC Group 1 carcinogen; DailyMed; DrugBank 

FDA Pregnancy Category D 

everolimus 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; Drugbank 

exemestane 10:00 antineoplastic agents FDA Pregnancy Category X DailyMed; DrugBank 

floxuridine 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

fludarabine 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

fluorouracil 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

flutamide 10:00 antineoplastic agents Indicated only for men; FDA DailyMed; DrugBank 

Pregnancy Category D 

fulvestrant 10:00 antineoplastic agents FDA Pregnancy Category D DailyMed; DrugBank 

gemcitabine 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

gemtuzumab 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

ozogamicin 

goserelin 10:00 antineoplastic agents FDA Pregnancy Category X DailyMed; Drugbank 

hydroxyurea 10:00 antineoplastic agents yes Special warning on handling DailyMed; DrugBank 

bottles and capsules 

FDA Pregnancy Category D 

idarubicin 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

ifosfamide 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

(continued) 

10 
Table 1(Contintued). Antineoplastic drugs including those with 

manufacturers' safe handling guidance (MSHG) 

Drug AHFS classification MSHG Reason for listing Links 

imatinib 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

irinotecan 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

ixabepilone 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

letrozole 10:00 antineoplastic agents FDA pregnancy Category X DailyMed; DrugBank 

leuprolide 10:00 antineoplastic agents yes FDA Pregnancy Category X DailyMed; Drugbank 

lomustine 10:00 antineoplastic agents yes IARC Group 2A carcinogen; DailyMed; DrugBank 

FDA Pregnancy Category D 

mechlorethamine 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

megestrol 10:00 antineoplastic agents FDA Pregnancy Category X DailyMed; DrugBank 

melphalan 10:00 antineoplastic agents yes IARC Group 1 carcinogen; DailyMed; DrugBank 

FDA Pregnancy Category D 

mercaptopurine 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

methotrexate 10:00 antineoplastic agents yes FDA Pregnancy Category X DailyMed; DrugBank 

mitomycin 10:00 antineoplastic agents yes IARC Group 2B; FDA Preg- DailyMed; DrugBank 

nancy Category D 

mitotane 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

mitoxantrone 10:00 antineoplastic agents yes IARC Group 2B; FDA Preg- DailyMed; DrugBank 

nancy Category D 

nelarabine 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

nilotinib 10:00 antineoplastic agents FDA Pregnancy Category D DailyMed; DrugBank 

omacetaxin 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

oxaliplatin 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

paclitaxel 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

pazopanib 10:00 antineoplastic agents FDA Pregnancy Category D DailyMed; DrugBank 

pemetrexed 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

pentostatin 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

pralatrexate 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

(continued) 

m 
Table 1(Contintued). Antineoplastic drugs including those with 

manufacturers' safe handling guidance (MSHG) 

Drug AHFS classification MSHG Reason for listing Links 

procarbazine 10:00 antineoplastic agents yes IARC Group 2A carcinogen; DailyMed; DrugBank 

FDA Pregnancy Category D 

romidepsin 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed 

sorafenib 10:00 antineoplastic agents FDA Pregnancy Category D DailyMed; DrugBank 

streptozocin 10:00 antineoplastic agents yes IARC Group 213; FDA Preg- DailyMed; DrugBank 

nancy Category D 

sunitinib 10:00 antineoplastic agents FDA Pregnancy Category D DailyMed; DrugBank 

tamoxifen 10:00 antineoplastic agents IARC Group 1 carcinogen; DailyMed; DrugBank 

FDA Pregnancy Category D 

temozolomide 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

temsirolimus 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

teniposide 10:00 antineoplastic agents yes IARC Group 2A carcinogen; DailyMed; DrugBank 

FDA Pregnancy Category D 

thioguanine 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

thiotepa 10:00 antineoplastic agents yes IARC Group 1 carcinogen; DailyMed; DrugBank 

