NIOSH List of Antineoplastic and Other Hazardous Drugs in

NIOSH List of Antineoplastic

and Other Hazardous Drugs

in Healthcare Settings, 2016

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

National Institute for Occupational Safety and Health

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, 2016

This document is in the public domain and may be freely copied or reprinted.

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Suggested Citation

NIOSH [2016]. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, 2016. 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 Occupa-

tional Safety and Health, DHHS (NIOSH) Publication Number 2016-161 (Supersedes 2014-138).

NIOSH evaluation of hazardous drugs does not cover NIOSH classication of chemical carcinogens.

Although NIOSH hazardous drug evaluation includes consideration of carcinogenicity and geno-

toxicity, this evaluation is tailored to identify and evaluate data from human toxicity proles, animal

studies and in vitro studies unique to evaluating therapeutic agents. For example, NIOSH consults a

variety of resources including, but not limited to, safety data sheets, product labeling approved by the

U.S. Food and Drug Administration and databases such as DailyMed and DrugBank. For more infor-

mation on NIOSH classication of chemical carcinogens see “NIOSH Chemical Carcinogen Policy,”

http://www.cdc.gov/niosh/index.htm.

DHHS (NIOSH) Publication No. 2016-161

September 2016

iii

List of Acronyms

AHFS American Hospital Formulary Service

ASHP American Society of Health-System Pharmacists (formerly, American Society

of Hospital Pharmacy)

BCG Bacillus Calmette–Guérin

BSC Biological safety cabinet

CACI Compounding aseptic containment isolator

CFR Code of Federal Regulations

CSTD Closed system drug-transfer device

DPI Drug package insert

EPA Environmental Protection Agency

FDA Food and Drug Administration

HEPA High-eciency particulate air

HIPEC Heated intraperitoneal chemotherapy

IARC International Agency for Research on Cancer

IV Intravenous

MRHD Maximum Recommended Human Dose

MSHG Manufacturer’s safe handling guidance

NIOSH National Institute for Occupational Safety and Health

OEL Occupational exposure limit

OSHA Occupational Safety and Health Administration

ONS Oncology Nursing Society

PPE Personal protective equipment

SC Subcutaneous

SDS Safety Data Sheet (formerly Material Safety Data Sheet)

USP United States Pharmacopeial Convention

Preamble: e National Institute for Occupational Safety and Health (NIOSH) Alert: Pre-

venting Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Healthcare

Settings was published in September 2004 (http://www.cdc.gov/niosh/docs/2004-165/). In

Appendix A of the Alert, NIOSH identied a sample list of hazardous drugs. e list was

compiled from information provided by four institutions that had generated lists of haz-

ardous drugs for their respective institutions, as well as a list from the Pharmaceutical Re-

search and Manufacturers of America (PhRMA). e 2004 list was updated in 2010, 2012,

and 2014. e current update (2016) adds 34 drugs, ve of which have safe-handling rec-

ommendations from the manufacturers. In 2014, a new format was developed for the list of

hazardous drugs, as described below. e review process for the addition of the new listings

is described in the Federal Register: http://www.cdc.gov/niosh/docket/review/docket233a/

pdfs/233a_2015-12857.pdf.

Drugs Considered Hazardous

I. General Approach to Handling

Hazardous Drugs

Early concerns about occupational exposure to

antineoplastic drugs rst 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 eect) or

cause irreversible eects. As the use and number

of these potent drugs increase, so do opportuni-

ties for hazardous exposures among healthcare

workers. For example, antineoplastic drugs such as

cyclophosphamide and methotrexate have proved

benecial for treating nonmalignant diseases such

as rheumatoid arthritis and multiple sclerosis.

In the Alert (NIOSH 2004) and updates to the haz-

ardous drug list (NIOSH 2010 and 2012), NIOSH

had previously recommended standard precau-

tions (universal precautions) be taken in handling

hazardous drugs. Given the addition of new drug

formulations and drugs in tablet and/or capsule

form to the list, no single approach can cover the

diverse potential occupational exposures to the

drugs. All listed drugs are considered hazardous,

but safe-handling precautions can vary with the

activity and the formulation of the drug. Table 5

provides some guidance on engineering controls

and personal protective equipment (PPE) that ap-

plies to all listed drugs. e current NIOSH ap-

proach involves three groups of drugs:

 Group 1: Antineoplastic drugs (AHFS Classi-

cation 10:00) [ASHP/AHFS DI 2016]. Note that

many of these drugs may also pose a reproduc-

tive risk for susceptible populations (Table 1).

 Group 2: Non-antineoplastic drugs that meet

one or more of the NIOSH criteria for a haz-

ardous 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 reproduc-

tive risk to men and women who are actively

trying to conceive and women who are preg-

nant or breast feeding, because some of these

drugs may be present in breast milk (Table 3).

All hazardous drugs, regardless of the formula-

tion, should be labeled as such to prevent improper

handling. e majority of the reproductive risks as-

sociated with the drugs listed in Table 3 apply to

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 according to recommended proce-

dures, especially if they must be prepared asepti-

cally, some populations of workers may not be at

reproductive risk from handling drugs in Group 3.

ese include workers who are excluded from the

susceptible populations for specic reasons such as

age or infertility. In addition, drugs for which the

manufacturer includes safe-handling guidance in

the DPI are indicated. NIOSH carries out a haz-

ard identication 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 healthcare settings (Table 5). is

guidance does not cover all possible situations but

provides general recommendations for the typical

handling situations in healthcare.

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 dened as hazard-

ous may not pose a signicant risk of direct occu-

pational exposure because of their dosage formula-

tion (for example, coated tablets or capsules—solid,

intact medications that are administered to patients

without modication of 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 con-

tact and/or inhalation when the tablets are counted

[Shahsavarani et al. 1993; Ahmad et al. 2014]. 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 [Fent et al. 2014].

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 nonpermeable

gowns and double gloves (Table 5). Guidelines for

the safe compounding, administration, and dispos-

al of hazardous drugs have been developed by sev-

eral organizations [NIOSH 2004; ASHP 2006; ONS

2011; USP 2016, OSHA 2016]. However, the lack of

proper training for handling antineoplastic drugs

in other specialty areas may be an issue that needs

to be addressed [Abel 2000; Polovich and Giesker

2011; Menonna-Quinn et al. 2013].

II. Dening Hazardous Drugs

Hazardous drugs include those used for cancer che-

motherapy, antiviral drugs, hormones, some bio-

engineered drugs, and other miscellaneous drugs.

e NIOSH denition of hazardous drugs used in

the Alert is based on a denition originally devel-

oped in 1990 by the American Society of Hospital

Pharmacists [ASHP 1990], currently known as the

American Society of Health-System Pharmacists.

us, the NIOSH denition may not accurately in-

dicate the potential toxicity criteria associated with

some of the newer-generation pharmaceuticals

used in healthcare. For example, bioengineered

drugs target specic sites in the body, and although

they may or may not pose a risk to healthcare work-

ers, some may pose a risk to patients.

NIOSH and other organizations are still gather-

ing data on the potential toxicity and health eects

related to highly potent drugs and bioengineered

drugs. erefore, when working with any hazard-

ous drug, healthcare workers should follow the

approaches described in Table 5, along with any

recommendations included in the manufacturer’s

Safety Data Sheet (SDS) or the drug package inserts

(DPIs).

