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
NIOSH List of Antineoplastic and Other
Hazardous Drugs in Healthcare Settings, 2014
ii
1
This document is in the public domain and may be freely copied or reprinted
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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 Occupa-
tional 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 • People
TM
ii
1
Preamble:. e National Institute for Occupational Safety and Health (NIOSH) Alert: Preventing Occu-
pational 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 identi-
ed a sample list of major hazardous drugs. e list was compiled from information provided by four insti-
tutions 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). e 2004 list was updated in 2010 and
2012. e current update (2014) adds 27 drugs and includes a review of the 2004 list 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. e review process for the addition
of the new listings is described in the Federal Register: http://www.cdc.gov/niosh/docket/review/docket233/
pdf/CDC-2013-0007.pdf.
General Approach to Handling
Hazardous Drugs
In the Alert (NIOSH 2004) and updates to the haz-
ardous drug list (NIOSH 2012), NIOSH has recom-
mended standard precautions or universal precau-
tions 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. e current
NIOSH approach involves three groups of drugs:
Group 1: Antineoplastic drugs (AHFS Classi-
cation 10:00) [ASHP/AHFS DI 2013]. 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 pregnant
or breast feeding, because some of these drugs
may be present in breast milk (Table 3).
e majority of the reproductive risks associat-
ed with the drugs listed in Table 3 are focused on
women, but some can apply to men only (such as re-
duced fertility or sperm count) or to both men and
women. Although all hazardous drugs should be
handled accordingly, especially if they must be pre-
pared aseptically, some populations of workers may
not be at serious risk from handling drugs in Group
3. ese include workers who are excluded from the
susceptible populations for specic 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 identication on each drug on the
basis of the NIOSH criteria for a hazardous drug.
No attempt has been made to perform risk assess-
ments on each drug or to propose exposure limits.
NIOSH has provided guidance for personal protec-
tive equipment and ventilated engineering controls
for some of the various scenarios in which a drug
may be handled in health care settings (Table 5).
is guidance cannot cover all possible situations
but provides general recommendations for the ma-
jor handling events typically seen in health care.
Dening Hazardous Drugs
Hazardous drugs include those used for cancer che-
motherapy, antiviral drugs, hormones, some bioen-
gineered drugs, and other miscellaneous drugs. e
denition of hazardous drugs used in the Alert is
based on a denition originally developed in 1990
by the American Society of Hospital Pharmacists
Drugs Considered Hazardous
2
3
[ASHP 1990], currently known as the American
Society of Health-System Pharmacists. us, the
denition may not accurately reect the potential
toxicity criteria associated with some of the new-
er-generation pharmaceuticals entering the health
care setting. For example, bioengineered drugs tar-
get specic 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 eects relat-
ed to highly potent drugs and bioengineered drugs.
erefore, when working with any hazardous drug,
health care workers should follow the approaches
described in Table 5, along with any recommen-
dations included in the manufacturer’s Safety Data
Sheet (SDS).
ASHP Denition of Hazardous
Drugs
ASHP denes 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 [McDiarmid et al. 1991;
Arrington and McDiarmid 1993; ASHP 2006; Mas-
soomi et al. 2008; Eisenberg 2009; ONS 2011]. e
criteria are prioritized to reect the hierarchy of
potential toxicity described below. Since the haz-
ardous drugs covered by the Alert were designed as
therapeutic agents for humans, human toxicity pro-
les should be considered superior to any data from
animal models or in vitro systems. Additional guid-
ance for dening hazardous drugs is available in the
following sources: carcinogenicity [61 Fed Regist
17960–18011 (1996b); IARC 2014], teratogenicity
[56 Fed Regist 63798–63826 (1991)], developmen-
tal 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 po-
tential for occupational exposure.