FDA Pregnancy Category D 

topotecan 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

toremifene 10:00 antineoplastic agents FDA Pregnancy Category D DailyMed; DrugBank 

trimetrexate 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

triptorelin 10:00 antineoplastic agents FDA Pregnancy Category X DailyMed 

valrubicin 10:00 antineoplastic agents yes FDA Pregnancy Category C DailyMed; DrugBank 

vandetanib 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

vemurafenib 10:00 antineoplastic agents FDA Pregnancy Category D DailyMed; DrugBank 

vinblastine 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

vincristine 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; Drugbank 

vinorelbine 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank 

vorinostat 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; Drugbank 

12 
The drugs in Table 2 meet one or more of the NIOSH criteria for a hazardous drug. Unopened, intact tablets 

and capsules may not pose the same degree of occupational exposure risk as injectable drugs, which usually 

require extensive preparation. Cutting, crushing, or otherwise manipulating tablets and capsules will increase 

the risk of exposure to workers. Some of these drugs may represent an occupational hazard to males or females 

who are actively trying to conceive, women wllo are pregnant or may become pregnant, or wonien who are 

breast feeding, because they may be present in breast milk. Manufacturers' safe-handling guidance (MSHG) 

is typically in Section 16 of the drug package insert. See Table S for safe-handling recommendations. AHFS = 

American Hospital Formulary Service; MHRD = maximum recommended human dose. 

'Drugs in red font were added in 2014. 

"International Agency for Research on Cancer, www.iarc.fr 

"'Drugs in blue font meet one or more additional criteria for a hazardous drug and also pose a potential reproductive hazard. 

Table 2. Non-antineoplastic drugs that meet one or more of the NIOSH criteria for a 

hazardous drug including those with manufacturers' safe handling guidance (MSHG) 

Drug AHFS classification MSHG Reason for listing Links 

abacavir' 8:18.08.20 nucleoside and FDA Pregnancy Category C; DailyMed; DrugBank 

reverse transcriptase malignant tumors observed 

inhibitors in male and female mice 

arid rats; genotoxic in in vivo 

micronucleus test. 

alefacept 84:92 skin and mucous 

membrane agents, miscellaneous 

apomorphine 28:36.20.08 Nonergotderivative dopamine 

receptor agonists 

azathioprine 92:44 immunosuppressant yes 

agents 

carbamazepine 28:12:92 anticonvulsants, 

miscellaneous 

Increased frequency of DailyMed; DrugBank 

malignancies observed in 

treated patients; FDA Pregnancy Category B 

FDA Pregnancy Category C; DailyMed; DrugBank 

genotoxic in several in vitro 

assays. 

IARC Group 1 carcinogen**; DailyMed; DrugBank 

FDA Pregnancy Category D*** 

Black Box warning for DailyMed; Drugbank 

aplastic anemia; congenital 

malformations in offspring 

of mothers who took drug; 

rapid transplacental passage; 

FDA Pregnancy 

Category D 

(continued) 

13 
Table 2(Contintued). Non-antineoplastic drugs that meet one or more of the 

NIOSH criteria for a hazardous drug including those with 

manufacturers' safe handling guidance (MSHG) 

Drug AHFS classification MSHG Reason for listing Links 

chloramphenicol 8:12:08 chloramphenicols IARC Group 2A carcinogen; DailyMed; DrugBank 