A. ASHP Denition of Hazardous Drugs

ASHP denes hazardous drugs in its 1990 revision

of the Technical Assistance Bulletin on Handling

Hazardous Drugs

[ASHP 1990]. e bulletin gives

criteria for identifying potentially hazardous drugs

that should be handled in accordance with an es-

tablished safety program [ASHP 2006; Massoomi

et al. 2008; Eisenberg 2009; ONS 2011]. e crite-

ria are prioritized to reect the hierarchy of poten-

tial toxicity described below. Since the hazardous

drugs covered by the Alert were designed as thera-

peutic agents for humans, human toxicity proles

should be given more weight than data from ani-

mal models or in vitro systems. Additional guid-

ance for dening hazardous drugs is available from

the following sources: carcinogenicity [61 Fed

togenicity [56 Fed Register 63798–63826 (1991)],

developmental toxicity [56 Fed Register 63798–

63826 (1991)], and reproductive toxicity [61 Fed

B. NIOSH Revision of ASHP Denition

1. e 1990 ASHP denition 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

toxicity

†

*ASHP [1990] denition 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. The level of toxicity reects 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 in laboratory animals that produces serious

organ toxicity, developmental toxicity, or reproductive tox-

icity has been used by the pharmaceutical industry to devel-

op occupational exposure limits (OELs) of less than 10 µg/

after applying appropriate uncertainty factors [Sargent

 Reproductive toxicity

†

 Organ toxicity at low doses

†

 Genotoxicity

‡

 Structure and toxicity proles of new

drugs that mimic existing drugs deter-

mined hazardous by the above criteria

2. Determining Whether a Drug is Hazardous

Many hazardous drugs used to treat cancer (for ex-

ample, alkylating agents) bind to or damage DNA.

Other antineoplastic drugs, some antivirals, antibi-

otics, and bioengineered drugs interfere with cell

growth or proliferation, 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 eects

for treated patients and their ospring. ese non-

selective actions can also cause adverse eects in

healthcare workers who are inadvertently exposed

to hazardous drugs. However, drugs other than

those used to treat cancer may have toxic proper-

ties similar to those of the antineoplastic drugs. For

some other drugs, adverse reproductive eects are

the primary characteristic of concern for occupa-

tional exposure. NIOSH evaluates the potential of

proposed additions to the list on the basis of these

and other characteristics of the drugs.

is document presents criteria and sources of in-

formation for determining whether a drug is haz-

ardous. When a drug has been judged to be hazard-

ous, 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 haz-

ardous drug as outlined above, NIOSH takes the

following approach.

and Kirk 1988; Naumann and Sargent 1997; Sargent et al.

2002]. OELs in this range are typically established for po-

tent or toxic drugs in the pharmaceutical industry. Under all

circumstances, an evaluation of all available data should be

conducted to protect healthcare workers.

‡

In evaluating mutagenicity for potentially hazardous drugs,

responses from multiple test systems are needed before pre-

cautions can be required for handling such agents. e EPA

evaluations include the type of cells aected and in vitro ver-

sus in vivo testing [51 Fed Register 34006–34012 (1986)].

Reproductive and Developmental Toxicity

NIOSH takes into account the dose for animal test-

ing of reproductive and developmental toxicity. If

adverse eects are observed in animal testing near,

at, or below the maximum recommended human

dose (MRHD), NIOSH considers it to be highly rel-

evant. If doses producing an adverse eect are many

times the MRHD, usually NIOSH does not consider

them in its evaluation.

For reproductive and developmental eects,

NIOSH notes if there was maternal toxicity, in ad-

dition to the dose. Eects on the fetus in the ab-

sence of maternal toxicity are considered relevant.

Many drugs with an FDA pregnancy category X

rating meet the criteria for a hazardous drug and

are listed, but each drug is evaluated individually.

Similarly, for Category D, these drugs are oen

listed because many meet the criteria for being

hazardous. Any available human data are consid-

ered signicant. In June 2015, the FDA removed

the pregnancy letter categories (A, B, C, D, and

X) in prescription drug labeling. e new label-

ing was renamed “Pregnancy,” “Lactation,” and

“Females and Males of Reproductive Potential”

[FDA 2015]. e plan for the new labeling is to be

phased in gradually for drugs approved on or aer

June 2001, but it went into eect immediately for

drugs and biologic products submitted aer June

2015. erefore, the pregnancy letter categories are

still in eect for most of the drugs described in this

document, for the immediate future.

Carcinogenicity

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-specic. Any avail-

able human data are considered signicant.

Genotoxicity

For eects of genotoxicity, NIOSH gives greater

weight to in vivo testing than in vitro testing. How-

ever, adverse outcomes in several in vitro tests will

be considered in its evaluation.

Organ Toxicity

For organ toxicity, the low-dose criterion in the

denition (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.

Other

Drugs with safe-handling guidelines from the man-

ufacturer are automatically put on the list because

the manufacturer has determined their properties

warrant special handling.

A NIOSH internal committee performs an initial

review of all new FDA drug approvals and new

warnings on existing drugs for a two-year period.

Following this review, an expert panel consisting of

peer reviewers and stakeholders reviews the pro-

posed additions (and deletions, when applicable),

using information in DrugBank, DailyMed, and

the DPIs and SDSs. Additionally, a Federal Reg-

ister Notice is published requesting comments on

the proposed changes to the list. A nal review of

all information is performed by NIOSH, and the

updated list is published on the NIOSH Hazardous

Drug Topic Page (http://www.cdc.gov/niosh/top-

ics/hazdrug/) and in the Federal Register.

In addition to using the list of hazardous drugs

presented here, each organization should create its

own list of drugs considered to be hazardous, based

on drugs in its formulary. is document presents

guidance for making such a facility-specic list (see

section entitled How to Generate Your Own List of

Hazardous Drugs). Subsequently, newly purchased

drugs should be evaluated against the organiza-

tion’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 [Chaee et al. 2010;

Badry et al. 2013; Kaestli et al. 2013]. Although the

classication schemes may dier somewhat, the

drugs listed as hazardous are quite similar.

Individual organizations may not have adequate

resources for determining their own list of hazard-

ous drugs. If so, the list of hazardous drugs in this

document will help employers and workers to de-

termine when precautions are needed. However, re-

liance on such a published list is a concern because

it quickly becomes outdated as new drugs continu-

ally enter the market or listed drugs are removed

when additional information becomes available.

NIOSH will update this list periodically by adding

drugs that meet its criteria and removing those that

no longer meet its criteria. is hazardous drug list

will be posted on the NIOSH website at www.cdc.

gov/niosh/topics/hazdrug/. In addition, drugs that

have safe-handling guidance from the manufactur-

ers in the DPIs will be posted on this website aer

they are approved by the FDA.

III. How to Generate Your Own List

of Hazardous Drugs

A. OSHA Hazard Communication

e OSHA hazard communication standard [29

CFR 1910.1200] requires employers to develop

a hazard communication program appropriate

for their unique workplaces. An essential part of

the program is the identication of all hazardous

chemicals a worker may encounter in the facility.

Compliance with the OSHA hazard communica-

tion standard entails developing a list of hazardous

chemicals (in this case, drugs) as part of the written

hazardous communication program and inform-

ing workers where that list can be obtained. e

criteria OSHA uses to identify hazardous chemi-

cals, including hazardous drugs, are provided in

that standard. Institutions may wish to compare

their lists to the listing in this document or on the

NIOSH website.

It is not likely that every healthcare provider or fa-

cility will use all drugs that have received U.S. Food

and Drug Administration (FDA) approval. Instead,

compliance requires practice-specic assessments

for drugs used at any one time by a facility. How-

ever, hazardous drug evaluation is a continual pro-

cess. Each facility must assess each new drug that

enters its workplace to determine if it needs to be

included in the Hazard Communication program

and, when appropriate, reassess its list of hazardous

drugs when new toxicological data become avail-

able. Toxicological data are oen incomplete or

unavailable for investigational drugs. However, if

their mechanism of action suggests that there may

be a concern, it is prudent to handle them as haz-

ardous drugs until adequate information becomes

available to exclude them.

B. NIOSH List of Hazardous Drugs

e following list (Tables 1–3) contains those drugs

that NIOSH has reviewed according to the criteria

in the NIOSH denition of a hazardous drug. e

list was compiled from the following:

 the 2014 NIOSH update to the list

 the NIOSH 2016 update to the list, for which

34 drugs were added (including ve with the

manufacturers’ safe-handling warnings).

e OSHA hazard communication standard re-

quires a written program including a list of chemi-

cals that meet the Hazard Communication de-

nitions for hazardous, labelling, and employee

training. e mandate applies not only to health-

care professionals who provide direct patient care

but also to others who support patient care by par-

ticipating in product acquisition, storage, transpor-

tation, housekeeping, and waste disposal. Institu-

tions may want to adopt this list or compare theirs

with the list on the NIOSH website.

