Federal Register / Vol. 79, No. 163 / Friday, August 22, 2014 / Rules and Regulations 49661 

Census Bureau for statistical purposes. 

In addition, EEI is used by federal 

government agencies, such as the 

Department of State, Immigration and 

Customs Enforcement, and Customs and 

Border Protection (CBP) for export 

control; by other federal government 

agencies such as the Bureau of 

Economic Analysis, Bureau of Labor 

Statistics, and Bureau of Transportation 

Statistics for statistical purposes; and by 

other federal agencies as authorized by 

the Secretary of Commerce or the 

Census Bureau Director consistent with 

the agencies’ statutory or legal 

authorities as provided for in paragraph 

(e) of this section. Absent such 

authorization, information collected 

pursuant to this Part shall not be 

disclosed to anyone by any officer, 

employee, contractor, agent of the 

federal government or other parties with 

access to the EEI other than to the 

USPPI or the authorized agent of the 

USPPI. Such disclosure shall be limited 

to that information provided by each 

party pursuant to this Part. 

(b) Viewing and using EEI for official 

purposes. (1) The EEI may be viewed 

and used by federal agencies authorized 

to use export data for official purposes 

as defined to include, but not limited to: 

(i) Improving compliance with U.S. 

export laws and regulations; 

(ii) Detecting and preventing 

violations of export, census, customs, 

homeland security, national resource 

and other laws, regulations and treaties; 

(iii) Analysis to assess threats to U.S. 

and international security such as 

money laundering, and other potential 

violations of U.S. and foreign criminal 

laws; 

(iv) Enforcement of U.S. exportrelated laws and regulations; 

(v) Investigation and prosecution of 

possible violations of U.S. exportrelated laws and regulations; 

(vi) Proof of export for enforcement of 

laws relating to exemption from or 

refund, drawback or other return of 

taxes, duties, fees or other charges; 

(vii) Analyzing the impact of 

proposed and implemented trade 

agreeements and fulfilling U.S. 

obligations under such agreements; and 

(viii) Preparation of statistics. 

(2) The Census Bureau may provide 

the EEI to the USPPI or authorized 

agent, for compliance and audit 

purposes. Such disclosure shall be 

limited to that information provided to 

the AES by the USPPI or the authorized 

agent. 

(c) Supplying EEI for nonofficial 

purposes. The official report of the EEI 

submitted to the U.S. government shall 

not be disclosed by the USPPI, the 

authorized agent, or representative of 

the USPPI for ‘‘nonofficial purposes,’’ 

either in whole or in part, or in any form 

including but not limited to electronic 

transmission, paper printout, or 

certified reproduction. ‘‘Nonofficial 

purposes’’ are defined to include but not 

limited to providing the official EEI: 

(1) In support of claims for exemption 

from Federal or state taxation, except as 

related to paragraph (b)(1)(vi) of this 

section; 

(2) To the U.S. Internal Revenue 

Service for purposes not related to 

export control or compliance; 

(3) To state and local government 

agencies, and nongovernmental entities 

or individuals for any purpose; and 

(4) To foreign entities or foreign 

governments for any purpose. 

(d) Ocean manifest data can be made 

public under provision of CBP 

regulations. For information appearing 

on the outward manifest, 19 CFR 103.31 

allows a shipper (or their authorized 

employee or official) to submit a 

certification for confidential treatment 

of the shipper’s name and address. 

(e) Determination by the Secretary of 

Commerce. Under 13 U.S.C. 301(g), the 

EEI collected and accessed by the 

Census Bureau is exempt from public 

disclosure unless the Secretary or 

delegate determines that such 

exemption would be contrary to the 

national interest. The Secretary or 

delegate may make such information 

available, if he or she determines it is in 

the national interest, taking such 

safeguards and precautions to limit 

dissemination as deemed appropriate 

under the circumstances. In determining 

whether it is contrary to the national 

interest to apply the exemption, the 

maintenance of confidentiality and 

national security shall be considered as 

important elements of national interest. 

The unauthorized disclosure of 

confidential EEI granted under a 

National Interest Determination renders 

such persons subject to the civil 

penalties provided for in Subpart H of 

this part. 

(f) Penalties. Disclosure of 

confidential EEI by any officer, 

employee, contractor, or agent of the 

federal government, except as provided 

for in paragraphs (b) and (e) of this 

section renders such persons subject to 

the civil penalties. 

Dated: August 15, 2014. 

John H. Thompson, 

Director, Bureau of the Census. 

[FR Doc. 2014–19972 Filed 8–21–14; 8:45 am] 

BILLING CODE 3510–07–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: Final rule. 

SUMMARY: With the issuance of this final 

rule, the Administrator of the Drug 

Enforcement Administration 

reschedules hydrocodone combination 

products from schedule III to schedule 

II of the Controlled Substances Act. This 

scheduling action is pursuant to the 

Controlled Substances Act which 

requires that such actions be made on 

the record after opportunity for a 

hearing through formal rulemaking. 

This action imposes 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 with, conduct 

chemical analysis with, or possess) or 

propose to handle hydrocodone 

combination products. 

DATES: This rule is effective October 6, 

2014. 

FOR FURTHER INFORMATION CONTACT: 

Imelda L. Paredes, Office of Diversion 

Control, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, Virginia 

22152, Telephone: (202) 598–6812. 

SUPPLEMENTARY INFORMATION: 

Outline 

I. Legal Authority 

II. Background 

III. Determination To Transfer Hydrocodone 

Combination Products (HCPs) to 

Schedule II 

IV. Comments Received 

A. Support of the Proposed Rule 

B. Request for Extended Comment Period 

C. Clarification of Affected Drugs and 

Substances 

D. Opposition to the Proposed Rule 

1. Authority to Control Drugs or 

Substances 

2. Requirements Applicable to 

Prescriptions 

3. Patient Access to Medicine 

4. Impacts on Unique Populations 

5. Impacts on Long-Term Care Facilities 

(LTCFs) 

6. Abuse Prevention 

7. Diversion Prevention 


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49662 Federal Register / Vol. 79, No. 163 / Friday, August 22, 2014 / Rules and Regulations 

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 discussed in a memorandum of 

understanding entered into by 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 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. 58 FR 35460, July 1, 1993. 

3Specifically: (iii) ‘‘Not more than 300 milligrams 

of dihydrocodeinone (hydrocodone) per 100 

milliliters or not more than 15 milligrams per 

dosage unit, with a fourfold or greater quantity of 

an isoquinoline alkaloid of opium;’’ (iv) ‘‘Not more 

than 300 milligrams of dihydrocodeinone 

(hydrocodone) per 100 milliliters or not more than 

15 milligrams per dosage unit, with one or more 

active nonnarcotic ingredients in recognized 

therapeutic amounts’’ 

4 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 

October 2013 the FDA approved ZohydroTM ER, a 

single-entity, extended release schedule II product. 

ZohydroTM ER was launched on March 3, 2014. 

Accordingly, all of the historical data regarding 

hydrocodone from different national and regional 

databases that support this rule should refer to 

HCPs only, regardless of whether the database 

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

combination products.’’ 

5The DEA presentation is available at http://

www.fda.gov/downloads/advisorycommittees/

committeesmeetingmaterials/drugs/

drugsafetyandriskmanagmentadvisorycommittee/

ucm346941.pdf. 

8. Responsibilities of Pharmacists 

9. Requirements Applicable to 

Manufacturers and Distributors 

10. Economic Impact 

11. Proposed Alternatives 

V. Scheduling Conclusion 

VI. Determination of Appropriate Schedule 

VII. Requirements for Handling HCPs 

VIII. Regulatory Analyses 

I. 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, every controlled 

substance is classified into one of five 

schedules based upon its potential for 

abuse, currently accepted medical use 

in treatment in the United States, and 

the degree of dependence the drug or 

other 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). 

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 * * *.’’ The Attorney 

General has delegated this scheduling 

authority to the Administrator of the 

DEA. 28 CFR 0.100(b). 

The Administrator may initiate the 

scheduling of any drug or other 

substance (1) on her 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 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 and an evaluation of all relevant 

data by the DEA. This final action 

imposes the regulatory controls and 

administrative, civil, and criminal 

sanctions of schedule II controlled 

substances on any person who handles, 

or proposes to handle, HCPs. 

II. 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 in DEA 

regulations 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, hydrocodone was 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. Pub. L. 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)).3 Any other hydrocodone 

single-entity products or combinations 

of hydrocodone with other substances 

outside the range of specified doses are 

listed in schedule II of the CSA.4

III. Determination To Transfer 

Hydrocodone Combination Products 

(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. The DEA received a 

petition requesting that HCPs be 

controlled in schedule II of the CSA. In 

response, 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, 126 Stat. 993) 

(FDASIA). Section 1139 of the FDASIA 

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 

HCPs ‘‘and the impact of up-scheduling 

these products.’’ Accordingly, on 

January 24 and 25, 2013, the FDA held 

a public Drug Safety and Risk 

Management Advisory Committee 

(DSaRM) meeting, at which the DEA 

made a presentation.5 The DSaRM 

Committee included members with 

scientific and medical expertise in the 

subject of opioid abuse, and a patient 

representative. Members included 


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6The term ‘‘ultimate user’’ means a person who 

has lawfully obtained, and who possesses, a 

controlled substance for his own use or for the use 

of a member of his household or for an animal 

owned by him or by a member of his household. 

21 U.S.C. 802(27). 

7Comments from the ‘‘general public’’ are 

distinguished from those submitted by ‘‘ultimate 

users’’ when the commenter did not specifically 

indicate in their comment that they personally use 

HCPs. 

8The term ‘‘mid-level practitioner’’ means an 

individual practitioner, other than a physician, 

dentist, veterinarian, or podiatrist, who is licensed, 

registered, or otherwise permitted by the United 

States or the jurisdiction in which he/she practices, 

to dispense a controlled substance in the course of 

professional practice. 21 CFR 1300.01(b). 

representatives from the 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 DSaRM voted 

19 to 10 in favor of recommending that 

HCPs be placed into schedule II. 

According to the FDA, 768 comments 

were submitted to the FDA by patients, 

patient groups, advocacy groups, and 

professional societies. 

Upon evaluating the scientific and 

medical evidence, along with the above 

considerations mandated by the 

FDASIA, the HHS on December 16, 

2013, submitted to the Administrator of 

the DEA its scientific and medical 

evaluation 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 in schedule II of the 

CSA. 

The HHS stated that the comments 

received during the open public hearing 

and submitted to the docket, and the 

discussion of the DSaRM members of 

the FDA DSaRM meeting provided 

support for its conclusion that: (1) 

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; (2) 

there is significant diversion of HCPs; 

and (3) 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 

that it gave careful consideration to the 

fact that the members of the DSaRM 

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 DSaRM, the 

health benefits and risks, and the 

information available about the impact 

of rescheduling, and concluded that 

HCPs have high potential for abuse. 

After a review of the available data, 

including the scientific and medical 

evaluation and the scheduling 

recommendation from the HHS, the 

Administrator of the DEA published in 

the Federal Register a notice of 

proposed rulemaking (NPRM) entitled 

‘‘Schedules of Controlled Substances: 

Rescheduling of Hydrocodone 

Combination Products from Schedule III 

to Schedule II’’ which proposed to 

reschedule HCPs from schedule III to 

schedule II of the CSA. 79 FR 11037, 

Feb. 27, 2014. Both the DEA and HHS 

eight-factor analyses, as well as the 

DEA’s Economic Impact Analysis (EIA), 

were made available in their entirety in 

the public docket for this rule (Docket 

No. DEA–389) and are available at 

http://www.regulations.gov/

#!docketDetail;D=DEA-2014-0005 under 

‘‘Supporting and Related Material.’’ The 

proposed rule provided an opportunity 

for interested persons to file a request 

for hearing in accordance with DEA 

regulations by March 31, 2014. No 

requests for such a hearing were 

received by the DEA. The NPRM also 

provided an opportunity for interested 

persons to submit written comments on 

the proposal on or before April 28, 2014. 

The DEA specifically solicited 

comments on the economic impacts of 

rescheduling with a request that 

commenters describe the specific nature 

of any impact on small entities and 

provide empirical data to illustrate the 

extent of such impact. 

IV. Comments Received 

The DEA received 573 comments on 

the proposed rule to reschedule HCPs. 

Fifty-two percent (52%) (298 comments) 

supported, or supported with 

qualification, controlling HCPs in 

schedule II of the CSA. Forty-one 

percent (41%) (235 comments) opposed 

rescheduling HCPs into schedule II. 

Seven percent (7%) (40 comments) did 

not take a definitive position regarding 

rescheduling of HCPs. 

Comments were submitted by a 

variety of individuals, including among 

others: Federal and State Government 

officials, manufacturers, distributors, 

pharmacies, surgeons, emergency 

physicians, dentists, physician 

assistants, nurse practitioners, 

pharmacists and pharmacy students, 

ultimate users of HCPs, and members of 

the general public.6 7 The DEA also 

received comments from a number of 

national and regional trade associations 

with memberships comprised of 

manufacturers and distributors, 

pharmacists, pharmacies, physicians, 

pain specialists, doctors of optometry, 

physician assistants, nurse practitioners, 

and long term care facilities (LTCFs). In 

addition, the DEA received comments 

from patient advocacy groups. The 5 

commenter categories with the most 

submissions were physicians (13%; 73 

comments); mid-level practitioners 8

(5%; 31 comments); pharmacists and 

pharmacy students (21%; 122 

comments); the general public (44%; 

250 comments); and ultimate users (6%; 

35 comments). 