FDA Pregnancy Category C 

cidofovir 8:18:32 nucleoside and yes FDA Pregnancy Category C DailyMed; Drugbank 

nucleotides 

cyclosporine 92:44 immunosuppressive IARC Group 1 carcinogen; DailyMed; Drugbank 

agents FDA pregnancy Category C 

deferiprone 64:00 Heavy metal Genotoxic in vitro and in vivo; DailyMed; DrugBank 

antagonists FDA Pregnancy 

Category D 

dexrazoxane 92:56 protective agents yes FDA Pregnancy Category C; DailyMed; DrugBank 

secondary malignancies 

observed in patients treated 

long term with Razoxane (a 

racemic mixture containing 

dexrazane); genotoxic in 

vitro and in vivo; in laboratory studies, testicular 

atrophy observed at or 

below the human dose 

diethylstilbestrol NA IARC Group 1 carcinogen; DrugBank 

FDA Pregnancy Category X 

divalproex 28:12:92 anticonvulsants, Black Box warning for tera- DailyMed 

miscellaneous togenicity; FDA Pregnancy 

Category D; tumors seen in 

laboratory studies at doses 

below MRHD 

enticavir 8:18:32 nucleosides and yes FDA Pregnancy Category C DailyMed; DrugBank 

nucleotides 

(continued) 

14 
Table 2(Continued). Non-antineoplastic drugs that meet one or more of the 

NIOSH criteria for a hazardous drug including those with 

manufacturers' safe handling guidance (MSHG) 

Drug AHFS classification MSHG Reason for listing Links 

estradiol 68:16:04 estrogens Black Box warning for malig- DailyMed; DrugBank 

nant neoplasms; increased 

risk of endometrial cancer, 

breast cancer, and ovarian 

cancer; in laboratory studies, 

increased frequency of carcinomas of the breast, uterus, 

cervix, vagina, testis, and 

liver; present in breast milk; 

FDA Pregnancy Category X 

estrogen/ 68:12 contraceptives IARC Group 1 carcinogen; DailyMed 

progesterone FDA Pregnancy Category X 

combinations 

estrogens, 68:16:04 estrogens Black Box warning for endo- DailyMed 

conjugated metrial cancer and cardiovascular risks; long-term use 

in women and laboratory 

studies increases frequency 

of several cancers; FDA Pregnancy Category X 

estrogens, 68:16:04 estrogens 

esterified 

estropipate 68:16:04 estrogens 

fingolimod 92:20 biologic response 

modifiers 

Black Box warning for DailyMed 

endometrial cancer and cardiovascular risks: FDA Pregnancy Category X 

Black Box warning for endo- DailyMed; DrugBank 

metrial carcinoma in postmenopausal women and 

use during pregnancy; FDA 

Pregnancy Category X 

FDA Pregnancy Category DailyMed; DrugBank 

C; in laboratory studies, 

increased malformations 

and embryo-fetal deaths at 

less than the RHD; malignant 

lymphomas observed in 

male and female mice. 

(continued) 

15 
Table 2(Continued). Non-antineoplastic drugs that meet one or more of the 

NIOSH criteria for a hazardous drug including those with 

manufacturers' safe handling guidance (MSHG) 

Drug AHFS classification MSHG Reason for listing Links 

fluoxymesterone 68:08 androgens Tumors in mice and rats and DailyMed; DrugBank 

possibly humans; FDA Pregnancy Category X 

fosphenytoin 28:12.12 hydantoins Metabolized to phenytoin; DailyMed; DrugBank 

FDA Pregnancy Category D 

ganciclovir 8:18:32 nucleosides and yes FDA Pregnancy Category C DailyMed; DrugBank 

nucleotides 

leflunomide 92:36 disease-modifying Teratogenic in laboratory DailyMed; DrugBank 

antirheumatic agents studies at 1/10 HD; marked 

postnatal survival at 1/100 

HD; FDA Pregnancy Category X; severe liver injury 

reported in patients; carcinogenicity observed at doses 

below HD 

lenalidomide 92:20 biologic response yes Analog of thalidomide; FDA DailyMed; DrugBank 

modulators Black box warnings for limb 

abnormalaties; pregnancy Category X; in laboratory studies, 

caused thalidomide-type limb 

defects in monkey offspring 

liraglutide 68:20.06 incretin mimetics FDA Pregnancy Category C; DailyMed; DrugBank 

recombinant Black Box warning for thyroid C-cell tumors, with 

supporting evidence in laboratory studies; also in laboratory studies, teratogenic at 

or below the MRHD. 