NIOSH Revision of ASHP
Denition
e 1990 ASHP denition of hazardous drugs
*
was
revised by the NIOSH Working Group on Hazard-
ous Drugs for the Alert. Drugs considered hazard-
ous include those that exhibit one or more of the
following six characteristics in humans or animals:
Carcinogenicity
Teratogenicity or other developmental
toxicity
†
Reproductive toxicity
†
Organ toxicity at low doses
†
Genotoxicity
‡
Structure and toxicity proles of new drugs that
mimic existing drugs determined hazardous by
the above criteria
*
1. Genotoxicity (i.e., mutagenicity and clastogenicity in
short-term test systems)
2. Carcinogenicity in animal models, in the patient popu-
lation, 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 eects, but some exhibit toxicity at
low doses. e level of toxicity reects a continuum from rel-
atively nontoxic to production of toxic eects in patients at
low doses (for example, a few milligrams or less). For exam-
ple, 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 occu-
pational exposure limits (OELs) of less than 10 µg/m
3
aer
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, re-
sponses from multiple test systems are needed before precau-
tions can be required for handling such agents. e EPA eval-
uations include the type of cells aected and in vitro versus in
vivo testing [51 Fed. Regist. 34006–34012 (1986)].
2
3
Determining Whether a Drug is
Hazardous
Many hazardous drugs used to treat cancer (for exam-
ple, alkylating agents) bind to or damage DNA. Oth-
er antineoplastic drugs, some antivirals, antibiotics,
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 eects for treated patients
and their ospring. ese nonselective actions can
also cause adverse eects in health care workers
who are inadvertently exposed to hazardous drugs.
Early concerns about occupational exposure to an-
tineoplastic drugs rst appeared in the 1970s. Al-
though 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 eect) or cause irreversible
eects. As the use and number of these potent drugs
increase, so do opportunities for hazardous expo-
sures among health care workers. For example, an-
tineoplastic drugs such as cyclophosphamide have
immunosuppressant eects that proved benecial
for treating nonmalignant diseases such as rheuma-
toid arthritis and multiple sclerosis [Baker et al. 1987;
Moody et al. 1987; Chabner et al. 1996; Abel 2000].
e lack of proper training for handling antineoplas-
tic drugs in other specialty areas may be an issue that
needs to be addressed [Polovich and Giesker 2011;
Menonna-Quinn et al. 2013].
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 hazard-
ous drug as outlined above, NIOSH takes the fol-
lowing approach.
NIOSH takes into account the dose for animal
testing, for reproductive and developmental tox-
icity, and for carcinogenicity testing. If adverse
eects are observed near, at, or below the max-
imum recommended human dose (MRHD),
NIOSH considers it to be highly relevant. If dos-
es producing an adverse eect are many times
the MRHD, usually NIOSH does not consider
them in its evaluation.
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-specic. Any avail-
able human data are considered signicant.
For eects of genotoxicity, NIOSH looks at in
vivo testing over in vitro testing. However, ad-
verse outcomes in several in vitro tests will be
considered in its evaluation.
For reproductive and developmental eects,
NIOSH notes if there was maternal toxicity, in
addition to the dose. Eects on the fetus in the
absence of maternal toxicity are considered rele-
vant. Drugs with an FDA pregnancy category X
rating are typically listed as hazardous. Drugs in
Category D are oen listed as hazardous, but it
will depend on the individual drug. Any avail-
able human data are considered signicant.
For organ toxicity, the low dose criterion in the
denition (a daily therapeutic dose of 10 mg/day
or a dose of 1 mg/kg per day in laboratory ani-
mals) 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 pre-
sented here, each organization should create its own
list of drugs considered to be hazardous. is doc-
ument presents guidance for making such a facili-
ty-specic 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 add-
ed to the list if they are deemed hazardous. Organi-
zations have developed various approaches to iden-
tifying and classifying hazardous drugs [Chaee et
al. 2010; Badry et al. 2013; Kaestli et al. 2013]. Al-
though the classication schemes may dier some-
what, the drugs listed as hazardous are quite similar.
Individual organizations may not have adequate re-
sources for determining their own list of hazardous
4
5
drugs. If so, the list of hazardous drugs in this docu-
ment 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 addi-
tional information becomes available. NIOSH will
update this list periodically, adding new drugs con-
sidered to be hazardous and removing those that re-
quire reclassication. is hazardous drug list will
be posted on the NIOSH website at www.cdc.gov/
niosh/topics/hazdrug/.
How to Generate Your Own List
of Hazardous Drugs
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 identication 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 dening hazardous drugs
and (2) posting a list of the hazardous drugs to en-
sure worker safety. Institutions may wish to com-
pare their lists to the listing in this document or on
the NIOSH website.