CAUTION: Drugs purchased and used by a fa-

cility may have entered the marketplace aer the

list below was assembled. erefore, this list may

not be all-inclusive.

If 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 DPI. You may also check with other insti-

tutions that might be using the same drug. If any

of the documents mention carcinogenicity, geno-

toxicity, teratogenicity (Section 13 in the DPI), or

reproductive or developmental toxicity (Section 8),

or if the DPI contains safe-handling warnings (Sec-

tion 16), then use the precautions stipulated in the

Alert. If the drug meets one or more of the crite-

ria for hazardous drugs in the NIOSH denition,

handle it as hazardous.

e list of hazardous drugs will be updated peri-

odically on the website http://www.cdc.gov/niosh/

topics/hazdrug/.

is list supersedes the lists from 2004 (http://www.

cdc.gov/niosh/docs/2004-165/), 2010, 2012, and

2014 (http://www.cdc.gov/niosh/docs/2014-138/).

C. Where to Find Information Related to

Drug Toxicity

Practice-specic lists of hazardous drugs (usually

developed by pharmacy or nursing departments)

should be comprehensive, including all hazard-

ous 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, formerly Material

Safety Data Sheets)

 Product labeling approved by the U.S. FDA

(DPIs)

 International Agency for Research on Cancer

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

 DrugBank: http://www.drugbank.ca/

 DailyMed: http://dailymed.nlm.nih.gov/dai-

lymed/

 Special health warnings from drug manufac-

turers, FDA, and other professional groups and

organizations

 Reports and case studies published in medical

and other healthcare profession journals

 Evidence-based recommendations from other

facilities that meet the criteria dening hazard-

ous drugs

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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) [2016]. Hazardous drugs:

handling in healthcare settings. Chapter 800 (USP

39-NF 34), www.usp.org/usp-nf.

Acknowledgments

is document was written by omas 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. Vanessa

Williams provided graphic design and production

services.

NIOSH List of Antineoplastic and Other Hazard-

ous Drugs in Healthcare Settings, 2016

NIOSH performs a hazard identication for each

of the drugs in the following tables, based on its

criteria as described above. e actual risk to

healthcare workers depends on toxicity of the

drugs, how the drugs can enter the body (e.g., der-

mal, inhalation, or ingestion), and how the drugs

are handled—how they are manipulated, how of-

ten they are handled, and the exposure controls in

place, such as the type of engineering controls and

personal protective equipment (PPE) (see Table 5).

For example,

 Dispensing a single tablet to a patient may pose

a relatively low risk to the healthcare worker. A

single pair of gloves may be adequate.

 Repeatedly counting, cutting, or crushing tab-

lets may pose a higher risk for worker exposure

than dispensing a single tablet and contamina-

tion to the workplace if exposure controls 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 several intravenous doses of an an-

tineoplastic drug typically poses a higher po-

tential risk to the worker. In addition to double

gloving and a protective gown, an engineering

control such as a BSC or CACI, possibly sup-

plemented with a CSTD (closed system drug-

transfer device), is necessary to protect the

drug, environment, and healthcare worker.

e drugs in Table 1 meet one or more of the NIOSH criteria for a hazardous drug. In addition to many of

these drugs being cytotoxic, the majority are hazardous to males or females who are actively trying to conceive,

women who are pregnant or may become pregnant, and women who are breast feeding, because they may be

present in breast milk.

ese drugs represent an occupational hazard to healthcare workers and should always be handled with use of

recommended 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. e manufacturer’s safe-handling guidance (MSHG) is typically in Section 16 of the DPI. See Table

5 for safe-handling recommendations.

Abbreviations and footnotes. AHFS = American Hospital Formulary Service; MRHD = maximum recommend-

ed human dose.

Drugs in red font were added in 2016.

National Toxicology Program classications (http://ntp.niehs.nih.gov/pubhealth/roc/index.html):

Known To Be Hu-

man Carcinogens;

***

Reasonably Anticipated To Be Human Carcinogens.

†

International Agency for Research on Cancer (www.iarc.fr): Group 1, Carcinogenic to Humans; Group 2A, Probably Car-

cinogenic to Humans; Group 2B, Possibly Carcinogenic to Humans.

‡

BCG, although classied as a vaccine, is used in the treatment of certain cancers. BCG should be prepared with aseptic tech-

niques. 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 de-

vice, then respiratory protection, gloves, and a gown should be worn to avoid inhalation or contact with BCG organisms.

‡‡

MSHG was removed in 2015 by the manufacturer.

Table 1. Group 1: Antineoplastic drugs, including those with the

manufacturer’s safe-handling guidance (MSHG)

Drug AHFS classication MSHG Supplemental information Links

abiraterone 10:00 antineoplastic

agents

Women who are pregnant

or may be pregnant should

not handle without protec-

tion (e.g., gloves); FDA

Pregnancy Category X

DailyMed; DrugBank

ado-trastuzumab

emtansine

10:00 antineoplastic

agents

yes Conjugated monoclonal

antibody; FDA Pregnancy

Category D

DailyMed; DrugBank

afatinib* 10:00 antineoplastic

agents

Special warnings on

contraception for females

while taking and 2 weeks

post-treatment; FDA Preg-

nancy Category D

DailyMed; DrugBank

(Continued)

Drug AHFS classication MSHG Supplemental information Links

altretamine 10:00 antineoplastic

agents

yes FDA Pregnancy Category D DailyMed; DrugBank

amsacrine NA antineoplastic

agents

yes IARC Group 2B

†

DrugBank

anastrozole 10:00 antineoplastic

agents

FDA Pregnancy Category X DailyMed; DrugBank

arsenic trioxide 10:00 antineoplastic

agents

yes IARC Group 1 carcinogen;

NTP**; FDA Pregnancy

Category D

DailyMed; DrugBank

axitinib 10:00 antineoplastic

agents

Teratogenic, embryotoxic

and fetotoxic in mice at ex-

posures lower than human

exposures; FDA Pregnancy

category D

DailyMed; DrugBank

azacitidine 10:00 antineoplastic

agents

yes IARC Group 2A carcinogen;

NTP***; FDA Pregnancy

Category D

DailyMed; DrugBank

Bacillus

Calmette Guerin

(BCG)

80:12 vaccines yes See special handling

requirements

‡

; FDA Preg-

nancy Category C

DailyMed

belinostat 10:00 antineoplastic

agents

yes May cause teratogenicity

and/or embryo-fetal lethal-

ity because it is a genotoxic

drug and targets actively

dividing cells; FDA Preg-

nancy Category D

DailyMed; DrugBank

bendamustine 10:00 antineoplastic

agents

yes FDA Pregnancy Category D DailyMed; DrugBank

bexarotene 10:00 antineoplastic

agents

FDA Pregnancy Category X DailyMed; DrugBank

bacalutimide 10:00 antineoplastic

agents

FDA Pregnancy Category X DailyMed; DrugBank

bleomycin 10:00 antineoplastic

agents

yes IARC Group 2B; FDA Preg-

nancy Category D

DailyMed; DrugBank

bortezomib 10:00 antineoplastic

agents

yes FDA Pregnancy Category D DailyMed; DrugBank

Table 1 (Continued). Group 1: Antineoplastic drugs, including those with the

manufacturer’s safe-handling guidance (MSHG)

(Continued)

Drug AHFS classication MSHG Supplemental information Links

bosutinib 10:00 antineoplastic

agents

FDA Pregnancy Category D DailyMed; DrugBank

brentuximab

vedotin

10:00 antineoplastic

agents

yes Conjugated monoclonal

antibody; FDA Pregnancy

Category D

DailyMed; DrugBank

busulfan 10:00 antineoplastic

agents

yes IARC Group 1 carcinogen;