medroxyproges- 68:32 progestins yes IARC Group 2B; FDA Preg- DailyMed; DrugBank 

terone acetate nancy Category X 

(continued) 

16 
Table 2(Continued). Non-antineoplastic drugs that meet one or more of the 

NIOSH criteria for a hazardous drug including those with 

manufacturers' safe handling guidance (MSHG) 

Drug AHFS classification MSHG Reason for listing Links 

mycophenolate 92:44 immunosuppressive Black Box warning for DailyMed; DrugBank 

mofetil agents embryo fetal toxicity, malignancies and serious infections; Increased risk of firsttrimester pregnancy loss and 

increased risk of congenital 

malformations; FDA Pregnancy Category D; Special 

warning: tablets should not 

be crushed and capsules 

should not be opened or 

crushed. Avoid inhalation 

or direct contact with skin 

or mucous membranes of 

the powder contained in 

capsules and oral suspension 

(before or after constitution). 

If such contact occurs, wash 

thoroughly with soap and 

water; rinse eyes with plain 

water. 

mycophenolic 92:44 immunosuppressive Black Box warning for first DailyMed; DrugBank 

acid agents trimester pregnancy loss 

and an increased risk of congenital malformations; FDA 

Pregnancy Category D; Black 

Box warning for lymphomas 

and other malignancies; 

genotoxic in vitro and in vivo 

nevirapine 8:18.08.16 nonnucleoside FDA Pregnancy Category B; DailyMed; DrugBank 

reverse transcriptase in laboratory studies, hepainhibitors tocellular adenomas and carcinomas at doses lower than 

human dose. 

oxcarbazepine 28:12:92 anticonvulsants, Tumors observed in labora- DailyMed; Drugbank 

miscellaneous tory studies at 1/10 MRHD; 

FDA Pregnancy Category C 

(continued) 

17 
Table 2(Continued). Non-antineoplastic drugs that meet one or more of the 

NIOSH criteria for a hazardous drug including those with 

manufacturers' safe handling guidance (MSHG) 

Drug AHFS classification MSHG Reason for listing Links 

palifermin 84:16 cell stimulants and 

proliferants 

phenoxyben- 12:16:04:04 non-selective 

zamine alpha-andrenergic blocking 

agents 

phenytoin 28:12.12 hydantoins 

pipobroman NA 

progesterone 68:32 progestins 

progestins 68:12 contraceptives 

propylthiouracil 68:36.08 antithyroid agents 

raloxifene 68:16:12 estrogen agonists-antagonists 

rasagiline 28:36 antiparkinsonian 

agents 

risperidone 28:16:08:04 atypical antipsychotics 

sirolimus 92:44 immunosuppressive 

agents 

FDA Pregnancy Category C; DailyMed; Drugbank 

potential for stimulation of 

tumor growth 

IARC Group 2B; FDA Preg- DailyMed; DrugBank 

nancy Category C 

IARC 2B; FDA Pregnancy Cat- DailyMed; DrugBank 

egory D 

FDA Pregnancy Category D Drugbank 

IARC Group 2B DailyMed; Drugbank 

FDA Pregnancy Category X 

IARC 2B; FDA Pregnancy Cat- DailyMed; DrugBank 

egory D 

Abortion and developmental DailyMed; Drugbank 

abnormalities seen at low 

doses in laboratory studies; 

evidence of tumors at low 

doses in laboratory studies; 

FDA Pregnancy Category X 

FDA Pregnancy Category C DailyMed; Drugbank 

Evidence of tumors at low DailyMed; DrugBank 

doses in laboratory studies; 

may be prolactin-mediated; 

FDA Pregnancy Category C 

AKA rapamycin; increased DailyMed; DrugBank 

risk of lymphomas and other 

malignancies; embryotoxic 

and fetotoxic at 0.2 HD; FDA 

Pregnancy Category C 

(continued) 

