Federal Register / Vol. 79, No. 39 / Thursday, February 27, 2014 / Proposed Rules 11037 

Director, Office of Trade Agreements 

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[FR Doc. 2014–03633 Filed 2–26–14; 8:45 am] 

BILLING CODE 3510–17–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–389] 

Schedules of Controlled Substances: 

Rescheduling of Hydrocodone 

Combination Products From Schedule 

III to Schedule II 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Drug Enforcement 

Administration (DEA) proposes to 

reschedule hydrocodone combination 

products from schedule III to schedule 

II of the Controlled Substances Act. This 

proposed action is based on a 

rescheduling recommendation from the 

Assistant Secretary for Health of the 

Department of Health and Human 

Services and an evaluation of all other 

relevant data by the DEA. If finalized, 

this action would impose the regulatory 

controls and administrative, civil, and 

criminal sanctions applicable to 

schedule II controlled substances on 

persons who handle (manufacture, 

distribute, dispense, import, export, 

engage in research, conduct 

instructional activities, or possess) or 

propose to handle hydrocodone 

combination products. 

DATES: Interested persons may file 

written comments on this proposal 

pursuant to 21 CFR 1308.43(g). 

Electronic comments must be 

submitted, and written comments must 

be postmarked, on or before April 28, 

2014. Commenters should be aware that 

the electronic Federal Docket 

Management System will not accept 

comments after midnight Eastern Time 

on the last day of the comment period. 


TKELLEY on DSK3SPTVN1PROD with PROPOSALS
11038 Federal Register / Vol. 79, No. 39 / Thursday, February 27, 2014 / Proposed Rules 

Interested persons, defined as those 

‘‘adversely affected or aggrieved by any 

rule or proposed rule issuable pursuant 

to section 201 of the Act (21 U.S.C. 

811),’’ 21 CFR 1300.01, may file a 

request for hearing or waiver of an 

opportunity for a hearing or to 

participate in a hearing pursuant to 21 

CFR 1308.44 and in accordance with 21 

CFR 1316.45, 1316.47, 1316.48 or 

1316.49, as applicable. Requests for 

hearing, notices of appearance, and 

waivers of an opportunity for a hearing 

or to participate in a hearing must be 

received on or before March 31, 2014. 

ADDRESSES: To ensure proper handling 

of comments, please reference ‘‘Docket 

No. DEA–389’’ on all electronic and 

written correspondence. The DEA 

encourages that all comments be 

submitted electronically through the 

Federal eRulemaking Portal which 

provides the ability to type short 

comments directly into the comment 

field on the Web page or attach a file for 

lengthier comments. Please go to 

www.regulations.gov and follow the online instructions at that site for 

submitting comments. Paper comments 

that duplicate electronic submissions 

are not necessary. Should you, however, 

wish to submit written comments, in 

lieu of electronic comments, they 

should be sent via regular or express 

mail to: Drug Enforcement 

Administration, Attention: DEA Federal 

Register Representative/ODW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. All requests for a hearing and 

waivers of participation must be sent to: 

Drug Enforcement Administration, 

Attention: Hearing Clerk/LJ, 8701 

Morrissette Drive, Springfield, Virginia 

22152. 

FOR FURTHER INFORMATION CONTACT: 

Ruth A. Carter, Office of Diversion 

Control, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, Virginia 

22152, Telephone: (202) 598–6812. 

SUPPLEMENTARY INFORMATION: 

Posting of Public Comments 

Please note that all comments 

received in response to this docket are 

considered part of the public record and 

will be made available for public 

inspection online at 

www.regulations.gov. Such information 

includes personal identifying 

information (such as your name, 

address, etc.) voluntarily submitted by 

the commenter. 

The Freedom of Information Act 

(FOIA) applies to all comments 

received. If you want to submit personal 

identifying information (such as your 

name, address, etc.) as part of your 

comment, but do not want it to be made 

publicly available, you must include the 

phrase ‘‘PERSONAL IDENTIFYING 

INFORMATION’’ in the first paragraph 

of your comment. You must also place 

all of the personal identifying 

information you do not want made 

publicly available in the first paragraph 

of your comment and identify what 

information you want redacted. 

If you want to submit confidential 

business information as part of your 

comment, but do not want it to be made 

publicly available, you must include the 

phrase ‘‘CONFIDENTIAL BUSINESS 

INFORMATION’’ in the first paragraph 

of your comment. You must also 

prominently identify the confidential 

business information to be redacted 

within the comment. If a comment has 

so much confidential business 

information that it cannot be effectively 

redacted, all or part of that comment 

may not be made publicly available. 

Comments containing personal 

identifying information or confidential 

business information identified as 

directed above will be made publicly 

available in redacted form. 

An electronic copy of this document 

and supplemental information to this 

proposed rule are available at 

www.regulations.gov for easy reference. 

If you wish to personally inspect the 

comments and materials received or the 

supporting documentation the DEA 

used in preparing the proposed action, 

these materials will be available for 

public inspection by appointment. To 

arrange a viewing, please see the ‘‘For 

Further Information Contact’’ paragraph 

above. 

Request for Hearing, Notice of 

Appearance at Hearing, or Waiver of an 

Opportunity for a Hearing or To 

Participate in a Hearing 

Pursuant to the provisions of the 

Controlled Substances Act (CSA), 21 

U.S.C. 811(a), this action is a formal 

rulemaking ‘‘on the record after 

opportunity for a hearing.’’ Such 

proceedings are conducted pursuant to 

the provisions of the Administrative 

Procedure Act (APA), 5 U.S.C. 551–559. 

21 CFR 1308.41–1308.45; 21 CFR Part 

1316 subpart D. In accordance with 21 

CFR 1308.44(a)–(c), requests for a 

hearing, notices of appearance, and 

waivers of an opportunity for a hearing 

or to participate in a hearing may be 

submitted only by interested persons, 

defined as those ‘‘adversely affected or 

aggrieved by any rule or proposed rule 

issuable pursuant to section 201 of the 

Act (21 U.S.C. 811).’’ 21 CFR 1300.01. 

Requests for hearing and notices of 

appearance must conform to the 

requirements of 21 CFR 1308.44(a) or 

(b), and 1316.47 or 1316.48 as 

applicable, and include a statement of 

the interest of the person in the 

proceeding and the objections or issues, 

if any, concerning which the person 

desires to be heard. Any waiver must 

conform to the requirements of 21 CFR 

1308.44(c) and 1316.49, including a 

written statement regarding the 

interested person’s position on the 

matters of fact and law involved in any 

hearing. 

Please note that pursuant to 21 U.S.C. 

811(a)(1), the purpose and subject 

matter of a hearing held in relation to 

this rulemaking is restricted to: ‘‘(A) 

find[ing] that such drug or other 

substance has a potential for abuse, and 

(B) mak[ing] with respect to such drug 

or other substance the findings 

prescribed by subsection (b) of section 

812 of [title 21] for the schedule in 

which such drug is to be placed * * *.’’ 

Requests for a hearing, notices of 

appearance at a hearing, and waivers of 

an opportunity for a hearing or to 

participate in a hearing must be 

submitted to the DEA using the address 

information provided above. 

Legal Authority 

The DEA implements and enforces 

titles II and III of the Comprehensive 

Drug Abuse Prevention and Control Act 

of 1970, as amended. Titles II and III are 

referred to as the ‘‘Controlled 

Substances Act’’ and the ‘‘Controlled 

Substances Import and Export Act,’’ 

respectively, and are collectively 

referred to as the ‘‘Controlled 

Substances Act’’ or the ‘‘CSA’’ for the 

purpose of this action. 21 U.S.C. 801– 

971. The DEA publishes the 

implementing regulations for these 

statutes in title 21 of the Code of Federal 

Regulations (CFR), parts 1300 to 1321. 