It is not likely that every health care provider or fa-
cility will 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. In-
stead, compliance requires practice-specic assess-
ments 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, reas-
sessment of their presence on hazardous drug lists
as toxicological data become available to support
re-categorization. Toxicological data are oen in-
complete 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 be-
comes 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 dened as hazardous may
not pose a signicant risk of direct occupational expo-
sure 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 cabi-
net [Simmons 2010; Goodin et al. 2011]. Uncoated tab-
lets may present a risk of exposure from dust by skin
contact and/or inhalation when the tablets are counted
[Shahsavarani et al. 1993].
All hazardous drugs, regardless of the formulation,
should be labeled as such to prevent improper han-
dling. Tablet and capsule forms of hazardous drugs
should not be placed in automated counting ma-
chines, which subject them to stress and may intro-
duce powdered contaminants into the work area.
Counting and pouring of hazardous drugs should be
done carefully, and clean equipment should be ded-
icated for use with these drugs. Crushing tablets or
opening capsules should be avoided and liquid for-
mulations 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 com-
pounding, administration, and disposal of hazardous
drugs have been developed by several organizations
[NIOSH 2004; ASHP 2006; ONS 2011; USP 2014].
Where to Find Information
Related to Drug Toxicity
Practice-specic 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
4
5
by a local practice. Here are some of the resources
that employers can use to evaluate the hazard po-
tential 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/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 health care profession journals
Evidence-based recommendations from other
facilities that meet the criteria dening hazard-
ous drugs
Identication of Hazardous
Drugs
e following list (Tables 1–3) contains those drugs
that NIOSH has reviewed according to the criteria
in the NIOSH denition of a hazardous drug. e
list was compiled from the following:
the original list published in 2004 (NIOSH
2004), which was a compilation of ve lists avail-
able 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 2014 update to the list, for which 27
drugs were added (including ve with manufac-
turers’ safe-handling warnings) and one drug,
tetracycline, was deleted on the basis of re-evalu-
ation and feedback from stakeholders (Table 4b).
e OSHA hazard communication standard re-
quires hazardous drugs to be handled with use of
special precautions. e 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, trans-
portation, housekeeping, and waste disposal. Insti-
tutions 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 aer the list be-
low 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 manufactur-
er or the drug package insert. You may also check
with other institutions that might be using the same
drug. If any of the documents mention carcinoge-
nicity, 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 pre-
cautions stipulated in the Alert. If the drug meets
one or more of the criteria for hazardous drugs in
the NIOSH denition, handle it as hazardous.
e list of hazardous drugs will be updated peri-
odically on the website, hpp://www.cdc.gov/niosh/
topics/hazd r ug /.
is list supersedes both the 2004 list, http://www.
cdc.gov/niosh/docs/2004-165/ and the 2012 list
http://www.cdc.gov/niosh/docs/2012-150.
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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. Ryan
Dufour, Nicole Romero, and Vanessa Williams pro-
vided graphic design and production services.
6
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NIOSH List of Antineoplastic and Other Hazardous Drugs
in Healthcare Settings 2014
NIOSH performs a hazard identication on each of
the drugs in the following tables. e actual risk to
health care workers depends on what is done with
the drugs—how they are manipulated, how oen
they are handled, and what type of engineering con-
trols 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 tab-
lets 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 con-
tainment isolator) is not available, then double
gloves, a protective gown, respiratory protec-
tion, 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 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 supple-
mented with a CSTD (closed system drug trans-
fer device), is required to protect the drug, envi-
ronment, and health care worker.
8
9
Table 1. Antineoplastic drugs including those with
manufacturers’ safe handling guidance (MSHG)
Drug AHFS classication MSHG Reason for listing Links
abiraterone* 10:00 antineoplastic agents Women who are pregnant
or women who may be
pregnant should not handle
without protection (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
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**;
FDA Pregnancy Category D
DailyMed; DrugBank
azacitidine 10:00 antineoplastic agents yes IARC Group 2A carcinogen;
FDA Pregnancy Category D
DailyMed; DrugBank
e drugs in Table 1 meet one or more of the NIOSH criteria for a hazardous drug. ese drugs represent an
occupational hazard to health care workers and should always be handled with use of recommended engi-
neering 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. Cut-
ting, 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 majority 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 feed-
ing, 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 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 Cancer (www.iarc.fr).
***
BCG, although classied 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 recommended. All
equipment, supplies, and receptacles in contact with BCG should be handled and disposed of as biohazardous.