18 
Table 2(Continued). Non-antineoplastic drugs that meet one or more of the 

NIOSH criteria for a hazardous drug including those with 

manufacturers' safe handling guidance (MSHG) 

Drug AHFS classification MSHG Reason for listing Links 

spironolactone 24:32.20 mineralocorticoid FDA Pregnancy Category C; DailyMed; DrugBank 

receptor antagonists black box warning for 

tumorogenicity in laboratory 

studies. 

tacrolimus 92:44 immunosuppressive Increased risk of lymphomas DailyMed; DrugBank 

agents and other malignancies; 

reproductive effects seen in 

laboratory studies below the 

MRHD; excreted in breast 

milk; FDA Pregnancy Category C 

thalidomide 92:20 biologic response yes FDA Pregnancy Category X DailyMed; DrugBank 

modulators 

uracil mustard NA yes FDA Pregnancy Category D DrugBank 

valganciclovir 8:18:32 nucleosides and yes FDA Pregnancy Category C DailyMed; DrugBank 

nucleotides 

zidovudine 8:18:08 antiretroviral agents IARC Group 213; FDA Preg- DailyMed; DrugBank 

nancy Category C 

19 
The drugs in Table 3 primarily meet the NIOSH criteria for reproductive hazards. They represent a potential 

occupational hazard to males or females who are actively trying to conceive, women who are pregnant or 

may become pregnant, or breast feeding as they may be present in breast milk. Unopened, intact tablets and 

capsules may not pose the same degree of occupational risk as injectable drugs that usually require extensive 

preparation. Cutting, crushing or otherwise manipulating tablets and capsules will increase the risk of exposure to workers. Manufacturers' safe handling guidance (MSHG) is typically in Section 16 of the drug package 

insert. See Table S for safe handling recommendations. 

'Drugs in red font were added in 2014. 

Table 3. Non-antineoplastic drugs that primarily have adverse reproductive effects 

Drug AHFS classification Reason for listing Links 

acitretin 88:04 vitamin A Black Box warning on adverse DailyMed; DrugBank 

reproductive effects; FDA 

Pregnancy Category X 

alitretinoin 84:92 skin and mucous FDA Pregnancy Category D DailyMed; DrugBank 

membrane agents, miscellaneous 

ambrisentan 24:12:92 vasodilating agents, Black Box warning on adverse DailyMed; 

miscellaneous reproductive effects; reduced 

sperm counts in patients; FDA 

Pregnancy Category X 

bosentan 24:12:92 vasodilating agents, Black Box warning on adverse DailyMed; DrugBank 

miscellaneous reproductive effects; FDA 

Pregnancy Category X 

cabergoline 28:36:20:04 ergot-derivative Inhibition of conception and DailyMed; DrugBank 

dopamine receptor agonists embryo fetal effects at doses 

below recommended human 

dose; FDA Pregnancy Category B 

cetrorelix 92:40 gonadotropin- FDA Pregnancy Category X DailyMed; DrugBank 

releasing hormone anagonists 

choriogonado- 68:18 gonadotropins FDA pregnancy Category C; DailyMed; DrugBank 

tropin may cause fetal harm when 

administered to a pregnant 

woman. 

(continued) 

20 
Table 3(Continued). Non-antineoplastic drugs that primarily 

have adverse reproductive effects 

Increased risk of congenital DailyMed; DrugBank 

abnormalities when taken in 

first trimester; FDA Pregnancy 

Category D 

FDA Pregnancy Category C; DailyMed; DrugBank 

published animal reproduction and development studies 

indicate it causes embryofetal 

toxicity, teratogenicity, and 

altered postnatal development at exposures within or 

above the clinical therapeutic 

range 

Hazardous only for women DailyMed; DrugBank 

in late pregnancy; FDA Pregnancy Category C 

Teratogenic in laboratory DailyMed; DrugBank 

studies at'/z MRHD; FDA Pregnancy Category X 

Women warned not to DailyMed; DrugBank 

handle; FDA Pregnancy Category X 

Use is contraindicated during DailyMed; DrugBank; 