FDA Pregnancy Category D

DailyMed; DrugBank

cabazitaxel 10:00 antineoplastic

agents

yes FDA Pregnancy Category D DailyMed; DrugBank

cabozantinib 10:00 antineoplastic

agents

Embryolethal in rats at ex-

posures below the recom-

mended human dose; FDA

Pregnancy category D

DailyMed; DrugBank

capecitabine 10:00 antineoplastic

agents

yes Metabolized to 5-uo-

rouracil; FDA Pregnancy

Category D

DailyMed; DrugBank

carboplatin 10:00 antineoplastic

agents

yes FDA Pregnancy Category D DailyMed; DrugBank

carlzomib 10:00 antineoplastic

agents

Special warnings on

contraception while taking

and 2 weeks post- treat-

ment; FDA Pregnancy

category D

DailyMed; DrugBank

carmustine 10:00 antineoplastic

agents

yes IARC Group 2A carcinogen;

NTP***; FDA Pregnancy

Category D

DailyMed; DrugBank

chlorambucil 10:00 antineoplastic

agents

yes IARC Group 1 carcinogen;

NTP**; FDA Pregnancy

Category D

DailyMed; DrugBank

cisplatin 10:00 antineoplastic

agents

yes IARC Group 2A carcinogen;

NTP***; FDA Pregnancy

Category D

DailyMed; DrugBank

cladribine 10:00 antineoplastic

agents

yes FDA Pregnancy Category D DailyMed; DrugBank

clofarabine 10:00 antineoplastic

agents

yes FDA Pregnancy Category D DailyMed; DrugBank

Table 1 (Continued) Group 1: Antineoplastic drugs, including those with the

manufacturer’s safe-handling guidance (MSHG)

(Continued)

Drug AHFS classication MSHG Supplemental information Links

crizotinib 10:00 antineoplastic

agents

FDA Pregnancy Category D DailyMed; DrugBank

cyclophospha-

mide

10:00 antineoplastic

agents

yes IARC Group 1 carcinogen;

NTP**; FDA Pregnancy

Category D

DailyMed; Drugbank

cytarabine 10:00 antineoplastic

agents

yes FDA Pregnancy Category D DailyMed; DrugBank

dabrafenib 10:00 antineoplastic

agents

Special warnings on

contraception for females

while taking and 2 weeks

post-treatment; FDA Preg-

nancy Category D

DailyMed; DrugBank

dacarbazine 10:00 antineoplastic

agents

yes NTP***; 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 2B, AKA dau-

nomycin; FDA Pregnancy

Category D

DailyMed; Drugbank

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;

NTP***; FDA Pregnancy

Category D

DailyMed; DrugBank

enzalutamide 10:00 antineoplastic

agents

Embryo-fetal toxicity in

mice at exposures that

were lower than in patients

receiving the recommend-

ed dose; FDA Pregnancy

Category X

DailyMed; DrugBank

Table 1 (Continued). Group 1: Antineoplastic drugs, including those with the

manufacturer’s safe-handling guidance (MSHG)

(Continued)

Drug AHFS classication MSHG Supplemental information Links

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;

FDA Pregnancy Category D

DailyMed; DrugBank

everolimus 10:00 antineoplastic

agents

yes FDA Pregnancy Category D DailyMed; Drugbank

exemestane 10:00 antineoplastic

agents

FDA Pregnancy Category X DailyMed; DrugBank

oxuridine 10:00 antineoplastic

agents

yes FDA Pregnancy Category D DailyMed; DrugBank

udarabine 10:00 antineoplastic

agents

yes FDA Pregnancy Category D DailyMed; DrugBank

uorouracil 10:00 antineoplastic

agents

yes FDA Pregnancy Category D DailyMed; DrugBank

utamide 10:00 antineoplastic

agents

Indicated only for men;

FDA Pregnancy Category D

DailyMed; DrugBank

fulvestrant 10:00 antineoplastic

agents

FDA Pregnancy Category D DailyMed; DrugBank

gemcitabine 10:00 antineoplastic

agents

yes FDA Pregnancy Category D DailyMed; DrugBank

gemtuzumab

ozogamicin

10:00 antineoplastic

agents

yes FDA Pregnancy Category D DailyMed; DrugBank

goserelin 10:00 antineoplastic

agents

FDA Pregnancy Category X DailyMed; Drugbank

histrelin 10:00 antineoplastic

agents

Can cause fetal harm when

administered to a pregnant

patient, with the possibility

of spontaneous abortion;

FDA Pregnancy Category X

DailyMed; DrugBank

Table 1 (Continued). Group 1: Antineoplastic drugs, including those with the

manufacturer’s safe-handling guidance (MSHG)

(Continued)

Drug AHFS classication MSHG Supplemental information Links

hydroxyurea 10:00 antineoplastic

agents

yes Special warning on han-

dling bottles and capsules;

FDA Pregnancy Category D

DailyMed; DrugBank

idarubicin 10:00 antineoplastic

agents

yes FDA Pregnancy Category D DailyMed; DrugBank

ifosfamide 10:00 antineoplastic

agents

yes FDA Pregnancy Category D DailyMed; DrugBank

imatinib 10:00 antineoplastic

agents

yes FDA Pregnancy Category D DailyMed; DrugBank

irinotecan 10:00 antineoplastic

agents

yes FDA Pregnancy Category D DailyMed; DrugBank

ixazomib 10:00 antineoplastic

agents

yes Male and female patients

of childbearing potential

must use eective contra-

ceptive measures during

and for 3 months following

treatment

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;

NTP***; FDA Pregnancy

Category D

DailyMed; DrugBank

mechloretha-

mine

10:00 antineoplastic

agents

yes NTP***; FDA Pregnancy

Category D

DailyMed; DrugBank

megestrol 10:00 antineoplastic

agents

yes Nursing should be dis-

continued if megestrol is

required; women at risk of

pregnancy should avoid

exposure; FDA Pregnancy

Category X

DailyMed; DrugBank

melphalan 10:00 antineoplastic

agents

yes IARC Group 1 carcinogen;

NTP**; FDA Pregnancy

Category D

DailyMed; DrugBank

(Continued)

Table 1 (Continued). Group 1: Antineoplastic drugs, including those with the

manufacturer’s safe-handling guidance (MSHG)

Drug AHFS classication MSHG Supplemental information Links

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-

nancy Category D

DailyMed; DrugBank

mitotane 10:00 antineoplastic

agents

yes FDA Pregnancy Category D DailyMed; DrugBank

mitoxantrone 10:00 antineoplastic

agents

yes IARC Group 2B; FDA Preg-

nancy Category D

DailyMed; DrugBank

nelarabine 10:00 antineoplastic

agents

yes FDA Pregnancy Category D DailyMed; DrugBank

nilotinib 10:00 antineoplastic

agents

FDA Pregnancy Category D DailyMed; DrugBank

omacetaxine 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

panobinostat 10:00 antineoplastic

agents

yes Special warnings on

contraception for females

while taking and 1 month

post-treatment;

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

pertuzumab 10:00 antineoplastic

agents

Black Box warning on

embryo-fetal death and

birth defects; FDA Preg-

nancy Category D

DailyMed; DrugBank

(Continued)

Table 1 (Continued). Group 1: Antineoplastic drugs, including those with the

manufacturer’s safe-handling guidance (MSHG)

Drug AHFS classication MSHG Supplemental information Links

pipobroman NA FDA Pregnancy Category D DrugBank

pomalidomide 10:00 antineoplastic

agents

yes Females of reproductive

potential must use two

forms of contraception or

continuously abstain from

heterosexual sex dur-

ing and for 4 weeks after

stopping treatment; FDA

Pregnancy Category X

DailyMed; DrugBank

ponatinib 10:00 antineoplastic

agents

FDA Pregnancy Category D DailyMed; DrugBank

pralatrexate 10:00 antineoplastic

agents

yes FDA Pregnancy Category D DailyMed; DrugBank

procarbazine 10:00 antineoplastic

agents

yes IARC Group 2A carcinogen;

NTP***; FDA Pregnancy

Category D

DailyMed; DrugBank

regorafenib 10:00 antineoplastic

agents

Black Box warning on

severe and sometimes fatal

hepatotoxicity; total loss of

pregnancy at doses lower

than recommended hu-

man dose; FDA Pregnancy

Category D

DailyMed; DrugBank

romidepsin 10:00 antineoplastic

agents

yes FDA Pregnancy Category D DailyMed; DrugBank

sorafenib 10:00 antineoplastic

agents

FDA Pregnancy Category D DailyMed; DrugBank

streptozocin 10:00 antineoplastic

agents

yes IARC Group 2B; NTP***;