If preparation cannot be performed in a containment device, then respiratory protection, gloves, and a gown
should be worn to avoid inhalation or contact with BCG organisms.
(continued)
8
9
Drug AHFS classication MSHG Reason for listing Links
bacillus
calmette Guerin
(BCG)***
80:12 vaccines yes See special handling
requirements**; FDA Preg-
nancy Category C
DailyMed
bendamustine 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed;
bexarotene 10:00 antineoplastic agents FDA Pregnancy Category X DailyMed; DrugBank
bicalutimide 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
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
capecitabine 10:00 antineoplastic agents yes Metabolized to 5-uoro-
uracil; FDA Pregnancy Cate-
gory D
DailyMed; DrugBank
carboplatin 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank
carmustine 10:00 antineoplastic agents yes IARC Group 2A carcinogen;
FDA Pregnancy Category D
DailyMed; DrugBank
chlorambucil 10:00 antineoplastic agents yes IARC Group 1 carcinogen;
FDA Pregnancy Category D
DailyMed; DrugBank
cisplatin 10:00 antineoplastic agents yes IARC Group 2A carcinogen;
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
crizotinib 10:00 antineoplastic agents FDA Pregnancy Category D DailyMed
cyclophospha-
mide
10:00 antineoplastic agents yes IARC Group 1 carcinogen;
FDA Pregnancy Category D
DailyMed; Drugbank
cytarabine 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank
Table 1 (Continued). Antineoplastic drugs including those with
manufacturers’ safe handling guidance (MSHG)
(continued)
10
11
Drug AHFS classication MSHG Reason for listing Links
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 2B, AKA dauno-
mycin; FDA Pregnancy Cat-
egory D
DailyMed; Drugbank
decitabine 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; Drugbank
degarelix 10:00 antineoplastic agents yes 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;
FDA Pregnancy Category D
DailyMed; DrugBank
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
Table 1 (Continued). Antineoplastic drugs including those with
manufacturers’ safe handling guidance (MSHG)
(continued)
10
11
Table 1 (Continued). Antineoplastic drugs including those with
manufacturers’ safe handling guidance (MSHG)
Drug AHFS classication MSHG Reason for listing Links
goserelin 10:00 antineoplastic agents FDA Pregnancy Category X DailyMed; Drugbank
hydroxyurea 10:00 antineoplastic agents yes Special warning on handling
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
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;
FDA Pregnancy Category D
DailyMed; DrugBank
mechloreth-
amine
10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank
megestrol 10:00 antineoplastic agents 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;
FDA Pregnancy Category D
DailyMed; DrugBank
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
(continued)
12
13
Table 1 (Continued). Antineoplastic drugs including those with
manufacturers’ safe handling guidance (MSHG)
Drug AHFS classication MSHG Reason for listing Links
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
procarbazine 10:00 antineoplastic agents yes IARC Group 2A carcinogen;
FDA Pregnancy Category D
DailyMed; DrugBank
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 2B; FDA Preg-
nancy Category D
DailyMed; DrugBank
sunitinib 10:00 antineoplastic agents FDA Pregnancy Category D DailyMed; DrugBank
tamoxifen 10:00 antineoplastic agents IARC Group 1 carcinogen;
FDA Pregnancy Category D
DailyMed; DrugBank
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;
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;
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
trimetrexate 10:00 antineoplastic agents yes FDA Pregnancy Category D DailyMed; DrugBank
triptorelin 10:00 antineoplastic agents FDA Pregnancy Category X DailyMed
(continued)
12
13
Table 1 (Continued). Antineoplastic drugs including those with
manufacturers’ safe handling guidance (MSHG)
Drug AHFS classication MSHG Reason for listing Links
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
14
15
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 classication MSHG Reason for listing Links
abacavir
*
8:18.08.20 nucleoside and
reverse transcriptase
inhibitors
FDA Pregnancy Category C;
malignant tumors observed
in male and female mice
and rats; genotoxic in in vivo
micronucleus test.
DailyMed; DrugBank
alefacept 84:92 skin and mucous
membrane agents, miscel-
laneous
Increased frequency of
malignancies observed in
treated patients; FDA Preg-
nancy Category B
DailyMed; DrugBank
apomorphine 28:36.20.08 Nonergot-
derivative dopamine
receptor agonists
FDA Pregnancy Category C;
genotoxic in several in vitro
assays.