The CSA and its implementing 

regulations are designed to prevent, 

detect, and eliminate the diversion of 

controlled substances and listed 

chemicals into the illicit market while 

providing for the legitimate medical, 

scientific, research, and industrial needs 

of the United States. Controlled 

substances have the potential for abuse 

and dependence and are controlled to 

protect the public health and safety. 

Under the CSA, controlled substances 

are classified into one of five schedules 

based upon their potential for abuse, 

their currently accepted medical use, 

and the degree of dependence the 

substance may cause. 21 U.S.C. 812. The 

initial schedules of controlled 

substances established by Congress are 

found at 21 U.S.C. 812(c), and the 

current list of all scheduled substances 

is published at 21 CFR Part 1308. 21 

U.S.C. 812(a). 


TKELLEY on DSK3SPTVN1PROD with PROPOSALS
Federal Register / Vol. 79, No. 39 / Thursday, February 27, 2014 / Proposed Rules 11039 

1Hydrocodone combination products (HCPs) are 

pharmaceuticals containing specified doses of 

hydrocodone in combination with other drugs in 

specified amounts. These products are approved for 

marketing for the treatment of pain and for cough 

suppression. 

2As set forth in a memorandum of understanding 

entered into by the HHS, the Food and Drug 

Administration (FDA), and the National Institute on 

Drug Abuse (NIDA), the FDA acts as the lead agency 

within the HHS in carrying out the Secretary’s 

scheduling responsibilities under the CSA, with the 

concurrence of the NIDA. 50 FR 9518, Mar. 8, 1985. 

The Secretary of the HHS has delegated to the 

Assistant Secretary for Health of the HHS the 

authority to make domestic drug scheduling 

recommendations. 

3 In the United States there are currently no 

approved, marketed, products containing 

hydrocodone in combination with other active 

ingredients that fall outside schedule III of the CSA. 

Further, until recently, there were no approved 

hydrocodone single-entity schedule II products. In 

Oct. 2013, the FDA approved ZohydroTM ER, a 

single-entity, extended release schedule II product. 

The sponsor of this product in a press release dated 

Oct. 25, 2013, stated that ZohydroTM ER will be 

launched in approximately four months. 

Accordingly, all of the historical data regarding 

hydrocodone from different national and regional 

databases that support this proposal should refer to 

HCPs only, regardless of whether the database 

utilizes the term ‘‘hydrocodone’’ or ‘‘hydrocodone 

combination products.’’ 

4FDASIA, SEC1139. SCHEDULING OF 

HYDROCODONE. (a) IN GENERAL.—Not later than 

60 days after the date of enactment of this Act, if 

practicable, the Secretary of Health and Human 

Services (referred to in this section as the 

‘‘Secretary’’) shall hold a public meeting to solicit 

advice and recommendations to assist in 

conducting a scientific and medical evaluation in 

connection with a scheduling recommendation to 

the Drug Enforcement Administration regarding 

drug products containing hydrocodone, combined 

with other analgesics or as an antitussive. (b) 

STAKEHOLDER INPUT.—In conducting the 

evaluation under subsection (a), the Secretary shall 

solicit input from a variety of stakeholders 

including patients, health care providers, harm 

prevention experts, the National Institute on Drug 

Abuse, the Centers for Disease Control and 

Prevention, and the Drug Enforcement 

Administration regarding the health benefits and 

risks, including the potential for abuse and the 

impact of up-scheduling of these products. 

Pursuant to 21 U.S.C. 811(a)(1), the 

Attorney General may, by rule, ‘‘add to 

such a schedule or transfer between 

such schedules any drug or other 

substance if he (A) finds that such drug 

or other substance has a potential for 

abuse, and (B) makes with respect to 

such drug or other substance the 

findings prescribed by [21 U.S.C. 812(b)] 

for the schedule in which such drug is 

to be placed * * *.’’ Pursuant to 28 CFR 

0.100(b), the Attorney General has 

delegated this scheduling authority to 

the Administrator of the DEA. 

The CSA provides that the scheduling 

of any drug or other substance may be 

initiated by the Attorney General (1) on 

his own motion; (2) at the request of the 

Secretary of the Department of Health 

and Human Services (HHS); or (3) on 

the petition of any interested party. 21 

U.S.C. 811(a). This proposed action was 

initiated by a petition to reschedule 

hydrocodone combination products 

(HCPs) 1 from schedule III to schedule II 

of the CSA, and is supported by, inter 

alia, a recommendation from the 

Assistant Secretary for Health of the 

HHS.2 If finalized, this action would 

impose the regulatory controls and 

administrative, civil, and criminal 

sanctions of schedule II controlled 

substances on any person who handles, 

or proposes to handle, HCPs. 

Background 

Hydrocodone was listed in schedule II 

of the CSA upon the enactment of the 

CSA in 1971. Public Law 91–513, 84 

Stat. 1236, sec. 202(c), schedule II, 

paragraph (a), clause (1) (codified at 21 

U.S.C. 812(c)); initially codified at 21 

CFR 308.12(b)(1)(x) (36 FR 7776, April 

24, 1971) (currently codified at 21 CFR 

1308.12(b)(1)(vi)). At that time, HCPs in 

specified doses (containing no greater 

than 15 milligrams (mg) hydrocodone 

per dosage unit or not more than 300 mg 

hydrocodone per 100 milliliters) were 

listed in schedule III of the CSA when 

formulated with specified amounts of an 

isoquinoline alkaloid of opium or one or 

more therapeutically active nonnarcotic 

ingredients. Public Law 91–513, 84 Stat. 

1236, sec. 202(c), schedule III, 

paragraph (d), clauses (3) and (4) 

(codified at 21 U.S.C. 812(c)); initially 

codified at 21 CFR 308.13(e)(3) and (4) 

(36 FR 7776, April 24, 1971) (currently 

codified at 21 CFR 1308.13(e)(1)(iii) and 

(iv)). Any other products that contain 

single-entity hydrocodone or 

combinations of hydrocodone and other 

substances outside the range of 

specified doses are listed in schedule II 

of the CSA.3

Proposed Determination To Transfer 

HCPs to Schedule II 

Pursuant to 21 U.S.C. 811(a), 

proceedings to add a drug or substance 

to those controlled under the CSA, or to 

transfer a drug between schedules, may 

be initiated on the petition of any 

interested party. In response to a 

petition the DEA had received 

requesting that HCPs be controlled in 

schedule II of the CSA, in 2004 the DEA 

submitted a request to the HHS to 

provide the DEA with a scientific and 

medical evaluation of available 

information and a scheduling 

recommendation for HCPs, pursuant to 

21 U.S.C 811(b) and (c). In 2008 the 

HHS provided to the DEA its 

recommendation that HCPs remain 

controlled in schedule III of the CSA. In 

response, in 2009, the DEA requested 

that the HHS re-evaluate their data and 

provide another scientific and medical 

evaluation and scheduling 

recommendation based on additional 

data and analysis. 

On July 9, 2012, President Obama 

signed the Food and Drug 

Administration Safety and Innovation 

Act (Pub. L. 112–144) (FDASIA). 

Section 1139 of the FDASIA 4 directed 

the Food and Drug Administration 

(FDA) to hold a public meeting to 

‘‘solicit advice and recommendations’’ 

pertaining to the scientific and medical 

evaluation in connection with its 

scheduling recommendation to the DEA 

regarding drug products containing 

hydrocodone, combined with other 

analgesics or as an antitussive. 

Additionally the Secretary was required 

to solicit stakeholder input ‘‘regarding 

the health benefits and risks, including 

the potential for abuse’’ of hydrocodone 

combination products and the impact of 

up-scheduling of these products. 