pregnancy because of its DrugBank 

uterotonic effects; FDA Pregnancy Category C 

Women shoutd not handle DailyMed; Drugbank 

crushed or broken finasteride 

tablets when they are pregnant or may potentially be 

pregnant due to potentia) 

risk to a male fetus; FDA Pregnancy Category X 

Drug AHFS classification Reason for listing Links 

clonazepam 28:12:08 benzodiapines 

colchicine 92:16 antigout agents 

dinoprostone 76:00 oxytocics 

dronedarone 24:04:04 antiarrythmics 

dutasteride 92:08 S-alpha reductase 

inhibitors 

ergonovine/meth- 76:00 oxytocics 

ylergonovine 

finasteride 92:08 S-alpha reductase 

inhibitors 

(continued) 

21 
Table 3(Continued). Non-antineoplastic drugs that primarily 

have adverse reproductive effects 

Drug AHFS classification Reason for listing Links 

fluconazole 8:18.08 azoles FDA Pregnancy Category C; DailyMed; DrugBank 

case reports describe congenital anomalies in infants 

exposed in utero to maternal 

fluconazole (400-800 mg/ 

day) during most or all of the 

first trimester, similar to those 

seen in animal studies 

FDA Pregnancy Category X DailyMed 

68:18 gonadotropins Defects of forelimbs and DailyMed; DrugBank7 

central nervous system and 

alterations in sex ratio have 

been reported in laboratory 

studies; FDA pregnancy Category C 

92:32 complement inhibitors FDA Pregnancy Category C; DailyMed; DrugBank 

in laboratory studies, premature birth and abortion rates 

increased at a dose that was 

less than 1/40th the MRHD 

and delayed parturition and 

fetal death occurred at 0.5 

and 2-fold, respectively, the 

MRHD 

68:18 gonadotropins FDA Pregnancy Category X Drugbank 

68:08 androgens FDA Pregnancy Category X DailyMed; DrugBank 

76:00 oxytocics When given to pregnant DailyMed; DrugBank 

women results in termination 

of pregnancy; FDA Pregnancy 

Category X 

misoprostol 56:28.28 prostaglandins FDA Pregnancy Category X DailyMed; DrugBank 

ganirelix 92:40 gonadotropineleasing hormone 

antagonists 

gonadotropin, 

chorionic 

icatibant 

mentropins 

methyltestosterone 

mifepristone 

(continued) 

22 
Table 3(Continued). Non-antineoplastic drugs that primarily 

have adverse reproductive effects 

Drug AHFS classification Reason for listing Links 

nafarelin 68:18 gonadotropins Note: Given only as nasal DailyMed; DrugBank 

spray; no potential for occupational exposure; FDA Pregnancy Category X 

oxytocin 76:00 oxytocics Hazardous only for women in DailyMed; DrugBank 

3rd trimester; FDA Pregnancy 

Category C 

paroxetine 28:16:04:20 selective sero- Increased risk of congenital DailyMed; Drugbank 

tonin uptake inhibitors abnormalities when taken in 

first trimester; complications 

in pregnancy when taken in 

third trimester; FDA Pregnancy Category D 

pentetate calcium NA Severe teratogenic effects in DailyMed 

trisodium laboratory studies in dogs: 

supplied in ampule which 

can lead to occupational 

exposure; FDA Pregnancy 

Category C 

plerixafor 20:16 hematopoietic agents Teratogenic in laboratory DailyMed; DrugBank 

studies; FDA Pregnancy Category D 

ribavirin 8:18:32 nucleosides and Teratogenic and embryotoxic DailyMed; DrugBank 

nucleotides effects in several laboratory 

studies; contraindicated in 

women who are pregnant 

and in the male partners of 

women who are pregnant; 