DailyMed; DrugBank
azathioprine 92:44 immunosuppressant
agents
yes IARC Group 1 carcinogen**;
FDA Pregnancy Category D***
DailyMed; DrugBank
carbamazepine 28:12:92 anticonvulsants,
miscellaneous
Black Box warning for
aplastic anemia; congenital
malformations in ospring
of mothers who took drug;
rapid transplacental passage;
FDA Pregnancy
Category D
DailyMed; Drugbank
e 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 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 Section 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 Cancer, www.iarc.fr
***
Drugs in blue font meet one or more additional criteria for a hazardous drug and also pose a potential re-
productive hazard.
(continued)
14
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 classication MSHG Reason for listing Links
chloramphenicol 8:12:08 chloramphenicols IARC Group 2A carcinogen;
FDA Pregnancy Category C
DailyMed; DrugBank
cidofovir 8:18:32 nucleoside and
nucleotides
yes FDA Pregnancy Category C DailyMed; Drugbank
cyclosporine 92:44 immunosuppressive
agents
IARC Group 1 carcinogen;
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
dexrazane); genotoxic in
vitro and in vivo; in labo-
ratory studies, testicular
atrophy observed at or
below the human dose
DailyMed; DrugBank
diethylstilbestrol NA IARC Group 1 carcinogen;
FDA Pregnancy Category X
DrugBank
divalproex 28:12:92 anticonvulsants,
miscellaneous
Black Box warning for tera-
togenicity; FDA Pregnancy
Category D; tumors seen in
laboratory studies at doses
below MRHD
DailyMed
entecavir 8:18:32 nucleosides and
nucleotides
yes FDA Pregnancy Category C DailyMed; DrugBank
(continued)
16
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 classication MSHG Reason for listing Links
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 carci-
nomas of the breast, uterus,
cervix, vagina, testis, and
liver; present in breast milk;
FDA Pregnancy Category X
DailyMed; DrugBank
estrogen/
progesterone
combinations
68:12 contraceptives IARC Group 1 carcinogen;
FDA Pregnancy Category X
DailyMed
estrogens,
conjugated
68:16:04 estrogens Black Box warning for endo-
metrial cancer and cardio-
vascular risks; long-term use
in women and laboratory
studies increases frequency
of several cancers; FDA Preg-
nancy Category X
DailyMed
estrogens,
esteried
68:16:04 estrogens Black Box warning for
endometrial cancer and car-
diovascular risks: FDA Preg-
nancy Category X
DailyMed
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 response
modiers
FDA Pregnancy Category
C; in laboratory studies,
increased malformations
and embryo-fetal deaths at
less than the RHD; malignant
lymphomas observed in
male and female mice.
DailyMed; DrugBank
(continued)
16
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 classication MSHG Reason for listing 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
leunomide 92:36 disease-modifying
antirheumatic agents
Teratogenic in laboratory
studies at 1/10 HD; marked
postnatal survival at 1/100
HD; FDA Pregnancy Cate-
gory X; severe liver injury
reported in patients; carcino-
genicity observed at doses
below HD
DailyMed; DrugBank
lenalidomide 92:20 biologic response
modulators
yes Analog of thalidomide; FDA
Black box warnings for limb
abnormalaties; pregnancy Cat-
egory X; in laboratory studies,
caused thalidomide-type limb
defects in monkey ospring
DailyMed; DrugBank
liraglutide
recombinant
68:20.06 incretin mimetics FDA Pregnancy Category C;
Black Box warning for thy-
roid C-cell tumors, with
supporting evidence in lab-
oratory studies; also in labo-
ratory studies, teratogenic at
or below the MRHD.
DailyMed; DrugBank
medroxyproges-
terone acetate
68:32 progestins yes IARC Group 2B; FDA Preg-
nancy Category X
DailyMed; DrugBank
(continued)
18
19
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 classication MSHG Reason for listing Links
mycophenolate
mofetil
92:44 immunosuppressive
agents
Black Box warning for
embryo fetal toxicity, malig-
nancies and serious infec-
tions; Increased risk of rst-
trimester pregnancy loss and
increased risk of congenital
malformations; FDA Preg-
nancy 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.
