# Final

Data Collection on the Toxicity, Use

, and Disposal of Hazardous Drugs Report

Prepared for: 

# U.S. Environmental Protection Agency Materials Recovery and Waste Management Division Office of Resource Conservation and Recovery

1200 Pennsylvania Avenue, NW Washington, D.C. 20460

Prepared by: 

# Eastern Research Group, Inc.

14555 Avion Parkway

Suite 200 Chantilly, VA 20151

- 1102

September 20 11

EPA Contract No. EP

- W

- 10

- 055 Task Order SOL

- HQ

- 11

- 00035

### i Contents

Page Contents

................................ ................................ ................................ ............................... i List of Tables

................................ ................................ ................................ ...................... ii Executive Summary

................................ ................................ ................................ ............ v

1. I NTRODUCTION TO THE 

### H AZARDOUS 

### D RUG 

### D ATA 

### C OLLECTION



### ................................ ....... 1

- 1

2. R ESOURCE 

### C ONSERVATION AND 

### R ECOVERY 

### A CT 

### R EGULATIONS FOR 

### U AND 

### P L ISTED 

### W ASTES



### ................................ ................................ ................................ ................ 2

- 1

3. I DENTIFICATION OF 

### H AZARDOUS 

### D RUGS AND 

### R EVIEW OF 

### T OXICITY 

### D ATA



### ..................... 3

- 1 3.1 NIOSH List of Hazardous Drugs

................................ ................................ ......... 3

- 1 3.2 OSHA List of Hazardous Drugs

................................ ................................ .......... 3

- 2 3.3 Proposed Additions and Deletions to the NIOSH Hazardous Drug List

............. 3

- 3 3.4 Collection of Toxicity Data

................................ ................................ ................. 3

- 3 3.4.1 Data Sources

................................ ................................ ............................ 3

- 3 3.4.2 Data Collection Approach

................................ ................................ ........ 3

- 6 3.4.3 Design of Hazardous Drugs Toxicity Data Spreadsheet

.......................... 3

- 6 3.5 Review of Lethal Toxicity Data

................................ ................................ ........... 3

- 6

4. E XTENT OF 

### D RUG 

### U SE AND 

### C URRENT 

### D ISPOSAL 

### P RACTICES



### ................................ ........... 4

- 1 4.1 Extent of Drug Use

................................ ................................ .............................. 4

- 1 4.2 Current Drug Disposal Practices

................................ ................................ .......... 4

- 3 4.2.1 Regulations Affecting Drug Disposal Practices

................................ ...... 4

- 5 4.2.2 Federal Drug Administration’s Recommendations for Flushing Unused Drugs

................................ ................................ ........................... 4

- 6

5. R EFERENCES



### ................................ ................................ ................................ ..................... 5

- 1

Appendix A: LIST OF HAZARDOUS DRUGS REVIEWED BY ERG

Appendix B: TOXICITY DATA

Appendix C: LIST OF CONTROLLE D SUBSTANCES BY DEA SCHEDULE

### ii List of Tables

Page

3

- 1 Sources of Formulary Information

................................ ................................ ................... 3

- 4

3

- 2 Sources of Lethal Dose Data

................................ ................................ ............................ 3

- 4

3

- 3 Sources of Toxicity Information

................................ ................................ ...................... 3

- 4

4

- 1 Commonly Prescribed Drugs in 2005 and 2009

................................ .............................. 4

- 2

4

- 2 U.S. Production Ranges for Appendix A Drugs

................................ .............................. 4

- 3

4

- 3 Current Drug Dispos al Practices at Healthcare Facilities

................................ ................ 4

- 4

4

- 4 Drugs Recommended for Disposal By Flushing

................................ ............................. 4

- 6

A

- 1 List of Drugs Reviewed by ERG and Tier Assignments

................................ ..................... 1

C

- 1 Schedule I Controlled Substances

................................ ................................ ........................ 1

C

- 2 Schedule II Controlled Substances

................................ ................................ ...................... 4

C

- 3 Schedule III Controlled Substances

................................ ................................ ..................... 6

C

- 4 Schedule IV Controlled Substances

................................ ................................ ................... 10

C

- 5 Schedule V Controlled Substances

................................ ................................ .................... 12

### iii ACRONYM LIST

ACGIH: American Conference of Government Industrial Hygienists AHFS DI: American Hospital Formulary Service Drug Information ASHP: American Society of Health

- System Pharmacists BEI: Biological Exposure Indices CASRN: Chemical Abstracts Service Registry Number CCL3: Contaminant Candidate List 3 CFR: Code of Federal Regula tions CPDB: Carcinogenic Potency Database CSA: Controlled Substances Act CSF: Cancer Slope Factor CUS/IUR: Chemical Update System/Inventory Update Rule DEA: Drug Enforcement Administration DSSTox: Distributed Structure

- Searchable Toxicity DWEL: Drinki ng Water Equivalent Level EPA: U.S. Environmental Protection Agency ERG: Eastern Research Group, Inc. FDA: U.S. Food and Drug Administration FR: Federal Register HA: Health Advisories HSDB: Hazardous Substances Data Bank IARC: International Agenc y for Research on Cancer IDLH: Immediately Dangerous to Life or Health Concentration IRIS: Integrated Risk Information System IUR: Inhalation Unit Risk IV: Intravenous LC: Lethal Concentration LD: Lethal Dose LDL: Lowest Dose Causing Lethality LTHA: Lifetime Health Advisory MCL: Maximum Contaminant Level mg/kg: Milligrams per Kilogram mg/L: Milligrams per Liter MRDD: Maximum Recommended Daily Dose MRTD: Maximum Recommended Therapeutic Dose NCEA: National Center for Environmental Assessment N IH: National Institutes of Health NIOSH: National Institute for Occupational Safety and Health NLM: National Library of Medicine NTP: National Toxicology Program OEHHA: Office of Environmental Health Hazard Assessment ORCR: Office of Resource Conserv ation and Recovery OSHA: Occupational Safety and Health Administration OW: Office of Water PEL: Permissible Exposure Limit PhRMA: Pharmaceutical Research and Manufacturers of America RCRA: Resource Conservation and Recovery Act

### iv

REL: Recommended Exposu re Limit RoC: Report on Carcinogens RfC: Reference Concentration RfD: Reference Dose RTECS: Registry of Toxic Effects of Chemical Substances TLV: Threshold Limit Value

### v

EXECUTIVE SUMMARY

With the advent of new chemotherapy (antineoplastic) drugs

, as well as the development of a variety of new drugs that exhibit hazardous properties, it has become important for the U.S. Environmental Protection Agency’s ( EPA’s ) Office of Resource Conservation and Recovery (ORCR) to conduct ad ditional research to update U and P coded hazardous wastes to address those drugs that present an acute toxicity risk or could cause serious irreversible illness if disposed of improperly. The disposal of hazardous drugs impacts both land and water , as imp roperly

- disposed drugs can end up in the municipal waste landfills and waters of the United States. Eastern Research Group, Inc. ( ERG ) is supporting EPA in its collection and analysis of toxicity, use

, and disposal data for drugs that exhibit hazardous pr operties under Task Order SOL

- HQ

- 11

- 00035.

ERG collected toxicity, extent of use, and disposal data for 20 4 drugs: 172 drugs identified as hazardous by the National Institute for Occupational Safety and Health ( NIOSH ) and the Occupational Safety and Health Administration ( OSHA ) and 3 2 drugs that NIOSH proposed for addition to its hazardous drug list . ERG then created a M icrosoft ExcelTM spreadsheet to capture the toxicity data for th ose drugs and analyzed the lethality data to determine the appropriate tier category for each drug (see Section 3.4) . Based on the lethal dose data analysis, ERG found that 11 drugs on the NIOSH or OSHA lists of hazardous drugs meet the specific criteria set forth in Code of Federal Regulations (CFR) §261.11 for acute toxici ty

. Three of these drugs are already included on the federal Resource Conservation and Recovery Act (RCRA) list of hazardous chemicals (U list).

 

### Carmustine ( 154

- 93

- 8 )

 

### Cisplatin ( 15663

- 27

- 1 )

 

### Colchicine ( 64

- 86

- 8 )

 

### Dactinomycin ( 50

- 76

- 0 )

 

### Mechlore thamine ( 51

- 75

- 2 )

 

### Melphalan ( 148

- 82

- 3 )

– EPA Waste Code U150  

### Mitomycin ( 50

- 07

- 7 )

– EPA Waste Code U010

 

### Mitoxantrone HCl ( 70476

- 82

- 3 )

 

### Oxytocin ( 50

- 56

- 6 )

 

### Thiotepa ( 52

- 24

- 4 )

 

### Uracil mustard ( 66

- 75

- 1 )

– EPA Waste Code U237

An additional 114 drugs 1 

### on the NIOSH or OSHA lists did not meet the specific criteria in §261.11 for acute toxicity, but did have lethal doses for other animals or humans.

ERG also reviewed available public literature to determine whether the 204 drugs are commonly prescribed in the United States. Based on data for 2009, 1 2 antineoplastic agents (chemotherap y drugs) and eight other classification drugs were among the top 200 prescribed . ERG did not identify any available data to determine quantitie s of drug waste disposed by healthcare facilities.

1 Two of the 114 drugs (D ocetaxel and Mycophenolic acid ) were categorized as Tier 2 drugs based on one of the Chemical Abstracts Service Registry Number s (CASRNs); the drugs fall into the Tier 3 category based on the other CASRN. Seventeen of the 114 Tier 2 drugs have very little lethality data (borderline Tie r 3). One of the 114 Tier 2 drugs almost meets the Tier 1 criteria (P odofilox [ 518

- 28

- 5 ])

.

### 1

- 1

1. I NTRODUCTION TO THE 

### H AZARDOUS 

### D RUG 

### D ATA 

### C OLLECTION


### On December 2, 2008, EPA proposed adding hazardous pharmaceutical (drug) wastes to the Federal universal waste program (73 Federal Register [ FR ] 73520) to provide a hazardous pharmaceutical waste disposal system that is protective of public health and the environment. Through the public comments on the proposal and via outside communications, stakeholders asserted that numerous drugs are harmful to human health and the environment when improperly disposed; however, these drugs have not yet been recognized as hazardous waste by EPA.

Drug waste includes discarded drugs and associated equipment generated by hospitals and other facilities that use such drugs. A number of drugs are included on the U and P coded hazardous waste lists as commercial chemical products. However, EPA created these lists more than 30 years ago and there are now many newer chemotherapy and other toxic drugs that sho uld be assessed for potential listing as U or P wastes. This document summarizes data and other information collected for 204 drugs identified as hazardous or potentially hazardous by NIOSH and OSHA. Within this document, Section 2 presents a brief overvie w of the toxicity requirements for chemicals listed on the U and P coded hazardous waste lists ; Section 3 describes how ERG collected and analyzed the data to categorize each drug into a tier ; and Section 4 describes the extent of use for the drugs reviewe d and provides an overview of current healthcare industry disposal practices.

### 2

- 1

2. R ESOURCE 

### C ONSERVATION AND 

### R ECOVERY 

### A CT 

### R EGULATIONS FOR 

### U AND 

### P L ISTED 

### W ASTES


### Under the Resource Conservation and Recovery Act (RCRA), EPA may c lassify a chemical as hazardous if the chemical is specifically listed in the regulations or exhibits certain characteristics. Thus, a drug waste may be considered hazardous under RCRA if:

 

### The drug or its sole active ingredient is specifically listed on t he P l ist: Acutely Hazardous Waste (40 CFR 261.33(e)) or the U l ist: Discarded Commercial Chemical Products (40 CFR 261.33(f)); and/or

 

### The waste exhibits one or more hazardous waste characteristic as defined in 40 CFR 261.21

- 24, (ignitability, corrosivity , reactivity, or toxicity).

Furthermore, 40 CFR 261.11 outlines the criteria for listing a waste as acutely hazardous (i.e., P l ist). A waste is acutely hazardous if it has been found to be fatal to humans in low doses or, in the absence of data on human toxicity, the waste has been shown in studies to meet certain lethal dose ( LD ) 50 

### (lethal dose that kills 50 percent of animals t ested) or lethal concentration ( LC ) 50 

### (lethal concentration that kills 50 percent of animals tested) values, or is otherwise capable of causing or significantly contributing to an increase in serious irreversible, or incapacitating reversible, illness. A d rug is acutely hazardous waste if it meets one or more of the following LD 50 

### and LC 50 

### values:

 

### Oral LD 50 

### toxicity (in rats) of less than 50 milligrams per kilogram (mg/kg);

 

### Inhalation LC 50 

### toxicity (in rats) of less than 2 milligrams per liter (mg/L); or

 

### De rmal LD 50 

### toxicity (in rabbits) of less than 200 mg/kg.

### 3

- 1

3. I DENTIFICATION OF 

### H AZARDOUS 

### D RUGS AND 

### R EVIEW OF 

### T OXICITY 

### D ATA


### To identify the drugs for this project’s data collection and review, ERG compiled a list of drugs based on the NIOSH List of Antineoplastic and Other Hazardous Drugs in Health c are Settings 2010 ; a list of hazardous drugs developed by OSHA and included in t he OSHA Technical Manual ( e ffective date: January 1, 1999 ) ; and 32 drug chemicals proposed for addition to the NIOSH list . ERG identified 204 unique drugs using these three data sources. One drug, A rsenic
t rioxide

, is already included on the P list of haza rdous wastes ; therefore, ERG did not collect any data for it

. The NIOSH list s included “ E rgonovine/ M ethylergonovine ” and “ Valproic acid/Divalproex Sodium (Na)” ; however, since each drug has a unique CASRN, ERG captured information for those drugs individually. ERG identified an additional drug

, D enileukin diftitox 2



### , during the project

. App endix A includes the list of drugs ERG evaluated under this project.

