NIOSH res onse to NIOSH Docket No.233, Hazardous Dru List U date 2014 

Commenter Drug Comment NIOSH Response 

Stephen R, Gomez, PhD; bevacizumab Requested the exclusion of NIOSH re-evaluated bevacizumab in light of 

Patricia Weideman, bevacizumab from the new information on its bioavailability in the 

PhD, Genentech NIOSH hazardous drug list occupational setting provided by the 

based on lack of exposure in manufacturer and it was determined that the new 

occupational setting. wamings were not sufficient to warrant its 

listing. Following a final review, the expert 

panel concurred with not listing this drug as 

hazardous. 

William H. Houser, dexmedetomidine Requested that Initially, the expert panel recommended listing 

PhD, DABT, Hospira dexmedetomidine not be dexmedetomidine as a hazardous drug based on 

listed as hazardous based on fetal toxicity in laboratory studies. The NIOSH 

limited exposure potential Hazardous Drug Committee re-evaluated 

for healthcare workers. dexmedetomidine in light of new information 

provided by the manufacturer on the limited 

potential for occupational exposure and 

determined that it will not be listed for 2014. 

Following a final review, the expert panel 

concurred with not listing this drug as hazardous. 

Christopher J. Topoleski, Fluconazole Only those workers who are Fluconazole will be listed on the 2014 hazardous 

American Society of at reproductive risk, and not drug list with specific recommendations about its 

Health-System all workers, should be reproductive risk. NIOSH will be adding a table 

Pharmacists protected from exposure. of recommendations for personal protective 

Occupational exposure is equipment and engineering controls. 

limited due to dosage 

formulation. May support 

listing if additional 

information on managing 

these drugs were provided 

on personal protective 

equipment. 
nevirapine Occupational exposure is 

limited due to dosage 

formulation. May support 

listing if additional 

information on managing 

these drugs were provided 

on personal protective 

equipment. 

Nevirapine will be listed on the 2014 hazardous 

drug list with specific recommendations about its 

formulation. It will be listed on the 2014 

hazardous drug list in a non-antineoplastic drug 

category based on hepatocellular adenomas and 

carcinomas in laboratory studies at doses lower 

than human dose in laboratory studies. NIOSH 

will be adding a table of recommendations for 

personal protective equipment and engineering 

controls. 

propylthiouracil Only those workers who are Propylthiouracil will be listed on the 2014 

at reproductive risk, and not hazardous drug list in a non-antineoplastic drug 

all workers, should be category based on its IARC classification of 2B, 

protected from exposure. with additional recommendations about its 

Occupational exposure is reproductive risk. NIOSH will be adding a table 

limited due to dosage of recommendations for personal protective 

formulation. May support equipment and engineering controls. 

listing if additional 

information on managing 

these drugs were provided 

on personal protective 

e ui ment. 

spironolactone Only those workers who are Spironolactone will be listed on the 2014 

at reproductive risk, and not hazardous drug list. It will be listed on the 2014 

all workers, should be hazardous drug list in a non-antineoplastic drug 

protected from exposure. category based on a new black box warning for 

Occupational exposure is tumorogenicity in laboratory studies. No 

limited due to dosage adverse reproductive effects were identified for 

formulation. May support this drug. N10SH will be adding a table of 

listing if additional recommendations for personal protective 

information on managing equipment and engineering controls. 

these drugs were provided 

on personal protective 

equipment. 
voriconazole Only those workers who are Voriconazole will be listed on the 2014 

at reproductive risk, and not hazardous drug list with specific 

all workers, should be recominendations about its reproductive risk. 

protected from exposure. NIOSH will be adding a table of 

Occupational exposure is recommendations for personal protective 

limited due to dosage equipment and engineering controls. 

formulation. May support 

listing if additional 

information on managing 

these drugs were provided 

on personal protective 

equi ment. 

bevacizumab Requested the exclusion of NIOSH re-evaluated bevacizumab in light of 

bevacizumab from the new information on its bioavailability in the 

NIOSH hazardous drug list occupational setting provided by the 

based on lack of exposure in manufacturer and it was determined that the new 

occupational setting. warnings were not sufficient to warrant its 

listing. Following a final review, the expert 

panel concurred witli not listing this drug as 

hazardous. 