DailyMed; DrugBank
mycophenolic
acid
92:44 immunosuppressive
agents
Black Box warning for rst
trimester pregnancy loss
and an increased risk of con-
genital malformations; FDA
Pregnancy Category D; Black
Box warning for lymphomas
and other malignancies;
genotoxic in vitro and in vivo
DailyMed; DrugBank
nevirapine 8:18.08.16 nonnucleoside
reverse transcriptase
inhibitors
FDA Pregnancy Category B;
in laboratory studies, hepa-
tocellular adenomas and car-
cinomas at doses lower than
human dose.
DailyMed; DrugBank
oxcarbazepine 28:12:92 anticonvulsants,
miscellaneous
Tumors observed in labora-
tory studies at 1/10 MRHD;
FDA Pregnancy Category C
DailyMed; Drugbank
(continued)
18
19
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 classication MSHG Reason for listing Links
palifermin 84:16 cell stimulants and
proliferants
FDA Pregnancy Category C;
potential for stimulation of
tumor growth
DailyMed; Drugbank
phenoxyben-
zamine
12:16:04:04 non-selective
alpha-andrenergic blocking
agents
IARC Group 2B; FDA Preg-
nancy Category C
DailyMed; DrugBank
phenytoin 28:12.12 hydantoins IARC 2B; FDA Pregnancy Cat-
egory D
DailyMed; DrugBank
pipobroman NA FDA Pregnancy Category D Drugbank
progesterone 68:32 progestins IARC Group 2B DailyMed; Drugbank
progestins 68:12 contraceptives FDA Pregnancy Category X
propylthiouracil 68:36.08 antithyroid agents IARC 2B; FDA Pregnancy Cat-
egory D
DailyMed; DrugBank
raloxifene 68:16:12 estrogen ago-
nists-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 immunosuppressive
agents
AKA rapamycin; increased
risk of lymphomas and other
malignancies; embryotoxic
and fetotoxic at 0.2 HD; FDA
Pregnancy Category C
DailyMed; DrugBank
(continued)
20
21
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 classication MSHG Reason for listing Links
spironolactone 24:32.20 mineralocorticoid
receptor antagonists
FDA Pregnancy Category C;
black box warning for
tumorogenicity in laboratory
studies.
DailyMed; DrugBank
tacrolimus 92:44 immunosuppressive
agents
Increased risk of lymphomas
and other malignancies;
reproductive eects seen in
laboratory studies below the
MRHD; excreted in breast
milk; FDA Pregnancy Cate-
gory C
DailyMed; DrugBank
thalidomide 92:20 biologic response
modulators
yes FDA Pregnancy Category X 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 Preg-
nancy Category C
DailyMed; DrugBank
20
21
Table 3. Non-antineoplastic drugs that primarily have adverse reproductive eects
Drug AHFS classication Reason for listing Links
acitretin 88:04 vitamin A Black Box warning on adverse
reproductive eects; FDA
Pregnancy Category X
DailyMed; DrugBank
alitretinoin 84:92 skin and mucous
membrane agents, miscel-
laneous
FDA Pregnancy Category D DailyMed; DrugBank
ambrisentan 24:12:92 vasodilating agents,
miscellaneous
Black Box warning on adverse
reproductive eects; reduced
sperm counts in patients; FDA
Pregnancy Category X
DailyMed;
bosentan 24:12:92 vasodilating agents,
miscellaneous
Black Box warning on adverse
reproductive eects; FDA
Pregnancy Category X
DailyMed; DrugBank
cabergoline 28:36:20:04 ergot-derivative
dopamine receptor agonists
Inhibition of conception and
embryo fetal eects at doses
below recommended human
dose; FDA Pregnancy Cate-
gory B
DailyMed; DrugBank
cetrorelix 92:40 gonadotropin-
releasing hormone anago-
nists
FDA Pregnancy Category X DailyMed; DrugBank
choriogonado-
tropin
68:18 gonadotropins FDA pregnancy Category X;
may cause fetal harm when
administered to a pregnant
woman.
DailyMed; DrugBank
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, 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 expo-
sure to workers. Manufacturers’ safe handling guidance (MSHG) is typically in Section 16 of the drug package
insert. See Table 5 for safe handling recommendations.
*
Drugs in red font were added in 2014.