Accordingly, on January 24–25, 2013, 

the FDA held a public Advisory 

Committee meeting at which the DEA 

made a presentation. The Advisory 

Committee included members with 

scientific and medical expertise in the 

subject of opioid abuse, and a patient 

representative. Members included 

representatives from National Institute 

on Drug Abuse (NIDA) and the Centers 

for Disease Control (CDC). There was 

also an opportunity for the public to 

provide comment. The Advisory 

Committee voted 19 to 10 in favor of 

recommending that hydrocodone 

combination products be placed into 

schedule II. According to the FDA, 768 

comments were submitted by patients, 

patient groups, advocacy groups, and 

professional societies to the FDA. 

Upon evaluating the scientific and 

medical evidence, along with the above 

considerations (e.g., recommendation of 

the Advisory Committee, the public 

comments, consideration of the health 

benefits and risks, and information 

about the impact of rescheduling) 

mandated by the FDASIA, the HHS on 

December 16, 2013, submitted to the 

Administrator of the DEA its scientific 

and medical evaluation (henceforth 

called HHS review) entitled, ‘‘Basis for 

the Recommendation to Place 

Hydrocodone Combination Products in 

Schedule II of the Controlled Substances 

Act.’’ Pursuant to 21 U.S.C. 811(b), this 

document contained an eight-factor 

analysis of the abuse potential of HCPs, 

along with the HHS’s recommendation 

to control HCPs under schedule II of the 

CSA. 

The HHS stated that the comments 

received during the open public 

hearing, to the docket, and the 

discussion of the Advisory Committee 


TKELLEY on DSK3SPTVN1PROD with PROPOSALS
11040 Federal Register / Vol. 79, No. 39 / Thursday, February 27, 2014 / Proposed Rules 

5Comprehensive Drug Abuse Prevention and 

Control Act of 1970, H.R. Rep. No 91–1444, 91st 

Cong., Sess.1 (1970) reprinted in U.S.C.C.A.N. 4566, 

4601. 

6TEDS is a program coordinated and managed by 

the SAMHSA. This database includes information 

on treatment admissions that are routinely collected 

by states to monitor their individual substance 

abuse treatment systems. Thus, TEDS includes data 

primarily from treatment facilities that receive 

public funds. TEDS includes information on 

demographic variables including age, gender, race 

and ethnicity. TEDS also reports on the top three 

drugs of abuse at the time of admission. TEDS does 

not include all drugs that may have been abused 

prior to admission. States and jurisdictions can 

choose whether or not to report the detailed listing. 

7The Drug Abuse Warning Network (DAWN) is 

a nationally representative public health 

surveillance system that continuously monitors 

drug-related visits to hospital EDs. The DAWN data 

are used to monitor trends in drug misuse and 

abuse in the United States. DAWN captures both ED 

visits that are directly caused by drugs and those 

in which drugs are a contributing factor but not the 

direct cause of the ED visit. 

8Unless otherwise specified, for purposes of this 

document ‘‘oxycodone products’’ refers to both its 

single-entity and its combination products. All 

oxycodone products are schedule II controlled 

substances. 

9 In DAWN, nonmedical use of pharmaceuticals 

includes taking more than the prescribed dose of a 

prescription pharmaceutical or more than the 

recommended dose of an over-the-counter 

pharmaceutical or supplement; taking a 

pharmaceutical prescribed for another individual; 

deliberate poisoning with a pharmaceutical by 

another person; and documented misuse or abuse 

of a prescription drug, an over-the-counter 

pharmaceutical, or a dietary supplement. 

10The American Association of Poison Control 

Centers (AAPCC) maintains the national database of 

information logged by the United States’ 57 Poison 

Control Centers (PCCs). Case records in this 

database are from self-reported calls: they reflect 

only information provided when the public or 

healthcare professionals report an actual or 

potential exposure to a substance (e.g., an ingestion, 

inhalation, or topical exposure, etc.), or request 

information/educational materials. Exposures do 

not necessarily represent a poisoning or overdose. 

The AAPCC is not able to completely verify the 

accuracy of every report made to member centers. 

Additional exposures may go unreported to PCCs 

and data referenced from the AAPCC should not be 

construed to represent the complete incidence of 

national exposures to any substance(s). 

11According to the AAPCC’s NPDS database, 

‘‘intentional reasons’’ include suspected suicide, 

misuse, abuse, and intentional unknown. 

12The Florida Department of Law Enforcement 

Medical Examiners Commission publishes an 

Annual Medical Examiners Report, the Annual and 

Interim Drugs in Deceased Persons Report. In order 

for a death to be considered ‘‘drug-related’’ at least 

one drug identified must be in the decedent; each 

identified drug is a drug occurrence. The State’s 

medical examiners were asked to distinguish 

between whether the drugs were the ‘‘cause’’ of 

death or merely ‘‘present’’ in the body at the time 

of death. A drug is only indicated as the cause of 

death when, after examining all evidence and the 

autopsy and toxicology results, the medical 

examiner determines the drug played a causal role 

in the death. It is not uncommon for a decedent to 

have multiple drugs listed as a cause of death. 

members of the FDA Advisory 

Committee meeting provided support 

for its conclusion that individuals are 

taking HCPs in amounts sufficient to 

create a hazard to their health or to the 

safety of other individuals or to the 

community; that there is significant 

diversion of HCPs; and that individuals 

are taking HCPs on their own initiative 

rather than on the basis of medical 

advice from a practitioner licensed by 

law to administer such drugs. The HHS 

stated it has also given careful 

consideration to the fact that the 

members of the Advisory Committee 

voted 19 to 10 in favor of rescheduling 

HCPs from schedule III to schedule II 

under the CSA. The HHS considered the 

increasing trends, the public comments, 

the recommendation of the Advisory 

Committee, the health benefits and 

risks, and the information available 

about the impact of rescheduling, and 

concluded that HCPs have high 

potential for abuse. 

Summary of Eight Factor Analyses 

The DEA has reviewed the scientific 

and medical evaluation and scheduling 

recommendation provided by the HHS, 

and all other relevant data, and 

completed its own eight-factor review 

document pursuant to 21 U.S.C. 811(c). 

Included below is a brief summary of 

each factor as considered by the DEA in 

its proposed rescheduling action. Both 

the DEA and HHS analyses are available 

in their entirety in the public docket for 

this proposed rule (Docket No. DEA– 

389) at www.regulations.gov under 

‘‘Supporting and Related Material.’’ Full 

analysis of, and citations to, information 

referenced in this summary may also be 

found in the supporting material. 

1. The Drug’s Actual or Relative 

Potential for Abuse 

The term ‘‘abuse’’ is not defined in 

the CSA. However, the legislative 

history of the CSA provides the 

following criteria to determine whether 

a particular drug or substance has a 

potential for abuse: 5

(a) Individuals are taking the drug or 

other substance in amounts sufficient to 

create a hazard to their health or to the 

safety of other individuals or to the 

community; or 

(b) There is a significant diversion of 

the drug or other substance from 

legitimate drug channels; or 

(c) Individuals are taking the drug or 

other substance on their own initiative 

rather than on the basis of medical 

advice from a practitioner licensed by 

law to administer such drugs; or 

(d) The drug is so related in its action 

to a drug or other substance already 

listed as having a potential for abuse to 

make it likely that it will have the same 

potential for abuse as such substance, 

thus making it reasonable to assume that 

there may be significant diversions from 

legitimate channels, significant use 

contrary to or without medical advice, 

or that it has a substantial capability of 

creating hazards to the health of the user 

or to the safety of the community. 

The DEA considered the HHS’s 

evaluation and all other relevant data, 

including data related to the above 

mentioned criteria, and finds that: 

(a) Individuals are using HCPs in 

amounts sufficient to create a hazard to 

their health, to the safety of other 

individuals, or to the community. 