As discussed above, 52% of all 

commenters (298 of 573 comments) 

supported, or supported with 

qualification, controlling HCPs in 

schedule II of the CSA. The majority of 

those supporting the rule were members 

of the general public and physicians. 

Comments submitted by the general 

public comprised 62% of the total 298 

comments that supported, or supported 

with qualification, the rescheduling. 

Seventy-four percent (74%) (184 of 250 

comments) of all comments submitted 

by the general public were in support, 

or supported with qualification, the 

rescheduling. Comments by physicians 

comprised 14% of the total 298 

comments that supported or supported 

with qualification rescheduling. Fiftysix percent (56%) (41 of 73 comments) 

of all comments submitted by 

physicians were in support, or 

supported with qualification, 

rescheduling. 

Forty-one percent (41%) of 

commenters (235 of 573 comments) 

opposed the proposal to reschedule 

HCPs from schedule III to schedule II of 

the CSA. The majority of those opposed 

to rescheduling HCPs were pharmacists, 

pharmacy students, and ultimate users. 

Pharmacists and pharmacy students 

comprised 31% of the total 235 

comments submitted in opposition to 

the rule. Sixty percent (60%) (122 

comments) of all comments submitted 

by pharmacists and pharmacy students 

were in opposition to the rule. 

Comments from ultimate users 

comprised 14% of the total 235 

comments in opposition to the rule. 

Ninety-one percent (91%) (32 of 35 

comments) of all comments submitted 

by ultimate users were in opposition to 

rescheduling. 

Further discussions of these 

comments are included below. 

A. Support of the Proposed Rule 

Two hundred ninety-eight 

commenters (52%) supported, or 

supported with qualification, 

controlling HCPs in schedule II of the 

CSA. Forty-one percent (41%) of 

commenters opposed controlling HCPs 

in schedule II, and 7% of commenters 


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49664 Federal Register / Vol. 79, No. 163 / Friday, August 22, 2014 / Rules and Regulations 

did not have a clearly defined position 

either in support or in opposition to the 

rescheduling. The majority of those 

supporting the rule were members of the 

general public (62%) and physicians 

(14%), with 74% of comments from the 

general public supporting, or supporting 

with qualification, and 56% of 

comments from physicians supporting, 

or supporting with qualification, making 

HCPs schedule II controlled substances. 

Manufacturers, pharmacists, mid-level 

practitioners, pharmacy students, and 

trade associations also expressed 

support for the rule. Of all comments 

submitted, in support and opposition, 

40% of pharmacists, 9% of ultimate 

users, and 78% of the general public 

were in support. 

The State Attorney General and a U.S. 

Senator from the State with last year’s 

highest per capita rate of prescription 

drug overdose in the nation wrote in 

strong support of rescheduling HCPs. 

The State Attorney General wrote that, 

‘‘This reclassification is not only 

justified given the high abuse and 

addiction potential of hydrocodone 

prescription painkillers * * *, it is 

necessary to combat the drug abuse 

epidemic that is destroying so many [ ] 

communities. I urge you to proceed with 

your rulemaking without delay. The 

abuse of hydrocodone is an urgent 

problem that necessitates urgent 

action.’’ The U.S. Senator wrote that, 

‘‘rescheduling hydrocodone 

combination drugs would be a 

tremendous step forward in the fight to 

curb the prescription drug abuse 

epidemic that has ravaged * * * our 

country. It will help prevent these 

highly addictive drugs from getting into 

the wrong hands and devastating 

families and communities * * *. I urge 

the DEA to move quickly in finalizing 

its regulations so that we are able to 

save hundreds of thousands of lives.’’ 

Two U.S. Senators from two other 

States, wrote a joint comment in support 

of rescheduling, stating that: ‘‘As 

members of the Judiciary Committee 

and senators from states hit particularly 

hard by the opioid epidemic, we are 

well aware of the alarming rates of 

diversion and prescription drug abuse,’’ 

and ‘‘we fully support DEA’s efforts to 

combat this nationwide public health 

crisis.’’ All three Senators expressed 

their desire that patients maintain 

access to legitimate care. 

A major component of the 

rescheduling of HCPs was to evaluate 

their abuse potential as required under 

21 U.S.C. 812(b)(2). Many commenters 

indicated support for controlling HCPs 

in schedule II based on the scientific 

evidence demonstrating the high abuse 

potential of HCPs, evidence that HCPs 

may lead to severe psychological or 

physical dependence, history and 

current pattern of abuse, significance of 

abuse, and risk to the public health and 

safety. Of the total 47 commenters who 

referenced the scientific, medical, and 

epidemiological data that was used to 

support the statutory requirement under 

21 U.S.C. 812(b)(2) for control of HCPs 

in schedule II of the CSA, 29 agreed 

with the data used to support control of 

HCPs in schedule II. Nineteen 

commenters specifically discussed the 

eight-factor analysis that was conducted 

in support of rescheduling HCPs into 

schedule II. Ten of those 19 commenters 

were in agreement with the DEA’s 

analysis. Nine of the commenters who 

cited the DEA’s eight-factor analysis 

indicated that the presented evidence 

was congruent with the requirements for 

placing a drug or other substance into 

schedule II of the CSA. (One 

commenter, while in agreement with the 

conclusion of the eight-factor analysis, 

did not favor rescheduling HCPs.) 

Commenters generally agreed that 

there is psychological and physical 

dependence associated with HCPs that 

support placement into schedule II. For 

example, one commenter stated that 

rescheduling HCPs from schedule III to 

schedule II ‘‘would be in the best 

interest of the general public’’ because 

he has personally witnessed the 

increase in abuse of prescription pain 

medication over the course of his 45- 

year career as a pharmacist. Additional 

supportive comments included that the 

mechanism of action of hydrocodone is 

identical to oxycodone and morphine, 

both in schedule II as combination and 

single-entity products. Some 

commenters indicated that lower doses 

of hydrocodone in HCPs do not lower 

abuse and therefore agreed with the 

transfer to schedule II. Other 

commenters mentioned that HCPs are 

metabolized to hydromorphone, a 

schedule II opioid, and also have similar 

mechanisms of action to other schedule 

II opioids including oxycodone, 

morphine, and fentanyl, suggesting that 

abuse potential would be comparable. 

Some of the commenters indicated that 

HCPs are more likely to be abused due 

to their greater availability. 

Many of the commenters cited one of 

their primary reasons for supporting the 

rule was that it would lead to tighter 

regulation of HCP prescriptions. For 

example, one commenter stated: 

‘‘Hydrocodone combination products 

should not be available with multiple 

refills on a single prescription and need 

to be prescribed more cautiously.’’ 

Similarly, another commenter stated: 

‘‘Rescheduling HPCs [sic] would 

directly address the problem of ‘leftover’ 

pills in parents [sic] medicine cabinets, 

and would keep kids safe. Furthermore, 

lowering the quantity a doctor can 

prescribe will decrease the number of 

drugs that are sold on the street, which 

will in turn decrease crime and decrease 

HCP abuse overtime [sic].’’ 

Many of the commenters wrote of 

their personal experiences with loved 

ones who suffer or had suffered with 

abuse and addiction, including many 

youths and young adults who have 

tragically died as a result of HCPs or 

other prescription opioids. The 

commenters wrote that the path to abuse 

and addiction was varied—sometimes 

beginning with a practitioner 

prescribing HCPs, and other times by 

recreational use of pills that were 

available for them to access as a result 

of practitioner overprescribing. Many of 

these commenters believe that 

controlling HCPs as a schedule II 

controlled substance will impose 

controls necessary to prevent the abuse 

and diversion of HCPs. 

DEA Response: The DEA appreciates 

the comments in support of this 

rulemaking. 

B. Request for Extended Comment 

Period 

The DEA received two comments 

requesting that the DEA reopen the 

period for public comment. One of the 

commenters specifically requested that 

the comment period be reopened for a 

minimum of 180 days. The stated 

justification of one of the commenters 

was that ‘‘[t]he current period is utterly 

inadequate to large segments of the 

population who have had no 

meaningful notice, have extremely 

limited internet access in small time 

periods through use of computers at 

public libraries and are particularly at 

risk from harm if this rule is adopted.’’ 

Both requests for extended comment 

periods were accompanied by 

meaningful comment along with the 

request for extension. 

DEA response: The Administrative 

Procedure Act does not set a minimum 

length of time for public comment. 21 

U.S.C. 553; Phillips Petroleum Co. v. 

U.S. E.P.A., 803 F.2d 545, 558–59 (10th 

Cir. 1986) (upholding the EPA’s refusal 

to extend the 45-day comment period on 

an NPRM, noting that courts have 

uniformly upheld comment periods of 

45 days or less) (internal citations 

omitted). However, both Executive 

Orders 12866 and 13563 provide that 

agencies should afford the public a 

comment period of at least 60 days. The 

DEA published in the Federal Register 

the NPRM proposing to reschedule 

HCPs into schedule II of the CSA on 

February 27, 2014. 79 FR 11037. The 


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DEA provided 60 days for interested 

persons to submit written comments 

(either online or through the mail) on 

the proposal. The comment period 

closed April 28, 2014. Seven hundred 

twenty-four submissions on the 

associated docket at http://

www.regulations.gov were submitted by 

the close of the comment period. 

Several paper submissions duplicating 

electronic submissions were received 

via the mail as well. (The 724 number 

differs from the finalized number of 573 

comments received because, as alluded 

to above, many commenters submitted 

multiple, duplicate submissions. 

Multiple submissions of exactly 

identical comments submitted by the 

same person or entity are considered by 

the DEA as only a single, submitted 

comment.) Based on the following 

considerations, the DEA declines to 

reopen the period for additional public 

comment. 

The Federal Register is published 

daily, Monday through Friday, except 

official holidays, by the Office of the 

Federal Register, National Archives and 

Records Administration, under the 

Federal Register Act (44 U.S.C. chapter 

15). Section 7 of the Federal Register 

Act (44 U.S.C. 307) provides that 

publication in the Federal Register 

constitutes constructive notice to 

persons subject thereto or affected 

thereby. The Federal Register is 

published in paper and on microfiche. 

It is also available online at no charge 

at http://www.gpo.gov/fdsys/. 

The NPRM was also available on 

http://www.regulations.gov to enable the 

public to conveniently access the 

proposal and the supporting materials. 

Of additional consideration, on the 

same day as publication in the Federal 

Register, the DEA issued a press release 

stating that the Administration had 

published in the Federal Register an 

NPRM to move HCPs from schedule III 

to schedule II (available at http://

www.justice.gov/dea/divisions/hq/2014/

hq022714.shtml). The press release 

advised individuals where a complete 

copy of the NPRM could be obtained as 

well as how they could submit 

comments in response to the proposal. 

The DEA accepted written comments 

submitted either through 

Regulations.gov or through the mail. 

In accordance with the 

Administrative Procedure Act, the 

DEA’s published NPRM included ‘‘the 

terms or substance of the proposed rule’’ 

and ‘‘a description of the subject and 

issues involved.’’ 5 U.S.C. 553(b)(3). The 

quality and quantity of the responses 

received in response to the published 

NPRM, as well as the variety of 

respondents, including those advocating 

on behalf of persons residing in LTCFs 

and other populations that may 

potentially feel distributional regulatory 

impacts, demonstrate to the DEA that 

there has been an adequate opportunity 

for meaningful public participation by 

interested persons in accordance with 

the Administrative Procedure Act. 5 

U.S.C. 553(c); Idaho Farm Bureau Fed’n 

v. Babbitt, 58 F.3d 1392, 1404 (9th Cir. 

1995) (holding that comments 

discussing the proposed action and 

supporting data were evidence that the 

public had obtained and reviewed the 

information and thus adequate 

opportunity for public comment had 

been given). 

The DEA notes that the submission by 

a nurse located in Australia shows that 

the published NPRM was widely read 

and reviewed. In addition, those 

commenters requesting additional time 

for comment accompanied their request 

for an extension with substantial 

comment on the rule. This demonstrates 

to the DEA that adequate notice and 

opportunity for meaningful comment 

was provided by the DEA on this 

rulemaking. 

C. Clarification of Affected Drugs and 

Substances 

The DEA received some comments, 

though limited in number, indicating it 

would be helpful to provide detailed 

discussion of what products are affected 

by this rule. One commenter specifically 

requested clarification as to whether the 

action would apply to cough syrups that 

contain hydrocodone. The second 

commenter requested the DEA not 

change the schedule of ZohydroTM ER. 

The third commenter requested that 

Zogenix, the manufacturer of 

ZohydroTM ER, be ‘‘allow[ed] to bring 

their new drug to market.’’ 

DEA response: This rulemaking action 

affects hydrocodone combination 

products, which are those substances 

described in 21 CFR 1308.13(e)(1) (iii) 

and (iv). All other products containing 

hydrocodone are already controlled in 

schedule II of the CSA and are not 

impacted by this action. ZohydroTM ER 

does not meet the definition of either 21 

CFR 1308.13(e)(1) (iii) or (iv); it is 

currently a schedule II controlled 

substance under 21 CFR 

1308.12(b)(1)(vi) and is not affected by 

this action. 