3.1 NIOS H List of Hazardous Drugs

The list of hazardous drugs presented in the NIOSH List of Antineoplastic and Other Hazardous Drugs in Health c are Settings 2010 comes from two evaluations. NIOSH published t he evaluation that identified the majority of the drugs in a September 2004 Alert , titled Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health c are Settings

. 3 

### App endix A of the Alert includ e s a sample list of hazardous drugs compiled from information received from the following:

 

### Four institutions that have generated lists of hazardous drugs for their respective facilities

 

### The Pharmaceutical Research and Manufacturers of America (PhRMA)

 

### The A merican Hospital Formulary Service Drug In formation (AHFS DI) monographs ( American Society of Health

- System Pharmacists [ ASHP ] /AHFS DI

, 2003)

For the 2004 Alert, drugs considered hazardous included those that exhibit one or more of the following six chara cteristics in humans or animals:

1. Carcinogenicity 2. Teratogenicity or other developmental toxicity 3. Reproductive toxicity 4. Organ toxicity at low doses 5. Genotoxicity 6. Structure and toxicity profiles of new drugs that mimic existing drugs determined hazardous by t he above criteria.

NIOSH’s second evaluation identified an additional 21 drugs that were new drugs or existing drugs that had new warnings from 2004 to 2007. The review process for the addition of the new

2 D enileukin was listed by NIOSH, however, ERG could not locate a CASRN for it. The National Library of Medicine (NLM) and U.S. Food and Drug Administration (FDA) so urce s , as well as the AHFS DI monograph, list ed D enileukin d iftitox ( 173146

- 27

- 5 ) , but not D enileukin. Therefore, ERG added D enileukin diftitox to the list of drugs.

3 NIOSH’s Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Healthcare Settings can be accessed at http://www.cdc.gov/niosh/docs/2004

- 165/

.

### 3

- 2

listings is described in the Federal Register (74 FR 19570, April 29, 2009). NIOSH reviewed the following:

 

### 60 new FDA

- approved drugs

 

### 60 drugs that received special warnings on reported adverse effects in patients

 

### 18 drugs included in the updated National Institutes of Health (NIH) Hazardous Drug List

Af ter expert review, scientific literature review, public comments, and stakeholder input, NIOSH identified 24 drugs 4 

### that met the NIOSH definition of hazardous drugs. In addition, NIOSH removed one drug from the 2004 list.

3.2 OSHA List of Hazardous Drugs

The list of hazardous drugs presented in the OSHA Technical Manual Section VI: Chapter 2

– Controlling Occupational Exposure to Hazardous Drugs is not intended as an all

- inclusive list. The sources for the list include the Physicians Desk Reference, Sectio n 10:00 in the American Hospital Formulary Service Drug Information ; International Agency for Research on Cancer ( IARC ) publications (particularly Volume 50) ; T he Johns Hopkins Hospital ; and the NIH Clinical Center Nursing Department. The list does not inc lude investigational drugs, but the manual notes that “they should be prudently handled as hazardous drugs until adequate information becomes available to exclude them” (OSHA, 1999).

The OSHA Technical Manual provides criteria for classifying drugs as haza rdous and cites the ASHP hazardous drug definition. The manual lists two ways to classify drugs as hazardous: 1) based on characteristic ; or 2) based on pharmacology/toxicology. The manual defines the four drug characteristics, each of which could be consi dered hazardous , as the following :

 

### Carcinogenicity

 

### Teratogenicity or fertility impairment

 

### Serious organ or other toxic manifestation at low doses in experimental animals or treated patients

 

### Genotoxicity

The manual includes the following major considerations by professionals trained in pharmacology/toxicology in designating drug s as hazardous:

 

### Is the drug designated as Therapeutic Category 10:00 (Antineoplastic Agent) in the AHFS DI ?

 

### Does the manufacturer suggest the use of special isolation t echniques in its handling, administration, or disposal?

 

### Is the drug known to be a human mutagen, carcinogen, teratogen

, or reproductive toxicant?

4 The 2010 document stated that only 21 drugs were added; this may have been based on information received by NIOSH following the 2009 notice.

### 3

- 3

 

### Is the drug known to be carcinogenic or teratogenic in animals (drugs known to be mutagenic in multiple bact erial systems or animals should also be considered hazardous)?

 

### Is the drug known to be acutely toxic to an organ system?

3.3 Proposed Additions and Deletions to the NIOSH Hazardous Drug List

In July 2011, NIOSH requested comments on proposed additions and d eletions to its list of hazardous drugs to be included in the NIOSH List of Antineoplastic and Other Hazardous Drugs in Health c are Settings 201 2 (NIOSH, 2011) . To identify potential new drugs to add to the list, NIOSH looked at the 48 new drugs that receiv ed FDA approval between June 2007 and December 2009 and 115 drugs that received special warnings (usually black box warnings) based on reported adverse effects in patients. NIOSH identified 45 drugs from the list of 169 drugs as candidate hazardous drugs. Seven of these drugs had safe handling instructions from its manufacturers

, and NIOSH decided to add these seven drugs without further review. NIOSH asked a panel of peer reviewers and stakeholders to review and comment on the remaining 38 candidate hazard ous drugs. After receiving the panel recommendations, NIOSH decided to add 24 drugs in addition to the 7 drugs with manufacturer’s warnings. N I O SH determined that these 24 drugs have one or more characteristic of a hazardous drug.

As part of its update t o the list of hazardous drugs, N I O SH proposed to delete 15 drugs from its 2010 list and requested its panel members to comment on the deletions. The proposed deletions include the following:

 Four drugs reclassified as not meeting the criteria for a hazard ous drug: A lemtuzumab, I nterferon alfa 2a, Interferon alfa 2b, and I nterferon alfa n3 (all antineoplastic agents).

 T wo radio

- pharmaceuticals with specific handling regulations set by the Nuclear Regulatory Commission : Ibritumomab tiuxetan and T ositumomab ( both antineoplastic agents)

.

 N ine others currently not available in the United States : D i enestrol and T rimetrexate glucuronate ( not antineoplastic agents) and I nterferon alfa n1, P erphosphamide, P iritrexim isethionate, P licamycin, P rednumustine, R altitrexed , and V indesine (antineoplastic agents) ( NIOSH, 2011b)

.

3.4 Collection of Toxicity Data

ERG collected formulary and toxicity information for the 204 drugs listed in App endix A of this document . ERG compiled the data into the M icrosoft ExcelTM spreadsheet, ORCR Drug Data.xls x , and included the spreadsheet as Appendix B of this report. The following subsections of this report describe the data sources ERG used for the toxicity data collection, the approach ERG used to collect the data, and ERG’s design of the ORCR drug data spreadsheet.

3.4.1 Data Sources

ERG searched for formulary information, lethal doses, and toxicity information for each drug

. Table 3

- 1 presents the data sources ERG used to identify formulary data. In addition, ERG

### 3

- 4

reviewed the 2011 AHFS DI catalog to supplement formulary information (use, route, form, strength, brand name) when information was not available in the data sources below.

Table 3

- 1 . Sources of Formulary Information

Source Formulary Information Webs ite

NLM ChemIDplus  CASRN http://chem.sis.nlm.nih.gov/chemidplus/ chemidlite.jsp
FDA Drugs@FDA  Generic name

 Proprietary/b rand name

 Active ingredient

 Strength s or concentrations

 Dose form and route

 Marketing status http://www.accessdata.fda.gov/scripts/c der/drugsatfda/index.cfm

NLM MedlinePlus  Drug use

 Use r oute

 Brand name http://www.nlm.nih.gov/medlineplus/dr uginformation.html



### In consideration of the definitional requirements for determining “hazardous” as it relates to RCRA §261.11 , ERG specifically search ed for human and animal lethal dose data in the sources identified in Table 3

- 2 . All sources provide the toxicity value type, species, route of exposure, dose, and primary source of the data (reference listed by the secondary source)

. ERG also captured the secondary sour ce (i.e., Hazardous Substances Data Bank [ HSDB ] , ChemIDplus, Registry of Toxic Effects of Chemical Su b stances [ RTECS ] ) for each toxicity value. The primary sources are listed for reference purposes; ERG did not obtain and review the primary
sources to ensu re accuracy of the information presented in the secondary sources.

Table 3

- 2 . Sources of Lethal Dose Data

Source Webs ite

NLM HSDB http://toxnet.nlm.nih.gov/cgi

- bin/sis/htmlgen?HSDB

NLM ChemIDplus http://chem.sis.nlm.nih.gov/chemidplus/chemidlite.jsp
NIOSH RTECS Through ERG’s Dialog subscription



### To supplement the lethal toxicity data, ERG searched data sources listed in Table 3

- 3 for additional non

- lethal toxicity information

.

Table 3

- 3 . Sources of Toxicity Information

Source Toxicity Benchmark Value Webs ite

NIOSH 2010 List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings  AHFS pharmacologic

- therapeutic classification http://www.cdc.gov/niosh/docs/2010

- 167/

### 3

- 5 Table 3

- 3 . Sources of Toxicity Information

Source Toxicity Benchmark Value Webs ite

EPA

, Distributed Structure

Searchable Toxicity (DSSTox)  Therapeutic c ategory

 Maximum Recommended Daily Dose (MRDD) http://www.epa.gov/ncct/dsstox/sdf_fda mdd.html

FDA  Maximum Recommended Therapeutic Dose (MRTD) http://www.fda.gov/aboutfda/centersoffi ces/cder/ucm092199.htm

IARC  Cancer classification http://monographs.iarc.fr/ENG/Classific ation/index.php National Toxicology Program (NTP) 12 th Report on Carcinogens (RoC)  Cancer a ssessment http://ntp.niehs.nih.gov/index.cfm?objec tid=03C9AF75

- E1BF

- FF40

- DBA9EC0928DF8B15 University of California, Berkeley Lab Carcinogenic Potency Database (CPDB )  T umorigenic dose (TD 50 ) for rats

 TD 50 for mice

 TD 50 for rhesus monkeys

 TD 50 for cynomulgus monkeys

 TD 50 for hamsters http://potency.berkeley.edu/chemnam ein dex.html

RTECS  Compound c lass (tumorigen, mutagen, primary irritant, reproductive effector)

 Substance name Through ERG’s Dialog subscription

EPA, National Center for Environmental Assessment (NCEA), Integrated Risk Information System (IRIS)  Reference Dose (RfD)

 Reference Concentration (RfC)

 Cancer slope factor (CSF)

 Inhalation unit risk (IUR)

 Cancer classification http://www.epa.gov/iris/

EPA Office of Water (OW)  Maximum Contaminant Level (MCL)

 1

- da y/10

- day Health Advisories (HA)

 Drinking Water Equivalent Level (DWEL)

 Lifetime Health Advisory (LTHA) http://www.epa.gov/safewater/mcl.html

http://www.epa.gov/waterscience/drinki ng/standards/dwstandards.pdf

NIOSH  Immediately Dangerous To Life or Health Concentration (IDLH)

 Recommended Exposure Limit (REL ) http://www.cdc.gov/niosh/idlh/intridl4.h tml

http://www.cdc.gov/niosh/npg/

OSHA  Permissible Exposure Limit (PEL) http://www.osha.gov/SLTC/pel/

American Conference of Government Industrial Hygienists (ACGIH)  Threshold Limit Value (TLV) ACGIH: 2011 TLVs and Biological Exposure Indices ( BEIs )



### As part of EPA OW development of the contaminant candidate list 3 (CCL3) chemicals, EPA collected toxicity and benchmark data. ERG reviewed the EPA OW data and found benchmarks for 13 of the drugs reviewed ( U.S. EPA , 2007 ). These benchmarks, from the Calif ornia Office of Environmental Health Hazard Assessment (OEHHA)

, are also included in the ORCR drug data spreadsheet developed for this project.

### 3

- 6

3.4.2 Data Collection Approach

ERG searched each data source by the drug name (i.e., generic name), CASRN, and brand name. ERG specifically search ed for lethal dose s in humans and animals that meet the specific criteria set forth in §261.11 for acute toxicity (e.g., oral LD 50 

### , dermal LD 50 

### , and inhalation LC 50 

### )

. When available, ERG also captured other lethal doses (e.g., lowest dose causing lethality, [ LDL 0 

### ] ).

3.4.3 Design of Hazardous Drugs Toxicity Data Spreadsheet

ERG collected and managed the data in a M icros o ft ExcelTM spreadsheet ORCR Drug Data .xlsx (see Appendix B ). The ORCR drug data spreadsheet includes the following worksheets:

 

### Data Dictionary

– explains the data captured in each worksheet

 

### Formulary Information

– captures formulary information for t he drugs

 

### Toxicity Information

– captures non

- lethal toxicity information for the drugs

 

### Lethal Doses

– captures lethal dose data

 

### Drug Tiers

– contains the tier assignment for each drug (see Section 3.4)

 

### OW OEHHA

– contains the OEHHA benchmarks as captured by EPA OW

3.5 Review of Lethal Toxicity Data

Following the collection of lethality data, ERG categorize d each drug into one of the following EPA

- defined tiers.