The HHS states that there are 

increasing trends in the adverse effects 

from abuse of HCPs, including 

emergency department (ED) visits, 

admissions to addiction treatment 

centers, and deaths in selected States. In 

2011, HCPs were listed in 3,376 

admissions for drug treatment as the 

primary drug of abuse and in 6,601 

admissions listing HCPs in addition to 

other drugs in the Treatment Episode 

Data Set (TEDS).6 HCPs are prescribed 

in an unprecedented manner and their 

total prescriptions exceed prescriptions 

for any other opioid analgesic; this 

characteristic drives their abuse 

potential and sets them apart from other 

opioid analgesics in terms of abuse 

risks. 

Drug Abuse Warning Network 

(DAWN) 7 data indicate that abuse of 

HCPs, similar to oxycodone products 8

(schedule II), has been associated with 

large numbers of admissions to the ED. 

For example, in 2011 the total number 

of ED visits related to nonmedical use 

of HCPs and oxycodone products were 

82,479 and 151,218, respectively.9 The 

American Association of Poison Control 

Centers’ National Poison Data System 10

(NPDS; formerly known as Toxic 

Exposure Surveillance System or TESS) 

reported that HCPs were involved in 

30,792 and 29,391 annual toxic 

exposures in 2011 and 2012, 

respectively. The corresponding data for 

oxycodone products was 19,423 and 

18,495. The majority of exposures for 

both drug products were for intentional 

reasons.11

The HHS mentions that nationwide 

estimates of overdose deaths due to 

HCPs cannot be quantified, but the 

available data for a limited number of 

States suggest that HCPs contribute to a 

substantial number of overdose deaths 

each year. According to the HHS, 

DAWN medical examiner (ME) data for 

five States from 2004 through 2010 

reported an increase of 63% and 133% 

in deaths related to HCPs and 

oxycodone products, respectively. 

According to the Florida Department of 

Law Enforcement (FDLE),12 HCPs have 


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Federal Register / Vol. 79, No. 39 / Thursday, February 27, 2014 / Proposed Rules 11041 

Although a medical examiner may determine a drug 

is present or detected in the decedent, the drug may 

not have played a causal role in the death. A 

decedent may have multiple drugs listed as present. 

13The NFLIS is a program of the DEA, Office of 

Diversion Control. NFLIS systematically collects 

drug identification results and associated 

information from drug cases submitted to and 

analyzed by State and local forensic laboratories. 

NFLIS represents an important resource in 

monitoring illicit drug abuse and trafficking, 

including the diversion of legally manufactured 

pharmaceuticals into illegal markets. NFLIS is a 

comprehensive information system that includes 

data from forensic laboratories that handle 

approximately 90% of an estimated 1.0 million 

distinct annual State and local drug analysis cases. 

NFLIS includes drug chemistry results from 

completed analyses only. 

14While NFLIS data is not direct evidence of 

abuse, it can lead to an inference that a drug has 

been diverted and abused. See 76 FR 77330, 77332, 

Dec. 12, 2011. 

15STRIDE is a database of drug exhibits sent to 

DEA laboratories for analysis. Exhibits from the 

database are from the DEA, other federal agencies, 

and local law enforcement agencies. 

16The National Survey on Drug Use and Health, 

formerly known as the National Household Survey 

on Drug Abuse (NHSDA), is conducted annually by 

the Department of Health and Human Service’s 

Substance Abuse and Mental Health Services 

Administration (SAMHSA). It is the primary source 

of estimates of the prevalence and incidence of 

nonmedical use of pharmaceutical drugs, illicit 

drugs, alcohol, and tobacco use in the United 

States. The survey is based on a nationally 

representative sample of the civilian, noninstitutionalized population 12 years of age and 

older. The NSDUH provides yearly national and 

state level estimates of drug abuse, and includes 

prevalence estimates by lifetime (i.e., ever used), 

past year, and past year abuse or dependence. 

17Monitoring the Future (MTF) is a national 

survey conducted by the Institute for Social 

Research at the University of Michigan under a 

grant from the NIDA that tracks drug use trends 

among American adolescents among the 8th, 10th, 

and 12th grades. 

been associated with large numbers of 

deaths in Florida. For example, in 2012, 

HCPs were associated with 777 deaths, 

while oxycodone products were 

associated with 1,426. 

As summarized below, a review of 

drug abuse indicators for HCPs over the 

past several years further indicates that 

these products, similar to oxycodone 

products, are among the most widely 

diverted and abused drugs in the 

country and have high potential for 

abuse. 

(b) There is a significant diversion of 

HCPs from legitimate drug channels. 

According to forensic laboratory data 

as reported by the National Forensic 

Laboratory System 13 14 (NFLIS) and the 

System to Retrieve Information from 

Drug Evidence 15 (STRIDE), HCPs, 

similar to oxycodone products, are 

among the top 10 most frequently 

encountered drugs. From 2002 through 

2010, total cases (from both NFLIS and 

STRIDE) for both HCPs and oxycodone 

products gradually increased with some 

decline in 2011 and 2012. From 2002 

through 2008, annual total cases 

involving HCPs (range: 9,106 in 2002 to 

33,611 in 2008) consistently exceeded 

those for oxycodone products (range: 

7,993 in 2002 to 28,343 in 2008). In 

2009, total cases for HCPs (37,894) were 

similar to that for oxycodone products 

(37,680). From 2010 through 2012, total 

cases for oxycodone products (47,238 in 

2010 and 41,915 in 2012) exceeded 

those for HCPs (39,261 in 2010 and 

34,832 in 2012). The DEA has 

documented a large number of diversion 

and trafficking cases involving HCPs. 

DEA investigations conducted from 

2005 through 2007 determined that 

HCPs were diverted from rogue Internet 

pharmacies. 

(c) Individuals are using HCPs on 

their own initiative rather than on the 

basis of medical advice. 

According to the data from the 

National Survey on Drug Use and 

Health 16 (NSDUH), the lifetime (i.e., 

ever used) users of HCPs for nonmedical 

purposes exceeded those for oxycodone 

products in the United States. For 

example, in 2004, over 17.7 million 

Americans age 12 years or older 

reported lifetime nonmedical use of 

HCPs as compared to over 11.9 million 

reported for oxycodone products. In 

2012, the corresponding data for HCPs 

and oxycodone products were over 25.6 

and 16 million, respectively. The 

NSDUH also reported large increases 

from 2004 through 2012 in the number 

of individuals using HCPs and 

oxycodone products for nonmedical 

purposes. 

The past year initiates (i.e., the first 

use of a substance within the 12 months 

prior to the interview date) of HCPs 

exceeded those of oxycodone products 

from 2002 through 2005. Past year 

initiates for HCPs were over 1.3, 1.4, 1.3 

and 1.3 million in 2002, 2003, 2004 and 

2005, respectively. The corresponding 

data for oxycodone products were over 

0.47, 0.5, 0.6 and 0.45 million. 

According to a report by the NSDUH, 

the combined data from 2002 through 

2005 indicate that 57.7% of persons 

who first used pain relievers 

nonmedically in the past year used 

HCPs while 21.7% used oxycodone 

products. The NSDUH data from 2002 

through 2006 also indicate that the 

lifetime users of HCPs have a higher 

propensity than that of lifetime users of 

oxycodone immediate release products 

(single-entity and combination products 

combined) to have used for nonmedical 

purposes any pain relievers in the past 

year. 