Other than ZohydroTM ER, all 

pharmaceuticals containing 

hydrocodone currently on the market in 

the United States are HCPs and are 

subject to this rulemaking. Hydrocodone 

is the most frequently prescribed opioid 

in the United States with nearly 137 

million prescriptions for HCPs 

dispensed in 2013. IMS Health, National 

Sales PerspectiveTM (NSP). There are 

several hundred brand name and 

generic hydrocodone products marketed 

with the most frequently prescribed 

combination being hydrocodone and 

acetaminophen (e.g., Vicodin®, 

Lortab®). Currently marketed HCPs 

approved as cough suppressants include 

Hycodan®, Mycodone®, Tussionex®, 

Pennkinetic®, Tussigon®, and several 

generics. 

D. Opposition to the Proposed Rule 

Two hundred thirty-five commenters 

(41% of all commenters) opposed the 

proposal to reschedule HCPs from 

schedule III to schedule II of the CSA. 

Many comments submitted in 

opposition came from pharmacists, 

including pharmacy school students/

interns (31%); the general public (23%); 

and ultimate users (14%). Of all 

comments submitted, in support and in 

opposition, 60% of pharmacists were 

opposed; 22% of the general public 

were opposed; and 91% of ultimate 

users were opposed. These commenters 

opposed the rescheduling HCPs for a 

variety of reasons. The comments in 

opposition can be grouped in the 

following general categories: (1) 

Concerns over the DEA’s authority to 

reschedule HCPs; (2) concerns over 

prescribing practices; (3) concerns 

regarding patient access to medicine; (4) 

concerns regarding impacts at LTCFs; 

(5) concerns that rescheduling HCPs 

will not prevent abuse or diversion; (6) 

concerns that rescheduling HCPs will 

increase provider and pharmacist 

workload; (7) concerns regarding 

economic impacts to manufacturers, 

distributors, pharmacies, physicians, 

and ultimate users; (8) concerns that 

alternatives to rescheduling had not 

been explored and/or implemented first; 

and (9) concerns about the amount of 

time to comply with the rule. Each of 

these general categories is addressed 

below. 

1. Authority To Control Drugs or 

Substances 

a. DEA’s Authority To Schedule 

Substances 

One commenter questioned the DEA’s 

general authority to schedule drugs. 

DEA response: Recognizing the need 

for a high level of scrutiny over 

controlled substances due to their 

potential for abuse and danger to the 

public health and safety, Congress 

established a closed system of 

distribution for all controlled substances 

with the passage of the Comprehensive 

Drug Abuse Prevention and Control Act 

of 1970. See H.R. Rep. No. 91–1444, 

1970 U.S.C.C.A.N. at 4566. The DEA 


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implements and enforces titles II and III 

of the Comprehensive Drug Abuse 

Prevention and Control Act of 1970, as 

amended. 28 CFR 0.100. 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 

DEA’s authority to implement and 

enforce the CSA, including adding to 

the schedules, has been repeatedly 

recognized and upheld in the Courts. 

E.g., U.S. v. Alexander, C.A.9 (Cal.) 

1982, 673 F.2d 287 (1982), cert. denied, 

459 U.S. 876 (Congress’ delegation to 

Attorney General of authority to 

reclassify controlled substances is 

constitutional); U.S. v. Roya, C.A.7 (Ill.) 

1978, 574 F.2d 386, cert. denied, 439 

U.S. 857 (finding no merit to the claim 

that the addition and reclassification of 

amobarbital and phenmetrazine as 

schedule II controlled substances by the 

Attorney General was an 

unconstitutional delegation of authority 

under separation of powers doctrine); 

U.S. v. Kinder, C.A.5 (Tex.) 1991, 946 

F.2d 362, cert. denied, 503 U.S. 987, 

cert. denied, 504 U.S. 946, rehearing 

denied, 505 U.S. 1238 (Attorney General 

followed proper procedures in 

reclassifying methamphetamine as 

schedule II controlled substance, 

pursuant to the CSA; Attorney General 

properly delegated his authority to the 

Director of the Bureau of Narcotics and 

Dangerous Drugs (BNDD) who then 

reclassified methamphetamine). 

b. Conflict With Other Federal Law 

One commenter questioned whether 

the rescheduling action would have 

illegal discriminatory effects, and 

‘‘violate laws against disability and age 

discrimination.’’ This same commenter 

also asserted without premise that the 

rescheduling action could potentially 

conflict with parts of the Affordable 

Care Act and ‘‘deprivation of rights 

under color of authority.’’ 

DEA response: Executive Order 12866 

of September 30, 1993, ‘‘Regulatory 

Planning and Review,’’ and Executive 

Order 13563 of January 18, 2011, 

‘‘Improving Regulation and Regulatory 

Review,’’ direct Federal agencies to 

assess costs and benefits of available 

regulatory alternatives and, if the 

regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety effects, distributive impacts, 

and equity). Paragraph (b)(1) of section 

1 of Executive Order 12866 specifically 

directs Federal agencies to ‘‘avoid 

regulations that are inconsistent, 

incompatible, or duplicative with its 

other regulations or those of other 

Federal agencies.’’ The DEA has 

reviewed the impacts of this scheduling 

action against the principles edified by 

Executive Orders 12866 and 13563 and 

finds no basis that it would have illegal 

discriminatory effects, or ‘‘violate laws 

against disability and age 

discrimination.’’ 

c. Factors Determinative of Control 

Twenty-six commenters opposed 

rescheduling HCPs as schedule II 

controlled substances based on concerns 

regarding the eight-factor analyses. 

Twenty-four commenters believed that 

the eight-factor analyses did not support 

rescheduling into schedule II and that 

HCPs should remain in schedule III. 

Two commenters believed that HCPs 

should be rescheduled into a lower 

schedule than schedule III. (One 

commenter stated that HCPs should be 

down-scheduled into schedule V and 

made over-the-counter for those 21 

years and older.) 

i. Evaluation of Abuse Potential of HCPs 

and Data Used To Support Placement of 

HCPs into Schedule II of the CSA 

Eighteen commenters expressed 

disagreement about the data that was 

used to support the statutory 

requirement under 21 U.S.C. 811(c) and 

812(b)(2) for placement into schedule II 

of the CSA. Some of these commenters 

stated that the available data are limited 

and do not support rescheduling HCPs 

into schedule II. Some commenters 

indicated that there was no scientific 

consensus in support of moving HCPs 

from schedule III to schedule II. 

Many of the comments in opposition 

to the proposed scheduling action were 

statements by ultimate users of HCPs 

that HCPs are not abused by patients 

with legitimate prescriptions. Some of 

the commenters stated that the small 

amounts of hydrocodone in HCPs have 

never contributed to addiction and 

acetaminophen in HCPs would actually 

decrease abuse rates. Commenters 

suggested that abuse potential of HCPs 

is lowered or negated by the fact that it 

is often used with other substances such 

as alcohol. Some commenters supported 

their assertions with statements that 

deaths are extremely rare with HCPs. 

DEA response: The DEA conducted a 

comprehensive evaluation of 

epidemiological, diversion, 

pharmacological, and pharmacokinetic 

data to conclude that HCPs have a high 

abuse potential. All of the data was 

reviewed collectively, and the data 

supports the finding that HCPs have a 

high abuse potential similar to other 

schedule II controlled substances, such 

as oxycodone products. The DEA’s 

decision to reschedule HCPs from 

schedule III to schedule II is also 

supported by the HHS review and the 

FDA’s DSaRM recommendation. 

The DEA disagrees that there is a lack 

of scientific consensus among scientific 

experts. Some commenters, in support 

of their dissenting opinions, cited some 

selective information presented in the 

briefing document for the FDA’s DSaRM 

meeting in January 2013. It should be 

noted that the DSaRM members 

received the selected information cited 

by the commenters, and, upon 

deliberating extensively on all the 

available data voted 19 to 10 in favor of 

rescheduling HCPs from schedule III to 

schedule II. The DEA’s determination of 

the appropriate schedule under the CSA 

in which to place HCPs is based on a 

comprehensive review of all available 

data, rather than selected portions of 

available data, and the DEA did in fact 

review and consider the selected 

information presented by the 

commenters. The DEA also considered 

the HHS scientific and medical 

evaluation and scheduling 

recommendations. 

The DEA finds that the scientific, 

medical, and epidemiological data are 

robust and support rescheduling HCPs 

into schedule II of the CSA. Various 

drug abuse indicators for HCPs indicate 

that HCPs are widely diverted and 

abused at rates largely similar to that of 

oxycodone products (schedule II). The 

data indicate that HCPs have an abuse 

potential similar to schedule II opioid 

analgesics such as oxycodone and their 

abuse is associated with severe 

psychological or physical dependence. 

Abuse of HCPs is also associated with 

large numbers of individuals being 

admitted to addiction treatment centers. 

Individuals are taking these drugs in 

sufficient quantities to create a hazard to 

their health, and abuse of HCPs is 

associated with large numbers of deaths. 

Further, data from several different drug 

abuse monitoring databases support the 

conclusion that HCPs have a high 

potential for abuse similar to other 

schedule II opioid analgesics. 

Contrary to the views expressed by 

some commenters, the review by the 

DEA and HHS of all the relevant data 

found that HCPs are abused at high rates 

and have high dependence potential as 

indicated by the data reported by the 

National Survey on Drug Use and 


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9Centers for Disease Control, CDC Grand Rounds: 

Prescription Drug Overdoses—a U.S. Epidemic, 

61(01) Morbidity and Mortality Weekly Report 

(MMWR) 10 (2012) (internal citations omitted) 

available at http://www.cdc.gov/mmwr/preview/

mmwrhtml/mm6101a3.htm. 

10Laxmaiah Manchikanti, MD et al., National All 

Schedules Prescription Electronic Reporting Act 

(NASPER): Balancing Substance Abuse and 

Medical Necessity, 5 Pain Physician 294, 299, n.3 

(2002). 

11As provided in the CSA’s legislative history: 

* * * [A] substance has a potential for abuse 

because of its depressant or stimulant effect on the 

central nervous system or its hallucinogenic effect 

if: (1) There is evidence that individuals are taking 

the drug or drugs containing such a substance in 

amounts sufficient to create a hazard to their health 

or to the safety of other individuals or of the 

community; or (2) There is a significant diversion 

of the drug or drugs containing such a substance 

from legitimate drug channels; or (3) Individuals are 

taking the drug or drugs containing such a 

substance on their own initiative rather than on the 

basis of medical advice from a practitioner licensed 

by law to administer such drugs in the course of 

his professional practice; or (4) The drug or drugs 

containing such a substance are new drugs so 

related in their action to a drug or drugs already 

listed as having a potential for abuse to make it 

likely that the drug will have the same potentiality 

for abuse as such drugs, 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. 

Comprehensive 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, 

4603. 

Health (NSDUH), Monitoring the Future 

(MTF), National Poison Data System 

(NPDS), Drug Abuse Warning Network 

(DAWN), and Treatment Episode Data 

Set (TEDS). There have been large 

numbers of deaths and emergency 

department visits associated with abuse 

of HCPs. In addition, the data indicate 

that HCPs and oxycodone products have 

similar abuse potential. Based on these 

considerations, the DEA believes that 

the high abuse and dependence 

potential and harm associated with 

HCPs support rescheduling into 

schedule II of the CSA. 

Contrary to statements made by some 

ultimate users, even low doses of HCPs 

have the potential for adverse impacts 

on the public health and safety. 

According to the CDC, while an 

estimated 80% of patients who are 

prescribed opioids are prescribed low 

doses (<100 mg morphine equivalent 

dose per day) by a single practitioner, 

these patients account for an estimated 

20% of all prescription drug overdoses.9

(An estimated 10% of patients who are 

prescribed opioids are prescribed high 

doses (≥100 mg morphine equivalent 

dose per day) by single prescribers. 

These patients account for an estimated 

40% of all prescription opioid 

overdoses. An estimated 10% of 

patients are patients who seek care from 

multiple doctors and are prescribed 

high daily doses of opioids. They 

account for another 40% of all opioid 

overdoses.) Id. 

After careful consideration of relevant 

data, the DEA finds that HCPs have 

abuse potential supporting placement 

into schedule II. 

ii. Criteria for Abuse 

One commenter wanted the DEA to 

draw distinctions among abuse, 

addiction, and dependence. A second 

commenter objected to the DEA’s 

consideration of ‘‘individuals 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’’ as a criterion of abuse. 

DEA response: As noted by 

researchers, ‘‘[t]here is no agreement 

between researchers for terms such as 

drug abuse, psychological dependence, 

drug dependence and drug addiction,’’ 

and that, ‘‘[o]ften these terms are used 

interchangeably.’’ 10 The DEA is aware 

that the most recent version of the 

Diagnostic and Statistical Manual, the 

DSM–V, released in 2013, removed the 

distinction between abuse and 

dependence for diagnostic purposes, 

and replaced them with a combined 

single disorder called ‘‘substance use 

disorder.’’ However, the DEA derives 

authority from the CSA, and when 

acting under its authority must speak 

under the terms and conditions imposed 

by it. The CSA does not define ‘‘abuse’’ 

in terms of the DSM; in fact it does not 

define the term at all. The CSA uses 

terms such as ‘‘potential for abuse,’’ 

‘‘pattern of abuse,’’ and ‘‘significance of 

abuse.’’ E.g., 21 U.S.C. 811 and 812. 