Tier 1 : Drugs on the NIOSH or OSHA lists of hazardous drugs with evidence of a low lethal dose in humans or lethal doses that meet the specific criteria set forth in §261.11 for acute toxicity, i.e., oral LD 50 

### (rat), dermal LD 50 

### (rabbit), or inhalation LC 50 

### (rat).

ERG assigned Tier 1 to any drug found to h ave lethal animal toxicity data that meets the following criteria :

 

### An oral LD 50 

### in rats less than 50 mg/kg

 

### An inhalation LC 50 

### in rats less than 2 mg/L

 

### A dermal LD 50 

### in rabbits less than 200 mg/kg

ERG identified 11 drugs as Tier 1 . Three of these drugs ar e already included on the federal RCRA list of hazardous chemicals (U list) :

 

### Carmustine ( 154

- 93

- 8 )

 

### Cisplatin ( 15663

- 27

- 1 )

 

### Colchicine ( 64

- 86

- 8 )

 

### Dactinomycin ( 50

- 76

- 0 )

 

### Mechlorethamine ( 51

- 75

- 2 )

 

### Melphalan ( 148

- 82

- 3 )

– EPA Waste Code U150  

### Mitomycin ( 50

- 07

- 7 )

– EPA Waste Code U010

 

### Mitoxantrone HCl ( 70476

- 82

- 3 )

 

### Oxytocin ( 50

- 56

- 6 )

 

### Thiotepa ( 52

- 24

- 4 )

 

### Uracil mustard ( 66

- 75

- 1 )

– EPA Waste Code U237

Tier 2: Drugs on the NIOSH or OSHA lists that do not meet t he specific criteria in §261.11 for acute toxicity, but have lethal doses for other animals comparable to criteria in §261.11 or evidence for documented toxicity in humans at “low” doses for carcinogenicity,

### 3

- 7

teratogenicity or other developmental toxicity, reproductive toxicity, or specific organ toxicity.

ERG assigned Tier 2 to any non

- Tier 1 drug found to have lethal animal or human toxicity data outside the criteria set forth in §261.11. NIOSH already determined that all drugs on its 2010 List of Antineo plastic and Other Hazardous Drugs in Health c are Settings exhibit one or more of the following six characteristics in humans or animals:

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

The drugs on OSHA’s list are considered hazardous by the following criteria:

1. Genotoxicity ; 2. Carcinogenicity ; 3. Teratogenicity or fertility impairment ; or 4. Serious organ or other toxic manifestation at low doses in experimental animals or treated patients

Therefore, documented evidence of toxicity exists for the drugs investigated for this project. ERG identified 114 drugs as Tier 2 (see Appendix B ). Two of the 114 drugs (Docetaxel and Mycophenolic acid) were categorized as Tier 2 drugs based on one of the CASRNs; the drugs fall into the Tier 3 category based on the other CASRN. Seventeen of the 114 Tier 2 drugs have very little lethality data (borderline Tier 3). One of the 114 Tier 2 drugs almost meets the Tier 1 criteria (Podofilox [518

- 28

- 5]).

Tier 3: Drugs on the NIOSH or OS HA lists that have limited human or animal data for the classes of toxicities noted above.

ERG assigned Tier 3 to any drug that does not have lethality data. ERG identified 79 drugs as Tier 3 (see Appendix B ). Two additional drugs (Docetaxel and Mycophenolic acid) were categorized as Tier 3 drugs based on one of the CASRNs; but were categorized as Tier 2 drugs based on the other CASRN. D enileukin dif titox (173146

- 27

- 5) was not originally included on either the NIOSH or OSHA list; however, no lethality data were available for the drug, and, therefore, ERG categorized it as a Tier 3 drug.

### 4

- 1

4. E XTENT OF 

### D RUG 

### U SE AND 

### C URRENT 

### D ISPOSAL 

### P RAC TICES


### ERG p e r formed a cursory review of publicly available information (secondary data) to gather data on the extent of drug use for the 204 drugs included in App endix A

. A more exhaustive literature search might produce more detailed and th o rough results. This section of the report presents the data ERG found on the extent of use for the drugs and an overview of current drug disposal practices at healthcare facilitie s.

4.1 Extent of Drug Use

ERG reviewed two lists of commonly prescribed drugs (top 300 in 2005 and top 200 in 2009) and production data from the Chemical Update System/Inventory Update Rule (CUS/IUR) to determine if any of the 204 reviewed drugs were commonly prescribed or manufactured. Table 4

- 1 lists the App endix A drugs that were als o commonly prescribed in 200 5 and 2009 ( RX List, Inc.

, 2011 and Pharmacy Times, 2010 ). Four drugs fall on both lists and none are antineoplastic agents: E strogens, conjugated (12126

- 59

- 9)

, E thinyl estradiol (57

- 63

- 6), R isperidone ( 106266

- 06

- 2 ) , and Divalpr oex N a (76584

- 70

- 8)

. In 2005, only one antineoplastic agent was on the list; however in 2009, 12 antineoplastic agents made the top 200 brand names prescribed.

Table 4

- 2 lists the production volume reported in the 2006 CUS/IUR database for four drugs reviewed by ERG ( U.S. EPA, 2006). Because some of the drugs reviewed for this project are more recently develo ped drugs, the majority did not have production data reported in the CUS/IUR database. In addition, drugs may be manufactured outside the United States and imported for use.

### 4

- 2 Table 4

- 1 . Comm only Prescribed Drugs in 2005 and 2009

App endix A Drugs in the Top 200 Drugs Prescribed in 2009 App endix A Drugs in the Top 300 Drugs Prescribed in 2005 Drug (Brand) Name CASRN Drug (Brand) Name CASRN

Antineoplastic Agents Antineoplastic Agents Anastrozole (Arimidex ® ) 120511

- 73

- 1 Tamoxifen (NA) 10540

- 29

- 1 Bortezomib (Velcade ® ) 179324

- 69

- 7 Capecitabine (Xeloda ® ) 154361

- 50

- 9 Non

- Antineoplastic Agents Docetaxel (Taxotere ® ) 148408

- 66

- 6; 114977

- 28

- 5 Colchicine (NA) 64

- 86

- 8

Gemcitabine (Gemzar ® ) 95058

- 81

- 4 Estradiol (V ivelle

- DOT ® ) 50

- 28

- 2 Imatinib mesylate (Gleevec ® ) 220127

- 57

- 1 Estrogens, conjugated (Premarin ® ) 12126

- 59

- 9 Letrozole (Femara ® ) 112809

- 51

- 5 Oxaliplatin (Eloxatin ® ) 61825

- 94

- 3 Estrogens, conjugated & Medroxyprogesterone acetate (Prempro ® ) 12126

- 59

- 9 & 71

- 58

- 9 Paclitaxel (Abraxane ® ) 33069

- 62

- 4 Pemetrexed (Alimta ® ) 137281

- 23

- 3 Sunitinib malate (Sutent ® ) 341031

- 54

- 7 Ethinyl estradiol, with Norgestimate and Norethindrone 57

- 63

- 6

Temozolomide (Temodar ® ) 85622

- 93

- 1 Finasteride (Proscar ® ) 98319

- 26

- 7 Medroxyprogesterone (NA) 520

- 85

- 4 Non

- Antineoplastic Agents Paroxetine HCl (Paxil CR ® ) 78246

- 49

- 8 Dutasteride (Avodart ® ) 164656

- 23

- 9 Progesterone (Prometrium ® ) 57

- 83

- 0 Estrogens, conjugated (Premarin ® ) 12126

- 59

- 9 Risperidone ( Risperdal ®) 106266

- 06

- 2 Ethinyl estradiol, with Norgestimate (Ortho Tri Cy Lo 28®) 57

- 63

- 6 Carbamazepine 298

- 46

- 4

Risperidone (Ri s perdal Consta ® ) 106266

- 06

- 2 Clonazepam 1622

- 61

- 3 Tacrolimus (Prograf

® ) 109581

- 93

- 3; 104987

- 11

- 3 Oxcarbazepine 28721

- 07

- 5

Testosterone (Androgel ® 1%) 58

- 22

- 0 Simvastatin 79902

- 63

- 9 Divalproex Na (Depakote ER® and Divalproex Sodium ER®) 76584

- 70

- 8 Divalproex Na 76584

- 70

- 8

Zoledronic acid (Reclast® and Zometa®) 118072

- 93

- 8 Source: RX List, Inc., 2011 ; Pharmacy Times, 2010 NA

– not applicable

### 4

- 3 Table 4

- 2 . U.S. Production Ranges for App endix A Drugs

U.S. Production Range App endix A Drugs Less than 500,000 pounds (lbs) Estradiol (50

- 28

- 2) Ethinyl estradiol (57

- 63

- 6) 1 to less than 10 million lbs Mercaptopurine (50

- 44

- 2; 6112

- 76

- 1) 1 billion lbs and greater Fluoxymesterone (76

- 43

- 7) Source: U.S. EPA, 2006



### ERG did not perform a separate data search to determine if the drugs are commonly combined with other active ingredients or compounds. However, from the data collecte d

, there are a few examples in which drugs are commonly combined with other active ingredients or compounds

. As noted in Table 4

- 1

, E thinyl estradiol may be combined with N orgestimate, N orethindrone, or N orgestral and the brand name Prempro ® contain s E strogens, conjugated and M edroxyprogesterone acetate

. The formulary da ta in Appendix B also lists whether the drug is present in medications with other active ingredients.

4.2 Current Drug Disposal Practices

Current drug disposal practices at healthcare facilities depend on multiple factors, including type of facility (large facilities such as pharmacies or hospitals v ersus small facilities such as long

term care facilities or medical offices), form of the drug (e.g., liquid or solid), and c urrent regulations. The primary disposal practices for drug wastes include: reverse distribution, collection with municipal trash or collection by waste hauler, and down the drain (U.S. EPA, 2008 c )

. Table 4

- 3 provides a brief description of these disposal practices and factors that affect how facilities select which disposal practice to use.

### 4

- 4 Table 4

- 3

. Current Drug Disposal Practices at Healthcare Facilities

Disposal Practice Description (U.S. EPA, 2008b) Type of Facilities Type of Drug (ERG, 2009) Regulations Affecting Disposal Practice Reverse Distribution Method used by healthcare facilities to

receive credit from the pharmaceutical manufacturer prior to disposal. The reverse distributor determines which medications can receive credit from the manufacturer and then arranges for disposal of the drug waste. T he drug is then disposed of via incineration or landfill (see below discussion of solid waste disposal). Larger facilities: Pharmacies and hospitals

Most, if not all, large hospitals use reverse distribution for unused pharmaceuticals that are potentiall y creditable (U.S. EPA, 2009)

. Typically solid dose forms or unopened containers (e.g., past expiration date)

. Controlled Substances Act

(CSA)

– limits transfer of controlled substances between Drug Enforcement A dministration ( DEA )

- registrants

.

Solid Waste Disposal Solid waste disposal includes collection of

everyday trash from healthcare facilities and collection of drug and other medical waste by a waste hauler. The solid waste is either disposed in a landfill or incinerated.

Facilities may also include drug waste in their biohazardous (red bag) waste which is either sterilized and landfilled or incinerated. Larger facilities, such as hospitals, pharmacies, and large medical clinics are more likely to have a drug waste management program and a contract with a waste hauler who specializes in drug waste (U.S. EPA, 2008b)

. Smaller facilities may choose to dispose of solid dose drug wastes in the regular trash (noncontrolled substance). To prevent disposal down the drain, smaller facilities might mix controlled substances with coffee grounds, kitty litter, etc. to render irretrievable. May be liquids in addition to solids Collection and disposal must

meet RCRA (or s tate) hazardous requirements for listed drugs.

CSA limits transfer of
contro lled substances between DEA

- registrants; if not a DEA

registrant, the controlled substance must be rendered irretrievable to prevent diversion control.

Chemotherapy waste s also have special requirements.

Down the Drain Disposal down the drain is easy to do and a

low cost way to dispose of drug waste.

Following disposal down the train, the wastewater may be treated in a septic tank or other onsite treatment system; however, this is not common.

Wastewater from most healthcare facilities is collected in a sewer system and transported via pipes to a municipal wastewater treatment system. This method is very common at smaller healthcare facilities (ERG, 2009)

. Liquids, such as partially

- used intra venous (IV) drugs, are commonly disposed down the drain, as are solid doses for diversion control

. Drain disposal also meets the

DEA requirements for controlled substances (U.S. EPA, 2008 c )

.

Local wastewater treatment systems (e.g., in California) may hav e practices in place to limit or ban disposal of drug waste down the drain (e.g., obtaining permission from POTW prior to discharge) (U.S. EPA, 2008b)

.