FDA Pregnancy Category D

DailyMed; DrugBank

sunitinib 10:00 antineoplastic

agents

FDA Pregnancy Category D DailyMed; DrugBank

tamoxifen 10:00 antineoplastic

agents

IARC Group 1 carcinogen;

NTP**; FDA Pregnancy

Category D

DailyMed; DrugBank

temozolomide 10:00 antineoplastic

agents

yes FDA Pregnancy Category D DailyMed; DrugBank

(Continued)

Table 1 (Continued). Group 1: Antineoplastic drugs, including those with the

manufacturer’s safe-handling guidance (MSHG)

Drug AHFS classication MSHG Supplemental information Links

temsirolimus 10:00 antineoplastic

agents

yes FDA Pregnancy Category D DailyMed; DrugBank

teniposide 10:00 antineoplastic

agents

yes IARC Group 2A carcinogen;

FDA Pregnancy Category D

DailyMed; DrugBank

thioguanine 10:00 antineoplastic

agents

yes FDA Pregnancy Category D DailyMed; DrugBank

thiotepa 10:00 antineoplastic

agents

yes IARC Group 1 carcinogen;

NTP**; FDA Pregnancy

Category D

DailyMed; DrugBank

topotecan 10:00 antineoplastic

agents

yes FDA Pregnancy Category D DailyMed; DrugBank

toremifene 10:00 antineoplastic

agents

FDA Pregnancy Category D DailyMed; DrugBank

trametinib 10:00 antineoplastic

agents

Embryotoxic and abortifa-

cient at doses less than rec-

ommended human dose;

FDA Pregnancy Category D

DailyMed; DrugBank

triuridine/tipi-

racil (combina-

tion only)

10:00 antineoplastic

agents

yes Embryo-fetal lethality and

embryo-fetal toxicity at

doses lower than or similar

to exposures at the recom-

mended human dose

DailyMed; DrugBank;

DrugBank

triptorelin 10:00 antineoplastic

agents

FDA Pregnancy Category X DailyMed; DrugBank

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

(Continued)

Table 1 (Continued). Group 1: Antineoplastic drugs, including those with the

manufacturer’s safe-handling guidance (MSHG)

Drug AHFS classication MSHG Supplemental information Links

vismodegib 10:00 antineoplastic

agents

Black Box warning on

embryo-fetal death or

severe birth defects; rec-

ommend eective contra-

ception for females during

therapy and for 7 months

after treatment; present in

semen; no sperm donation

during and 3 months post-

treatment; FDA Pregnancy

Category D

DailyMed; DrugBank

vorinostat 10:00 antineoplastic

agents

yes Adverse embryo-fetal

eects at less than the rec-

ommended human dose;

FDA Pregnancy Category D

DailyMed; DrugBank

ziv-aibercept 10:00 antineoplastic

agents

Embryotoxic and terato-

genic in rabbits at expo-

sure levels lower than

human exposures at the

recommended dose, with

increased incidences of ex-

ternal, visceral, and skeletal

fetal malformations; FDA

Pregnancy Category C

DailyMed; DrugBank

Table 1 (Continued). Group 1: Antineoplastic drugs, including those with the

manufacturer’s safe-handling guidance (MSHG)

e drugs in Table 2 meet one or more of the NIOSH criteria for a hazardous drug. Some of these drugs

may represent an occupational hazard to males or females who are actively trying to conceive, women who

are pregnant or may become pregnant, and women who are breast feeding, because they may be present in

breast milk.

Unopened, intact tablets and capsules may not pose the same degree of occupational exposure risk as in-

jectable drugs, which usually require extensive preparation. Cutting, crushing, or otherwise manipulating

tablets and capsules will increase the risk of exposure to workers. e manufacturer’s safe-handling guidance

(MSHG) is typically in Section 16 of the DPI. See Table 5 for safe-handling recommendations.

Abbreviations and footnotes. AHFS = American Hospital Formulary Service; MRHD = maximum recom-

mended human dose.

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

National Toxicology Program (http://ntp.niehs.nih.gov/pubhealth/roc/index.html): **Known To Be Human Car-

cinogens;

***

Reasonably Anticipated To Be Human Carcinogens.

†

International Agency for Research on Cancer (www.iarc.fr): Group 1, Carcinogenic to Humans; Group 2A, Probably

Carcinogenic to Humans; Group 2B, Possibly Carcinogenic to Humans.

‡

Drugs in red font were added in 2016.

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

hazardous drug, including those with the manufacturer’s safe-handling guidance (MSHG)

Drug AHFS classication MSHG Supplemental information Links

abacavir 8:18.08.20 nucleoside

and reverse transcrip-

tase inhibitors

FDA Pregnancy Category C;

malignant tumors observed

in male and female mice and

rats; genotoxic in in vivo mi-

cronucleus test

DailyMed; DrugBank

alefacept 84:92 skin and mucous

membrane agents,

miscellaneous

Increased frequency of malig-

nancies observed in treated

patients; FDA Pregnancy

Category B

DailyMed; DrugBank

apomorphine 28:36.20.08 non-ergot-

derivative dopamine

receptor agonists

FDA Pregnancy Category C;

genotoxic in several in vitro

assays

DailyMed; DrugBank

azathioprine 92:44 immunosup-

pressants

yes IARC Group 1 carcinogen

†

;

NTP**; FDA Pregnancy

Category D

DailyMed; DrugBank

(Continued)

Drug AHFS classication MSHG Supplemental information Links

carbamazepine 28:12:92 anticonvul-

sants, miscellaneous

Black Box warning for aplastic

anemia; congenital malforma-

tions in ospring of mothers

who took drug; rapid transpla-

cental passage; FDA Pregnan-

cy Category D*

DailyMed; DrugBank

chloramphenicol 8:12:08 chloram-

phenicols

IARC Group 2A carcinogen;

NTP***; FDA Pregnancy

Category C

DailyMed; DrugBank

cidofovir 8:18:32 nucleosides

and nucleotides

yes FDA Pregnancy Category C DailyMed; DrugBank

cyclosporine 92:44 immunosup-

pressive agents

IARC Group 1 carcinogen;

NTP**; FDA Pregnancy

Category C

DailyMed; DrugBank

deferiprone 64:00 heavy metal

antagonists

Genotoxic in vitro and in vivo;

FDA Pregnancy Category D

DailyMed; DrugBank

dexrazoxane 92:56 protective

agents

yes FDA Pregnancy Category

C; secondary malignancies

observed in patients treated

long term with Razoxane (a

racemic mixture containing

dexrazoxane); genotoxic in

vitro and in vivo; in laboratory

studies, testicular atrophy

observed at or below the hu-

man dose

DailyMed; DrugBank

diethylstilbestrol NA IARC Group 1 carcinogen;

NTP**; FDA Pregnancy

Category X

DrugBank

divalproex 28:12:92 anticonvul-

sants, miscellaneous

Black Box warning for tera-

togenicity; FDA Pregnancy

Category D; tumors seen in

laboratory studies at doses

below MRHD

DailyMed; DrugBank

(Continued)

Table 2 (Continued). Group 2: Non-antineoplastic drugs that meet one or more of the NIOSH criteria

for a hazardous drug, including those with the manufacturer’s safe-handling guidance (MSHG)

Drug AHFS classication MSHG Supplemental information Links

entecavir 8:18:32 nucleosides

and nucleotides

FDA Pregnancy Category C DailyMed; DrugBank

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

nant neoplasms; increased risk

of endometrial cancer, breast

cancer, and ovarian cancer; in

laboratory studies, increased

frequency of carcinomas of

the breast, uterus, cervix, va-

gina, testis, and liver; present

in breast milk; FDA Pregnancy

Category X

DailyMed; DrugBank

estrogen/ progester-

one combinations

68:12 contraceptives IARC Group 1 carcinogen;