Annie Lambert, abacavir Recommend a low risk NIOSH does not separate drugs into a high/low 

PharmD; Jeff Rochon, category risk category. Listing a drug as hazardous is 

PharmD; Alex Truchot, typically based on effects at therapeutic or lower 

MM, HEM, Washington doses. Abacavir will be listed on the 2014 

State Hazardous Drug hazardous drug list in a non-antineoplastic drug 

Advisory Committee category based on malignant tumors observed in 

male and female mice and rats and its 

genotoxicity in vivo. NIOSH will be adding a 

table of recommendations for personal protective 

equipment and engineering controls. 
Bevacizumab Stated that there is no 

occuparional risk 

NIOSH re-evaluated bevacizumab in light of 

new information on its bioavailability in the 

occupational setting provided by the 

manufacturer and it was determined that the new 

wamings were not sufficient to warrant its 

listing. Following a final review, the expert 

panel concurred with not listing this drug as 

hazardous. 

apomorphine Recommend a low risk NIOSH does not separate dmgs into a high/low 

category risk category. Listing a drug as hazardous is 

typically based on effects at therapeutic or lower 

doses. Apomorphine will be listed on the 2014 

hazardous drug list in a non-antineoplastic drug 

category based on its genotoxicity in several in 

vitro assays. NIOSH will be adding a table of 

recommendations for personal protective 

e ui ment and en ineering controls. 

deferiprone Risk at therapeutic doses NIOSH does not separate drugs into a high/low 

only risk category. Listing a drug as hazardous is 

typically based on effects at therapeutic or lower 

doses. Deferiprone will be listed on the 2014 

hazardous dmg list in a non-antineoplastic dmg 

category based on genotoxicity in vitro and in 

vivo, and with specific recommendations about 

its reproductive risk. NIOSH will be adding a 

table of recommendations for personal protective 

equipment and engineering controls. 
dexmedetomidine No evidence to support 

listing as hazardous 

Initially, the expert panel recommended ]isting 

dexmedetomidine as a hazardous drug based on 

fetal toxicity in laboratory studies. NIOSH reevaluated dexmedetomidine in light of new 

information provided by the manufacturer on the 

limited potential for occupational exposure and 

determined that it would not be listed for 2014. 

Following a final review, the expert panel 

concurred with not listing this drug as hazardous. 

ezogabine Recommend a low risk Ezogabine was initially recommended as 

category meeting the criteria for a hazardous drug based 

on adverse fetal effects. However, most effects 

on the fetus were associated with maternal 

toxicity. It was re-evaluated by the NIOSH 

Hazardous Drug Committee and it was 

detennined that it does not meet the criteria for a 

hazardous drug and will not be listed on the 

2014 hazardous drug list. Following a final 

review, the expert panel concurred with not 

listing this drug as hazardous. 

fingolimod Recommend a low risk NIOSH does not separate drugs into a high/low 

category; Risk at therapeutic risk category. Listing as a hazardous drug is 

doses only typically based on effects at therapeutic or lower 

doses. Fingolimod will be listed on the 2014 

hazardous drug list in a non-antineoplastic drug 

category based on malformations and embryofetal deaths at low doses and the observation of 

malignant lymphomas in laboratory studies, and 

with specific recommendations about its 

reproductive risk. NIOSH will be adding a table 

of recommendations for personal protective 

equipment and engineering controls. 
fluconazole Little evidence to support 

listing as hazardous 

Fluconazole will be listed on the 2014 hazardous 

drug list with specific recommendations about its 

reproductive risk. NIOSH will be adding a table 

of recommendations for personal protective 

e uipment and engineering controls. 

liraglutide Risk at therapeutic doses NIOSH does not separate drugs into a high/low 

only risk category. Listing as a hazardous drug is 

typically based on effects at therapeuric or lower 

doses. Liraglutide will be listed on the 2014 

hazardous drug list in a non-antineoplastic drug 

category based on the black box warning for 

thyroid C-cell tumors with supporting evidence 

in laboratory studies, and with specific 

recommendations about its reproductive risk. 