### 4

- 5

4.2.1 Regulations Affecting Drug Disposal Practices

Regulations that affect drug disposal practices include RCRA and CSA. Under CSA, controlled substances can only be transferred between DEA

- registrants and must be destroyed to prevent diversion. Smaller healthcare facilities typically do not have DEA registrations and must dispose

o f controlled substances onsite (DEA, 2011)

. The DEA divides controlled substances into five schedules (21 CFR Sections 1308.11 through 1308.15). DEA places a controlled substance in its respective schedule based on whether it has a currently accepted medica l use in treatment in the United States and its relative abuse potential and likelihood of causing dependence. The definition of the substances in the five schedules include s the following (DEA, 2011 b ):

 Schedule I Controlled Substances have a high potenti al for abuse, have no currently accepted medical use in treatment in the United States, and there is a lack of accepted safety for use of the drug or other substance under medical supervision.

 Schedule II Controlled Substances have a high potential for a buse which may lead to severe psychological or physical dependence. Examples of single entity schedule II narcotics include morphine and opium.

 Schedule III Controlled Substances have a potential for abuse less than substances in schedules I or II and abu se may lead to moderate or low physical dependence or high psychological dependence.

 Schedule IV Controlled Substances have a low potential for abuse relative to substances in schedule III.

 Schedule V Controlled Substances have a low potential for abuse relative to substances listed in schedule IV and consist primarily of preparations containing limited quantities of certain narcotics.

Appendix C includes a list of all controlled substances by schedule for reference purposes. For this project, ERG coll ected toxicity data for five controlled substances. Fluoxymesterone (76

- 43

- 7), Methyltestosterone (58

- 18

- 4), Testolactone (968

- 93

- 4), and Testosterone (58

- 22

- 0) are Schedule III controlled substances. Clonazepam (1622

- 61

- 3) is a Schedule IV controlled subs tance.

Drugs that are RCRA or s tate hazardous drugs must meet transportation and disposal requirements protective of the environment and public health

. Eight of the drugs in App endix A are included on the f

ederal RCRA U list ( U.S. EPA, 2008) :

 

### U035: Chlorambucil (305

- 03

- 3)

 

### U058: Cyclophosphamide (50

- 18

- 0; 6055

- 19

- 2)

 

### U059: Daunorubicin (as Daunomycin ) (20830

- 81

- 3)

 

### U089: Diethylstilbestrol (56

- 53

- 1)

 

### U150: Melphalan (148

- 82

- 3)

 

### U010: Mitomycin (as Mitomycin C) (50

- 07

- 7)

 

### U206: Streptozocin (18883

- 66

- 4)

 

### U237: Uracil mustard (66

- 75

- 1)

### 4

- 6

All of these drugs , except D iethylstilbestrol, are antineoplastic agents (i.e., chemotherap y drugs). In addition to f

ederal regulations, E RG reviewed hazardous waste lists for three s tates , including California, Florida, and North Carolina. California and North Carolina did not list any additional App endix A drugs in their list or summary of RCRA regulations (McGurk, 2002; NCDENR, 2011) . Florida identified three drugs in App endix A as being hazardous based on meeting the ignitability criteria (Waste Code D001): C armustine (154

- 93

- 8), E toposide (33419

- 42

- 0) and P aclitaxel ( 33069

- 62

- 4) . In addition, I darubicin (58957

- 92

- 9) was listed as

“ I darubicin/ I damycin” with an EPA waste code of U059 ( FLDEP, 2007)

. All of these drugs are also antineoplastic agents. One other antineoplastic age nt included on Florida’s list (and the f ederal U list) , but not included in App endix A

, is C hlornaphazin ( 494

- 03

- 1)

, EPA Waste Code U026

.

4.2.2 Federal Drug Administration’s Recommendations for Flushing Unused Drugs

The FDA published recommendations to consumers on when to flush unused drugs down the drain in it s document Disposal of Unused Medicines: What You Should Know (FDA, 2010). FDA recommends flushing of these drugs due to potential harm to someone from taking the drug when not prescribed to them. Table 4

- 4 includes a list of the drugs recommended for flushing by FDA. None of the se drugs are currently included on the federal RCRA hazardous waste list and ERG did not collect toxicity data for the 14 drugs i n Table 4

- 4.

Table 4

- 4

. Drugs Recommended for Disposal By Flushing

Active Ingr edient Active Ingredient CASRN Drug/Brand Name
Acetaminophen/Oxycodone Hydrochloride 103

- 90

- 2/124

- 90

- 3 Percocet

Aspirin / Oxycodone Hydrochloride 50

- 78

- 2/ 124

- 90

- 3 Percodan Diazepam (a) 439

- 14

- 5 Diastat/Diastat AcuDial Fentanyl (a) 437

- 38

- 7 Duragesic Fentanyl Citrate 990

- 73

- 8 Actiq ; Fentora ; Onsolis Hydromorphone Hydrochloride 71

- 68

- 1 Dilaudid ; Exalgo Meperidine H ydrochloride 50

- 13

- 5 Demerol Methadone Hydrochloride 1095

- 90

- 5 Dolophine Hydrochloride ; Methadose Methylphenidate (a) 113

- 45

- 1 Daytrana Morphine Sulfate 64

- 31

- 3; 6211

- 15

- 0 Avinza; Kadian; MS Contin; Oramorph SR Morphine Sulfate / Naltrexone Hydrochloride 64

- 31

- 3; 6211

- 15

- 0 / 16676

- 29

- 2 Embeda

Oxycodone Hydrochloride 124

- 90

- 3 Oxycontin Oxymorphone Hydrochloride 357

- 07

- 3 Opana ; Opana ER Sodium Oxybate 502

- 85

- 2 Xyrem Source: FDA, 2010. Disposal of Unused Medicines: What You Should Know. March.

a

– Drug is a controlled substance.

### 5

- 1

5. R EFERENCES



### 1. DEA (Drug Enforcement A dministration ). 2011. Controlled Substances: Alphabetical Order. January 18. Available online at: http://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf

. 2. DEA.2011b. Controll ed Substance Schedules (website). Accessed online September2011 at: http://www.deadiversion.usdoj.gov/schedules/index.html# Office of Diversion Control.

3. Eastern Research Group (ERG). 2009. Management Practices and Control Technologies for Unused Pharmaceu ticals at Health Care Facilities

– Final, Document Control Number 06570 . October 8. Available at www.regulation.gov: EPA

- HQ

- OW

- 2008

- 0517

- 0517

4. FDA (Food and Drug Administration). 2010. Disposal of Unused Medicines: What You Should Know. March. Available onl ine at: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/E nsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186187.htm

5. FLDEP ( Florida Department of Environmental Protection ) . 2007. List of Pharmaceuticals
t hat a re Potentially Hazardous Wastes W hen Discarded

. Hazardous Waste Regulation Section. December 3. Available online at: http://www.dep.state.fl.us/waste/quick_topics/publications/shw/hazardous/WastePharmLi stLetter12_07.pdf

. 6. Mcgurk, Jack. 2002. Management of Pharmaceutical Medical Waste. California Department of Health and Services. October 15. Available online at: http://ww w.cwea.org/p3s/documents/DHS%20Guidance%20Pharmacy%20Waste%20fro m%20Hospitals.pdf

. 7. NIOSH ( National Institute for Occupational Safety and Health ). 2010. NIOSH List o f Antineoplastic a nd Other Hazardous Drugs i n Healthcare Settings 2010

. Available online
at: http://www.cdc.gov/niosh/docs/2010

- 167/

. 8. NIOSH. 2011. Notice of Draft Document Available for Public Comment . Available online
at: http://www.cdc.gov/niosh/docket/review/docket190/pdfs/FRNFinal07192011.pdf

. 9. NIOSH. 2011b. NIOSH List of Antineoplastic a nd Other Hazardous Drugs i n Healthcare Settings 2012: Proposed Additions and Deletions to the NIOSH Hazardous Drug Lis t. Available online at: http://www.cdc.gov/niosh/docket/review/docket190/pdfs/Proposedchanges07112011.pdf

10. North Carolina Department of the Environment and Natural Resources (DENR). 2011. Part 261: Identification and List of Hazardous Wastes. Retrieved July 2011 from: http://wastenot.enr.state.nc.us/hwhome/webrules/pdf/0106_1.pdf

. 11. OSHA ( Occupational Safety and Health Administration ). 1999. OSHA Technical Manual

– E ffective Date: 1/20/1999; Directive Number: TED 01

- 00

- 015

. Available online at: http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html

. 12. Pharmacy Times. 2010. Top 200 Products in the U.S. Market by Sales, 2009. May, p35

. Available online at: http://www.pharmacytimes.com/media/pdf/PHTM_35.pdf

.

### 5

- 2

13. RX List, Inc. 2011. Top 300 Prescriptions for 2005

. Retrieved June 2011 from : http://www.rxlist.c om/script/main/art.asp?articlekey=79509

. 14. U.S. EPA (U.S. Environmental Protection Agency ). 2006

. Non

- confidential 2006 IUR Company/Chemical Records

. Available online at: http://cfpub.epa.gov/iursearch/i ndex.cfm

. 15. U.S. EPA. 2007. M icrosoft ExcelTM spreadsheet: APIUniverse_MRDD_CombinedListing_v3 .xls. Office of Water.

16. U.S. EPA. 2008. Hazardous Waste Listings: A User

- Friendly Reference Document (Draft). Available online at: http://www.epa.gov/wastes/hazard/wastetypes/pdfs/listing

ref.pdf

. 17. U.S. EPA. 2008b. Health Services Industry Study: Management and Disposal of Unused Pharmaceuticals (Interim Techn ical Report). August. Available at www.regulation.gov: EPA

- HQ

- OW

- 2006

- 0 771

- 1694.

18. U.S. EPA. 2008c. Unused Pharmaceuticals in the Health Care Industry: Interim Report (EPA

- 821

- R

- 08

- 010). August. Available online at: http://water.epa.gov/scitech/swguidance/pp cp/upload/2010_1_11_ppcp_hcioutreach.pdf

. 19. U.S. EPA. 2009. Memorandum: Health Care Industry Study

- Meeting with Stericycle, July 23, 2009. Office of Water, August 4, 2009. Available at www.regulation.gov: EPA

HQ

- OW

- 2008

- 0517

- 0333

.

### App endix A LIST OF HAZARDOUS DRUGS REVIEWED BY ERG

### A

- 1

Table A

- 1. List of Drugs Reviewed by ERG and Tier Assignments

Drug CASRN Source Tier Notes 1 Acitretin 55079

- 83

- 9 NIOSH 2011 2 Very little lethality data, borderline Tier 3. NIOSH proposed as an addition to its List of Hazardous Drugs

. 2 Aldesleukin 110942

- 02

- 4 NIOSH 2010 3 3 Alefacept 222535

- 22

- 0 NIOSH 2010 3 4 Alemtuzumab 216503

- 57

- 0; 126775

- 97

- 1 NIOSH 2010 3 NIOSH proposed deletion from List of Hazardous Drugs

. 5 Alitretinoin 5300

- 03

- 8 NIOSH 2010 3 6 Altretamine 645

- 05

- 6 NIOSH 2010/OSHA 2 7 Ambrisentan 177036

- 94

- 1 NIOSH 2011 3 NIOSH proposed as an addition to its List of Hazardous Drugs. 8 Aminoglutethimide 125

- 84

- 8 OSHA 2 9 Amsacrine 51264

- 14

- 3 NIOSH 2010 2 10 Anastrozole 120511

- 73

- 1 NIOSH 2010 3 NA Arsenic trioxide 1327

- 53

- 3 NIOSH 2010 NA Already included on the P list of hazardous wastes. No toxicity data collected. 11 Asparaginase 9015

- 68

- 3 NIOSH 2010/OSHA 2 12 Azacitidine 320

- 67

- 2 NIOSH 2010 2 13 Azathioprine 446

- 86

- 6 NIOSH 2010/OSHA 2 14 Bacillus Calmette

Guerin (BCG) D001500000 NIOSH 2010 3

15 Bendamustine HCl 3543

- 75

- 7 NIOSH 2011 2 NIOSH proposed as an addition to its List of Hazardous Drugs. 16 Bexarotene 153559

- 49

- 0 NIOSH 2010 3 17 Bicalutamide 90 357

- 06

- 5 NIOSH 2010 2 18 Bleomycin 11056

- 06

- 7 NIOSH 2010/OSHA 2 19 Bortezomib 179324

- 69

- 7 NIOSH 2010 2 20 Bosentan 147536

- 97

- 8 NIOSH 2010 3 21 Busulfan 55

- 98

- 1 NIOSH 2010/OSHA 2 22 Cabergoline 81409

- 90

- 7 NIOSH 2011 2 Very little lethality data, borderline Tier 3. NIOSH proposed as an addition to its List of Hazardous Drugs. 23 Capecitabine 154361

- 50

- 9 NIOSH 2010 2 Very little lethality data, borderline Tier 3. 24 Carbamazepine 298

- 46

- 4 NIOSH 2011 2 NIOSH proposed as an addition to its List of Hazardous Drugs. 25 Carboplatin 41575