(continued)
22
23
Drug AHFS classication Reason for listing Links
clonazepam 28:12:08 benzodiapines Increased risk of congenital
abnormalities when taken in
rst trimester; FDA Pregnancy
Category D
DailyMed; DrugBank
colchicine 92:16 antigout agents FDA Pregnancy Category C;
published animal reproduc-
tion and development studies
indicate it causes embryofetal
toxicity, teratogenicity, and
altered postnatal develop-
ment at exposures within or
above the clinical therapeutic
range
DailyMed; DrugBank
dinoprostone 76:00 oxytocics Hazardous only for women
in late pregnancy; FDA Preg-
nancy Category C
DailyMed; DrugBank
dronedarone 24:04:04 antiarrythmics Teratogenic in laboratory
studies at ½ MRHD; FDA Preg-
nancy Category X
DailyMed; DrugBank
dutasteride 92:08 5-alpha reductase
inhibitors
Women warned not to
handle; FDA Pregnancy Cate-
gory X
DailyMed; DrugBank
ergonovine/meth-
ylergonovine
76:00 oxytocics Use is contraindicated during
pregnancy because of its
uterotonic eects; FDA Preg-
nancy Category C
DailyMed; DrugBank;
DrugBank
nasteride 92:08 5-alpha reductase
inhibitors
Women should not handle
crushed or broken nasteride
tablets when they are preg-
nant or may potentially be
pregnant due to potential
risk to a male fetus; FDA Preg-
nancy Category X
DailyMed; Drugbank
Table 3 (Continued). Non-antineoplastic drugs that primarily
have adverse reproductive eects
(continued)
22
23
Table 3 (Continued). Non-antineoplastic drugs that primarily
have adverse reproductive eects
Drug AHFS classication Reason for listing Links
uconazole 8:18.08 azoles FDA Pregnancy Category C;
case reports describe con-
genital 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
ganirelix 92:40 gonadotropin-
eleasing hormone
antagonists
FDA Pregnancy Category X DailyMed
gonadotropin,
chorionic
68:18 gonadotropins Defects of forelimbs and
central nervous system and
alterations in sex ratio have
been reported in laboratory
studies; FDA pregnancy Cat-
egory C
DailyMed; DrugBank7
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
mentropins 68:18 gonadotropins FDA Pregnancy Category X Drugbank
methyltestos-
terone
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
(continued)
24
25
Table 3 (Continued). Non-antineoplastic drugs that primarily
have adverse reproductive eects
Drug AHFS classication Reason for listing Links
nafarelin 68:18 gonadotropins Note: Given only as nasal
spray; no potential for occu-
pational exposure; FDA Preg-
nancy Category X
DailyMed; DrugBank
oxytocin 76:00 oxytocics Hazardous only for women in
3rd trimester; FDA Pregnancy
Category C
DailyMed; DrugBank
paroxetine 28:16:04:20 selective sero-
tonin uptake inhibitors
Increased risk of congenital
abnormalities when taken in
rst trimester; complications
in pregnancy when taken in
third trimester; FDA Preg-
nancy Category D
DailyMed; Drugbank
pentetate calcium
trisodium
NA Severe teratogenic eects in
laboratory studies in dogs:
supplied in ampule which
can lead to occupational
exposure; FDA Pregnancy
Category C
DailyMed
plerixafor 20:16 hematopoietic agents Teratogenic in laboratory
studies; FDA Pregnancy Cate-
gory D
DailyMed; DrugBank
ribavirin 8:18:32 nucleosides and
nucleotides
Teratogenic and embryotoxic
eects in several laboratory
studies; contraindicated in
women who are pregnant
and in the male partners of
women who are pregnant;
FDA Pregnancy Category X
DailyMed; DrugBank
telavancin 8:12:28 glycopeptides Black Box warning for poten-
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
DailyMed; Drugbank
(continued)
24
25
Table 3 (Continued). Non-antineoplastic drugs that primarily
have adverse reproductive eects
*
Drug AHFS classication Reason for listing Links
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 anticonvulsants,
miscellaneous
FDA Pregnancy Category D DailyMed; DrugBank
tretinoin 84:16 cell stimulants and
proliferants
Black Box warning for severe
birth defects; Special FDA dis-
tribution system; FDA Preg-
nancy Category X
DailyMed; DrugBank
ulipristal 68:12 contraceptives FDA Pregnancy Category X DailyMed
valproate/valproic
acid
28:12:92 anticonvulsants,
miscellaneous
Black Box warning for terato-
genicity; congenital malfor-
mations including neural tube
defects and others; terato-
genic in multiple species; FDA
Pregnancy Category D
DailyMed; DailyMed;
DrugBank
vigabatrin 28:12:92 anticonvulsants,