According to the Monitoring the 

Future 17 (MTF) survey, from 2002 

through 2011 the annual prevalence of 

nonmedical use of Vicodin®, an HCP, 

ranged from about 8% to 10.5% among 

high school seniors (12th graders) and 

exceeded that of OxyContin® (4% to 

5.5%), an oxycodone extended release 

product. In 2012, the annual prevalence 

rate for nonmedical use of OxyContin®

was 1.6%, 3.0%, and 4.3% among 8th, 

10th and 12th graders, respectively. The 

corresponding rates for Vicodin® were 

1.3%, 4.4% and 7.5%. According to the 

MTF, the annual prevalence of 

nonmedical use of Vicodin® in college 

students and young adults was 3.8% 

and 6.3% in 2012. The corresponding 

data for OxyContin® were 1.2% and 

2.3%. The aforementioned data from 

drug abuse surveys (NSDUH and MTF) 

collectively indicate high prevalence of 

abuse of HCPs among Americans 

including students thereby indicating 

their high abuse potential. 

(d) HCPs are so related in their action 

to a drug or other substance already 

listed as having a potential for abuse to 

make it likely that they will have the 

same potential for abuse as such 

substance, thus making it reasonable to 

assume that there may be significant 

diversion from legitimate channels, 

significant use contrary to or without 

medical advice, or that they have a 

substantial capability of creating 

hazards to the health of the user or to 

the safety of the community. 

Hydrocodone possesses abuse liability 

effects substantially similar to morphine 

(schedule II) in both animals and 

humans. Hydrocodone, similar to 

morphine, is a m opioid receptor agonist 

and shares pharmacological properties 

with morphine. Hydrocodone 

substitutes for morphine in animals 

trained to discriminate the presence and 

absence of morphine. Hydrocodone, 

similar to morphine, is selfadministered by animals. Hydrocodone 

substitutes for morphine in opioiddependent subjects. Clinical abuse 

liability studies have also demonstrated 

that HCPs (Hycodan® or hydrocodone in 

combination with acetaminophen) are 

similar to morphine with respect to 

physiological effects, subjective effects, 

and drug ‘‘liking’’ scores. 

Hydrocodone/acetaminophen and 

oxycodone/acetaminophen combination 

products at equi-miotic doses, in 

general, produce similar profiles of 

psychopharmacological effects. These 

two opioid products produced 

prototypic opiate-like effects and 

psychomotor impairment of similar 

magnitudes. 

Collectively these data demonstrate 

that HCPs have a high potential for 

abuse similar to other schedule II opioid 

analgesic drugs such as morphine and 

oxycodone products. 


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11042 Federal Register / Vol. 79, No. 39 / Thursday, February 27, 2014 / Proposed Rules 

2. Scientific Evidence of the Drug’s 

Pharmacological Effects, if Known 

The HHS states that hydrocodone’s 

pharmacological effects are similar to 

other m opioid receptor agonists. It is 

effective as an antitussive agent and as 

an analgesic drug. Opioid analgesics 

have an important role in the 

management of pain. HCPs contain 

other nonnarcotic active ingredients 

such as acetaminophen, nonsteroidal 

anti-inflammatory drugs (NSAIDs) 

(aspirin and ibuprofen), 

chlorpheniramine or homatropine 

methylbromide. The mechanism of 

analgesic and antitussive effects of HCPs 

are different from those of nonnarcotic 

active ingredients present in HCPs. 

Acetaminophen and NSAIDs are less 

effective against severe pain, but have a 

recognized role in a variety of pain 

settings. 

HCPs, similar to other opioid 

analgesics such as oxycodone products, 

are associated with a substantial number 

of overdose, suicide, abuse, and 

dependence reports. Overdose of HCPs, 

similar to other opioid analgesics, can 

lead to respiratory depression and 

death. Common adverse effects of 

NSAIDs include gastrointestinal, 

cardiovascular, renal and renovascular 

adverse events, and hepatic injury. 

Acetaminophen has low incidence of 

gastrointestinal side effects and is a 

common household analgesic available 

over the counter. Overdoses of 

acetaminophen can cause severe hepatic 

damage and death. Opioid/

acetaminophen combination products 

are linked to numerous liver injuries. 

3. The State of Current Scientific 

Knowledge Regarding the Drug or Other 

Substance 

The HHS provided additional 

scientific information with focus on 

chemical and toxicological properties of 

hydrocodone and nonnarcotic 

components of HCPs. Hydrocodone is a 

semisynthetic opioid. The bitartrate salt 

form of hydrocodone is the main active 

component in all currently marketed 

HCPs. Nonnarcotic drugs present as coingredients are acetaminophen, aspirin, 

ibuprofen, chlorpheniramine or 

homatropine methylbromide. 

Hydrocodone and nonnarcotic drugs 

present in HCPs have potential to 

produce adverse effects. 

4. Its History and Current Pattern of 

Abuse 

Soon after introduction for clinical 

use, there were reports of hydrocodone 

abuse and addiction. By the 1950s, it 

was established that hydrocodone has 

an abuse liability similar to that of 

morphine. Data regarding the 

pharmacological effects of hydrocodone 

and its high potential for abuse were 

available prior to the enactment of the 

CSA and the placement of hydrocodone 

in schedule II reflects that knowledge 

base. In the United States, popularity of 

hydrocodone as a drug of abuse 

increased in the 1990s coinciding with 

its increased use as an analgesic. 

Currently HCPs are widely diverted and 

abused throughout the United States as 

demonstrated in national and regional 

drug-abuse-related databases. HCPs and 

oxycodone products (schedule II) are 

the two most common opioid analgesic 

products encountered by law 

enforcement. 

Data from DEA field offices indicate 

that HCPs are diverted and are among 

the most sought after licit drugs in every 

geographic region of the country. DEA 

case investigations document numerous 

methods of diversion of HCPs. These 

methods involve drug theft, doctor 

shopping, fraudulent oral (call-in) 

prescriptions, fraudulent prescriptions, 

diversion by registrants, and various 

other drug trafficking schemes. HCPs are 

abused by individuals of diverse ages 

from adolescents to older populations. 

According to the NSDUH, in 2012, of 

the 37 million people in the United 

States who used pain relievers 

nonmedically in their lifetime, over 25.6 

million (representing 9.9% of the 

United States population age 12 years or 

older) reported lifetime nonmedical use 

of HCPs. The MTF surveys indicate that 

from 2002 through 2012, 8.1% to 10.5% 

of high school seniors used Vicodin®, 

an HCP, for nonmedical purposes. In 

2012, the annual prevalence of 

nonmedical use of Vicodin® in college 

students and young adults was 3.8% 

and 6.3%, respectively. 

Several published epidemiological 

studies indicate that HCPs are widely 

abused. For example, a published 

epidemiological study reviewed 

prescription opioid abuse data collected 

by drug abuse experts (representatives 

of the nation’s methadone programs, 

treatment centers, impaired health care 

professional programs, NIDA grantees 

and high-prescribing physicians) and 

found that HCPs are one of the most 

commonly abused prescription opioid 

drugs. Rates of abuse, expressed as cases 

per 100,000 population, were the 

highest for hydrocodone and extended 

release oxycodone products, while the 

rest of the opioid analgesics, including 

immediate release oxycodone products, 

had lower rates. Another published 

epidemiological study also indicates 

that the rate of intentional exposure 

(abuse, intentional misuse, suicide or 

intentional unknown) was highest for 

HCPs at 3.75 per 100,000 population 

followed by oxycodone products at 1.81 

per 100,000. HCPs were involved in 

55% of all of the intentional exposure 

cases, whereas oxycodone products 

were involved in 27%. In addition, 

published data on toxic exposure calls 

received by Texas poison centers from 

1998 through 2009 showed that toxic 

exposure calls related to ingestion of the 

combination of HCPs, carisoprodol and 

alprazolam (commonly referred under 

street names such as ‘‘Holy Trinity,’’ 

‘‘Houston Cocktail,’’ or ‘‘Trio’’) have 

increased from 2000 through 2007 with 

some decline in 2009. 