- 94

- 4 NIOSH 2010/OSHA 2 26 Carmustine 154

- 93

- 8 NIOSH 2010/OSHA 1 27 Cetrorelix acetate 145672

- 81

- 7 NIOSH 2010 3 28 Chlorambucil 305

- 03

- 3 NIOSH 2010/OSHA 2 Already included on the U list of hazardous wastes (U035). 29 Chloramphenicol 56

- 75

- 7 NIOSH 2010/OSHA 2 30 Chlorotrianisene 569

- 57

- 3 OSHA 3 31 Chlorozotocin 54749

- 90

- 5 OSHA 2 32 Choriogonadotropin alfa 177073

- 44

- 8 NIOSH 2010 3

33 Cidofovir 149394

- 66

- 1; 113852

- 37

- 2 NIOSH 2010 3

34 Cisplatin 15663

- 27

- 1 NIOSH 2010/OSHA 1 35 Cladribine 4291

- 63

- 8 NIOSH 2010 2

### A

- 2

Table A

- 1. List of Drugs Reviewed by ERG and Tier Assignments

Drug CASRN Source Tier Notes 36 Clofarabine 123318

- 82

- 1 NIOSH 2010 3 37 Clonazepam 1622

- 61

- 3 NIOSH 2011 2 NIOSH proposed as an addition to its List of Hazardous Drugs. 38 Colchicine 64

- 86

- 8 NIOSH 2010 1 39 Cyclophosphamide 50

- 18

- 0; 6055

- 19

- 2 NIOSH 2010/OSHA 2 Already included on the U list of hazardous wastes (U058). 40 Cyclosporin 79217

- 60

- 0; 59865

- 13

- 3 NIOSH 2010/OSHA 2 Different data were found for the CASRN and alternate CASRN. 41 Cytarabine 147

- 94

- 4 NIOSH 2010/OSHA 2 42 Dacarbazine 4342

- 0 3

- 4 NIOSH 2010/OSHA 2 43 Dactinomycin 50

- 76

- 0 NIOSH 2010/OSHA 1 44 Dasatinib 302962

- 49

- 8; 863127

- 77

- 9 NIOSH 2010 3

45 Daunorubicin 20830

- 81

- 3 OSHA 2 Already included on the U list of hazardous wastes (U059)

. 46 Daunorubicin HCl 23541

- 50

- 6 NIOSH 2010 2 47 Decitabine 2353

- 33

- 5 NIOSH 2010 2 48 Degarelix 214766

- 78

- 6 NIOSH 2011 3 NIOSH proposed as an addition to its List of Hazardous Drugs. 49 Denileukin See Denileukin diftitox NIOSH 2010 3 ERG could not locate a CASRN for Denileukin. The NLM and FDA sources as well as the AHFS DI monograph listed Denileukin diftitox, but not Denileukin. Therefore, ERG added Denileukin diftitox to the list of drugs. 50 Denileukin diftitox 173146

- 27

- 5 AHFS 3

51 Dienestrol 84

- 17

- 3 NIOSH 2010 3 NIOSH proposed deletion from List of Hazardous Drugs. 52 Diethylstilbestrol 56

- 53

- 1 NIOSH 2010/OSHA 2 Already included on the U list of hazardous wastes (U089). 53 Dinoprostone 363

- 24

- 6 NIOSH 2010 2 54 Divalproex Na 76584

- 70

- 8 NIOSH 2011 3 NIOSH listed “Valproic acid/Divalproex Na”; however, since each drug has a unique CASRN, ERG captured information for them individually. NIOSH proposed as an addition to its List of Hazardous Drugs. 55 Docetaxel 148408

- 66

- 6; 114977

- 28

- 5 NIOSH 2010 3, 2 Different data were found for the CASRN and alternate CASRN, resulting in a different tier for each (148408

- 66

- 6 = Tier 3; 114977

- 28

- 5 = Tier 2). 56 Doxorubicin 23214

- 92

- 8 NIOSH 2010/OSHA 2 57 Dronedarone HCl 141625

- 93

- 6 NIOSH 2011 3 NIOSH proposed as an addition to its List of Hazardous Drugs. 58 Dutasteride 164656

- 23

- 9 NIOSH 2010 3 59 Efavirenz 154598

- 52

- 4 NIOSH 2011 3 NIOSH proposed as an addition to its List of Hazardous Drugs. 60 Entecavir 142217

- 69

- 4 NIOSH 2010 3

### A

- 3

Table A

- 1. List of Drugs Reviewed by ERG and Tier Assignments

Drug CASRN Source Tier Notes 61 Epirubicin 56420

- 45

- 2 NIOSH 2010 2 62 Ergonovine 60

- 79

- 7 NIOSH 2010 2 NIOSH listed “Ergonovine/ Methylergonovine”; however, since each drug has a unique CASRN, ERG captured information for them individually. 63 Estradiol 50

- 28

- 2 NIOSH 2010/OSHA 2 Very little lethality data, borderline Tier 3. 64 Estramustine 2998

- 57

- 4 OSHA 3 65 Estramustine phosphate 4891

- 15

- 0 NIOSH 2010 3 66 Estrogen

- progestin combinations NIOSH 2010 3

67 Estrogens, conjugated 1 2126

- 59

- 9 NIOSH 2010 2 Very little lethality data, borderline Tier 3. 68 Estrogens, esterified D042724000 NIOSH 2010 3 69 Estrone 53

- 16

- 7 NIOSH 2010 2 Very little lethality data, borderline Tier 3. 70 Estropipate 7280

- 37

- 7 NIOSH 2010 3 71 Ethinyl Estradiol 57

- 63

- 6 OSHA 2 72 Etoposide 33419

- 42

- 0 NIOSH 2010/OSHA 2 73 Everolimus 159351

- 69

- 6 NIOSH 2011 2 Very little lethality data, borderline Tier 3. NIOSH proposed as an addition to its List of Hazardous Drugs. 74 Exemestane 107868

- 30

- 4 NIOSH 2010 3 75 Finasteride 98319

- 26

- 7 NIOSH 2010 2 76 Floxuridine 50

- 91

- 9 NIOSH 2010/OSHA 2 77 Fludarabine 21679

- 14

- 1 NIOSH 2010 2 Very little lethality data, borderline Tier 3. 78 Fluorouracil 51

- 21

- 8 NIOSH 2010/OSHA 2 79 Fluoxymesterone 76

- 43

- 7 NIOSH 2010 2 Very little lethality data, borderline Tier 3. 80 Flutamide 13311

- 84

- 7 NIOSH 2010/OSHA 2 81 Fulvestrant 129453

- 61

- 8 NIOSH 2010 3 82 Ganciclovir 82410

- 32

- 0 NIOSH 2010/OSHA 2 83 Ganirelix acetate 129311

- 55

- 3 NIOSH 2010 3 84 Gemcitabine 95058

- 81

- 4 NIOSH 2010 3 85 Gemtuzumab ozogamicin 220578

- 59

- 6 NIOSH 2010 3

86 Gonadotropin, chorionic 9002

- 61

- 3 NIOSH 2010 3

87 Goserelin 65807

- 02

- 5 NIOSH 2010 3 88 Hydroxyurea 127

- 07

- 1 NIOSH 2010/OSHA 2 89 Ibritumomab tiuxetan 206181

- 63

- 7 NIOSH 2010 3 NIOSH proposed deletion from List of Hazardous Drugs. 90 Idarubicin 58957

- 92

- 9 NIOSH 2010/OSHA 2 91 Ifosfamide 3778

- 73

- 2; 84711

- 20

- 6 NIOSH 2010/OSHA 2

92 Imatinib mesylate 220127

- 57

- 1 NIOSH 2010 3

### A

- 4

Table A

- 1. List of Drugs Reviewed by ERG and Tier Assignments

Drug CASRN Source Tier Notes 93 Interferon alfa

- 2a 76543

- 88

- 9; 77907

- 69

- 8 NIOSH 2010 2 Different data were found on HSDB for the alternate CASRN. NIOSH proposed deletion from List of Hazardous Drugs. 94 Interferon alfa

- 2b 99210

- 65

- 8; 98530

- 12

- 2 NIOSH 2010 2 NIOSH proposed deletion from List of Hazardous Drugs. 95 Interferon alfa

- n1 308067

- 63

- 2 NIOSH 2010 3 NIOSH proposed deletion from List of Hazardous Drugs. 96 Interferon alfa

- n3 NIOSH 2010 3 NIOSH proposed deletion from List of Hazardous Drugs. 97 Interferon

- A OSHA 3 98 Irinotecan HCl 100286

- 90

- 6; 136572

- 09

- 3 NIOSH 2010 2

99 Isotretinoin 4759

- 48

- 2 OSHA 2 100 Ixabepilone 219989

- 84

- 1 NIOSH 2011 3 NIOSH proposed as an addition to its List of Hazardous Drugs. 101 Leflunomide 75706

- 12

- 6 NIOSH 2010 2 102 Lenalidomide 191732

- 72

- 6 NIOSH 2010 3 103 Letrozole 112809

- 51

- 5 NIOSH 2010 3 104 Leuprolide 53714

- 56

- 0 OSHA 3 105 Leuprolide acetate 74381

- 53

- 6 NIOSH 2010 2 106 Levamisole 14769

- 73

- 4 OSHA 2 107 Lomustine 13010

- 47

- 4 NIOSH 2010/OSHA 2 108 Mechlorethamine 51

- 75

- 2 NIOSH 2010/OSHA 1 109 Medroxyprogesterone 520

- 85

- 4 OSHA 3 110 Medroxyprogesterone
acetate 71

- 58

- 9 NIOSH 2010 2

111 Megestrol 3562

- 63

- 8 NIOSH 2010/OSHA 3 112 Melphalan 148

- 82

- 3 NIOSH 2010/OSHA 1 Already included on the U list of hazardous wastes (U150). 113 Menotropins 9002

- 68

- 0; 61489

- 71

- 2 NIOSH 2010 2

114 Mercaptopurine 50

- 44

- 2; 6112

- 76

- 1 NIOSH 2010/OSHA 2 Different data were found for the CASRN and alternate CASRN. 115 Methotrexate 59

- 05

- 2 NIOSH 2010/OSHA 2 116 Methylergonovine 113

- 42

- 8 NIOSH 2010 2 NIOSH listed “ergonovine/ methylergonovine”; however, since each drug has a unique CASRN, ERG captured information for them individually. 117 Methyltestosterone 58

- 18

- 4 NIOSH 2010 2 118 Mifepristone 84371

- 65

- 3 NIOSH 2010 3 119 Mitomycin 50

- 07

- 7 NIOSH 2010/OSHA 1 Already included on the U list of hazardous wastes (U010). 120 Mitotane 53

- 19

- 0 NIOSH 2010/OSHA 2 121 Mitoxantrone 65271

- 80

- 9 OSHA 2 122 Mitoxantrone HCl 70476

- 82

- 3 NIOSH 2010 1

### A

- 5

Table A

- 1. List of Drugs Reviewed by ERG and Tier Assignments

Drug CASRN Source Tier Notes 123 Mometasone furoate 83919

- 23

- 7 NIOSH 2011 2 Very little lethality data, borderline Tier 3. NIOSH proposed as an addition to its List of Hazardous Drugs. 124 Mycophenolate mofetil 128794

- 94

- 5 NIOSH 201 0 3 125 Mycophenolic acid 24280

- 93

- 1; 483

- 60

- 3 NIOSH 2011 2,3 Different data were found for the CASRN and alternate CASRN, resulting in a different tier for each (24280

- 93

- 1 = Tier 2; 483

- 60

- 3 = Tier 3). NIOSH proposed as an addition to its List of Hazardous Drugs. 126 Nafarelin 76932

- 56

- 4 NIOSH 2010/OSHA 3 127 Nelarabine 121032

- 29

- 9 NIOSH 2010 3 128 Nilotinib 641571

- 10

- 0 NIOSH 2011 3 NIOSH proposed as an addition to its List of Hazardous Drugs. 129 Nilutamide 63612

- 50

- 0 NIOSH 2010 2 130 Oxaliplatin 61825

- 94

- 3 NIOSH 2010 2 Very little lethality data, borderline Tier 3. 131 Oxcarbazepine 28721

- 07

- 5 NIOSH 2011 3 NIOSH proposed as an addition to its List of Hazardous Drugs. 132 Oxytocin 50

- 56

- 6 NIOSH 2010 1 133 Paclitaxel 33069

- 62

- 4 NIOSH 2010 2 134 Palifermin 162394

- 19

- 6 NIOSH 2010 3 135 Paroxetine HCl 78246

- 49

- 8 NIOSH 2010 2 136 Paroxetine mesylate 217797

- 14

- 3 NIOSH 2011 3 NIOSH proposed as an addition to its List of Hazardous Drugs. 137 Pazopanib HCl 635702

- 64

- 6 NIOSH 2011 3 NIOSH proposed as an addition to its List of Hazardous Drugs. 138 Pegaspargase 130167

- 69

- 0 NIOSH 2010 3 139 Pemetrexed 137281

- 23

- 3 NIOSH 2010 3 140 Pentamidine isethionate 140

- 64

- 7 NIOSH 2010 2 141 Pentetate calcium trisodium 12111

- 24

- 9 NIOSH 2010 2

142 Pentostatin 53910

- 25

- 1 NIOSH 2010 2 143 Perph osfamide 62435

- 42

- 1 NIOSH 2010 3 NIOSH proposed deletion from List of Hazardous Drugs. 144 Phenoxybenzamine HCl 63