One looks first to the face of a law to 

understand its meaning, and ‘‘[i]f the 

statute’s meaning is plain and 

unambiguous, there is no need for 

further inquiry.’’ United States v. Fisher, 

289 F.3d 1329, 1337–38 (11th Cir.2002) 

(internal quotation marks and citation 

omitted). However, if the language is 

ambiguous, the relevant legislative 

history may be used to aid in 

understanding meaning. United States 

v. Dodge, 597 F.3d 1347, 1352 (11th Cir. 

2010). The legislative history of the CSA 

suggests four factors that may be 

considered in determining whether a 

particular drug or substance has a 

‘‘potential for abuse,’’ including 

whether individuals are taking the drug 

or drugs containing such a substance on 

their own initiative rather than on the 

basis of medical advice from a 

practitioner licensed by law to 

administer such drugs in the course of 

his professional practice.11 Accordingly, 

the DEA uses this as one factor in 

determining a substance’s potential for 

abuse. 

‘‘Addict’’ is defined by the CSA as a 

person who ‘‘habitually uses any 

narcotic so as to endanger the public 

morals, health, safety, or welfare, or 

who is so far addicted to the use of 

narcotic drugs as to have lost the power 

of self-control with reference to his 

addiction.’’ 21 U.S.C. 802(1). The DEA 

uses this definition for the terms 

‘‘addict’’ and ‘‘addiction.’’ 

iii. Appropriate Drug Comparator 

One commenter asserted that HCPs 

were not compared to appropriate 

reference drugs and have lower abuse 

ratios and abuse potential than schedule 

II oxycodone combination products. 

Another commenter expressed the 

opinion that HCPs are substantially 

cheaper than oxycodone products 

which would affect drug selection as 

opposed to the notion that HCPs have 

more addiction potential. The 

commenters did not provide any 

appropriate alternative comparison drug 

for HCPs. 

DEA response: HCPs were compared 

to oxycodone products, currently 

schedule II controlled substances, to 

evaluate abuse potential. The DEA, in 

agreement with the HHS review, 

considers the comparison of HCPs to 

oxycodone products appropriate due to 

similarities between their 

pharmacological properties, therapeutic 

uses and patterns, as well as market 

history. In their eight-factor analysis, the 

FDA noted that it is not always possible 

to identify an ‘‘appropriate opioid 

comparator in Schedule III.’’ The FDA 

went on to state that: ‘‘While FDA 

considered codeine as a potential 

comparator, it was deemed 

inappropriate for several reasons * * *. 

Given the absence of an appropriate 

Schedule III comparator, FDA focused 

its analyses on comparing the abuse 

liability of hydrocodone combination 

products (Schedule III) with oxycodone 

products (Schedule II).’’ 

With regard to the comment about the 

lower costs of HCPs contributing to its 

high abuse potential, it is important to 

note that abuse potential of a given drug 

is also influenced by various other 

factors (e.g., pharmacological properties, 

ease of availability, etc.). Additionally, 

actual abuse data comparing HCPs and 

oxycodone combination drugs indicate 

that the abuse potential between the two 

drugs is similar. Contrary to the views 

expressed by some commenters, the 

review by the DEA of all the relevant 

data found that HCPs are abused at high 

rates and have high dependence 

potential as indicated by the data 


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49668 Federal Register / Vol. 79, No. 163 / Friday, August 22, 2014 / Rules and Regulations 

reported by the NSDUH, MTF, NPDS, 

DAWN, and TEDS. There have been 

large numbers of deaths and emergency 

department visits associated with abuse 

of HCPs. Based on these considerations, 

the DEA believes that the high abuse 

and dependence potential and harm 

associated with HCPs support 

rescheduling into schedule II of the 

CSA. 

iv. Balanced Presentation of the EightFactor Analysis 

Nine commenters disagreed with the 

conclusions in the DEA’s eight-factor 

analysis. These commenters asserted 

that the DEA’s eight-factor analysis was 

not a balanced presentation and did not 

include the therapeutic benefits or the 

negative impact on patients with a 

legitimate medical use for HCPs. In 

addition, some of the commenters stated 

that the DEA’s eight-factor analysis used 

flawed analytical methods and failed to 

show that HCPs were more dangerous or 

more abused than oxycodone. Several of 

these commenters requested that DEA 

include both sides of the clinical 

argument and peer-reviewed clinical 

research. 

DEA response: The DEA reviewed the 

required eight factors in accordance 

with the provisions stated in 21 U.S.C. 

811(c), specifically exploring the abuse 

potential and potential harms of HCPs. 

The DEA’s analysis also acknowledges 

that there is a currently accepted 

medical use, and accordingly 

therapeutic benefit, of HCPs. Consistent 

with the CSA, an evaluation of abuse 

and dependence potential, risk to the 

public health and safety, and other 

factors are included in the analysis. 21 

U.S.C. 811(c). The CSA does not require 

that HCPs be more dangerous or abused 

than oxycodone in order to be placed in 

schedule II. Rather, relative abuse 

potential must be established. The 

DEA’s analysis shows that HCPs have a 

high potential for abuse, and the abuse 

potential of HCPs is comparable to the 

schedule II controlled substance 

oxycodone. Thus, HCPs are 

appropriately placed in schedule II, 

along with oxycodone. Further, the 

analytical methods that were presented 

in the DEA’s eight-factor analysis were 

consistent with the HHS’s eight-factor 

analysis that was finalized in December 

2013. The DEA used the best available 

methods based on current science to 

complete the eight-factor analysis. 

2. Requirements Applicable to 

Prescriptions 

a. Authority To Prescribe HCPs as 

Schedule II Controlled Substances 

Nineteen commenters opposed 

rescheduling HCPs as schedule II 

controlled substances based on concerns 

related to the restricted authority of 

mid-level practitioners to prescribe 

medications that are schedule II 

controlled substances. 

DEA response: The DEA recognizes 

that some States do not allow all 

providers to prescribe schedule II 

controlled substances. However, it is 

outside of the DEA’s scope of authority 

under the CSA to determine what 

categories of practitioners may prescribe 

controlled substances. Under the CSA, it 

is up to each State to decide who has 

the authority to prescribe controlled 

substances within that State. This is 

reflected in 21 U.S.C. 823(f), which 

requires DEA to register a practitioner 

who is authorized under the laws of the 

State in which he practices unless the 

practitioner’s registration would be 

inconsistent with the public interest. 21 

U.S.C. 823, 824. This is also echoed in 

21 CFR 1306.03, which states that a 

practitioner can issue a prescription for 

controlled substances so long as the 

practitioner is authorized to prescribe 

controlled substances by the jurisdiction 

where he is licensed to practice his 

profession and is registered or exempted 

from registration pursuant to 21 CFR 

1301.22(c) and 21 CFR 1301.23. Each 

State has this authority, so long as it 

does not conflict with federal law. 

b. Transmittal Method of HCPs as 

Schedule II Controlled Substances 

i. Oral and Facsimile Prescriptions 

Multiple commenters opposed 

rescheduling HCPs as schedule II 

controlled substances based on concerns 

related to the transmittal methods 

available for schedule II as compared to 

schedule III controlled substances, 

specifically the circumstances required 

in order to provide oral prescriptions 

and to transmit prescriptions via 

facsimile. Both ultimate users and 

providers expressed concern that HCPs 

as schedule II controlled substances will 

not be available on nights and 

weekends. They were especially 

concerned about dental emergencies 

that might occur over the weekend. Four 

commenters stated that patients needing 

night or weekend prescriptions for HCPs 

will overburden Emergency 

Departments (EDs). 

DEA response: The requirements for 

issuing an emergency oral prescription 

for a schedule II controlled substance do 

not hinder legitimate access to HCPs. 

The procedural requirements relating to 

transmission of a legitimate prescription 

do not hinder legitimate access either. 

Contrary to concerns of commenters, 

practitioners will still be allowed to 

call-in prescriptions for HCPs in the 

event of an emergency. In the event of 

an emergency, as defined by 21 CFR 

290.10, a pharmacist may dispense a 

schedule II controlled substance upon 

receiving oral authorization of a 

prescribing individual practitioner in 

accordance with 21 CFR 1306.11(d). 

ii. Triplicate Prescriptions 

Five commenters opposed 

rescheduling HCPs as schedule II 

controlled substances based on concerns 

regarding ‘‘triplicate prescriptions.’’ One 

commenter stated that emergency 

physicians do not have triplicate 

prescription forms, and as a result, they 

will be required to prescribe drugs that 

are less effective for pain management. 

Two commenters stated that emergency 

physicians do not want to carry a 

triplicate prescription pad. 

DEA response: Neither the CSA nor 

DEA regulations require prescriptions to 

be prepared in triplicate. The DEA 

recognizes that some States, such as 

Texas and California, require the use of 

triplicate prescription forms for some or 

all controlled substances. As stated in 

the November 19, 2007, final rule, 

‘‘Issuance of Multiple Prescriptions for 

Schedule II Controlled Substances,’’ the 

‘‘DEA supports the efforts of States to 

take the specific action they deem 

necessary to prevent the diversion of 

controlled substances within their 

jurisdictions.’’ 72 FR 64921, 64923. 

Under the CSA, Congress envisioned that 

the Federal and State Governments would 

work in tandem to regulate activities relating 

to controlled substances. This is reflected in 

21 U.S.C. 903, which indicates that Congress 

did not intend to preempt state controlled 

substance laws, so long as such state laws do 

not conflict with federal law. Thus, each state 

may enact controlled substance laws that go 

beyond the requirements of the CSA, 

provided such laws do not conflict with the 

CSA. Given this aspect of the CSA, it would 

not be appropriate for DEA to seek to 

preempt or supersede state laws relating to 

the prescribing of controlled substances, 

provided such laws do not conflict with the 

CSA or DEA regulations. 

Id. at 64927. 

c. Quantity and Frequency of Fills and 

Refills for HCPs as Schedule II 

Controlled Substances 

Pharmacists, prescribers, and ultimate 

users expressed concern about the 

quantity and frequency of fills and 

refills for HCPs as schedule II controlled 

substances that would be allowed if 

HCPs were placed into schedule II. 


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12United States v. Rosen, 582 F.2d 1032, 1036 

(5th Cir. 1978). 

Several commenters, mostly ultimate 

users, asserted that up-scheduling 

would result in patients being limited to 

a 30-day supply of medication and 

would correspondingly need to begin 

seeing their doctors monthly. Other 

commenters, primarily pharmacists and 

physicians, expressed their belief that 

rescheduling HCPs will result in larger 

quantities of pills being authorized on 

each prescription to prevent patients 

from running out of medication and 

being in pain. Most of these commenters 

had corresponding concerns that these 

larger prescriptions would lead to more 

unused medication in the home that 

would be available for diversion. 

Examples include the following: One 

commenter mentioned his concern that 

since larger prescriptions would be 

authorized, he would be unable to 

monitor whether the patient is taking 

the medication or taking too much of it. 

An emergency physician opined that 

removing the ability to get refills on 

HCPs may result in prescriptions for 

more potent medications being issued. 

One ultimate user was concerned that 

the elimination of refills on HCPs would 

result in patients getting insufficient 

quantities to treat the acute illness for 

which it was prescribed. 

DEA response: While courts have 

recognized that prescribing an 

‘‘inordinately large quantity of 

controlled substances’’ can be evidence 

of a violation of the CSA,12 generally 

neither the CSA nor DEA regulations 

impose a specific quantitative minimum 

or maximum limit on the amount of 

medication that may be prescribed on a 

single prescription, or the duration of 

treatment intended with the prescribed 

controlled substance. The quantity 

prescribed and dispensed is limited in 

an emergency situation as defined by 21 

CFR 290.10 when dispensing a schedule 

II controlled substance upon oral 

authorization in accordance with 21 

CFR 1306.11(d). The CSA and 

implementing regulations require all 

controlled substance prescriptions to be 

‘‘valid.’’ A prescription is not ‘‘valid’’ 

unless it is issued for a legitimate 

medical purpose and within the usual 

course of professional practice. 21 CFR 

1306.04(a). A pharmacist who fills a 

prescription has a corresponding 

responsibility, and the person who fills 

an illegitimate prescription is subject to 

penalty. Id. 

While the CSA and DEA regulations 

generally contain no specific limit on 

the quantity that may be prescribed on 

a single prescription, or the duration of 

treatment intended for a single 

prescription, some States do impose 

specific limits on prescribing schedule 

II controlled substances. Likewise, some 

limitations on the quantity or frequency 

of schedule II controlled substances may 

be limited by individual prescription 

benefit providers. Any limitations 

imposed by State law apply, in addition 

to the corresponding requirements 

under Federal law, so long as the State 

requirements do not conflict with or 

contravene the Federal requirements. 21 

U.S.C. 903; 21 CFR 1306.12(b)(1)(v); 

‘‘Clarification of Existing Requirements 

Under the Controlled Substances Act for 

Prescribing Schedule II Controlled 

Substances,’’ 70 FR 50408, Aug. 26, 

2005. 

Although the CSA prohibits refills of 

prescriptions for schedule II controlled 

substances, a practitioner may issue 

multiple schedule II prescriptions in 

order to provide up to a 90-day supply 

of medication in accordance with 21 

CFR 1306.12. Furthermore, DEA 

regulations do not require patients to be 

seen monthly by their provider. Rather, 

practitioners must determine on their 

own, based on sound medical judgment, 

and in accordance with established 

medical standards how often to see their 

patients when prescribing controlled 

substances. 