NTP**; FDA Pregnancy Cat-

egory X

DailyMed

estrogens, conju-

gated

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

metrial cancer and cardiovas-

cular risks; long-term use in

women and laboratory studies

increases frequency of several

cancers; NTP**; FDA Pregnan-

cy Category X

DailyMed; DrugBank

estrogens, esteried 68:16:04 estrogens Black Box warning for endo-

metrial cancer and cardio-

vascular risks; NTP**; FDA

Pregnancy Category X

DailyMed; DrugBank

estropipate 68:16:04 estrogens Black Box warning for endo-

metrial carcinoma in post-

menopausal women and

use during pregnancy; FDA

Pregnancy Category X

DailyMed; DrugBank

ngolimod 92:20 biologic re-

sponse modiers

FDA Pregnancy Category C; in

laboratory studies, increased

malformations and embryo-

fetal deaths at less than

the recommended human

dose; malignant lymphomas

observed in male and female

mice

DailyMed; DrugBank

(Continued)

Table 2 (Continued). Group 2: Non-antineoplastic drugs that meet one or more of the NIOSH criteria

for a hazardous drug, including those with the manufacturer’s safe-handling guidance (MSHG)

Drug AHFS classication MSHG Supplemental information Links

uoxymesterone 68:08 androgens Tumors in mice and rats and

possibly humans; FDA Preg-

nancy Category X

DailyMed; DrugBank

fosphenytoin 28:12.12 hydantoins Metabolized to phenytoin;

FDA Pregnancy Category D

DailyMed; DrugBank

ganciclovir 8:18:32 nucleosides

and nucleotides

yes FDA Pregnancy Category C DailyMed; DrugBank

leunomide 92:36 disease-modi-

fying antirheumatic

agents

Teratogenic in laboratory

studies at 1/10 human dose

(HD); marked postnatal surviv-

al at 1/100 HD; FDA Pregnancy

Category X; severe liver injury

reported in patients; carcino-

genicity observed at doses

below HD

DailyMed; DrugBank

lenalidomide 92:20 biologic re-

sponse modulators

yes Analog of thalidomide; FDA

Black Box warnings for limb

abnormalities; Pregnancy Cat-

egory X; in laboratory studies,

caused thalidomide-type limb

defects in monkey ospring

DailyMed; DrugBank

liraglutide

recombinant

68:20.06 incretin

mimetics

FDA Pregnancy Category C;

Black Box warning for thyroid

C-cell tumors, with supporting

evidence in laboratory stud-

ies; also in laboratory studies,

teratogenic at or below the

MRHD

DailyMed; DrugBank

medroxyprogester-

one acetate

68:32 progestins yes IARC Group 2B; FDA Pregnan-

cy Category X

DailyMed; DrugBank

methimazole

‡

68:36:08 antithyroid

agents

Appears in human breast milk;

FDA Pregnancy Category D

DailyMed; DrugBank

mipomersen 24:06:92 antilipemic

agents, miscellaneous

Black Box warning on hepa-

totoxicity; FDA Pregnancy

Category B

DailyMed; DrugBank

(Continued)

Table 2 (Continued). Group 2: Non-antineoplastic drugs that meet one or more of the NIOSH criteria

for a hazardous drug, including those with the manufacturer’s safe-handling guidance (MSHG)

Drug AHFS classication MSHG Supplemental information Links

mycophenolate

mofetil

92:44 immunosup-

pressive agents

Black Box warning for em-

bryo fetal toxicity, malignan-

cies, and serious infections;

increased risk of rst-trimester

pregnancy loss and increased

risk of congenital malforma-

tions; FDA Pregnancy Cat-

egory D; Special warning:

Tablets should not be crushed

and capsules should not be

opened or crushed. Avoid in-

halation 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.

DailyMed; DrugBank

mycophenolic acid 92:44 immunosup-

pressive agents

Black Box warning for rst

trimester pregnancy loss and

an increased risk of congenital

malformations; FDA Preg-

nancy Category D; Black Box

warning for lymphomas and

other malignancies; genotoxic

in vitro and in vivo

DailyMed; DrugBank

nevirapine 8:18.08.16 nonnucleo-

side reverse transcrip-

tase inhibitors

FDA Pregnancy Category B; in

laboratory studies, hepatocel-

lular adenomas and carci-

nomas at doses lower than

human dose

DailyMed; DrugBank

ospemifene 68:16:12 estrogen

agonists-antagonists

Black Box warning on in-

creased risk of endometrial

cancer in certain populations;

risk of adverse outcomes dur-

ing pregnancy and labor; FDA

Pregnancy Category X

DailyMed; DrugBank

oxcarbazepine 28:12:92 anticonvul-

sants, miscellaneous

Tumors observed in laborato-

ry studies at 1/10 MRHD; FDA

Pregnancy Category C

DailyMed; DrugBank

(Continued)

Table 2 (Continued). Group 2: Non-antineoplastic drugs that meet one or more of the NIOSH criteria

for a hazardous drug, including those with the manufacturer’s safe-handling guidance (MSHG)

Drug AHFS classication MSHG Supplemental information Links

palifermin 84:16 cell stimulants

and proliferants

FDA Pregnancy Category C;

potential for stimulation of

tumor growth

DailyMed; DrugBank

paliperidone 28:16:08:04 atypical

antipsychotics

Metabolite of risperidone; ex-

creted in human breast milk;

FDA Pregnancy Category C

DailyMed; DrugBank

phenoxybenzamine 12:16:04:04 non-selec-

tive alpha-andrenergic

blocking agents

IARC Group 2B; FDA

Pregnancy Category C

DailyMed; DrugBank

phenytoin 28:12.12 hydantoins IARC Group 2B; NTP***; FDA

Pregnancy Category D

DailyMed; DrugBank

progesterone 68:32 progestins IARC Group 2B; NTP*** DailyMed; DrugBank

progestins 68:12 contraceptives FDA Pregnancy Category X DailyMed

propylthiouracil 68:36.08 antithyroid

agents

IARC Group 2B; NTP***; FDA

Pregnancy Category D

DailyMed; DrugBank

raloxifene 68:16:12 estrogen

agonists-antagonists

Abortion and developmental

abnormalities seen at low

doses in laboratory studies;

evidence of tumors at low

doses in laboratory studies;

FDA Pregnancy Category X

DailyMed; DrugBank

rasagiline 28:36 antiparkinsonian

agents

FDA Pregnancy Category C DailyMed; DrugBank

risperidone 28:16:08:04 atypical

anti-psychotics

Evidence of tumors at low

doses in laboratory studies;

may be prolactin-mediated;

FDA Pregnancy Category C

DailyMed; DrugBank

sirolimus 92:44 immunosup-

pressive agents

AKA rapamycin; increased risk

of lymphomas and other ma-

lignancies; embryotoxic and

fetotoxic at 0.2 human dose;

FDA Pregnancy Category C

DailyMed; DrugBank

spironolactone 24:32.20 mineralo-

corticoid receptor

antagonists

FDA Pregnancy Category C;

Black Box warning for tumoro-

genicity in laboratory studies

DailyMed; DrugBank

(Continued)

Table 2 (Continued). Group 2: Non-antineoplastic drugs that meet one or more of the NIOSH criteria

for a hazardous drug, including those with the manufacturer’s safe-handling guidance (MSHG)

Drug AHFS classication MSHG Supplemental information Links

tacrolimus 92:44 immunosup-

pressive agents

Increased risk of lymphomas

and other malignancies;

reproductive eects seen in

laboratory studies below the

MRHD; excreted in breast milk;

FDA Pregnancy Category C

DailyMed; DrugBank

teriunomide 92:20 immunomodula-

tory agents

Black Box warning on severe

hepatotoxicity and terato-

genicity, including major

birth defects; FDA Pregnancy

Category X

DailyMed; DrugBank

thalidomide 92:20 biologic re-

sponse modulators

yes FDA Pregnancy Category X DailyMed; DrugBank

tofacitinib 92:36 disease modi-

fying antirheumatic

drugs

Black Box warning for lympho-

ma and other malignancies;

FDA Pregnancy Category C

DailyMed; DrugBank

uracil mustard NA yes FDA Pregnancy Category D DrugBank

valganciclovir 8:18:32 nucleosides

and nucleotides

yes FDA Pregnancy Category C DailyMed; DrugBank

zidovudine 8:18:08 antiretroviral

agents

IARC Group 2B; FDA

Pregnancy Category C

DailyMed; DrugBank

Table 2 (Continued). Group 2: Non-antineoplastic drugs that meet one or more of the NIOSH criteria

for a hazardous drug, including those with the manufacturer’s safe-handling guidance (MSHG)

e drugs in Table 3 primarily meet the NIOSH criteria for reproductive hazards. ey represent a potential

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

become pregnant, and women who are 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. e manufacturer’s safe-handling guidance (MSHG) is typically in Section 16 of the

DPI. See Table 5 for safe handling recommendations.