- 92

- 3 NIOSH 2011 2 NIOSH proposed as an addition to its List of Hazardous Drugs. 145 Pipobroman 54

- 91

- 1 NIOSH 2010/OSHA 2 146 Piritrexim isethionate 79483

- 69

- 5 NIOSH 2010 3 NIOSH proposed deletion from List of Hazardous Drugs. 147 Pitavastatin Ca 147526

- 32

- 7 NIOSH 2011 2 Very little lethality data, borderline Tier 3. NIOSH proposed as an addition to its List of Hazardous Drugs. 148 Plerixafor 110078

- 46

- 1 NIOSH 2011 3 NIOSH proposed as an addition to its List of Hazardous Drugs. 149 Plicamycin 18378

- 89

- 7 NIOSH 2010/OSHA 2 NIOSH proposed deletion from List of Hazardous Drugs. 150 Podofilox 518

- 28

- 5 NIOSH 2010 2 Has a dermal LD 50 in rabbits of 200 mg/kg, borderline Tier 1. 151 Podophyllum resin 9000

- 55

- 9 NIOSH 2010 2

### A

- 6

Table A

- 1. List of Drugs Reviewed by ERG and Tier Assignments

Drug CASRN Source Tier Notes 152 Pralatrexate 146464

- 95

- 1 NIOSH 2011 3 NIOSH proposed as an addition to its List of Hazardous Drugs. 153 Prednimustine 29069

- 24

- 7 NIOSH 2010 2 NIOSH proposed deletion from List of Hazardous Drugs. 154 Procarbazine 671

- 16

- 9 NIOSH 2010/OSHA 2 155 Progesterone 57

- 83

- 0 NIOSH 2010 2 156 Progestins P097000000 NIOSH 2010 3 157 Raloxifene 84449

- 90

- 1 NIOSH 2010 3 158 Raltitrexed 112887

- 68

- 0 NIOSH 2010 3 NIOSH proposed deletion from List of Hazardous Drugs. 159 Rasagiline mesylate 161735

- 79

- 1 NIOSH 2010 3 160 Ribavirin 36791

- 04

- 5 NIOSH 2010/OSHA 2 161 Risperidone 106266

- 06

- 2 NIOSH 2010 2 162 Romidepsin 128517

- 07

- 7 NIOSH 2011 2 Very little lethality data, borderline Tier 3. NIOSH proposed as an addition to its List of Hazardous Drugs. 163 Rufinamide 106308

- 44

- 5 NIOSH 2011 3 NIOSH proposed as an addition to its List of Hazardous Drugs. 164 Simvastatin 79902

- 63

- 9 NIOSH 2011 2 NIOSH proposed as an addition to its List of Hazardous Drugs. 165 Sirolimus 53123

- 88

- 9 NIOSH 2010 2 166 Sorafenib 284461

- 73

- 0 NIOSH 2010 3 167 Streptozocin 18883

- 66

- 4 NIOSH 2010/OSHA 2 Already included on the U list of hazardous wastes (U206). 168 Sunitinib malate 341031

- 54

- 7 NIOSH 2010 3 169 Tacrolimus 109581

- 93

- 3; 104987

- 11

- 3 NIOSH 2010 2

170 Tamoxifen 10540

- 29

- 1 NIOSH 2010/OSHA 2 171 Telavancin HCl 560130

- 42

- 9 NIOSH 2011 3 NIOSH proposed as an addition to its List of Hazardous Drugs. 172 Temsirolimus 162635

- 04

- 3 NIOSH 2011 3 NIOSH proposed as an addition to its List of Hazardous Drugs. 173 Temozolomide 85622

- 93

- 1 NIOSH 2010 2 Very little lethality data, borderline Tier 3. 174 Teniposide 29767

- 20

- 2 NIOSH 2010 2 175 Testolactone 968

- 93

- 4 NIOSH 2010/OSHA 3 176 Testosterone 58

- 22

- 0 NIOSH 2010 2 Very little lethality data, borderline Tier 3. 177 Tetracycline hydrochloride 64

- 75

- 5 NIOSH 2011 2 NIOSH proposed as an addition to its List of Hazardous Drugs. 178 Thalidomide 50

- 35

- 1 NIOSH 2010 2 179 Thioguanine 154

- 42

- 7 NIOSH 2010/OSHA 2 180 Thiotepa 52

- 24

- 4 NIOSH 2010/OSHA 1 181 Topotecan 123948

- 87

- 8 NIOSH 2010 3 182 Toremifene citrate 89778

- 27

- 8 NIOSH 2010 2 183 Tositumomab 192391

- 48

- 3; 208921

- 02

- 2 NIOSH 2010 3 NIOSH proposed deletion from List of Hazardous Drugs. 184 Tretinoin 302

- 79

- 4 NIOSH 2010 2 185 Trifluridine 70

- 00

- 8 NIOSH 2010 2 186 Trimetrexate glucuronate 82952

- 64

- 5 NIOSH 2010 2 NIOSH proposed deletion from List of Hazardous Drugs. 187 Triptorelin 57773

- 63

- 4 NIOSH 2010 3

### A

- 7

Table A

- 1. List of Drugs Reviewed by ERG and Tier Assignments

Drug CASRN Source Tier Notes 188 Uracil mustard 66

- 75

- 1 NIOSH 2010/OSHA 1 Already included on the U list of hazardous wastes (U237). 189 Valganciclovir 175865

- 60

- 8 NIOSH 2010 3 190 Valproic acid 99

- 66

- 1 NIOSH 2011 2 NIOSH listed “Valproic acid/Divalproex Na”; however, since each drug has a unique CASRN, ERG captured information for them individually. NIOSH proposed as an addition to its List of Hazardous Drugs. 191 Valrubicin 56124

- 62

- 0 NIOSH 2010 2 Very little lethality data, borderline Tier 3. 192 Vidarabine 24356

- 66

- 9; 5536

- 17

- 4 NIOSH 2010/OSHA 2

193 Vigabatrin 60643

- 86

- 9 NIOSH 2011 2 NIOSH proposed as an addition to its List of Hazardous Drugs. 194 Vinblastine 865

- 21

- 4 OSHA 2 195 Vinblastine sulfate 143

- 67

- 9 NIOSH 2010 2 196 Vincristine 57

- 22

- 7 OSHA 2 197 Vincristine sulfate 2068

- 78

- 2 NIOSH 2010 2 198 Vindesine 53643

- 48

- 4 NIOSH 2010 2 NIOSH proposed deletion from List of Hazardous Drugs. 199 Vinorelbine tartrate 125317

- 39

- 7 NIOSH 2010 3 200 Vorinostat 149647

- 78

- 9 NIOSH 2010 3 201 Zidovudine 30516

- 87

- 1 NIOSH 2010/OSHA 2 202 Ziprasidone HCl 122883

- 93

- 6; 138982

- 67

- 9 NIOSH 2011 3 NIOSH proposed as an addition to its List of Hazardous Drugs. 203 Zoledronic acid 118072

- 93

- 8 NIOSH 2011 2 Very little lethality data, borderline Tier 3. NIOSH proposed as an addition to its List of Hazardous Drugs. 204 Zonisamide 68291

- 97

- 4 NIOSH 2010 2

### B

- 1 Appendix B TOXICITY DATA

(See separate Excel file: ORCR Drug Data.xlsx )

### C

- 1 Appendix C LIST OF CONTROLLED S UBSTANCES BY DEA SCHEDULE

### C

- 1 Table C

- 1. Schedule I Controlled Substances

SUBSTANCE DEA NUMBER CSA

SCH NARC OTHER NAMES 1

- (1

- Phenylcyclohexyl)pyrrolidine 7458 I N PCPy, PHP, rolicyclidine 1

- (2

- Phenylethyl)

- 4

- phenyl

- 4

- acetoxypiperidine 9663 I Y PEPAP, synthetic heroin

1

- [1

- (2

- Thienyl)cyclohexyl]piperidine 7470 I N TCP, tenocyclidine

1

- [1

- (2

- Thienyl)cyclohexyl]pyrrolidine 7473 I N TCPy

1

- Methyl

- 4

- phenyl

- 4

- propionoxypiperidine 9661 I Y MPPP, synthetic heroin
2,5

- Dimethoxy

- 4

- (n)

- propylthiophenethylamine 7348 I N 2C

- T

- 7

2,5

- Dimethoxy

- 4

- ethylamphetamine 7399 I N DOET
2,5

- Dimethoxyamphetamine 7396 I N DMA, 2,5

- DMA
3,4,5

- Trimethoxyamphetamine 7390 I N TMA
3,4

- Methylenedioxyamphetamine 7400 I N MDA, Love Drug 3,4

- Methylenedioxymethamphetamine 7405 I N MDMA, Ecstasy, XTC
3,4

- Methylenedioxy

- N

ethylamphetamine 7404 I N N

- ethyl MDA, MDE, MDEA

3

- Methylfentanyl 9813 I Y China White, fentanyl

3

- Methylthiofentanyl 9833 I Y Chine White, fentanyl
4

- Bromo

- 2,5

- dimethoxyamphetamine 7391 I N DOB, 4

- bromo

- DMA

4

- Bromo

- 2,5

- dimethoxyphenethylamine 7392 I N 2C

- B, Nexus, has been sold as Ecstasy, i.e. MDMA
4

- Methoxyamphetamine 7411 I N PMA
4

- Methyl

- 2,5

- dimethoxyamphetamine 7395 I N DOM, STP

4

- Methylaminorex (cis isomer) 1590 I N U4Euh, McN

- 422
5

- Methoxy

- 3,4

- methylenedioxyamphetamine 7401 I N MMDA

5

- Methoxy

- N,N

diisopropyltryptamine 7439 I N 5

- MeO

- DIPT

5

- Methoxy

- N

- N

- dimethyltryptamine 7431 I N 5

- MeO

- DMT Acetorphine 9319 I Y Acetyl

- alpha

- methylfentanyl 9815 I Y Acetyldihydrocodeine 9051 I Y Acetylcodone Acetylmethadol 9601 I Y Methadyl acetate Allylprodine 9602 I Y Alphacetylmethadol except levo

alphacetylmethadol 9603 I Y
Alpha

- ethyltryptamine 7249 I N ET, Trip Alphameprodine 9604 I Y Alphamethadol 9605 I Y Alpha

- methylfentanyl 9814 I Y China White, fentanyl

### C

- 2 Table C

- 1. Schedule I Controlled Substances

SUBSTANCE DEA NUMBER CSA

SCH NARC OTHER NAMES Alpha

- methylthiofentanyl 9832 I Y China White, fentanyl Alpha

- methyltryptamine 7432 I N AMT
Aminorex 1585 I N has been sold as methamphetamine

Benzethidine 9606 I Y Benzylmorphine 9052 I Y Betacetylmethadol 9607 I Y

Beta

- hydroxy

- 3

- methylfentanyl 9831 I Y China White, fentanyl

Beta

- hydroxyfentanyl 9830 I Y China White, fentanyl Betameprodine 9608 I Y

Betamethadol 9609 I Y Betaprodine 9611 I Y

Bufotenine 7433 I N Mappine, N,N

- dimethylserotonin

Cathinone 1235 I N Constituent of "Khat" plant

Clonitazene 9612 I Y Codeine methylbromide 9070 I Y
Codeine

- N

- oxide 9053 I Y

CP

- 47497 7297 I N 5

- (1,1

- Dimethylheptyl)

- 2

- [(1R,3S)

- 3

- hydroxycyclohexyl phenol

CP

- 47497 C8 Homologue 7298 I N 5

- (1,1

- Dimethyloctyl)

- 2

- [(1R,3S)3

- hydroxycyclohexyl phenol Cyprenorphine 9054 I Y Desomorphine 9055 I Y

Dextromoramide 9613 I Y Palfium, Jetrium, Narcolo Diampromide 9615 I Y Diethylthiambutene 9616 I Y Diethyltryptamine 7434 I N DET

Difenoxin 9168 I Y Lyspafen Dihydromorphine 9145 I Y

Dimenoxadol 9617 I Y Dimepheptanol 9618 I Y Dimethylthiambutene 9619 I Y Dimethyltryptamine 7435 I N DMT Dioxaphetyl butyrate 9621 I Y
Dipipanone 9622 I Y Dipipan, phenylpiperone HCl, Diconal, Wellconal
Drotebanol 9335 I Y Metebanyl, oxymethebanol Ethylmethylthiambutene 9623 I Y

Etonitazene 9624 I Y Etorphine (except HCl) 9056 I Y

### C

- 3 Table C

- 1. Schedule I Controlled Substances

SUBSTANCE DEA NUMBER CSA

SCH NARC OTHER NAMES
Etoxeridine 9625 I Y
Fenethylline 1503 I N Captagon,amfetyline,ethyltheophylline amphetamine Furethidine 9626 I Y
Gamma Hydroxybutyric Acid 2010 I N GHB, gamma hydroxybutyrate, sodium oxybate
Heroin 9200 I Y Diacetylmorphine, diamorphine Hydromorphinol 9301 I Y Hydroxypethidine 9627 I Y
Ibogaine 7260 I N Constituent of "Tabernanthe iboga" plant
JWH