Note, however, that DEA regulations 

should not be ‘‘construed as mandating 

or encouraging individual practitioners 

to issue multiple prescriptions or to see 

their patients only once every 90 days 

when prescribing Schedule II controlled 

substances. Rather, individual 

practitioners must determine on their 

own, based on sound medical judgment, 

and in accordance with established 

medical standards, whether it is 

appropriate to issue multiple 

prescriptions and how often to see their 

patients when doing so.’’ 21 CFR 

1306.12(b)(2). The DEA does not 

regulate the general practice of medicine 

and the agency lacks the authority to 

issue guidelines (or make policy 

statements) that constitute advice on the 

general practice of medicine. 

3. Patient Access to Medicine 

The DEA received numerous 

comments, predominantly from ultimate 

users, who voiced concerns about the 

possible effects rescheduling would 

have on patients’ access to appropriate 

treatment for pain. Commenters were 

concerned about the possible need for 

increased provider visits, and associated 

increased time and cost to receive 

medical care. Commenters were 

concerned about access to health care 

providers, such as possibly needing to 

change health care providers and in 

some cases having to drive longer 

distances to get to practitioners’ offices 

because of limitations on types of 

practitioners who can prescribe 

schedule II controlled substances. 

Commenters were also concerned that 

rescheduling could result in doctors 

changing prescriptions to alternative 

medications which might be less 

effective for treating some kinds of pain 

and/or cause adverse health effects. 

a. Impact on Prescribing Practices 

Several commenters were concerned 

that because of the rescheduling, 

practitioners will be less likely to 

prescribe HCPs. One commenter 

suggested that since a practitioner can 

no longer call in or fax a prescription to 

the pharmacy, the practitioner will be 

reluctant to prescribe HCPs. Other 

commenters stated the scheduling 

action will impose additional burdens 

on practitioners and therefore they will 

stop prescribing for HCPs and prescribe 

less effective drugs. One commenter 

stated that many EDs do not typically 

prescribe schedule II narcotics. 

Likewise, two commenters suggested 

that cumbersome and slow ordering 

processes for schedule II substances will 

cause local shortages of HCPs, and thus 

practitioners will turn to prescribing 

other drugs. 

DEA Response: The processes and 

procedures associated with dispensing a 

controlled substance are not relevant 

factors to the determination of whether 

a substance should be controlled or 

under what schedule a substance should 

be placed if it is controlled. See 21 

U.S.C. 811 and 812. Nonetheless, 

controlling HCPs as a schedule II 

controlled substance should not hinder 

legitimate access to the medicine. As 

recognized and noted by commenters, 

scheduling a medication does not make 

it impossible to prescribe, dispense, or 

administer the medication. However, it 

does alert prescribing-practitioners, 

pharmacists medical support 

professionals and perhaps even some 

patients and non-professional caregivers 

that the medication has potential 

dangers for addiction and misuse, and 

careful monitoring and evaluation of use 

of such drugs is necessary for 

appropriate patient care. ‘‘The placing 

of a drug into [a particular schedule of 

the CSA] will alert a physician that the 

drug does cause physical and 

psychological dependence. This is 

valuable information for a physician to 

possess before prescribing any drug.’’ 50 

FR 8104, 8107, Feb. 28, 1985 

(‘‘Schedules of Controlled Substances; 

Rescheduling of Buprenorphine From 

Schedule II to Schedule V of the 

Controlled Substances Act’’). 


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49670 Federal Register / Vol. 79, No. 163 / Friday, August 22, 2014 / Rules and Regulations 

The DEA does not intend for 

legitimate patients to go without 

adequate care. A prescription for a 

controlled substance to be effective 

must be issued for a legitimate medical 

purpose by an individual practitioner 

acting in the usual course of his 

professional practice. 21 CFR 

1306.04(a). When a practitioner 

prescribes a medication that is a 

controlled substance for a patient, it 

must be because he/she has made a 

professional medical determination that 

it would be medically appropriate for 

the patient’s medical condition to treat 

with that specific controlled substance. 

The DEA recognizes that rescheduling 

a legitimately marketed pharmaceutical 

controlled substance may have some 

effect on the decision of a practitioner 

to prescribe that particular controlled 

substance. There may be some 

practitioners who are reluctant to 

prescribe a schedule II controlled 

substance although authorized by State 

law to do so. However, the DEA notes 

that other schedule II controlled 

substances are widely prescribed. Given 

that classification has not deterred 

practitioners from prescribing those 

drugs, the DEA believes that when a 

practitioner makes a medical 

determination that a particular 

controlled substance is appropriate to 

treat a patient’s medical condition, the 

practitioner will prescribe the 

appropriate controlled substance, 

regardless of the substance’s schedule. 

The DEA notes that a doctor from New 

York, one of the States that has already 

scheduled HCPs as schedule II 

controlled substances under State law, 

asserted in his comment that upscheduling ‘‘has reduced unconscious 

(or conscience-less) prescribing without 

impacting patients’ access to 

medications.’’ 

b. Impact of Criminal Action 

Some commenters expressed concern 

that transferring HCPs to schedule II 

would deter prescribers from properly 

treating pain for fear of facing criminal 

action. According to one commenter, 

many providers limit the number of 

pills for schedule II medications 

‘‘because they feel they are being 

watched by monitoring programs and 

are afraid the DEA ‘will investigate’ 

them for too many CII scripts.’’ 

DEA response: One of the most 

important principles underlying the 

CSA is that every prescription for a 

controlled substance must be issued for 

a legitimate medical purpose by an 

individual practitioner acting in the 

usual course of his professional 

practice. 21 CFR 1306.04(a); U.S. v. 

Moore, 423 U.S. 122 (1975) (holding 

registered physicians may be prosecuted 

for violation of the CSA when their 

activities fall outside the usual course of 

professional practice). The DEA policy 

statement entitled ‘‘Dispensing 

Controlled Substances for the Treatment 

of Pain,’’ 71 FR 52715, Sept. 6, 2006, 

makes clear that this longstanding 

requirement should in no way interfere 

with the legitimate practice of medicine 

or cause any practitioner to be reluctant 

to provide legitimate pain treatment. 

Practitioners (as well as ultimate users) 

become subject to administrative, civil, 

and/or criminal action when their 

activity involving controlled substances 

is not authorized by, or is in violation 

of, the CSA, regardless of whether the 

activity involves a schedule II 

controlled substance or a schedule III 

controlled substance. 

c. Impact on Drug Availability 

Two commenters suggested this rule 

will result in limited drug availability 

because wholesalers are limiting 

distributions to community pharmacies. 

These commenters assert that if a 

pharmacy goes over a pre-determined 

amount, they cannot obtain the needed 

pharmaceuticals until the following 

month. The commenter asserted that 

this practice may have particularly 

adverse impacts in rural areas where a 

pharmacy may only be serviced by one 

distributor. Another commenter 

suggested there will be local shortages 

of HCPs because of the cumbersome and 

slow schedule II ordering process. Two 

commenters were concerned that 

limited availability may result from 

delays associated with manufacturer 

production due to annual production 

requirements for schedule II controlled 

substances. 

DEA response: DEA registered 

distributors are required to provide 

effective controls against diversion of 

controlled substances. However, the 

DEA does not limit the quantity of 

controlled substances that may be 

legitimately distributed to pharmacies. 

Any arbitrary limits placed on 

community pharmacies by distributors 

are the result of a business decision of 

that distributor. 

The DEA does impose requirements 

for distributors to operate a system to 

disclose suspicious orders of controlled 

substances. 21 CFR 1301.74(b). 

Suspicious orders include orders of 

unusual size, orders deviating 

substantially from a normal pattern, and 

orders of unusual frequency. Id. Part of 

the due diligence associated with that 

requirement, as well as the general 

requirement under 21 CFR 1301.71(a) 

for registrants to ‘‘provide effective 

controls and procedures to guard against 

theft and diversion of controlled 

substances,’’ is to ‘‘know your 

customer.’’ While order volume may be 

one indicator of a suspicious order, the 

totality of circumstances must be used 

in making a determination. Generally, 

no single indicator is independently a 

suggestion that a given order is 

suspicious. Order volume should be 

examined not only on an industry-wide 

comparison level, but also on a local 

level. For example, a pharmacy located 

near an oncology clinic may be more 

likely to regularly order higher volumes 

of certain controlled pharmaceuticals 

than one that is not. 

The DEA does not find evidence to 

support the claim that the ordering 

process for schedule II controlled 

substances will result in limited 

availability of HCPs. A DEA Form 222, 

or its electronic equivalent—the 

Controlled Substance Ordering System 

(CSOS), is required for all distributions 

of schedule I or II controlled substances, 

with specific exceptions, 21 U.S.C. 

828(a); 21 CFR 1305.03, which enables 

the DEA to monitor the flow of these 

controlled substances from their point 

of manufacture through commercial 

distribution. It takes approximately an 

hour to complete each order using the 

paper DEA Form 222. It takes 

approximately three minutes to 

complete an order using CSOS. (The 

DEA Form 222 permits ten line items 

per form; electronic orders are not 

subject to the same requirement and 

may contain an unlimited number of 

transactions (line items)). While CSOS 

transactions are faster, the paper DEA 

Form 222 orders are also able to be 

processed quickly through the system. 

In 2013, 109,632 registrants ordered 

schedule I or II controlled substances. 

About 4.8 million orders were processed 

on Form 222s and 924,257 were 

processed electronically via CSOS 

(approximately 16% of all orders). The 

paper orders represented roughly 27.7 

million transactions (or about 6 per 

order); the electronic orders represented 

roughly 21.2 million transactions or 

slightly more than 23 per order. 

There should be no impact on 

availability due to schedule II annual 

production requirements (i.e., 

manufacturing quota). Registrants that 

manufacture hydrocodone are already 

required to obtain an annual quota in 

order to manufacture hydrocodone 

because it is a schedule II controlled 

substance unless and until it is 

formulated into dosage form HCPs. 

Manufacturing quotas are issued to 

bulk manufacturers who manufacture 

either from synthetic routes (e.g., 

hydrocodone from codeine), or 

extraction from narcotic raw material. 


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Federal Register / Vol. 79, No. 163 / Friday, August 22, 2014 / Rules and Regulations 49671 

Bulk manufacturing quota will not be 

impacted by the movement of HCPs 

from schedule III into schedule II. 

Procurement quotas are typically 

issued to dosage form manufacturers 

and repackagers or relablers for 

manufacturing activities. As related to 

HCPs, a procurement quota is required 

to: (1) Receive bulk Active 

Pharmaceutical Ingredients to be 

manufactured into dosage units; and (2) 

for a company to receive bulk finished 

dosage units for relabeling or 

repackaging. 

d. Providers Authorized To Prescribe 

Schedule II Controlled Substances 

Nine commenters expressed concern 

about the ability to access health care 

providers who can prescribe schedule II 

controlled substances. Specifically, 

commenters stated that mid-level health 

care providers such as physician 

assistants and nurse practitioners, who 

provide primary health care, cannot 

prescribe schedule II controlled 

substances in many States. As a result, 

these patients will not have access to 

the medicine they need to treat their 

pain. In addition, one commenter stated 

this will have a negative impact on 

patients who visit rural practices where 

mid-level practitioners often prescribe 

pain medication. Moreover, one 

commenter stated the scheduling action 

would make it mandatory for a patient 

to see a physician for pain. Another 

commenter stated that because of this 

scheduling they would now have to find 

new doctors, which would increase 

travel time and the amount of money 

spent on gas. 

DEA response: State authorization to 

handle controlled substances is both a 

necessary precondition for Federal 

authorization to handle controlled 

substances and a qualifying determinate 

as to the extent of the practitioner’s 

scope of authority in regard to such 

substances. U.S. v. Moore, 423 U.S. 122, 

141 (1975) (‘‘The federal registration, 

which follows automatically, extends no 

further [than the scope of authority 

granted by the State to practice 

medicine and to dispense drugs in 

connection with their professional 

practice].’’). A DEA registered 

practitioner may only engage in those 

activities involving controlled 

substances that are authorized by the 

laws of the State on which the 

practitioner’s Federal registration is 

based. If an individual practitioner, or a 

class of practitioners, has not been 

granted authorization to prescribe 

certain controlled substances that is the 

rightful determination of the State under 

its authority to regulate the practice of 

medicine. 

e. Treatment for Pain 

Concerns were raised that changes in 

the scheduling for HCPs could drive the 

use of alternative treatments. One class 

of commenters who were particularly 

concerned about this was emergency 

physicians who work in States that 

require triplicate prescriptions and/or 

facilities whose policy is not to handle 

schedule II controlled substances in 

their emergency departments. Some 

emergency providers in triplicateprescription States said that they did 

not carry triplicate prescriptions due to 

concerns about them being stolen. Some 

emergency physicians who work in 

States that require triplicate prescription 

forms (but who are able to write 

schedule II controlled substance 

prescriptions while working in their 

emergency departments) stated that if 

‘‘forced to get a triplicate,’’ then he will 

start writing for more schedule II 

controlled substances, such as Percocet, 

because it is a ‘‘better pain med[icine] 

than HCPs.’’ Other commenters were 

concerned that some prescribers might 

switch to prescribing ‘‘stronger drugs 

with significant abuse potential,’’ or 

alternatively switch to medications such 

as non-steroidal anti-inflammatory 

drugs (NSAIDs) which are less effective 

for treating some kinds of pain and may 

cause other adverse effects, leaving 

people in untreated pain. One 

commenter was concerned that 

tramadol would be prescribed in place 

of HCPs, which worried them because of 

issues with tramadol specific to renal 

patients. 