Drugs in red font were added in 2016.

Table 3. Group 3: Non-antineoplastic drugs that primarily have adverse reproductive eects

Drug AHFS classication Supplemental information Links

acitretin 88:04 vitamin A Black Box warning on adverse

reproductive eects; FDA Preg-

nancy Category X

DailyMed; DrugBank

alitretinoin 84:92 skin and mucous

membrane agents,

miscellaneous

FDA Pregnancy Category D DailyMed; DrugBank

ambrisentan 24:12:92 vasodilating

agents, miscellaneous

Black Box warning on adverse

reproductive eects; reduced

sperm counts in patients; FDA

Pregnancy Category X

DailyMed; DrugBank

bosentan 24:12:92 vasodilating

agents, miscellaneous

Black Box warning on adverse

reproductive eects; Pregnancy

Category X

DailyMed; DrugBank

cabergoline 28:36:20:04 ergot-

derivative dopamine

receptor agonists

Inhibition of conception and

embryo fetal eects at doses be-

low recommended human dose;

FDA Pregnancy Category B

DailyMed; DrugBank

cetrorelix 92:40 gonadotropin-

releasing hormone

antagonists

FDA Pregnancy Category X DailyMed; DrugBank

choriogonadotropin 68:18 gonadotropins FDA Pregnancy Category X; may

cause fetal harm when adminis-

tered to a pregnant woman

DailyMed; DrugBank

clomiphene* 68:16:12 estrogen

agonist-antagonists

FDA Pregnancy Category X DailyMed; DrugBank

clonazepam 28:12:08 benzodiaz-

epines

Increased risk of congenital

abnormalities when taken in

rst trimester; FDA Pregnancy

Category D

DailyMed; DrugBank

(Continued)

Drug AHFS classication Supplemental information Links

colchicine 92:16 anti-gout agents FDA Pregnancy Category C;

published animal reproduc-

tion and development studies

indicate it causes embryofetal

toxicity, teratogenicity, and al-

tered postnatal development at

exposures within or above the

clinical therapeutic range

DailyMed; DrugBank

dinoprostone 76:00 oxytocics Hazardous only for women in

late pregnancy; FDA Pregnancy

Category C

DailyMed; DrugBank

dronedarone 24:04:04 antiarrythmics Teratogenic in laboratory stud-

ies at ½ MRHD; FDA Pregnancy

Category X

DailyMed; DrugBank

dutasteride 92:08 5-alpha reductase

inhibitors

Women warned not to handle;

FDA Pregnancy Category X

DailyMed; DrugBank

eslicarbazepine 28:12:92 anticonvul-

sants, miscellaneous

Fetal malformations, fetal

growth retardation, embryo-

lethality, and reduced body

weights observed in animal

studies; excreted in human

breast milk; FDA Pregnancy

Category C

DailyMed; DrugBank

ergonovine/methylergo-

novine

76:00 oxytocics Use is contraindicated during

pregnancy because of its utero-

tonic eects; FDA Pregnancy

Category C

DailyMed; Drug-

Bank; DrugBank

nasteride 92:08 5-alpha reductase

inhibitors

Women should not handle

crushed or broken nasteride

tablets when they are pregnant

or may potentially be pregnant,

due to potential risk to a male

fetus; FDA Pregnancy Category X

DailyMed; DrugBank

uconazole 8:14.08 azoles FDA Pregnancy Category C;

case reports describe congeni-

tal anomalies in infants exposed

in utero to maternal uconazole

(400–800 mg/ day) during

most or all of the rst trimester,

similar to those seen in animal

studies

DailyMed; DrugBank

Table 3 (Continued). Group 3: Non-antineoplastic drugs that

primarily have adverse reproductive eects

(Continued)

Drug AHFS classication Supplemental information Links

ganirelix 92:40 gonadotropin-

releasing hormone

antagonists

FDA Pregnancy Category X DailyMed; DrugBank

gonadotropin, chorionic 68:18 gonadotropins Defects of forelimbs and central

nervous system and alterations

in sex ratio have been reported

in laboratory studies; FDA Preg-

nancy Category C

DailyMed; DrugBank

icatibant 92:32 complement

inhibitors

FDA Pregnancy Category C;

in laboratory studies, prema-

ture 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

DailyMed; DrugBank

lomitapide 24:06:92 antilipemic

agents, miscellaneous

FDA Pregnancy Category X DailyMed; DrugBank

macitentan 48:48 vasodilating

agents

Black Box warning for embryo-

fetal toxicity; special warnings

on contraception for females

while taking and 1 month

post-treatment; FDA Pregnancy

Category X

DailyMed; DrugBank

mentropins 68:18 gonadotropins FDA Pregnancy Category X DrugBank

methyltestosterone 68:08 androgens FDA Pregnancy Category X DailyMed; DrugBank

mifepristone 76:00 oxytocics When given to pregnant

women, results in termination

of pregnancy; FDA Pregnancy

Category X

DailyMed; DrugBank

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

nafarelin 68:18 gonadotropins Note: Given only as nasal spray;

no potential for occupational

exposure; FDA Pregnancy

Category X

DailyMed; DrugBank

oxytocin 76:00 oxytocics Hazardous only for women in

trimester; FDA Pregnancy

Category C

DailyMed; DrugBank

(Continued)

Table 3 (Continued). Group 3: Non-antineoplastic drugs that

primarily have adverse reproductive eects

Drug AHFS classication Supplemental information Links

pamidronate 92:24 bone resorption

inhibitors

Embryo-fetal toxicities at doses

below the recommended hu-

man dose; FDA Pregnancy

Category D

DailyMed; DrugBank

paroxetine 28:16:04:20 selective

serotonin uptake inhibi-

tors

Increased risk of congenital

abnormalities when taken in

rst trimester; complications

in pregnancy when taken in

third trimester; FDA Pregnancy

Category D

DailyMed; DrugBank

pasireotide 68:29:04 somostatin

agonists

Increased implantation loss

and decreased viable fetuses,

corpora lutea, and implantation

sites at doses less than the hu-

man recommended dose; FDA

Pregnancy Category C

DailyMed; DrugBank

pentetate calcium triso-

dium

NA Severe teratogenic eects in

laboratory studies in dogs; sup-

plied in ampule, which can lead

to occupational exposure; FDA

Pregnancy Category C

DailyMed

peginesatide 20:16 hematopoietic

agents

Adverse embryo-fetal eects,

including reduced fetal weight,

increased resorption, embryo-

fetal lethality, and cleft palate,

observed in doses below the

recommended human dose;

FDA Pregnancy Category C

DailyMed; DrugBank

plerixafor 20:16 hematopoietic

agents

Teratogenic in laboratory stud-

ies; FDA Pregnancy Category D

DailyMed; DrugBank

ribavirin 8:18:32 nucleosides and

nucleotides

Teratogenic and embryo-

toxic eects in several labora-

tory studies; contraindicated in

women who are pregnant and

in the male partners of women

who are pregnant; FDA Preg-

nancy Category X

DailyMed; DrugBank

(Continued)

Table 3 (Continued). Group 3: Non-antineoplastic drugs that

primarily have adverse reproductive eects

Drug AHFS classication Supplemental information Links

riociguat 48:48 vasodilating

agents

Exclude pregnancy before the

start of treatment, monthly

during treatment, and 1 month

after stopping treatment; FDA

Pregnancy Category X

DailyMed; DrugBank

telavancin 8:12:28 glycopeptides Black Box warning for potential

risk to fetus and adverse repro-

ductive outcomes; reduced fetal

weights and increased rates of

digit and limb malformations in

three species at clinical doses;