- 018 (also known as AM678) 7118 I N 1

- Pentyl

- 3

- (1

- naphthoyl)indole

JWH

- 073 7173 I N 1

- Butyl

- 3

- (1

- naphthoyl)indole

JWH

- 200 7200 I N 1

- [2

- (4

- Morpholinyl)ethyl]

- 3

- (1

- naphthoyl)indole
Ketobemidone 9628 I Y Cliradon

Levomoramide 9629 I Y Levophenacylmorphan 9631 I Y Lysergic acid diethylamide 7315 I N LSD, lysergide

Marihuana 7360 I N Cannabis, marijuana Mecloqualone 2572 I N Nubarene

Mescaline 7381 I N Constituent of "Peyote" cacti
Methaqualone 2565 I N Quaalude, Parest, Somnafac, Opitimil, Mandrax
Methcathinone 1237 I N N

- Methylcathinone, "cat" Methyldesorphine 9302 I Y Methyldihydromorphine 9304 I Y Morpheridine 9632 I Y Morphine methylbromide 9305 I Y Morphine methylsulfonate 9306 I Y Morphine

- N

- oxide 9307 I Y Myrophine 9308 I Y
N,N

- Dimethylamphetamine 1480 I N

N

- Benzylpiperazine 7493 I N BZP, 1

- benzylpiperazine

N

- Ethyl

- 1

- phenylcyclohexylamine 7455 I N PCE

N

- Ethyl

- 3

- piperidyl benzilate 7482 I N JB 323

N

- Ethylamphetamine 1475 I N NEA
N

- Hydroxy

- 3,4

- methylenedioxyamphetamine 7402 I N N

- hydroxy MDA

Nicocodeine 9309 I Y Nicomorphine 9312 I Y Vilan

### C

- 4 Table C

- 1. Schedule I Controlled Substances

SUBSTANCE DEA NUMBER CSA

SCH NARC OTHER NAMES
N

- Methyl

- 3

- piperidyl benzilate 7484 I N JB 336 Noracymethadol 9633 I Y Norlevorphanol 9634 I Y
Normethadone 9635 I Y Phenyldimazone Normorphine 9313 I Y Norpipanone 9636 I Y

Para

- Fluorofentanyl 9812 I Y China White, fentanyl Parahexyl 7374 I N Synhexyl, Peyote 7415 I N Cactus which contains mescaline

Phenadoxone 9637 I Y Phenampromide 9638 I Y Phenomorphan 9647 I Y Phenoperidine 9641 I Y Operidine, Lealgin

Pholcodine 9314 I Y Copholco, Adaphol, Codisol, Lantuss, Pholcolin
Piritramide 9642 I Y Piridolan Proheptazine 9643 I Y Properidine 9644 I Y Propiram 9649 I Y Algeril Psilocybin 7437 I N Constituent of "Magic mushrooms"
Psilocyn 7438 I N Psilocin, constituent of "Magic mushrooms"
Racemoramide 9645 I Y
Tetrahydrocannabinols 7370 I N THC, Delta

- 8 THC, Delta

- 9 THC, dronabinol and others

Thebacon 9315 I Y Acetylhydrocodone, Acedicon, Thebacetyl Thiofentanyl 9835 I Y Chine white, fentanyl

Tilidine 9750 I Y Tilidate, Valoron, Kitadol, Lak, Tilsa Trimeperidine 9646 I Y Promedolum
NARC

- Narcotic



### Table C

- 2. Schedule II Controlled Substances

SUBSTANCE DEA NUMBER CSA

SCH NARC OTHER NAMES
1

- Phenylcyclohexylamine 7460 II N PCP precursor

1

- Piperidinocyclohexanecarbonitrile 8603 II N PCC, PCP precursor
4

- Anilino

- N

- phenethyl

- 4

- piperidine (ANPP) 8333 II N ANPP

Alfentanil 9737 II Y Alfenta Alphaprodine 9010 II Y Nisentil

### C

- 5 Table C

- 2. Schedule II Controlled Substances

SUBSTANCE DEA NUMBER CSA

SCH NARC OTHER NAMES
Amobarbital 2125 II N Amytal, Tuinal Amphetamine 1100 II N Dexedrine, Adderall, Obetrol

Anileridine 9020 II Y Leritine Benzoylecgonine 9180 II Y Cocaine metabolite

Bezitramide 9800 II Y Burgodin

Carfentanil 9743 II Y Wildnil

Coca Leaves 9040 II Y
Cocaine 9041 II Y Methyl benzoylecgonine, Crack

Codeine 9050 II Y Morphine methyl ester, methyl morphine Dextropropoxyphene, bulk (non

- dosage forms) 9273 II Y Propoxyphene
Dihydrocodeine 9120 II Y Didrate, Parzone Dihydroetorphine 9334 II Y DHE Diphenoxylate 9170 II Y Ecgonine 9180 II Y Cocaine precursor, in Coca leaves Ethylmorphine 9190 II Y Dionin Etorphine HCl 9059 II Y M 99
Fentanyl 9801 II Y Duragesic, Oralet, Actiq, Sublimaze, Innovar
Glutethimide 2550 II N Doriden, Dorimide Hydrocodone 9193 II Y dihydrocodeinone Hydromorphone 9150 II Y Dilaudid, dihydromorphinone

Isomethadone 9226 II Y Isoamidone

Levo

- alphacetylmethadol 9648 II Y LAAM, long acting methadone, levomethadyl acetate Levomethorphan 9210 II Y Levorphanol 9220 II Y Levo

- Dromoran

Lisdexamfetamine 1205 II N Vyvanse Meperidine 9230 II Y Demerol, Mepergan, pethidine Meperidine intermediate

- A 9232 II Y Meperidine precursor
Meperidine intermediate

- B 9233 II Y Meperidine precursor, normeperidine Meperidine intermediate

- C 9234 II Y Meperidine precursor

Metazocine 9240 II Y

Methadone 9250 II Y Dolophine, Methadose, Amidone

Methadone intermediate 9254 II Y Methadone precursor
Methamphetamine 1105 II N Desoxyn, D

- desoxyephedrine, ICE, Crank, Speed Methylphenidate 1724 II N Concerta, Ritalin, Methylin Metopon 9260 II Y

### C

- 6 Table C

- 2. Schedule II Controlled Substances

SUBSTANCE DEA NUMBER CSA

SCH NARC OTHER NAMES
Moramide

- intermediate 9802 II Y
Morphine 9300 II Y MS Contin, Roxanol, Oramorph, RMS, MSIR
Nabilone 7379 II N Cesamet Opium extracts 9610 II Y Opium fluid extract 9620 II Y Opium poppy 9650 II Y Papaver somniferum Opium tincture 9630 II Y Laudanum Opium, granulated 9640 II Y Granulated opium Opium, powdered 9639 II Y Powdered opium Opium, raw 9600 II Y Raw opium, gum opium Oripavine 9330 II Y
Oxycodone 9143 II Y OxyContin, Percocet, Endocet, Roxicodone, Roxicet, Oxymorphone 9652 II Y Numorphan
Pentobarbital 2270 II N Nembutal

Phenazocine 9715 II Y Narphen, Prinadol Phencyclidine 7471 II N PCP, Sernylan

Phenmetrazine 1631 II N Preludin
Phenylacetone 8501 II N P2P, phenyl

- 2

- propanone, benzyl methyl ketone
Piminodine 9730 II Y
Poppy Straw 9650 II Y Opium poppy capsules, poppy heads Poppy Straw Concentrate 9670 II Y Concentrate of Poppy Straw, CPS Racemethorphan 9732 II Y Racemorphan 9733 II Y Dromoran

Remifentanil 9739 II Y Ultiva

Secobarbital 2315 II N Seconal, Tuinal

Sufentanil 9740 II Y Sufenta Tapentadol 9780 II Y

Thebaine 9333 II Y Precursor of many narcotics
NARC

- Narcotic



### Table C

- 3. Schedule III Controlled Substances

SUBSTANCE DEA NUMBER CSA

SCH NARC OTHER NAMES 13Beta

- ethyl

- 17beta

- hydroxygon

- 4

- en

- 3

-
one 4000 III N 17Alpha

- methyl

- 3alpha,17beta

- dihydroxy

5alpha

- androstane 4000 III N

### C

- 7 Table C

- 3. Schedule III Controlled Substances

SUBSTANCE DEA NUMBER CSA

SCH NARC OTHER NAMES 17Alpha

- methyl

- 3beta,17beta

- dihydroxy

5alpha

- androstane 4000 III N 17Alpha

- methyl

- 3beta,17beta

dihydroxyandrost

- 4

- ene 4000 III N 17Alpha

- methyl

- 4

- hydroxynandrolone (17alpha

- methyl 4

- hydroxy

- 17beta

hydroxyestr

- 4

- en

- 3

- one) 4000 III N

17Alpha

- methyl

- delta1

- dihydrotestosterone (17beta hydroxy

17alpha

- methyl

- 5alpha

- androst

- 1

- en

- 3

- one) 4000 III N 17

- Alpha

- methyl

- 1

- testosterone

19

- Nor

- 4,9(10)

- androstadienedione 4000 III N 19

- Nor

- 4

- androstenediol (3beta,17beta

dihydroxyestr

- 4 ene; 3alpha,17beta

dihydroxyestr

- 4

- ene) 4000 III N

19

- Nor

- 4

- androstenedione (estr

- 4

- en

- 3,17

- dione) 4000 III N

19

- Nor

- 5

- androstenediol (3beta,17beta

dihydroxyestr

- 5 ene; 3alpha,17beta

dihydroxyestr

- 5

- ene) 4000 III N

19

- Nor

- 5

- androstenedione (estr

- 5

- en

- 3,17

- dione) 4000 III N

1

- Androstenediol (3beta,17beta

dihydroxy

- 5alpha androst

- 1

- ene; 3alpha,17beta

- dihydroxy

- 5alpha androst

1

- ene) 4000 III N

1

- Androstenedione (5alpha

- androst

- 1

- en

3,17

- dione) 4000 III N 3Alpha,17beta

- dihydroxy

- 5alpha

androstane 4000 III N
3Beta,17beta

- dihydroxy

- 5alpha

androstane 4000 III N

4

- Androstenediol (3beta,17beta

dihydroxy

- androst

- 4 ene) 4000 III N 4

- AD

4

- Androstenedione (androst

- 4

- en

- 3,17

- dione) 4000 III N

4

- Dihydrotestosterone (17beta

hydroxyandrostan

- 3 one) 4000 III N Anabolex, Andractim, Pesomax, Stanolone 4

- Hydroxy

- 19

- nortestosterone (4,17beta

dihydroxyestr 4

- en

- 3

- one) 4000 III N

4

- Hydroxytestosterone (4,17beta

dihydroxyandrost

- 4 en

- 3

- one) 4000 III N

5

- Androstenediol (3beta,17beta

dihydroxy

- androst

- 5 ene) 4000 III N

5

- Androstenedione (androst

- 5

- en

- 3,17

- dione) 4000 III N

Amobarbital & noncontrolled active ingred. 2126 III N Amobarbital suppository dosage form 2126 III N Anabolic steroids 4000 III N "Body Building" drugs Androstanedione (5alpha

- androstan

- 3,17

- dione) 4000 III N

### C

- 8 Table C

- 3. Schedule III Controlled Substances

SUBSTANCE DEA NUMBER CSA

SCH NARC OTHER NAMES Aprobarbital 2100 III N Alurate Barbituric acid derivative 2100 III N Barbiturates not specifically listed Benzphetamine 1228 III N Didrex, Inapetyl Bolasterone (7alpha,17alpha

- dimethyl

17beta hydroxyandrost

- 4

- en

- 3

- one) 4000 III N
Boldenone (17beta

- hydroxyandrost

- 1,4

- diene

- 3

- one) 4000 III N Equipoise, Parenabol, Vebonol, dehydrotestosterone Boldione 4000 III N Buprenorphine 9064 III Y Buprenex, Temgesic, Subutex, Suboxone Butabarbital (secbutabarbital) 2100 III N Butisol, Butibel Butalbital 2100 III N Fiorinal, Butalbital with aspirin Butobarbital (butethal) 2100 III N Soneryl (UK) Calusterone (7beta,17alpha

- dimethyl

17beta hydroxyandrost

- 4

- en

- 3

- one) 4000 III N Methosarb

Chlorhexadol 2510 III N Mechloral, Mecoral, Medodorm, Chloralodol
Chlorphentermine 1645 III N Pre

- Sate, Lucofen, Apsedon, Desopimon Clortermine 1647 III N Voranil Clostebol (4

- chloro

- 17beta

hydroxyandrost

- 4

- en

- 3

- one) 4000 III N Alfa

- Trofodermin, Clostene, 4

- chlorotestosterone
Codeine & isoquinoline alkaloid 90 mg/du 9803 III Y Codeine with papaverine or noscapine
Codeine combination product 90 mg/du 9804 III Y Empirin,Fiorinal,Tylenol,ASA or APAP w/codeine Dehydrochloromethyltestosterone (4