DEA response: The DEA does not 

regulate the general practice of medicine 

and the agency lacks authority to issue 

guidelines (or make policy statements) 

that constitute advice on the general 

practice of medicine. A prescription for 

a controlled substance must be issued 

for a legitimate medical purpose by an 

individual practitioner acting in the 

usual course of his professional 

practice. 21 CFR 1306.04(a); U.S. v. 

Moore, 423 U.S. 122 (1975). A 

practitioner must use sound medical 

judgment to determine which controlled 

substance they will prescribe to 

appropriately treat his or her patient’s 

medical condition, rather than make a 

determination based upon whether a 

triplicate prescription form is required 

by the State or by their employer’s 

policy to not prescribe schedule II 

controlled substances. 

f. Shift to the Black Market 

Several commenters stated that 

making HCPs schedule II controlled 

substances would limit access to HCPs, 

causing people to buy drugs on the 

street, including HCPs and heroin. 

DEA response: As discussed above, 

schedule II controlled substances are 

readily available for legitimate medical 

use. 

g. Monitoring Access 

A national advocacy group for cancer 

patients requested that the DEA ‘‘require 

monitoring plans and an annual report 

to Congress, in the event that HCPs are 

upscheduled, that assess the impact on 

access by patients with legitimate needs, 

as emphasized and urged by HHS’’ and 

to ‘‘adjust policy accordingly if it finds 

that access is impeded for patients who 

legitimately need HCPs for pain 

management.’’ 

DEA response: Once upscheduled the 

DEA will continue to monitor the 

diversion of HCPs. However, it is 

outside the scope of the DEA’s authority 

under the CSA to require monitoring 

plans or reports not authorized under 

the Act. 

4. Impacts on Unique Populations 

The DEA received several comments 

regarding the impact on patients who 

suffer from chronic pain, cancer, rare 

diseases, chronic and end-stage renal 

disease, as well as dental and surgical 

post-op patients, and rural residents. 

Many commenters also voiced concerns 

about possible effects of rescheduling on 

the elderly and disabled. Several 

commenters who are affected by chronic 

pain voiced a concern that the 

scheduling action will be a burden and 

make it harder for them to obtain their 

medicine. As a result, these commenters 

stated they will suffer solely because of 

the people that abuse HCPs. Another 

commenter stated that because of this 

burden, patients might start selfmedicating. One commenter said that 

practitioners will start prescribing drugs 

that are not as effective as HCPs, which 

could have a negative impact on 

patients mentally. One commenter 

stated that many cancer patients are in 

chronic pain, and because of this action, 

these patients will suffer as they cannot 

get their required medication. Others 

suggested post-op patients will have to 

suffer in pain after their surgeries 

because they will not be able to get the 

required medications from doctors on 

weekends. Several commenters stated 

that patients in rural areas who are 

currently seen by mid-level 

practitioners will need to drive an hour 

or more to be treated by a physician 

because their mid-level provider is not 

authorized to issue prescriptions for 

schedule II controlled substances. In 

addition, another commenter stated that 

many rural physicians are already 


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49672 Federal Register / Vol. 79, No. 163 / Friday, August 22, 2014 / Rules and Regulations 

13The Lewin Group. CMS Review of Current 

Standards of Practice for Long-Term Care Pharmacy 

Services: Long-Term Care Pharmacy Primer. 

Prepared for: Centers for Medicare and Medicaid 

Services. December 30, 2004. 

14 Gary Bazalo, MS, MBA, and Richard C. Weiss, 

MS, Managed Solutions, LLC. Measurement of 

Unused Prescription Drugs in Medicare Part D 

Nursing Stays. Jan. 12, 2011 at p. 6 (reporting 

survey results of consulting pharmacists conducted 

by the American Society of Consultant 

Pharmacists). 

15Marti A. Burton and Linda J. May Ludwig, 

Fundamentals of Nursing Care: Concepts, 

Connections & Skills 857 (2011); Norman V. Carroll, 

Ph.D., Michael T. Rupp, Ph.D., and David A. 

Holdford, Ph.D., Analysis of Costs to Dispense 

Prescriptions in Independently Owned, Closed-Door 

Long-Term Care Pharmacies, 20(3) JMCP 291 (2014) 

(76% of independently owned, closed-door 

pharmacies dispense 76% of doses to LTCFs in 28– 

31 day cycles). 

16Comment of American Society of Consultant 

Pharmacists on Docket No. DEA–316, ‘‘Disposal of 

Controlled Substances,’’ Feb. 19, 2013 available at 

http://www.regulations.gov/

#!documentDetail;D=DEA-2012-0008-0144. 

17U.S. Department of Health and Human 

Services, Office of Inspector General, OEI–07–09– 

00110, Nursing Facilities’ Employment of 

Individuals with Criminal Convictions (2011), 

available at http://oig.hhs.gov/oei/reports/oei-07- 

09-00110.pdf. 

18Mac McLean, Drug Theft Affects Care, The 

Bulletin, Sept. 8, 2013, available at http://

www.bendbulletin.com/news/1340250-153/drugtheft-affects-care. 

overbooked, which will cause rural 

patients to suffer in pain until they can 

get an appointment. Another commenter 

stated that rural patients have a tough 

time physically picking up handwritten 

prescriptions. Several commenters 

noted that the nearest doctor is more 

than an hour away and that having to 

drive that distance once a month to 

obtain HCPs is inconvenient. 

DEA response: Scheduling 

determinations are based on scientific 

determinations regarding the 

substance’s potential for abuse, its 

potential for psychological and physical 

dependence, and whether the substance 

has a currently accepted medical use in 

treatment in the United States. 21 U.S.C. 

812(b). The DEA may not reschedule, or 

refuse to reschedule, a drug or other 

substance based merely on the 

population it is intended or approved to 

treat. 

5. Impact on Long-Term Care Facilities 

(LTCFs) 

a. Treatment for Pain 

Many commenters, including two 

U.S. Senators, requested that the DEA 

closely examine possible impacts of 

rescheduling HCPs in the long-term care 

facility (LTCF) setting. Many 

commenters had concerns that placing 

HCPs into schedule II will impact a 

substantial number of LTCF residents 

and may result in untreated pain due to 

the lack of ready-access to other 

appropriate medications. For example, 

according to one commenter, ‘‘HCPs are 

the current, albeit less preferred 

alternative because of its combination 

with acetaminophen, which has to be 

restricted in older adults due to toxicity 

risk. However, long-term care providers 

have been forced to use HCPs as a 

substitute for Schedule II drugs’’ 

because they are more readily available 

for administration due to less restrictive 

handling requirements for controlled 

substances in lower schedules than 

schedule II. According to this same 

commenter, ‘‘the remaining pain care 

options still in schedule II are not as 

clinically effective in treating pain for 

the elderly as HCPs.’’ 

Two commenters stated that LTCF 

residents, especially post-surgical 

patients, need medications immediately 

and that obtaining prescriptions is not 

quick because most LTCFs do not 

operate with in-house doctors on site. 

DEA response: As previously 

discussed, scheduling determinations 

are based on scientific determinations 

regarding the substance’s potential for 

abuse, its potential for psychological 

and physical dependence, and whether 

the substance has a currently accepted 

medical use in treatment in the United 

States. 21 U.S.C. 812(b). Nonetheless, 

the DEA has promulgated many 

regulations to accommodate the unique 

circumstances of LTCF residents. For 

example, in accordance with 21 CFR 

1306.11(f), a prescription for a schedule 

II controlled substance for a resident of 

an LTCF may be transmitted by the 

practitioner or practitioner’s agent to the 

dispensing pharmacy by facsimile. In 

accordance with 21 CFR 1306.13(b), a 

prescription for a schedule II controlled 

substance written for a patient in an 

LTCF may be filled by the pharmacy in 

partial quantities to include individual 

dosage units. 

b. Request for Exemption for LTCFs 

Several commenters requested that 

the DEA waive/exempt LTCFs from the 

more restrictive schedule II handling 

requirements with respect to HCPs. 

Some commenters asserted that such a 

waiver/exemption would be justified 

based on their assertion that there is a 

lower risk of misuse, abuse, and 

diversion of HCPs in an LTCF setting as 

compared to other settings. One 

nationwide professional association 

stated that: 

[T]he long-term care setting has special and 

unique protections against diversion that are 

required by federal regulations and makes 

abuse and diversion very difficult and 

therefore, less likely to occur. * * * The 

regulatory standards and mandatory 

procedural checks in most cases make it 

difficult or impossible for any suspected 

abuse or diversion to occur over a sustained 

period of time. This makes diversion by staff 

difficult * * *. Other than anecdotal case here 

and there, there is no evidence that diversion 

is a systemic or frequent problem in SNF 

[skilled nursing facility] setting nor that the 

current proposed rule will correct [it]. 

This same commenter asserted that 

the ‘‘nursing home population is 

unlikely to be drug abusers’’ because 

‘‘[t]heir health conditions often make 

them bed-bound or otherwise 

dependent on nurses for the 

administration of their medications.’’ 

DEA response. Nursing home 

residents take, on average, eight to ten 

medications per day.13 At least 17% of 

those medications are unused.14

Controlled substance medications are 

often stored and administered in LTCF 

settings as monthly punch cards (a.k.a. 

‘‘bingo cards’’), and liquid controlled 

substances are often dispensed in largevolume packaging.15 16 In addition, a 

2011 report by the HHS Office of 

Inspector General found that almost all 

sampled nursing facilities employed one 

or more individuals with at least one 

criminal conviction, and nearly half of 

sampled nursing facilities employed 

five or more individuals with at least 

one conviction. Further, 44% of 

employees with convictions were 

convicted of crimes against property 

(e.g., burglary, shoplifting, writing bad 

checks).17 LTCFs are unique potential 

sources of diversion because the care 

provided to residents results in the 

accumulation of large amounts of 

controlled substances in a single, unregistered, relatively unsecure 

environment, where the disabled and 

elderly cannot defend themselves or 

adequately report what has happened. 

While focusing on the limited 

mobility of many residents in LTCFs as 

justification for why LTCFs should be 

able to adhere to less restrictive 

handling requirements for HCPs, 

commenters gave little consideration to 

potential diversion by employees, 

contractors, outside professionals, or 

visitors who may have access to their 

facilities. Direct access to controlled 

substances around a vulnerable 

population provides many opportunities 

for diversion of controlled substances, 

to the detriment of the LTCF residents 

as well as the general public. For 

example, the Oregon Aging and People 

with Disabilities Division, alone, 

investigated 29 instances of drug theft at 

17 different LTCFs in three counties, 

between 2009 and 2013.18 The average 

was 15.8 cases of medication theft per 

1,000 beds/units, with the most often 

stolen products being narcotic 


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19 Id. 

20 Id. 

21 Keith H. Berge, et. al., Diversion of Drugs 

Within Health Care Facilities, a Multiple-Victim 

Crime: Patterns of Diversion, Scope, Consequences, 

Detection, and Prevention, 87(7) Mayo Clin. Proc. 

674 (2012). 

22 Id. 

23Wes Bledsoe, Criminal Offenders Residing in 

Long-Term Care Facilities, 2(3) J Forensic Nurs. 142 

(2006). 

24E.g., ‘‘Preventing the Accumulation of Surplus 

Controlled Substances at Long Term Care 

Facilities,’’ 66 FR 20833, Apr. 25, 2001; ‘‘Role of 

Authorized Agents in Communicating Controlled 

Substance Prescriptions to Pharmacies,’’ 75 FR 

61613, Oct. 6, 2010. 

painkillers—such as HCPs.19 These 

medication thefts occurred in both large 

nursing homes and small adult foster 

homes.20

Although not addressing LTCFs 

directly, the Mayo Clinic has reported 

on the diversion of drugs from within 

health care facilities and the threat to 

public health and safety such actions 

cause.21 Those risks included risk to 

patients receiving adulterated or 

contaminated drugs in place of the 

diverted drug as well as the risk of 

receiving substandard care from 

addicted employees.22 The Oregon 

investigations also included reports of 

having a patient’s medication replaced 

with blood pressure medication—thus 

causing the combined risk of not 

receiving proper medication with the 

risk of overdose of another medication. 

The most cursory of searches readily 

reveals multiple allegations reported in 

the news of thefts of controlled 

substances in nursing homes. For 

example, in 2012 six nursing home 

employees in Oklahoma were charged 

with operating a drug ring out of the 

facility for whom they were employed. 

Charges Filed in Nursing Home Drug 

Theft, KWGS News, July 5, 2012, 

available at http://publicradiotulsa.org/

post/charges-filed-nursing-home-drugtheft. The Oklahoma Bureau of 

Narcotics (OBN) reported that 9,000 

dosage units of controlled substances 

had been diverted from the facility by 

the nursing home employees, 8,400 of 

which involved hydrocodone. Press 

Release, Oklahoma Bureau of Narcotics 

and Dangerous Drugs Control (July 5, 

2012) (on file with the Oklahoma 

Bureau of Narcotics); Oklahoma Nursing 

Home Employees Accused of Running 

Drug Ring: State v. Alexander, 15 No. 1 

Westlaw Journal Nursing Home 4 

(2012). The spokesman for OBN stated 

that employees would call in fraudulent 

prescriptions of hydrocodone for 

residents: ‘‘These residents had not been 

prescribed the Hydrocodone by doctors. 