FDA Pregnancy Category X 

telavancin 8:12:28 glycopeptides Black Box warning for poten- DailyMed; Drugbank 

tial risk to fetus and adverse 

reproductive outcomes; 

reduced fetal weights and 

increased rates of digit and 

limb malformations in three 

species at clinical doses; FDA 

Pregnancy Category C 

(continued) 

23 
Table 3(Continued). Non-antineoplastic drugs that primarily 

have adverse reproductive effects` 

Drug AHFS classification Reason for listing Links 

testosterone 68:08 androgens Children should avoid contact DailyMed; DrugBank 

with unwashed or unclothed 

application sites on skin; FDA 

Pregnancy Category X 

topiramate 28:12.92 anticonvulsants, FDA Pregnancy Category D DailyMed; DrugBank 

miscellaneous 

tretinoin 84:16 cell stimulants and Black Box warning for severe DailyMed; DrugBank 

proliferants birth defects; Special FDA distribution system; FDA Pregnancy Category X 

ulipristal 68:12 contraceptives FDA Pregnancy Category X DailyMed 

valproate/valproic 28:12:92 anticonvulsants, Black Box warning for terato- DailyMed; DailyMed; 

acid miscellaneous genicity; congenital malfor- DrugBank 

mations including neural tube 

defects and others; teratogenic in multiple species; FDA 

Pregnancy Category D 

vigabatrin 28:12:92 anticonvulsants, Malformations seen in labora- DailyMed; Drugbank 

miscellaneous tory studies below the MRHD; 

FDA Pregnancy Category C 

voriconazole 8:14.08 azoles FDA Pregnancy Category D DailyMed; DrugBank 

warfarin 20:12.04.08 coumarin FDA Pregnancy Category D DailyMed; DrugBank 

derivatives 

ziprasidone 28:16:08:04 atypical Developmental toxicity, DailyMed; Drugbank 

antipsychotics including possible teratogenic effects at doses similar 

to human therapeutic doses; 

an increase in the number 

of pups born dead and a 

decrease in postnatal survival 

at less than MRHD; FDA Pregnancy Category C 

(continued) 

24 
Table 3(Continued). Non-antineoplastic drugs that primarily 

have adverse reproductive effects' 

Drug AHFS classification Reason for listing Links 

zoledronic acid 92:24 bone resorption Number of stillbirths DailyMed; DrugRank 

inhibitors increased and survival of neonates decreased in laboratory 

studies at low doses; FDA 

Pregnancy Category D 

zonisamide 28:12:92 anticonvulsants, Teratogenic in multiple DailyMed; Drug[3ank 

miscellaneous animal species; FDA Pregnancy Category C 

25 
Table 4lists drugs that were deleted from the 2004 and 2012 NIOSH hazardous drug lists. The 20041ist was 

a composite of five separate lists. When the drugs on that list were reviewed against the NIOSH criteria for 

hazardous drugs, these 11 drugs did not meet the criteria. Tetracycline was removed from the 2012 list on the 

basis of feedback from stakeholders. 

*AHFS = American Hospital Formulary Service. 

Table 4a. Drugs deleted from the 2004 hazardous drug list for not 

meeting the NIOSH criteria for hazardous drugs 

Drug AHFS Classification' 

aldesleukin 10:00 antineoplastic agents 

asparaginase 10:00 antineoplastic agents 

denileukin 10:00 antineoplastic agents 

estrone 68:16.04 estrogens 

nilutamide 10:00 antineoplastic agents 

pegaspargase 10:00 antineoplastic agents 

pentamidine isethionate 8:40 miscellaneous anti-infectives 

podofilox/podophyllum resin 84:36 miscellaneous skin and mucous membrane agents 

(mitotic inhibitor) 