5. The Scope, Duration, and 

Significance of Abuse 

The HHS mentions that abuse of HCPs 

is considerable and is associated with 

considerable negative public health 

impact. The extent of nonmedical use of 

HCPs by adolescents is higher than for 

oxycodone products. These data are of 

significant concern as this may reflect 

particular risk for younger individuals. 

The HHS also states that because of the 

large number of prescriptions, large 

amounts of HCPs are potentially 

available for illicit use. Large numbers 

of adversely affected individuals and 

the severity of the adverse effects related 

to abuse of HCPs suggest that 

individuals are taking these products in 

amounts sufficient to create a hazard to 

their health and to the safety of other 

individuals and the community. Abuse 

of HCPs is associated with progressively 

increasing trends in serious adverse 

effects, including ED visits, admissions 

for abuse treatment, and in mortality 

data in selected States. The HHS cites 

the widespread prescriptions for HCPs 

as one of the reasons for these adverse 

outcomes. According to the HHS, data 

suggests that HCPs have high potential 

for abuse. 

The DEA notes that initial reports of 

abuse of HCPs in the U.S. were 

published in the 1960s. Since the 1990s, 

the diversion and abuse of HCPs has 

escalated in the country. By the late 

1990s, there were large increases in the 

diversion and abuse of HCPs. HCPs, 

similar to oxycodone products, are 

widely diverted and abused 

pharmaceutical opioid analgesics. HCPs 

are associated with significant illicit 

activity and abuse. Federal, State and 

local forensic laboratory data rank HCPs 

as one of the two most frequently 

encountered opioid pharmaceuticals in 

submissions to the laboratories. For 

example, in 2012, there were over 

34,000 exhibits for HCPs (NFLIS). All 

DEA field divisions across the U.S. have 

reported that HCPs are among the most 

sought after pharmaceuticals. 


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Federal Register / Vol. 79, No. 39 / Thursday, February 27, 2014 / Proposed Rules 11043 

18 Drug poisoning deaths include unintentional 

and intentional poisoning deaths resulting from 

overdoses of a drug, being given the wrong drug, 

using the drug in error, or using a drug 

inadvertently. 

19Total poisoning deaths include those resulting 

from drugs, and those associated with solid or 

liquid biologics, gases or vapors, or other 

substances. Poisoning deaths are from all manners, 

including unintentional, suicide, homicide, and 

undetermined intent. 

20FAERS is a computerized information database 

designed to support FDA’s surveillance program for 

the post-marketing safety of all drug and 

therapeutic biologic products. FDA receives adverse 

drug reaction reports from manufacturers as 

required by regulation. Health care professionals 

and consumers voluntarily submit reports through 

the MedWatch program. All reported adverse terms 

are coded according to standardized international 

terminology, MedDRA (the Medical Dictionary for 

Regulatory Activities). These numbers are crude 

reports and may include duplicates. These reports 

were not individually reported to determine the 

association between the drug and the adverse event 

reported and may contain concomitant use of other 

medications. 

21The top 20 most frequently reported adverse 

event terms associated with all hydrocodone reports 

(a report may contain more than one adverse event) 

received from 1969 to 2012 in the FAERS, in 

decreasing frequency, were: Completed suicide, 

overdose, cardio-respiratory arrest, toxicity to 

various agents, cardiac arrest, respiratory arrest, 

drug ineffective, intentional overdose, nausea, 

intentional drug misuse, vomiting, death, drug 

abuse, accidental overdose, pain, dizziness, 

medication error, drug dependence, headache, and 

drug abuser. 

In 2012, according to the poison 

control centers data (NPDS), there were 

over 29,390 toxic exposures involving 

HCPs. In 2002, there were over 25,000 

DAWN ED visits associated with HCPs 

and it was ranked sixth among all 

controlled substances. According to 

DAWN, the nonmedical use related ED 

visits for HCPs were 86,258; 95,972; and 

82,480 in 2009, 2010, and 2011, 

respectively. A number of data sources 

indicate that abuse of HCPs is associated 

with a large number of deaths. 

According to NSDUH, there were large 

numbers of lifetime and past year 

initiates of HCPs for nonmedical 

purposes and these numbers exceeded 

those of oxycodone. According to the 

MTF, about 8% to 10% of high school 

seniors reported nonmedical use of 

Vicodin®, an HCP, in recent years. 

DEA case investigations document 

numerous methods of diversion of 

HCPs. These methods involve drug 

theft, doctor shopping, fraudulent oral 

(call-in) prescriptions, fraudulent 

prescriptions, diversion by registrants, 

and various other drug trafficking 

schemes. 

6. What, if Any, Risk There Is to the 

Public Health 

Despite the medical value of HCPs as 

antitussive and analgesic drugs, the 

misuse and abuse of these products 

present numerous risks to the public 

health. Many of the risk factors 

associated with these products are 

common risks shared with other m 

opioid receptor agonists. These include 

the risks of developing tolerance, 

dependence and addiction, and the 

attendant problems associated with 

these risks including death. According 

to the CDC, from 1999 to 2010, the 

number of drug poisoning deaths 18

involving any opioid analgesic (e.g., 

oxycodone, methadone, or 

hydrocodone) markedly increased (over 

four-fold), from 4,030 to 16,651, and 

accounted for 43% of the 38,329 drug 

poisoning deaths and 39% of the 42,917 

total poisoning deaths 19 in 2010. In 

1999, opioid analgesics were involved 

in 24% of the 16,849 drug poisoning 

deaths and 20% of the 19,741 total 

poisoning deaths. 

The HHS reviewed the HCPs related 

adverse events that were reported to the 

FDA Adverse Events Reporting System 

(FAERS) 20 from 1969 through 2012 and 

compared them to those associated with 

oxycodone products. The most common 

adverse events reported for HCPs 

included terms such as complete 

suicide, intentional overdose, drug 

abuse, drug dependence, and drug 

abuser.21 The HHS found that both 

HCPs and oxycodone products are 

associated with substantial numbers of 

reports of overdose, suicide, abuse, and 

dependence reports. Both products have 

large numbers of adverse events 

reported that reflect abuse, misuse and 

injury due to inappropriate use. HCPs 

had fewer such reports than oxycodone 

products. 

According to the DAWN, ED mentions 

associated with HCPs and oxycodone 

products are the highest among all 

opioid analgesics suggesting that both 

HCPs and oxycodone products have a 

great adverse risk to the public health. 

According to the HHS, DAWN ME data 

for five States from 2004 through 2010 

reported an increase of 63% and 133% 

in deaths related to HCPs and 

oxycodone products, respectively. 

According to the FDLE, HCPs have been 

associated with large numbers of deaths 

in Florida in recent years. According to 

the NPDS annual reports, since 2002, 

annual figures for toxic exposures 

(within the category of opioid analgesic 

drugs) were the largest for HCPs, 

followed by oxycodone products (see 

summary of Factor 1 above). From 2006 

through 2012, NPDS reported a total of 

84,798 single substance exposures 

related to HCPs resulting in 195 deaths. 

The corresponding data for oxycodone 

products is 57,219 exposures and 173 

deaths. 

7. Its Psychic or Physiological 

Dependence Liability 

According to the HHS, data from 

animal and human studies indicate the 

dependence potential of hydrocodone. 

The severe dependence potential is 

reflected by the number of individuals 

admitted to addiction treatment centers 

citing HCPs as their substance of abuse. 

The HHS also states that the treatment 

admissions linked to abuse of HCPs are 

increasing. The HHS concluded that 

abuse of HCPs may lead to severe 

psychological or physical dependence. 