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
warfarin 20:12.04.08 coumarin
derivatives
FDA Pregnancy Category D DailyMed; DrugBank
ziprasidone 28:16:08:04 atypical
antipsychotics
Developmental toxicity,
including possible terato-
genic eects 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 Preg-
nancy Category C
DailyMed; Drugbank
(continued)
26
27
Table 3 (Continued). Non-antineoplastic drugs that primarily
have adverse reproductive eects
*
Drug AHFS classication Reason for listing Links
zoledronic acid 92:24 bone resorption
inhibitors
Number of stillbirths
increased and survival of neo-
nates decreased in laboratory
studies at low doses; FDA
Pregnancy Category D
DailyMed; DrugBank
zonisamide 28:12:92 anticonvulsants,
miscellaneous
Teratogenic in multiple
animal species; FDA Preg-
nancy Category C
DailyMed; DrugBank
26
27
Table 4a. Drugs deleted from the 2004 hazardous drug list for not
meeting the NIOSH criteria for hazardous drugs
Drug AHFS Classication
*
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
podolox/podophyllum resin 84:36 miscellaneous skin and mucous membrane agents
(mitotic inhibitor)
testolactone 10:00 antineoplastic agents
triuridine 52:04.06 antivirals
vidarabine 52:04.06 antivirals
Table 4 lists drugs that were deleted from the 2004 and 2012 NIOSH hazardous drug lists. e 2004 list was
a composite of ve 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 4b. Drugs deleted from the 2012 list on the basis of stakeholder comments
Drug AHFS Classication*
Tetracycline 8:12.24 tetracyclines
28
29
Table 5 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. is guidance applies
to the drugs in Tables 1–3. For more detailed information on safe-handling practices, see the reference list
[NIOSH 2004; ASHP 2006; USP 2008; ONS 2011].
Table 5. 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
Intact tablet or
capsule
Administration
from unit-dose
package
no (single
glove
should be
used)
no no no N/A
Tablets or cap-
sules
Cutting,
crushing or
otherwise
manipulating
tablets or cap-
sules
yes yes no yes, if not done
in a control
device
yes
†
Administration yes yes no
2
yes, if powder
generated
N/A
Oral liquid
drug
Compounding yes yes yes, if not
done in
a control
device
yes, if not done
in a control
device
yes
†
Administration yes yes no
‡
no
‡
N/A
Topical drug Compounding yes yes yes yes, if not done
in a control
device
yes
†
Administration yes yes yes, if liquid
that could
splash
‡
yes, if inhalation
potential
N/A
Ampoule Opening yes yes yes, if not
done in
a control
device
yes, if not done
in a control
device
yes, BSC or
CACI
(continued)
28
29
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,
intramuscular
injection
Preparation
(withdrawing
from vial or
ampoule)
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
‡
yes, if inhalation
potential
‡
N/A
Intravenous
solution
Compounding yes yes yes, if not
done in
a control
device
yes, if not done
in a control
device
yes, BSC or
CACI; recom-
mend use of
CSTD
Administration
of prepared
solution
§
yes yes yes, if liquid
that could
splash
‡
yes, if inhalation
potential
‡
N/A; recom-
mend use of
CSTD
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; recom-
mend use of
CSTD
Administration
(bladder, HIPEC,
limb perfusion,
etc.)
yes yes yes yes N/A
Powder/
solution for
inhalation
Inhalation yes yes yes yes yes, when
applicable
*e 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 [NIOSH 2004; ASHP 2006; USP 2008, and ONS 2011]. BSC
= Class II biological safety cabinet; CACI = compounding aseptic containment isolator; CSTD = closed system drug transfer device; HIPEC = hyper-
thermic intraperitoneal chemotherapy.
†
For nonsterile preparations, an engineering control such as a fume hood or Class I BSC is sucient. 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 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 administered by feeding tube.
§
Intravenous tubing already attached and primed.
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TTY: 1–888–232–6348
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or visit the NIOSH website at www.cdc.gov/niosh.
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DHHS (NIOSH) Publication No. 2014-138 (Supersedes 2012-150)
safer • healthier • people
tm
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