NIOSH will be adding a table of 

recommendations for personal protective 

e ui ment and engineering controls. 

nevirapine Recommend a low risk NIOSH does not separate drugs into a high/low 

category; Risk at therapeutic risk category. Listing as a hazardous drug is 

doses only typically based on effects at therapeutic or lower 

doses. Nevirapine will be listed on the 2014 

hazardous drug list in a non-antineoplastic drug 

category based on hepatocellular adenomas and 

carcinomas in laboratory studies at doses lower 

than human dose. NIOSH will be adding a table 

of recommendations for personal protective 

equipment and engineering controls. 
propylthiouracil Risk at therapeutic doses NIOSH does not separate drugs into a high/low 

only risk category. Listing as a hazardous drug is 

typically based on effects at therapeutic or lower 

doses. Propylthiouracil will be listed on the 

2014 hazardous drug list in a non-antineoplastic 

drug category based on its IARC classiflcation of 

2B, and with additional recommendations about 

its reproductive risk. NIOSH will be adding a 

table of recommendations for personal protective 

equi ment and engineering controls. 

tesamorelin Recommend a reproductive Tesamorelin will not be listed on the 2014 

risk category only; Risk at hazardous drug list. It is listed as a Preb ancy 

tberapeutic doses only Category X because there is no benefit to a 

pregnant woman. The NIOSH Hazardous Drug 

Committee re-evaluated tesamorelin and 

determined that it did not meet the criteria for a 

hazardous drug and would not be listed for 2014. 

Following a final review, the expert panel 

concurred with not listing this drug as hazardous. 

topiramate Recommend a low risk NIOSH does not separate drugs into a high/low 

category; Risk at therapeutic risk category. Listing as a hazardous drug is 

doses only typically based on effects at therapeutic or lower 

doses. Topiramate will be listed on the 2014 

hazardous drug list with specific 

recommendations about its reproductive risk. 

NIOSH will be adding a table of 

recommendations for personal protective 

e uipment and engineering controls. 

ulipristal Recommend a reproductive Ulipristal will be listed on the 2014 hazardous 

risk category only drug list witli specific recommendations about its 

reproductive risk. NIOSH will be adding a table 

of recoinmendations for personal protective 

equipment and engineering controls. 
voriconazole Recommend a reproductive Voriconazole will be listed on the 2014 

risk category only hazardous dnag list with specific 

recormnendations about its reproductive risk. 

NIOSH will be adding a table of 

recommendations for personal protective 

equipment and engineering controls. 

warfariu Recornmend a low risk NIOSH does not separate drugs into a high/low 

category risk category. Listing as a hazardous drug is 

typically based on effects at therapeutic or lower 

doses. Warfarin will be listed on the 2014 

hazardous drug list with specific 

recommendations about its reproductive risk. 

NIOSH will be adding a table of 

recommendations for personal protective 

e ui ment and en ineering controls. 

general comments Support a tiered approach NIOSH does not separate drugs into a high/low 

risk category. NIOSH has developed a multicate ory approach similar to a tiered ap roacb. 

Elizabeth A. Treanor, Monoclonal Worker exposure is minimal At the cun-ent time, NIOSH only lists conjugated 

Phylmar Group antibodies due to large molecular monoclonal antibodies that have manufacturers' 

weight safe handling warnings. The NIOSH Hazardous 

Drug Committee re-evaluated bevacizumab in 

light of new infonnation provided by the 

manufacturer on its bioavailability and 

detennined that it would not be listed for 2014. 