The DEA notes that as evident from 

the NSDUH data from 2002 through 

2006, the propensity of the lifetime 

users of HCPs to develop substance use 

disorders on any pain relievers is higher 

than that of lifetime users of any pain 

relievers, as well as lifetime users of 

oxycodone products other than 

OxyContin® (i.e., oxycodone immediate 

release single-entity products and 

immediate release combination 

products). The FAERS data (from 1969 

through August 28, 2008) indicate that 

the abuse and dependence reports 

associated with HCPs expressed as a 

percentage of all its adverse events 

(13.3%) were similar (both in magnitude 

and temporal distribution) to that for 

oxycodone products other than 

OxyContin® (13.6%). 

The DEA also notes that according to 

several published epidemiological 

surveys and retrospective review of 

medical records of addiction treatment 

populations, HCPs are among the most 

abused opioid pharmaceuticals in 

prescription opioid dependent 

individuals in the country and are 

frequently mentioned as the primary 

drug of abuse in these subjects. 

The above data collectively indicate 

that HCPs, similar to oxycodone 

products, have high potential to cause 

severe psychological or physiological 

dependence. 

8. Whether the Substance Is an 

Immediate Precursor of a Substance 

Already Controlled Under the CSA 

HCPs are not immediate precursors of 

a substance already controlled under the 

CSA, as defined in 21 U.S.C. 811(e). 

Conclusion 

Based on consideration of the 

scientific and medical evaluation and 

accompanying recommendation of the 

HHS, and based on the DEA’s 

consideration of its own eight-factor 

analysis, the DEA finds that these facts 

and all other relevant data constitute 

substantial evidence of high potential 

for abuse of HCPs. As such, the DEA 

hereby proposes to transfer HCPs from 


TKELLEY on DSK3SPTVN1PROD with PROPOSALS
11044 Federal Register / Vol. 79, No. 39 / Thursday, February 27, 2014 / Proposed Rules 

22For purposes of performing regulatory analysis, 

the DEA uses the definition of a ‘‘practitioner’’ as 

a physician, veterinarian, or other individual 

licensed, registered, or otherwise permitted, by the 

United States or the jurisdiction in which he/she 

practices, to dispense a controlled substance in the 

schedule III to schedule II under the 

CSA. 

Proposed Determination of Appropriate 

Schedule 

The CSA outlines the findings 

required to transfer a drug or other 

substance between schedules (I, II, III, 

IV, or V) of the CSA. 21 U.S.C. 811(a); 

21 U.S.C. 812(b). After consideration of 

the analysis and rescheduling 

recommendation of the Assistant 

Secretary for Health of the HHS and 

review of available data, the 

Administrator of the DEA, pursuant to 

21 U.S.C. 811(a) and 21 U.S.C. 812(b)(2), 

finds that: 

1. HCPs have a high potential for 

abuse similar to that of schedule II 

substances; 

2. HCPs have a currently accepted 

medical use in treatment in the United 

States. According to the HHS, several 

pharmaceutical products containing 

hydrocodone in combination with 

acetaminophen, aspirin, NSAIDS, and 

homatropine are approved by FDA for 

use as analgesics for pain relief and for 

the symptomatic relief of cough and 

upper respiratory symptoms associated 

with allergies and colds; and 

3. Abuse of HCPs may lead to severe 

psychological or physical dependence 

similar to that of schedule II substances. 

Based on these findings, the 

Administrator of the DEA concludes 

that HCPs warrant control in schedule II 

of the CSA. 21 U.S.C. 812(b)(2). 

Requirements for Handling HCPs 

If this rule is finalized as proposed, 

persons who handle HCPs would be 

subject to the CSA’s schedule II 

regulatory controls and administrative, 

civil, and criminal sanctions applicable 

to the manufacture, distribution, 

dispensing, importing, exporting, 

research, and conduct of instructional 

activities, including the following: 

Registration. Any person who handles 

(manufactures, distributes, dispenses, 

imports, exports, engages in research, or 

conducts instructional activities with) 

HCPs, or who desires to handle HCPs, 

would be required to be registered with 

the DEA to conduct such activities 

pursuant to 21 U.S.C. 822, 823, 957, 

958, and in accordance with 21 CFR 

parts 1301 and 1312. 

Security. HCPs would be subject to 

schedule II security requirements and 

would need to be handled and stored 

pursuant to 21 U.S.C. 821, 823, 871(b) 

and in accordance with 21 CFR 

1301.71–1301.93. 

Labeling and Packaging. All labels 

and labeling for commercial containers 

of HCPs would need to comply with 21 

U.S.C. 825, 958(e), and be in accordance 

with 21 CFR part 1302. 

Quotas. A quota assigned pursuant to 

21 U.S.C. 826 and in accordance with 21 

CFR part 1303 would be required in 

order to manufacture HCPs. 

Inventory. Any person who becomes 

registered with the DEA after the 

effective date of the final rule would be 

required to take an initial inventory of 

all stocks of controlled substances 

(including HCPs) on hand on the date 

the registrant first engages in the 

handling of controlled substances, 

pursuant to 21 U.S.C. 827, 958, and in 

accordance with 21 CFR 1304.03, 

1304.04, and 1304.11(a) and (b). 

After the initial inventory, every DEA 

registrant would be required to take a 

new inventory of all stocks of controlled 

substances on hand every two years, 

pursuant to 21 U.S.C. 827, 958, and in 

accordance with 21 CFR 1304.03, 

1304.04, and 1304.11. 

Records. Every DEA registrant would 

be required to maintain records with 

respect to HCPs pursuant to 21 U.S.C. 

827, 958, and in accordance with 21 

CFR parts 1304, 1307, and 1312. 

Reports. Every DEA registrant would 

be required to submit reports regarding 

HCPs to the Automation of Reports and 

Consolidated Order System (ARCOS) 

pursuant to 21 U.S.C. 827 and in 

accordance with 21 CFR 1304.33. 

Orders for HCPs. Every DEA registrant 

who distributes HCPs would be required 

to comply with order form 

requirements, pursuant to 21 U.S.C. 828, 

and in accordance with 21 CFR part 

1305. 

Prescriptions. All prescriptions for 

HCPs would need to comply with 21 

U.S.C. 829, and would be required to be 

issued in accordance with 21 CFR part 

1306, and part 1311 subpart C. 

Importation and Exportation. All 

importation and exportation of HCPs 

would need to be in compliance with 21 

U.S.C. 952, 953, 957, 958, and in 

accordance with 21 CFR part 1312. 

Liability. Any activity involving HCPs 

not authorized by, or in violation of, the 

CSA, would be unlawful, and may 

subject the person to administrative, 

civil, and/or criminal sanctions. 

Regulatory Analyses 

Executive Orders 12866 and 13563 

In accordance with 21 U.S.C. 811(a), 

this proposed scheduling action is 

subject to formal rulemaking procedures 

performed ‘‘on the record after 

opportunity for a hearing,’’ which are 

conducted pursuant to the provisions of 

5 U.S.C. 556 and 557. The CSA sets 

forth the procedures and criteria for 

scheduling a drug or other substance. 

Such actions are exempt from review by 

the Office of Management and Budget 

(OMB) pursuant to Section 3(d)(1) of 

Executive Order 12866 and the 

principles reaffirmed in Executive Order 

13563. 

Executive Order 12988 

This proposed regulation meets the 

applicable standards set forth in 

sections 3(a) and 3(b)(2) of Executive 

Order 12988 Civil Justice Reform to 

eliminate drafting errors and ambiguity, 

minimize litigation, provide a clear legal 

standard for affected conduct, and 

promote simplification and burden 

reduction. 