There is no evidence that any resident 

was deprived of their legitimate 

medications. Evidence suggests some of 

the employees would personally use 

small amount of the diverted 

medication, but the majority of the 

fraudulent drugs were sold on the 

streets * * *.’’ Id. 

Criminal acts at LTCFs ‘‘often go 

undocumented, are seldom reported to 

law enforcement, and are rarely 

prosecuted.’’23 Even so, theft and 

diversion at LTCFs likely occurs on a 

local level, and when reported, are 

investigated and prosecuted at the local 

level. The diversion of controlled 

substances at LTCFs, whether widespread or discrete events, are a threat to 

the public health and safety, especially 

considering that such activity poses a 

real and direct threat to a vulnerable 

population. Public health and safety 

threats to disadvantaged, 

underrepresented, and historically 

vulnerable populations, including the 

elderly and mentally, physically, and 

emotionally/behaviorally disabled, 

disordered, or challenged, must be taken 

that much more seriously by those 

public bodies charged with protecting 

the public health and welfare. The DEA 

further notes that the misuse, abuse, and 

diversion of controlled substances, 

including pharmaceutical controlled 

substances, are not limited to any 

particular age group or functional level. 

c. Transmission Method for 

Prescriptions 

One commenter requested two 

changes to the transmittal methods for 

prescriptions: (1) Allow a prescribing 

practitioner to call in to the pharmacy 

an order for a limited supply, up to a 72 

hour quantity, of a schedule II 

medication for an LTCF patient in an 

emergency situation, under existing 

regulations for schedule III–V controlled 

substances; and (2) Allow a 

practitioner’s agent, acting on behalf of 

a prescribing practitioner, to call in the 

prescribing practitioner’s verbal order 

for a small (72 hour) supply of a 

schedule II medication for an LTCF 

patient in an emergency situation, under 

existing regulations for schedule III–V 

controlled substances. 

DEA response: The CSA requires that 

prescriptions for schedule II controlled 

substances be written, except in 

emergency situations as defined by the 

HHS. 21 U.S.C. 829(a). Pursuant to 21 

CFR 1306.11(d), in the case of an 

emergency situation, a pharmacist may 

dispense a schedule II controlled 

substance upon receiving oral 

authorization from a prescribing 

individual practitioner provided that 

the quantity prescribed and dispensed is 

limited to the amount adequate to treat 

the patient during the emergency period 

(dispensing beyond the emergency 

period must be pursuant to a written 

prescription signed by the prescribing 

individual practitioner). 

The DEA recognizes the unique 

challenges and issues pertaining to 

handling and using controlled 

substances at LTCFs and has previously 

addressed these issues within the limits 

of the CSA.24 For example, a 

prescription for a schedule II controlled 

substance for an LTCF resident may be 

transmitted by the practitioner or the 

practitioner’s agent to the dispensing 

pharmacy by facsimile. 21 CFR 

1306.11(f). In addition, a prescription 

for a schedule II controlled substance 

for an LTCF resident may be filled in 

partial quantities to include individual 

dosage units. 21 CFR 1306.13(b). 

It is emphasized that a DEA registered 

practitioner may not delegate to a nurse, 

a pharmacist, or anyone else, his or her 

authority to make a medical 

determination whether to prescribe a 

particular controlled substance. Note 

that the practitioner remains responsible 

for ensuring that the prescription 

conforms in all essential respects to the 

law and regulations, 21 CFR 1306.05(f). 

75 FR 61613, 61614, Oct. 6, 2010. This 

requires the practitioner alone to 

determine on a prescription by 

prescription basis whether the 

prescription is supported by a legitimate 

medical purpose and that all the 

essential elements of the prescriptions 

are met. 

d. E-Prescribing 

One commenter requested that the 

DEA ‘‘promote the adoption of eprescribing by requiring facilities and 

their respective pharmacy suppliers to 

allow physicians to electronically 

prescribe controlled substances 

consistent with the law and appropriate 

safeguards.’’ 

DEA response: This request is outside 

the scope of this rulemaking. 

e. Emergency Kits 

One commenter requested that the 

DEA ‘‘promote adoption of consistent 

and effective laws and policies across 

all states for the content and use of 

emergency kits (E-Kits) in the PA/LTC 

setting.’’ 

DEA response: This request is outside 

the scope of this rulemaking. 

6. Abuse Prevention 

Commenters raised concerns that, 

despite the scheduling of drugs, 

individuals will always find substances 

to abuse. These commenters argued that 

the proposed schedule II controls for 


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HCPs will not address or stop the abuse 

of HCPs because other schedule II 

controlled substances such as 

oxycodone products are highly abused 

and diverted. 

DEA response: The cycle of abuse 

between licit and illicit opioids, abuse 

of licit and illicit non-narcotic 

prescription drugs, and continued abuse 

of schedule I controlled substances such 

as LSD demonstrates that what 

individuals and communities are facing 

is not a problem specific to HCPs. 

Rather, it is an addiction problem. 

Heroin use and prescription drug abuse 

are both addictions that begin with use 

and are sustained and promoted through 

increased trafficking. This serious 

public health problem can be addressed 

by education, appropriate screening and 

treatment, recovery, support, and 

enforcement. These initiatives can be 

effective regardless of whether the 

problem is fed by heroin or prescription 

drugs, including HCPs, and the DEA 

supports all of these initiatives to 

address both prescription drug misuse 

and abuse and heroin use. 

The problem of prescription drug 

abuse is fueled due to a combination of 

excessive prescribing, drug availability 

through friends and family, rogue pain 

clinics, practitioners who prescribe 

pharmaceutical controlled substances 

without legitimate medical purpose or 

outside the usual course of professional 

practice, pharmacies that dispense 

illegitimate prescriptions, and supply 

chain wholesalers and manufacturers 

that fail to provide effective controls 

and procedures to guard against 

diversion—all of which fuel illicit 

access at the expense of the public 

health and safety. 

A balanced drug control strategy, one 

that includes strong enforcement, 

education, prevention, and treatment 

components, can make significant 

progress in protecting our nation from 

the dangers of drug abuse. 

The DEA’s enforcement responsibility 

as it pertains to drugs and other 

substances is clearly delineated in 

Federal law. Pursuant to 21 U.S.C. 

811(a), the CSA authorizes the DEA, 

under authority delegated by the 

Attorney General, to add to a schedule 

any drug or other substance if it is found 

that the drug or other substance has a 

potential for abuse, and makes with 

respect to such drug or other substance 

the findings prescribed by 21 U.S.C. 

812(b). As such, the legal system 

established by Congress specifically 

accounts for new substances to be added 

to the list of controlled substances 

without regard to the number of 

substances already controlled. See also 

21 U.S.C. 812(a) (‘‘Such schedules shall 

initially consist of * * *’’ (emphasis 

added)). 

The dynamic structure constructed in 

the establishment of the schedules of 

controlled substances takes into 

consideration that the conclusions 

reached under each of the eight-factors 

specified under 21 U.S.C. 811(c) may 

change over time. Scientific knowledge 

about a drug or substance grows, 

pharmacological knowledge increases, 

history and current patterns of abuse 

change, etc. The CSA scheduling 

protocols also take into account that 

new drug applications for drugs with 

abuse potential are submitted to and 

approved by the FDA as well as that 

clandestine chemists attempt to 

manipulate the molecular structures of 

controlled substances to create synthetic 

drugs that would have the same 

pharmacologic properties of a controlled 

drug, but not expose the chemist or 

distributor to criminal violations. The 

CSA, however does not only account for 

one-time scheduling determinations 

regarding the control of drugs and other 

substances. In addition to the initial 

control of drugs and other substances to 

schedules, the CSA likewise takes into 

account and provides for the transfer of 

a drug or other substance between 

schedules, or for a drug or other 

substance to be removed entirely from 

the schedules. 21 U.S.C. 811(a) and (b). 

Nevertheless, the DEA disagrees that 

control of HCPs in schedule II will not 

decrease abuse of HCPs. Control of 

HCPs in schedule II will result in 

increased monitoring of these drugs as 

well as increased safeguards for 

legitimate prescriptions. 

7. Diversion Prevention 

Commenters also questioned whether 

moving HCPs to schedule II would 

reduce diversion of HCPs. These 

commenters argued that the proposed 

schedule II controls for HCPs will not 

address or stop the diversion of HCPs 

because other schedule II controlled 

substances such as oxycodone products 

are still diverted despite their schedule 

II status. 

DEA response: The DEA disagrees 

that control of HCPs as schedule II 

controlled substances will not decrease 

their diversion. Control of HCPs into 

schedule II will result in increased 

monitoring of these drugs as well as 

increased safeguards for legitimate 

prescriptions. 

8. Responsibilities of Pharmacists 

The DEA received many comments, 

from pharmacists, physicians, ultimate 

users, and the general public, who were 

concerned that the increased 

administrative burden on pharmacists 

that might occur as a result of moving 

HCPs into schedule II would cause 

pharmacists to devote time to the 

administrative burdens rather than on 

patient counseling and safety. 

Commenters stated that the 

administrative burden would be greatly 

increased in the pharmacy setting 

because: separate prescriptions would 

have to be entered for every HCP; 

pharmacists would have to count the 

prescriptions, as technicians are not 

legally allowed to do so in some States; 

inventories would be required of all 

HCPs; and increased workload 

associated with recordkeeping 

requirements (i.e., DEA Form 222). 

DEA response: The processes and 

procedures associated with dispensing a 

controlled substance are not relevant 

factors to the determination of whether 

a substance should be controlled or 

under what schedule a substance should 

be placed if it is controlled. See 21 

U.S.C. 811 and 812. 

9. Requirements Applicable to 

Manufacturers and Distributors 

a. Effective Date 

Several of the comments submitted by 

members of industry (manufacturers, 

wholesale distributors, veterinary 

distributors, retail pharmacies), and/or 

trade associations representing them, 

focused on the timeframe for 

implementation of various handling 

requirements. A national trade 

association comprised of manufacturers 

and distributors of generic 

pharmaceutical products requested that 

the DEA ‘‘allow sufficient time for all 

parts of the supply chain to integrate the 

new requirements into their business 

operations.’’ Similar requests were also 

posed by an individual manufacturer of 

HCPs, a wholesale distributor, and a 

retail pharmacy/mail pharmacy service 

provider, each who proposed a blanket 

six month delay before a final rule 

would go into effect. A national trade 

association comprised of distributors 

requested that the DEA allow at least 12 

to 24 months, with opportunity for 

additional extension for individual 

registrants on an as needed basis, from 

the effective date of the final rule to 

allow for changes to facilities, policies 

and procedures. The national trade 

association requested that during the 

interim period registrants be allowed to 

continue to hold HCPs in cages rather 

than to be immediately required to place 

these items in vaults. Specifically, the 

association proposed that the DEA 

‘‘[r]ecognize a registrant’s compliance 

with the physical security requirements 

if the registrant has, by the 

implementation date of the storage 


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25SAMHSA, Center for Behavioral Health 

Statistics and Quality, Data Review, Associations of 

Nonmedical Pain Reliever Use and Initiation of 

Heroin Use in the United States. August 2013 

available at http://www.samhsa.gov/data/2k13/ 

DataReview/DR006/nonmedical-pain-reliever-use2013.htm. 

26Hedegaard H, Chen L–H, and Warner M. Quick 

Stats: Rates of Drug Poisoning Deaths Involving 

Heroin, * by Selected Age and Racial/Ethnic 

Groups—United States, 2002 and 2011, MMWR 

2014; 63:595. 

requirements resulting from a 

rescheduling decision, submitted to the 

agency plans, blueprints, sketches, or 

other materials, including but not 

limited to signed contracts with 

contractors to implement any proposed 

physical security changes to the 

registrant’s premises, and has otherwise 

been and continues to be in compliance 

with physical security requirements 

pursuant to [21 CFR 1301.72] for HCPs 

subject to this rescheduling decision as 

of the date prior to the effective date of 

a rescheduling decision.’’ The national 

trade association additionally requested 

that the DEA provide specifics regarding 

the ‘‘process for submission of the 

materials demonstrating the vault 

construction plans’’ and how they might 

be able to ‘‘demonstrate compliance in 

lieu of vault construction completion.’’ 

DEA Response: In accordance with 

the Administrative Procedure Act, 

generally, DEA scheduling actions are 

effective 30 days from the date of 

publication of the final rule in the 

Federal Register. 5 U.S.C. 553(d). In 

order to ensure the continued 

availability of HCPs for legitimate 

medical use, while also ensuring they 

are not subject to misuse, abuse, and 

diversion, the DEA is establishing an 

effective date 45 days from the date of 

publication of this final rule. This 45- 

day period is a reasonable amount of 

time for registrants to comply with the 

handling requirements for a schedule II 

controlled substance and was 

established upon a full consideration of 

the totality of circumstances specific to 

HCPs. 