Following a final review, the expert panel 

concurred with not listing this drug as hazardous. 
general comments NIOSH should describe its The multi-category approach that NIOSH has 

approach in adding or proposed will include this type of infonnation. 

deleting a drug from the list The process will be described in detail the 2014 

by incorporating this update. 

infonnation into the alert 

general comments Describe how the This is not practical as the review process 

assessment process was involves several steps in the process. In general, 

applied to each drug there is a review by an expert panel and a public 

comment period. NIOSH reviews all available 

information and makes the final decision on each 

individual drug. NIOSH will be listing the 

reasons why each drug is listed in the 20141ist. 

Ryan A. Forrey, abacavir Should not be added to list The fonnat will change to a multi-category 

PhannD, MS, Ohio State in its current format approach. Abacavir will be listed on the 2014 

University hazardous drug list in a non-antineoplastic drug 

category based on malignant tumors observed in 

male and female mice and rats and its 

genotoxicity in vivo. NIOSH will be adding a 

table of recommendations for personal protective 

equipment and engineering controls. 

apomorphine Should not be added to list The fonnat will change to a multi-category 

in its current fonnat approach. Listing as a hazardous drug is 

typically based on effects at therapeutic or lower 

doses. Apomorphine will be listed on the 2014 

hazardous drug list in a non-antineoplastic drug 

category based on its genotoxicity in several in 

vitro assays. NIOSH will be adding a table of 

recommendations for personal protective 

equipment and engineering controls. 
deferipone Should not be added to list 

in its current fonnat 

The fonnat will change to a multi-category 

approach. Deferiprone will be listed on the 2014 . 

hazardous drug list in a non-antineoplastic drug 

category based on genotoxicity in vitro and in 

vivo, and with specific recommendations about 

its reproductive risk. NIOSH will be adding a 

table of recommendations for personal protective 

equi ment and engineerin controls. 

dexmedetomine Should not be added to list Initially, the expert panel recommended listing 

in its current fonnat dexmedetomidine as a hazardous drug based on 

fetal toxicity in laboratory studies. The NIOSH 

Hazardous Drug Committee re-evaluated 

dexmedetomidine in light of new infonnation 

provided by the manufacturer on the limited 

potential for occupational exposure and 

detennined that it will not be listed for 2014. 

Following a final review, the expert panel 

concurred with not listin this dru as hazardous. 

ezogabine Should not be added to list Ezogabine was initially recommended as 

in its cunent fonnat meeting the criteria for a hazardous drug based 

on adverse feta] effects. However, most effects 

on the fetus were associated with matemal 

toxicity. It was re-evaluated by the NIOSH 

Hazardous Drug Committee and it was 

detennined that it does not meet the criteria for a 

hazardous drug and will not be listed on the 

2014 hazardous drug list. Following a final 

review, the expert panel concurred with not 

listing this drug as hazardous. 

10 
fingolimod Should not be added to list The format will change to a multi-category 

in its current fonnat approach. Listing as a hazardous drug is 

typically based on effects at therapeutic or lower 

doses. Fingolimod will be listed on the 2014 

hazardous drug list in a non-antineoplastic drug 

category based on malformations and embryofetal deaths at low doses and the observation of 

malignant lymphomas in laboratory studies, and 

with specific recommendations about its 

reproductive risk. NIOSH will be adding a table 

of recommendations for personal protective 

e ui ment and engineering controls. 

icatibant Should not be added to list The fonnat will change to a multi-category 

in its current fonnat approach. Icatibant will be listed on the 2014 

hazardous drug list with specific 

recommendations about its reproductive risk. 

NIOSH will be adding a table of 

recommendations for personal protective 

e ui ment and engineering controls. 

liraglutide Should not be added to list The format will change to a multi-category 

in its cun-ent format approach. Listing as a hazardous drug is 

typically based on effects at therapeutic or lower 

doses. Liraglutide will be listed on the 2014 

hazardous drug list in a non-antineoplastic drug 

category based on the black box waming for 

thyroid C-cell tumors with supporting evidence 

in laboratory studies; and with specific 

recommendations about its reproductive risk. 