Executive Order 13132 

This proposed rulemaking does not 

have federalism implications warranting 

the application of Executive Order 

13132. The proposed rule does not have 

substantial direct effects on the States, 

on the relationship between the national 

government and the States, or the 

distribution of power and 

responsibilities among the various 

levels of government. 

Executive Order 13175 

This proposed rule does not have 

tribal implications warranting the 

application of Executive Order 13175. It 

does not have substantial direct effects 

on one or more Indian tribes, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes. 

Regulatory Flexibility Act 

The Administrator, in accordance 

with the Regulatory Flexibility Act (5 

U.S.C. 601–612) (RFA), has reviewed 

this proposed rule, and by approving it, 

certifies that it will not have a 

significant economic impact on a 

substantial number of small entities. 

The purpose of this proposed rule is to 

place HCPs into schedule II of the CSA. 

No less restrictive measures (i.e., noncontrol or control in a lower schedule) 

would enable the DEA to meet its 

statutory obligation under the CSA. 

HCPs are widely prescribed drugs for 

the treatment of pain and cough 

suppression. Handlers of HCPs 

primarily include manufacturers, 

distributors, exporters, pharmacies, 

practitioners, mid-level practitioners, 

and hospitals/clinics.22 It is possible 


TKELLEY on DSK3SPTVN1PROD with PROPOSALS
Federal Register / Vol. 79, No. 39 / Thursday, February 27, 2014 / Proposed Rules 11045 

course of professional practice, but does not include 

a pharmacist, pharmacy, or hospital (or other 

person other than an individual). 

23The estimated break-down is as follows: 50 

manufacturers, 4 exporters, 683 distributors, 50,774 

pharmacies, and 314,840 practitioners/mid-level 

practitioners/hospitals/clinics. 

that other registrants, such as importers, 

researchers, analytical labs, teaching 

institutions, etc., also handle HCPs. 

However, based on its understanding of 

its registrant population, the DEA 

assumes for purposes of this analysis 

that for all business activities other than 

manufacturers, distributors, exporters, 

pharmacies, practitioners, mid-level 

practitioners, and hospitals/clinics, that 

the volume of HCPs handled is nominal, 

and therefore de minimis to the 

economic impact determination of this 

proposed rescheduling action. 

Because HCPs are so widely 

prescribed, for the purposes of this 

analysis, the DEA conservatively 

assumes all distributors, exporters, 

pharmacies, practitioners, mid-level 

practitioners, and hospitals/clinics 

currently registered with the DEA to 

handle schedule III controlled 

substances are also handlers of HCPs. 

The DEA estimated the number of 

manufacturers and exporters handling 

HCPs directly from DEA records. In 

total, the DEA estimates that nearly 1.5 

million controlled substance 

registrations, representing 

approximately 376,189 entities, would 

be affected by this rule. 

The DEA does not collect data on 

company size of its registrants. The DEA 

used DEA records and multiple 

subscription-based and public data 

sources to relate the number of 

registrations to the number of entities 

and the number of entities that are small 

entities. The DEA estimates that of the 

376,189 entities that would be affected 

by this rule, 366,351 are ‘‘small entities’’ 

in accordance with the RFA and Small 

Business Administration size standards. 

5 U.S.C. 601(6); 15 U.S.C. 632.23

The DEA examined the registration, 

security (including storage), labeling 

and packaging, quota, inventory, 

recordkeeping and reporting, ordering, 

prescribing, importing, exporting, and 

disposal requirements for the 366,351 

small entities estimated to be affected by 

the proposed rule. The DEA estimates 

that only the physical security 

requirements will have material 

economic impact and such impacts will 

be limited to manufacturers, exporters, 

and distributors. Many manufacturers 

and exporters are likely to have 

sufficient space in their existing vaults 

to accommodate HCPs. However, the 

DEA understands that some 

manufacturers, exporters, and 

distributors will need to build new 

vaults or expand existing vaults to store 

HCPs in compliance with schedule II 

controlled substance physical security 

requirements. Due to the uniqueness of 

each business, the DEA made 

assumptions based on research and 

institutional knowledge of its registrant 

community to quantify the costs 

associated with physical security 

requirements for manufacturers, 

exporters and distributors. 

The DEA estimates there will be 

significant economic impact on 1 (2.0%) 

of the affected 50 small business 

manufacturers, and 54 (7.9%) of the 

affected 683 small business distributors. 

The DEA estimates no significant 

impact on the remaining affected 4 

small business exporters, 50,774 small 

business pharmacies, or 314,840 small 

business practitioners/mid-level 

practitioners/hospitals/clinics. In 

summary, 55 of the 366,351 (0.015%) 

affected small entities are estimated to 

experience significant impact, (i.e., 

incur costs greater than 1% of annual 

revenue) if the proposed rule were 

finalized. The percentage of small 

entities with significant economic 

impact is below the 30% threshold for 

all registrant business activities. The 

DEA’s assessment of economic impact 

by size category indicates that the 

proposed rule will not have a significant 

effect on a substantial number of these 

small entities. 

The DEA’s assessment of economic 

impact by size category indicates that 

the proposed rule to reschedule HCPs as 

schedule II controlled substances will 

not have a significant economic impact 

on a substantial number of small 

entities. The DEA will consider written 

comments regarding the DEA’s 

economic analysis of the impact of such 

rescheduling, including this 

certification, and requests that 

commenters describe the specific nature 

of any impact on small entities and 

provide empirical data to illustrate the 

extent of such impact. 

Unfunded Mandates Reform Act of 1995 

On the basis of information contained 

in the ‘‘Regulatory Flexibility Act’’ 

section above, the DEA has determined 

and certifies pursuant to the Unfunded 

Mandates Reform Act (UMRA) of 1995 

(2 U.S.C. 1501 et seq.), that this action 

would not result in any Federal 

mandate that may result ‘‘in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100,000,000 or more 

(adjusted for inflation) in any one year 

* * *.’’ Therefore, neither a Small 

Government Agency Plan nor any other 

action is required under provisions of 

the UMRA of 1995. 

Paperwork Reduction Act of 1995 

This action does not impose a new 

collection of information requirement 

under the Paperwork Reduction Act of 

1995 (44 U.S.C. 3501–3521). This action 

would not impose recordkeeping or 

reporting requirements on State or local 

governments, individuals, businesses, or 

organizations. An agency may not 

conduct or sponsor, and a person is not 

required to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

List of Subjects in 21 CFR Part 1308 

Administrative practice and 

procedure, Drug traffic control, 

Reporting and recordkeeping 

requirements. 

For the reasons set out above, 21 CFR 

part 1308 is proposed to be amended to 

read as follows: 

PART 1308—SCHEDULES 

CONTROLLED SUBSTANCES 

■ 1. The authority citation for 21 CFR 

part 1308 continues to read as follows: 

Authority: 21 U.S.C. 811, 812, 871(b) 

unless otherwise noted. 

§ 1308.13 [Amended] 

■ 2. Amend § 1308.13 by removing 

paragraphs (e)(1)(iii) and (iv) and 

redesignating paragraphs (e)(1)(v) 

through (viii) as (e)(1)(iii) through (v), 

respectively. 

Dated: February 21, 2014. 

Michele M. Leonhart, 

Administrator. 

[FR Doc. 2014–04333 Filed 2–26–14; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

24 CFR Parts 50 and 58 

[Docket No. FR–5616–P–01] 

RIN 2506–AC34 

Environmental Compliance 

Recordkeeping Requirements 

AGENCY: Office of Secretary, HUD. 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

revise the regulations governing the 

format used for conducting the required 

environmental reviews for HUD 

program and policy actions. HUD’s 

current regulations require that HUD 

staff document part 50 environmental 

review compliance using form HUD– 


TKELLEY on DSK3SPTVN1PROD with PROPOSALS