testolactone 10:00 antineoplastic agents 

trifluridine 52:04.06 antivirals 

vidarabine 52:04.06 antivirals 

Table 4b. Drugs deleted from the 2012 list on the basis of stakeholder comments 

Drug AHFS Classification* 

Tetracycline 8:12.24 tetracyclines 

26 
no no N/A 

no yes, if not done yest 

in a control 

device 

noz yes, if powder N/A 

generated 

yes, if not yes, if not done yest 

done in in a control 

a control device 

device 

no# no$ N/A 

yes yes, if not done yest 

in a control 

device 

yes, if liquid yes, if inhalation N/A 

that could potential 

splash# 

yes, if not yes, if not done yes, BSC or 

done in in a control CACI 

a control device 

device 

Table S provides general guidance for some of the possible scenarios that may be encountered in health care 

settings where hazardous drugs are handled, but it cannot cover all possible situations. 'Ihis guidance applies 

to the drugs in Tables 1-3. For more detailed information on safe-handling practices, see the reference list 

[NIOSH 2O04; ASHP 2006; USP 2008; ONS 2011]. 

Table 5. Personal protective equipment and engineering controls for 

working with hazardous drugs in healthcare settings' 

Ventilated 

Double Protective Eye Respiratory engineering 

Formulation Activity gloves gown protection protection controls 

Intact tablet or Administration no (single no 

capsule from unit-dose glove 

package should be 

used) 

Tablets or cap- Cutting, yes yes 

sules crushing or 

otherwise 

manipulating 

tablets or capsules 

Administration yes yes 

Oralliquid Compounding yes yes 

drug 

Administration yes yes 

Topical drug Compounding yes yes 

Administration yes yes 

Ampoule Opening yes yes 

(continued) 

27 
Table 5(Continued). Personal protective equipment and engineering controls for 

working with hazardous drugs in healthcare settings" 

Formulation Activity 

Double 

gloves 

Protective 

gown 

Eye 

protection 

Respiratory 

protection 

Ventilated 

engineering 

controls 

Subcutaneous, Preparation yes yes yes, if not yes, if not done yes, BSC or 

intramuscular (withdrawing done in in a control CACI 

injection from vial or a control device 

ampoule) device 

Administration yes yes yes, if liquid yes, if inhalation N/A 

from prepared that could potentiali 

syringe splash' 

Intravenous Compounding yes yes yes, if not yes, if not done yes, BSC or 

solution done in in a control CACI; recoma control device mend use of 

device CSTD 

Administration yes yes yes, if liquid yes, if inhalation N/A; recomof prepared that could potential= mend use of 

solution` splasht CSTD 

Solution for Compounding yes yes yes, if not yes, if not done yes, BSC or 

irrigation done in in a control CACI; recoma control device mend use of 

device CSTD 

Administration yes yes yes yes N/A 

(bladder, HIPEC, 

limb perfusion, 

etc.) 

Powder/ Inhalation yes yes yes yes yes, when 

solution for applicable 

inhalation 

*The table provides general guidance for some of the possible scenarios that may be encountered in healthcare settings, but cannot cover all possible 

situations. For more detailed information on safe handling practices, see the reference list [NIOSI I 2004; ASHP 2006; USP 2008, and ONS 2011 ]. 13SC 

= Class II biological safety cabinet; CACI = compounding aseptic containment isolator; CS'I'D = closed system drug transfer device; HIPF,C = hyperthermic intraperitoneal chemotherapy ~ 

'For nonsterile preparations, an engineering control such as a fume hood or Class I BSC is sufficient. It is recommended that these activities be carried 

out in a control device, but it is recognired that under so ne circumstances, it is not possible. If the activity is perfor ned in an engineering control that 

is used for sterile intravenous preparations, a thorough cleaning is required following the activity. 

*Required if patient may resist (infant, unruly patient, veterinary patient) or if adniinistered by feeding tube. 

°Intravenous tubing already attached and primed. 

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