FDA Pregnancy Category C

DailyMed; DrugBank

temazepam 28:24:08 benzodiaz-

epines

Increased risk of congenital

malformations associated

with treatment during the rst

trimester of pregnancy; FDA

Pregnancy Category X

DailyMed; DrugBank

testosterone 68:08 androgens Children should avoid contact

with unwashed or unclothed

application sites on skin; FDA

Pregnancy Category X

DailyMed; DrugBank

topiramate 28:12.92 anticonvul-

sants, miscellaneous

FDA Pregnancy Category D DailyMed; DrugBank

tretinoin 84:16 cell stimulants

and proliferants

Black Box warning for severe

birth defects; Special FDA distri-

bution system; FDA Pregnancy

Category X

DailyMed; DrugBank

ulipristal 68:12 contraceptives FDA Pregnancy Category X DailyMed

valproate/valproic acid 28:12:92 anticonvul-

sants, miscellaneous

Black Box warning for terato-

genicity; congenital malforma-

tions, including neural tube

defects; teratogenic in multiple

species; FDA Pregnancy Cat-

egory D

DailyMed; DailyMed;

DrugBank

vigabatrin 28:12:92 anticonvul-

sants, miscellaneous

Malformations seen in labora-

tory studies below the MRHD;

FDA Pregnancy Category C

DailyMed; Drugbank

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

(Continued)

Table 3 (Continued). Group 3: Non-antineoplastic drugs that

primarily have adverse reproductive eects

Drug AHFS classication Supplemental information Links

warfarin 20:12.04.08 coumarin

derivatives

FDA Pregnancy Category D DailyMed; DrugBank

ziprasidone 28:16:08:04 atypical

antipsychotics

Developmental toxicity, includ-

ing possible teratogenic eects

at doses similar to human thera-

peutic doses; an increase in the

number of pups born dead and

a decrease in postnatal survival

at less than MRHD; FDA Preg-

nancy Category C*

DailyMed; DrugBank

zoledronic acid 92:24 bone resorption

inhibitors

Number of stillbirths increased

and survival of neonates de-

creased in laboratory studies

at low doses; FDA Pregnancy

Category D

DailyMed; DrugBank

zonisamide 28:12:92 anticonvul-

sants, miscellaneous

Teratogenic in multiple miscel-

laneous animal species; FDA

Pregnancy Category D

DailyMed; DrugBank

Table 3 (Continued). Group 3: Non-antineoplastic drugs that

primarily have adverse reproductive eects

Table 4 would list drugs that were deleted from the 2014 NIOSH hazardous drug list for the 2016 update; how-

ever, there are no deletions to report.

Table 5. Personal protective equipment and engineering controls for

working with hazardous drugs in healthcare settings*

Formulation Activity

Double

chemo-therapy

gloves

Protective

gown

Eye/face

protection

Respiratory

protection

Ventilated

engineering

control

All types of

hazardous

drugs

Receiving,

unpacking, and

placing in storage

no (single glove

can be used,

unless spills

occur)

yes, when

spills and

leaks occur

no yes, when

spills and

leaks occur

Intact tablet or

capsule

Administration

from unit-dose

package

no (single glove

can be used)

no no no N/A

Tablets or

capsules

Cutting, crushing,

or manipulating

tablets or cap-

sules; handling

uncoated tablets

yes yes no yes, if not

done in

a control

device

yes

†

Administration no (single glove

can be used)

no yes, if vomit

or potential

to spit up

‡

no N/A

Table 5 provides general guidance for some of the possible scenarios that may be encountered in healthcare

settings where hazardous drugs are handled, but it cannot cover all possible situations.

Abbreviations and footnotes. BSC = Class II biological safety cabinet; CACI = compounding aseptic containment

isolator; CSTD = closed system drug-transfer device; HIPEC = hyperthermic intraperitoneal chemotherapy.

is guidance applies to the drugs in Tables 1–3. For more detailed information on safe-handling practices, see the refer-

ence list [NIOSH 2004; ASHP 2006; ONS 2011; USP 2016; OSHA 2016].

†

For nonsterile preparations, a ventilated engineering control such as a fume hood or Class I BSC or a HEPA-ltered enclo-

sure (such as a powder hood) is sucient if the control device exhaust is HEPA ltered or appropriately exhausted to the

outside of the building. It is recommended that these activities be carried out in a control device, but it is recognized that

under some circumstances, it is not possible. If the activity is performed in a ventilated 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, patient pre-disposed to spitting out, patient who has diculty swal-

lowing, veterinary patient) or if the formulation is hard to swallow.

Sterile gloves are required for aseptic drug preparation in BSC or CACI.

Intravenous tubing already attached and primed.

(Continued)

Formulation Activity

Double

chemo-therapy

gloves

Protective

gown

Eye/face

protection

Respiratory

protection

Ventilated

engineering

control

Oral liquid

drug or feed-

ing tube

Compounding yes yes yes, if not

done in

a control

device

yes, if not

done in

a control

device

yes

†

Administration yes yes yes, if vomit

or potential

to spit up

‡

no N/A

Topical drug Compounding yes yes yes, if not

done in

a control

device

yes, if not

done in

a control

device

yes

†

, BSC or

CACI (Note:

carmustine

and mus-

targen are

volatile)

Administration yes yes yes, if liquid

that could

splash

‡

yes, if inhala-

tion poten-

tial

N/A

Subcutaneous/

intra-muscular

injection from

a vial

Preparation

(withdrawing

from vial)

yes yes yes, if not

done in

a control

device

yes, if not

done in

a control

device

yes, BSC or

CACI

Administration

from prepared

syringe

yes yes yes, if liquid

that could

splash

‡

no N/A

Withdrawing

and/or mixing

intravenous or

intramuscular

solution from a

vial or am-

poule

Compounding yes

yes no no yes, BSC or

CACI; use of

CSTD rec-

ommended

Administration of

prepared solution

yes yes yes; if liquid

that could

splash

‡

no N/A; CSTD

required per

USP 800 if

the dosage

form allows

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

working with hazardous drugs in healthcare settings*

(Continued)

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

working with hazardous drugs in healthcare settings*

Formulation Activity

Double

chemo-therapy

gloves

Protective

gown

Eye/face

protection

Respiratory

protection

Ventilated

engineering

control

Solution for

irrigation

Compounding yes yes yes, if not

done in

a control

device

yes, if not

done in

a control

device

yes, BSC or

CACI; use of

CSTD rec-

ommended

Administration

(bladder, HIPEC,

limb perfusion,

etc.)

yes yes yes yes N/A

Powder/solu-

tion for inhala-

tion/ aerosol

treatment

Compounding yes yes yes, if not

done in

a control

device

yes, if not

done in

a control

device

yes, BSC or

CACI

Aerosol adminis-

tration

yes yes yes yes yes, when

applicable

Administration yes yes yes, if liquid

that could

splash

‡

yes, if inhala-

tion poten-

tial

N/A

Drugs and

metabolites in

body uids

Disposal and

cleaning

yes yes yes, if liquid

that could

splash

yes, if inhala-

tion poten-

tial

N/A

Drug-contami-

nated waste

Disposal and

cleaning

yes yes yes, if liquid

that could

splash

yes, if inhala-

tion poten-

tial

N/A

Spills Cleaning yes yes yes yes N/A

To receive NIOSH documents or more information about occupational

safety and health topics, contact NIOSH at

1–800–CDC–INFO (1–800–232–4636)

TTY: 1–888–232–6348

E-mail: cdcinfo@cdc.gov

or visit the NIOSH Website at www.cdc.gov/niosh.

For a monthly update on news at NIOSH, subscribe to NIOSH eNews by

visiting www.cdc.gov/niosh/eNews.

DHHS (NIOSH) Publication No. 2016–161 (Supersedes 2014-138)

Delivering on the Nation’s promise:

safety and health at work for all people

through research and prevention