- chloro

- 17beta hydroxy

- 17alpha

methylandrost

- 1,4

- dien

- 3

- one) 4000 III N Oral

- Turinabol

Delta1

- dihydrotestosterone ( 17beta

hydroxy

- 5alpha androst

- 1

- en

- 3

- one) 4000 III N 1

- Testosterone Desoxymethyltestosterone 4000 III N Dihydrocodeine combination product 90 mg/du 9807 III Y Synalgos

- DC, Compal

Dronabinol (synthetic) in sesame oil in soft gelatin capsule as approved by FDA 7369 III N Marinol, synthetic THC in sesame oil/soft gelatin as approved by FDA Drostanolone (17beta

- hydroxy

- 2alpha

methyl

- 5alpha androstan

- 3

- one) 4000 III N Drolban, Masterid, Permastril

Embutramide 2020 III N Tributane Ethylestrenol (17alpha

- ethyl

- 17beta

hydroxyestr

- 4

- ene) 4000 III N Maxibolin, Orabolin, Durabolin

- O, Duraboral Ethylmorphine combination product 15 mg/du 9808 III Y Fluoxymesterone (9

- fluoro

- 17alpha

methyl 11beta,17beta

- dihydroxyandrost

- 4

-
en

- 3

- one) 4000 III N Anadroid

- F, Halotestin, Ora

Testryl
Formebolone (2

- formyl

- 17alpha

- methyl

11alpha,17beta

- dihydroxyandrost

- 1,4

- dien

- 3

- one) 4000 III N Esiclene, Hubernol

Furazabol (17alpha

- methyl

- 17beta

hydroxyandrostano[2,3

- c]

- furazan) 4000 III N Frazalon, Miotolon, Qu Zhi Shu

### C

- 9 Table C

- 3. Schedule III Controlled Substances

SUBSTANCE DEA NUMBER CSA

SCH NARC OTHER NAMES Gamma Hydroxybutyric Acid preparations 2012 III N Xyrem Hydrocodone & isoquinoline alkaloid <15 mg/du 9805 III Y Dihydrocodeinone+papaverine or noscapine Hydrocodone combination product <15 mg/du 9806 III Y Lorcet, Lortab,Vicodin, Vicoprofen,Tussionex, Norco Ketamine 7285 III N Ketaset, Ketalar, Special K, K Lysergic acid 7300 III N LSD precursor Lysergic acid amide 7310 III N LSD precursor Mestanolone (17alpha

- methyl

- 17beta

hydroxy

- 5alpha androstan

- 3

- one) 4000 III N Assimil, Ermalone, Methybol, Tantarone Mesterolone (1alpha

- methyl

- 17beta

hydroxy

- 5alpha androstan

- 3

- one) 4000 III N Androviron, Proviron, Testiwop

Met handienone (17alpha

- methyl

- 17beta

hydroxyandrost

- 1,4

- diene

- 3

- one) 4000 III N Dianabol, Metabolina, Nerobol, Perbolin Methandriol (17alpha

- methyl

3beta,17beta dihydroxyandrost

- 5

- ene) 4000 III N Sinesex, Stenediol, Troformone

Methenolone (1

- methyl

- 17beta

- hydroxy

5alpha

- androst 1

- en

- 3

- one) 4000 III N Primobolan, Primobolan Depot, Primobolan S Methyldienolone (17alpha

- methyl

- 17beta

hydroxyestr 4,9(10)

- dien

- 3

- one) 4000 III N Methyltestosterone (17alpha

- methyl

17beta hydroxyandrost

- 4

- en

- 3

- one) 4000 III N Android, Oreton, Testred, Virilon
Methyltrienolone (17alpha

- methyl

- 17beta

hydroxyestr 4,9,11

- trien

- 3

- one) 4000 III N Metribolone
Methyprylon 2575 III N Noludar Mibolerone (7alpha,17alpha

- dimethyl

17beta hydroxyestr

- 4

- en

- 3

- one) 4000 III N Cheque, Matenon
Morphine combination product/50 mg/100 ml or gm 9810 III Y Nalorphine 9400 III Y Nalline Nandrolone (17beta

- hydroxyestr

- 4

- en

- 3

- one) 4000 III N Deca

- Durabolin, Durabolin, Durabolin

- 50 Norbolethone (13beta,17alpha

- diethyl

17beta hydroxygon

- 4

- en

- 3

- one) 4000 III N Genabol
Norclostebol (4

- chloro

- 17beta

hydroxyestr

- 4

- en

- 3

- one 4000 III N Anabol

- 4

- 19, Lentabol

Norethandrolone (17alpha

- ethyl

- 17beta

hydroxyestr

- 4 en

- 3

- one) 4000 III N Nilevar, Pronabol, Solevar
Normethandrolone (17alpha

- methyl

17beta hydroxyestr

- 4

- en

- 3

- one) 4000 III N Lutenin, Matronal, Orgasteron

Opium combination product 25 mg/du 9809 III Y Paregoric, other combination products Oxandrolone (17alpha

- methyl

- 17beta

hydroxy

- 2

- oxa 5alpha

- androstan

- 3

- one) 4000 III N Anavar, Lonavar, Oxandrin, Provitar, Vasorome Oxymesterone (17alpha

- methyl

- 4,17beta dihydroxyandrost

- 4

- en

- 3

- one) 4000 III N Anamidol, Balnimax, Oranabol, Oranabol 10 Oxymetholone (17alpha

- methyl

- 2

- hydroxymethylene 17beta

- hydroxy

5alpha

- androstan

- 3

- one) 4000 III N Anadrol

- 50, Adroyd, Anapolon, Anasteron, Pardroyd

Pentobarbital & noncontrolled active ingred. 2271 III N FP

- 3 Pentobarbital suppository dosage form 2271 III N WANS

### C

- 10 Table C

- 3. Schedule III Controlled Substances

SUBSTANCE DEA NUMBER CSA

SCH NARC OTHER NAMES

Phendimetrazine 1615 III N Plegine, Prelu

- 2, Bontril, Melfiat, Statobex Secobarbital & noncontrolled active ingred 2316 III N Secobarbital suppository dosage form 2316 III N Stanozolol (17alpha

- methyl

- 17beta

hydroxy

- 5alpha androst

- 2

- eno[3,2

- c]

- pyrazole) 4000 III N Winstrol, Winstrol

- V

Stenbolone (17beta

- hydroxy

- 2

- methyl

-- 5alpha

- androst 1

- en

- 3

- one) 4000 III N Stimulant compounds previously excepted 1405 III N Mediatric Sulfondiethylmethane 2600 III N Sulfonethylmethane 2605 III N Sulfonmethane 2610 III N Talbutal 2100 III N Lotusate Testolactone (13

- hydroxy

- 3

- oxo

- 13,17

- secoandrosta 1,4

- dien

- 17

- oic acid lactone) 4000 III N Teolit, Teslac
Testosterone (17beta

- hydroxyandrost

- 4

-
en

- 3

- one) 4000 III N Android

- T, Androlan, Depotest, Delatestryl Tetrahydrogestrinone (13beta,17alpha

diethyl

- 17beta hydroxygon

- 4,9,11

- trien

- 3

- one) 4000 III N THG

Thiamylal 2100 III N Surital Thiopental 2100 III N Pentothal Tiletamine & Zolazepam Combination Product 7295 III N Telazol
Trenbolone (17beta

- hydroxyestr

- 4,9,11

- trien

- 3

- one) 4000 III N Finaplix

- S, Finajet, Parabolan

Vinbarbital 2100 III N Delvinal, vinbarbitone NARC

- Narcotic



### Table C

- 4. Schedule IV Controlled Substances

SUBSTANCE DEA NUMBER CSA

SCH NARC OTHER NAMES Alprazolam 2882 IV N Xanax Barbital 2145 IV N Veronal, Plexonal, barbitone Bromazepam 2748 IV N Lexotan, Lexatin, Lexotanil
Butorphanol 9720 IV N Stadol, Stadol NS, Torbugesic, Torbutrol Camazepam 2749 IV N Albego, Limpidon, Paxor

Cathine 1230 IV N Constituent of "Khat" plant, (+)

- norpseudoephedrine Chloral betaine 2460 IV N Beta Chlor Chloral hydrate 2465 IV N Noctec Chlordiazepoxide 2744 IV N Librium, Libritabs, Limbitrol, SK

- Lygen Clobazam 2751 IV N Urbadan, Urbanyl Clonazepam 2737 IV N Klonopin, Clonopin Clorazepate 2768 IV N Tranxene Clotiazepam 2752 IV N Trecalmo, Rize, Clozan, Veratran Cloxazolam 2753 IV N Akton, Lubalix, Olcadil, Sepazon

### C

- 11 Table C

- 4. Schedule IV Controlled Substances

SUBSTANCE DEA NUMBER CSA

SCH NARC OTHER NAMES Delorazepam 2754 IV N Dexfenfluramine 1670 IV N Redux Dextropropoxyphene dosage forms 9278 IV Y Darvon, propoxyphene, Darvocet, Propacet Diazepam 2765 IV N Valium, Diastat Dichloralphenazone 2467 IV N Midrin, dichloralantipyrine Diethylpropion 1610 IV N Tenuate, Tepanil Difenoxin 1 mg/25 ug AtSO4/du 9167 IV Y Motofen

Estazolam 2756 IV N ProSom, Domnamid, Eurodin, Nuctalon Ethchlorvynol 2540 IV N Placidyl Ethinamate 2545 IV N Valmid, Valamin Ethyl loflazepate 2758 IV N Fencamfamin 1760 IV N Reactivan Fenfluramine 1670 IV N Pondimin, Ponderal Fenproporex 1575 IV N Gacilin, Solvolip Fludiazepam 2759 IV N Flunitrazepam 2763 IV N Rohypnol, Narcozep, Darkene, Roipnol Flurazepam 2767 IV N Dalmane Fospropofol 2138 IV N Lusedra Halazepam 2762 IV N Paxipam Haloxazolam 2771 IV N Ketazolam 2772 IV N Anxon, Loftran, Solatran, Contamex Loprazolam 2773 IV N Lorazepam 2885 IV N Ativan Lormetazepam 2774 IV N Noctamid Mazindol 1605 IV N Sanorex, Mazanor Mebutamate 2800 IV N Capla Medazepam 2836 IV N Nobrium Mefenorex 1580 IV N Anorexic, Amexate, Doracil, Pondinil
Meprobamate 2820 IV N Miltown, Equanil, Micrainin, Equagesic, Meprospan Methohexital 2264 IV N Brevital Methylphenobarbital (mephobarbital) 2250 IV N Mebaral, mephobarbital

Midazolam 2884 IV N Versed Modafinil 1680 IV N Provigil Nimetazepam 2837 IV N Erimin Nitrazepam 2834 IV N Mogadon Nordiazepam 2838 IV N Nordazepam, Demadar, Madar Oxazepam 2835 IV N Serax, Serenid

- D Oxazolam 2839 IV N Serenal, Convertal Paraldehyde 2585 IV N Paral Pemoline 1530 IV N Cylert

Pentazocine 9709 IV N Talwin, Talwin NX, Talacen, Talwin Compound Petrichloral 2591 IV N Pentaerythritol chloral, Periclor Phenobarbital 2285 IV N Luminal, Donnatal, Bellergal

- S

Phentermine 1640 IV N Ionamin, Fastin, Adipex

- P, Obe

- Nix, Zantryl Pinazepam 2883 IV N Domar

### C

- 12 Table C

- 4. Schedule IV Controlled Substances

SUBSTANCE DEA NUMBER CSA

SCH NARC OTHER NAMES Pipradrol 1750 IV N Detaril, Stimolag Fortis Prazepam 2764 IV N Centrax Quazepam 2881 IV N Doral Sibutramine 1675 IV N Meridia

SPA 1635 IV N 1

- dimethylamino

- 1,2

- diphenylethane, Lefetamine Temazepam 2925 IV N Restoril Tetrazepam 2886 IV N Myolastan, Musaril Triazolam 2887 IV N Halcion Zaleplon 2781 IV N Sonata Zolpidem 2783 IV N Ambien, Ivadal, Stilnoct, Stilnox Zopiclone 2784 IV N Lunesta NARC

- Narcotic



### Table C

- 5. Schedule V Controlled Substances

SUBSTANCE DEA NUMBER CSA

SCH NARC OTHER NAMES Codeine preparations

- 200 mg/100 ml or 100
gm V Y Cosanyl,Robitussin A

C,Cheracol,Cerose,Pediacof Difenoxin preparations

- 0.5 mg/25 ug AtSO4/du V Y Motofen
Dihydrocodeine preparations 10 mg/100 ml or 100 gm V Y Cophene

- S, various others
Diphenoxylate preparations 2.5 mg/25 ug AtSO4 V Y Lomotil, Logen Ethylmorphine preparations 100 mg/100 ml or 100 gm V Y

Lacosamide 2746 V N Vimpat Opium preparations

- 100 mg/100 ml or /100
gm V Y Parepectolin, Kapectolin PG, Kaolin Pectin P.G. Pregabalin 2782 V N Lyrica Pyrovalerone 1485 V N Centroton, Thymergix NARC

- Narcotic