NIOSH will be adding a table of 

recommendations for personal protective 

equipment and engineering controls. 

11 
misoprostol Should not be added to list The fonnat will change to a multi-category 

in its current fonnat approach. Misoprostol will be listed on the 2014 

hazardous drug list with specific 

recommendations about its reproductive risk. 

NIOSH will be adding a table of 

recommendations for personal protective 

equi ment and engineerin controls. 

nevirapine Should not be added to list 

in its cun•ent format 

The fonnat will change to a multi-category 

approach. Nevirapine will be listed on the 2014 

hazardous drug list in a non-antineoplastic drug 

category based on hepatocellular adenomas and 

carcinomas in laboratory studies at doses lower 

than human dose. NIOSH will be adding a table 

of recommendations for personal protective 

equi ment and engineering controls. 

propylthiouracil Should not be added to list The fonnat will change to a multi-category 

in its current format approach. Listing as a hazardous drug is 

typically based on effects at therapeutic or lower 

doses. Propylthiouracil will be listed on the 

2014 hazardous drug list in a non-antineoplastic 

drug category based on its IARC classification 

of 2B, and with additional recominendations 

about its reproductive risk. NIOSH will be 

adding a table of recommendations for personal 

rotective e ui ment and engineering controls. 

spironolactone Should not be added to list The fonnat will change to a rnulti-category 

in its current fonnat approach. Spironolactone will be listed on the 

2014 hazardous drug list in a non-antineoplastic 

drug category based on a new black box warning 

for tumorogenicity in ]aboratory studies. 

NIOSH will be adding a table of 

recommendations for personal protective 

equipinent and engineering controls. 

12 
tesamorelin Should not be added to list Tesamorelin will not be listed on the 2014 

in its current format hazardous drug ]ist. It is listed as a Pregnancy 

Category X because there is no benefit to a 

pregnant woman. The NIOSH Hazardous Dnxg 

Committee re-evaluated tesamorelin and 

determined that it did not meet the criteria for a 

hazardous drug and would not be listed for 2014. 

Following a final review, the expert panel 

concurred with not listing this drug as hazardous. 

topiramate Should not be added to list 

in its currerit fonnat 

The format will change to a multi-category 

approach. Topiramate will be listed on the 2014 

hazardous drug list with specific 

recommendations about its reproductive risk. 

NIOSH will be adding a table of 

recommendations for personal protective 

e uipment and engineering controls. 

ulipristal Should not be added to list The format will change to a multi-category 

in its current fonnat approach. Ulipristal will be listed on the 2014 

hazardous drug list with specific 

recommendations about its reproductive risk. , 

NIOSH will be adding a table of ', 

recommendations for personal protective , 

e ui ment and en ineering controls. 

voriconazole Should not be added to list The fonnat will change to a mLilti-category i 

- in its current fonnat approach. Voriconazole will be listed on the I 

2014 hazardous drug list with specific 

recommendations about its reproductive risk. 

NIOSH will be adding a table of 

recommendations for personal protective 

equipment and engineering controls. 

13 
warfarin Should not be added to list The format will change to a multi-category ' 

in its current fonnat approach. Warfarin will be listed on the 2014 

hazardous drug list with specific 

recommendations about its reproductive risk. 

~ NIOSH will be adding a table of 

recommendations for personal protective 

e uipment and en ineering controls. 

general comments Encourages NIOSH to NIOSH performs a hazazd identification only. 

develop a risk-stratification Each institution using a drug should determine 

methodology for its the risk to employees in that institution. The 

hazardous dnxg list fonnat will change to a multi-category approach 

which will be similar to what is being 

recommended. NIOSH will be adding a table of 

recommendations for personal protective 

e uipment and engineering controls. 

14