The DEA understands that 45 days to 

implement all schedule II handling 

requirements may be perceived as short 

by some distributors. While the DEA 

acknowledges that the supply chain will 

need to plan and coordinate efforts, and 

may even need to temporarily modify 

existing ordering and inventory 

management practices, the DEA is 

required to consider the risk of 

diversion and risk to public health and 

safety of U.S. residents. 

As summarized in the NPRM and the 

DEA presentation at the January 24, 

2013, public DSaRM meeting, available 

at http://www.fda.gov/downloads/ 

advisorycommittees/committeesmeeting

materials/drugs/drugsafetyand

riskmanagmentadvisorycommittee/ 

ucm346941.pdf, and discussed in detail 

in the supporting eight-factor analyses, 

HCPs are being abused with adverse 

effects both individually and to the 

public health and safety, accordingly, it 

should be placed into schedule II as 

soon as practicable. Prescription drug 

abuse refers to the intentional misuse of 

a medication by using more than 

medically indicated in order to feel the 

drug’s psychoactive effects and/or using 

the drug in a manner that is not 

medically indicated. Prescription drug 

abuse has increased exponentially in the 

last 15 years and is the Nation’s fastest 

growing drug problem. Factors 

including excessive prescriptions, drug 

availability through friends and family, 

Internet trafficking, rogue pain clinics, 

pharmacies that dispense illegitimate 

prescriptions, and failed safeguards by 

wholesalers and manufacturers to guard 

against diversion have all contributed to 

the prescription drug abuse problem. 

The increase in prescription drug 

abuse has also been attributed to ease of 

obtaining the drug and the 

misconception that abusing prescription 

drugs is much safer than using and 

abusing street drugs. According to the 

2012 Partnership Attitude Tracking 

Study (PATS), 43% of teenagers believe 

that prescription medications are 

‘‘easier to obtain’’ than illegal drugs. In 

addition, the 2012 PATS also reported 

that 27% of teens believe that misusing 

or abusing prescription drugs is ‘‘safer’’ 

than using street drugs. Some of the 

increased demand for prescription 

opioid painkillers is from people who 

use them non-medically (using drugs 

without a prescription or just for the 

high they cause), sell them, or get them 

from multiple prescribers at the same 

time (CDC Vital Signs, July 2014, Opioid 

Painkiller Prescribing, Where You Live 

Makes a Difference). 

According to the 2012 National 

Survey on Drug Use and Health 

(NSDUH), approximately 2.6% or 6.8 

million people ages 12 and older are 

nonmedical users of prescription drugs. 

Abuse of opioid drugs, including HCPs, 

can lead to addiction, respiratory 

depression, and death. There were more 

than 16,000 deaths due to abuse of 

opioid drugs including HCPs in 2010. 

That is more than 1,333 people dying 

each month. According to the CDC, 

38,329 people died from a drug 

overdose in the United States in 2010. 

Of these deaths, 22,134 people or 60% 

involved prescription drugs. Seventyfive percent of the prescription drug 

overdose deaths (16,651 people) were 

due to opioid drugs primarily 

containing oxycodone, hydrocodone, or 

methadone. 

Abuse of prescription drugs is 

particularly alarming since data are 

strongly indicating that prescription 

opioid drug abuse can lead to heroin 

abuse.25 Specifically, the data show that 

the population with the highest rate of 

heroin initiation was that population 

with prior nonmedical pain reliever use. 

The rate of heroin initiation among prior 

nonmedical pain reliever users was 

approximately 19 times greater than 

those who did not have such prior use. 

The rate of heroin initiation increased 

with increases in the frequency of past 

year nonmedical pain reliever use. Id. 

The DEA has long held that increased 

heroin use is driven primarily by an 

increase in the misuse and abuse of 

prescription opioid drugs, particularly 

HCPs. The DEA’s investigations indicate 

that the cost of prescription opioid 

drugs on the street may be as high as 

$80.00 per tablet and makes it difficult 

for teens and young adults to purchase 

drugs in support of their addiction. 

Therefore, abusers of prescription 

opioid drugs may resort to using heroin, 

a much cheaper alternative that 

produces similar euphoric effects, to 

keep the drug seeker/abuser from 

experiencing painful withdrawal 

symptoms. According to the most recent 

NSDUH, there were 335,000 heroin 

users in 2012, which is more than 

double the number in 2007 (161,000). In 

the decade from 2002 to 2011, the 

annual number of drug poisoning deaths 

involving heroin doubled, from 2,089 

deaths in 2002 to 4,397 deaths in 

2011.26

HCPs are the most prescribed drug in 

the United States. Production of HCPs 

has increased from 15,359 kilograms in 

1998 to 63,338 kilograms in 2012 (IMS, 

2014). Increased production of HCPs is 

directly due to the increased 

prescription of these drugs to treat and 

alleviate pain. Even though there is 

legitimate use of HCPs, data indicate 

that a considerable population misuse 

HCPs. The National Poison Data System 

(NPDS) reported during the period of 

2006–2012, that 45.4% of the total 

exposures to HCPs were considered 

intentional exposures, a surrogate to 

usage for abuse or misuse. The high 

percentage of HCPs for misuse supports 

that HCPs are contributing to 

prescription opioid drug abuse and may 

consequently lead to heroin abuse and 

death. 

In order to prevent continued misuse, 

abuse and diversion, it is necessary to 

set an effective date for this scheduling 

action, including security and labeling 

requirements, with all reasonable haste. 


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27NAICS 424210—Drugs and druggists’ sundries 

merchant wholesalers; Merchant wholesalers, 

except manufacturers’ sales branches and offices. 

28The inventory turnover ratio of 11.3 was 

calculated by dividing the 2007 ‘‘cost of goods 

sold’’ for the industry of $280,481,051,000 by the 

average end-of-year 2006 and 2007 total inventories 

of $24,782,835,000. 

29 IMS Health, National Sales Perspective TM

(NSP). 

After careful consideration of the risk to 

the U.S. public health and safety related 

to the diversion and abuse of HCPs, the 

DEA believes the 45-day effective date 

is reasonable. 

From the 2007 Economic Census, the 

DEA estimates that the inventory 

turnover ratio for the industry 27 is 

approximately 11.3.28 The inventory 

turnover ratio represents the number of 

times the inventory sells (turns) in a 

year. The 11.3 inventory turnover ratio 

equates to an average of 32 days to sell 

inventory. The 11.3 turnover ratio is 

consistent with that of large distributors 

where financial information was 

publicly available and reviewed. The 

inventory turnover ratio is a reasonable 

estimate for the entire industry and all 

products under the circumstances. 

Publicly reviewed data show that about 

85% of all revenues (an indirect 

indicator of dosage units moved) from 

drug distribution in the United States 

come from three public wholesalers, 

each with annual revenue in the 

billions. The DEA additionally notes 

that many regional and specialist 

pharmaceutical wholesalers have been 

acquired by the largest three 

distribution companies. Because the 32 

days to sell inventory is an average 

based on industry-wide Census data, it 

is possible for an individual company 

and/or product line to experience a 

shorter or longer time to sell. 

Since HCPs are the most prescribed 

opioid drugs in the United States, with 

over 137 million prescriptions 

dispensed in 2013,29 the DEA expects 

distributors to continue to receive and 

distribute HCPs at high volume and 

with regularity; thus, anticipating 

shorter than average days to sell HCPs 

than the overall industry average ratio. 

In other words, the very high volume of 

sales indicates that HCPs are moving 

very quickly through the supply chain 

to meet demand, indicating high 

turnover and low inventory. However, 

to accommodate those manufacturers 

and distributors that have lower than 

average industry turnover ratio, the DEA 

is establishing an effective date of this 

final rule, including labeling and 

packaging requirements, 45 days from 

the date of publication. Based on the 

available information, and the lack of 

specific information regarding 

manufacturer and distributor inventory 

practices with respect to HCPs, the DEA 

believes this will provide a reasonable 

time for distributors to sell existing 

stock with pre-control labeling and 

packaging (C–III) and to stock inventory 

with post-control labeling and 

packaging (C–II). 

The DEA anticipates manufacturers to 

begin developing inventory of HCPs 

with schedule II labels prior to the 

effective date of the rule to have stock 

ready to be distributed upon effect of 

this rule. The DEA estimates that 45 

days is a reasonable amount of time for 

manufacturers and distributors to 

deplete existing inventory of HCPs. The 

packaging and labeling requirements for 

manufacturers and distributors do not 

apply to dispensers. Dispensers with 

HCPs in commercial containers labeled 

as schedule III may continue to dispense 

these HCPs after the implementation of 

this rule. 

The DEA believes that HCPs labeled 

as C–III can be exchanged with HCPs 

containing new labels at nominal cost. 

The rule allows this exchange in a 

similar manner to the return of expired 

controlled substances authorized under 

existing regulations. Since 

manufacturers are expected to have 

ready-inventory of HCPs with new 

labels, exchanges are expected to occur 

without delay. In this rule, the DEA is 

allowing transfers of HCPs labeled as 

schedule III to be returned in exchange 

for HCPs labeled as schedule II without 

the requirement for procurement quota. 

Therefore, the DEA believes HCP 

manufacturers and distributors can 

reasonably make the necessary labeling 

changes and have inventory to meet the 

demands of customers. 

The DEA acknowledges distributors 

may need to make some modifications 

to their inventory management system 

and operating procedures. However, 

these changes are expected to be 

procedural changes with only nominal 

impact on the burden created by the 

activities. For example, a distributor 

will need to receive, unpack, record the 

product in inventory, store, accept 

orders, and ship out to customers. These 

are all activities that occur regardless of 

the control status of HCPs. The 

anticipated changes may be a 

modification to the inventory 

management system and possible 

expansion of storage space (vaults). 

The DEA has carefully considered the 

security requirements for compliance 

with this rule. As confirmed by the 

national trade association comprised of 

distributors, current distributors of 

HCPs are DEA registrants with existing 

controlled substance storage facilities 

that comply with DEA regulations. The 

DEA believes the DEA regulations 

provide flexibility that enables the 

supply chain to quickly implement the 

new rule without delay or significant 

cost. 

Modifications necessary for physical 

security compliance will be a one-time 

modification primarily to provide for 

appropriate storage. The DEA 

understands that handlers of HCPs may 

also need to make modifications to their 

current security procedures for 

compliance. To a lesser extent, there 

may be necessary modifications to 

operating procedures, staff training, and 

amendments to suspicious order 

monitoring systems. However, due to 

the high diversion and abuse profile of 

HCPs, it is reasonably likely that most, 

if not all, manufacturers and distributors 

already provide controls and procedures 

to guard against theft and diversion of 

HCPs. That is, due to the high diversion 

potential of HCPs, most, if not all, 

manufacturers and distributors likely 

already have operating procedures (e.g., 

suspicious order monitoring systems, 

staff training) to guard against theft and 

diversion of HCPs, thereby necessitating 

minimal (if any) changes to these nonphysical security controls. The DEA 

believes that a 45-day period will 

provide handlers of HCPs a reasonable 

amount of time to implement any onetime modifications to comply with the 

DEA regulations. Registrants are familiar 

with the applicable security regulations, 

and already have systems in place with 

respect to other schedule II controlled 

substances. Accordingly, it is reasonable 

to revise operating procedures, amend 

monitoring systems, and train staff with 

respect to HCPs as schedule II 

controlled substances within the 45-day 

compliance timeframe. 

The DEA has specifically chosen not 

to stagger implementation dates of 

handling requirements for the reasons 

stated herein. Also, different 

implementation dates leads to confusion 

and inconsistent application of the law, 

particularly with respect to 

rescheduling a drug from schedule III to 

schedule II. Schedule II and III 

substances are subject to different 

recordkeeping and reporting 

requirements, for example, and 

registrants would have difficulty 

keeping and maintaining records and 

inventories. Also, if one registrant 

category were to handle HCPs as 

schedule III controlled substances while 

another registrant category were to 

handle HCPs as schedule II controlled 

substances, it would be confusing (for 

the registrants and for enforcement 

authorities), particularly with respect to 

the relevant transaction records. 


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The DEA strongly advises registrants 

to work closely with their local DEA 

office regarding submission of materials, 

storage containers, all applicable 

security requirements, and any 

necessary modifications due to 

compliance with this rule. 21 CFR 

1301.71(d); see also 21 CFR 1307.03. 

After 45 days from the date of 

publication, HCPs will be subject to 

schedule II security requirements and 

must be handled and stored pursuant to 

21 U.S.C. 821 and 823 and in 

accordance with 21 CFR 1301.71– 

1301.93. 

b. Distribution of C–III Labeled HCPs 

Post Implementation 

The comments of a manufacturer, 

wholesale distributor, and national 

trade association comprised of 

distributors, each discussed their 

concerns about how commercial 

containers of HCPs labeled as ‘‘C–III’’ 

would be handled. The manufacturer 

requested that the DEA allow at least 

nine months from the date of issuance 

of the final rule for distribution of 

commercial products labeled as ‘‘C–III’’ 

in order to allow time for the supply 

chain to be restocked. This same 

company also requested that the DEA 

clarify the ability of reverse distributors 

and other registrants to continue to 

handle HCPs labeled as ‘‘C–III’’ for at 

least three months after the expiration 

date of the substance, in order to 

account for handling HCPs for purposes 

of destruction. The wholesale 

distributor wrote in favor of immediate 

implementation of the use of DEA Form 

222, while allowing HCPs already 

labeled as C–III to be continuously 

distributed until depleted. 

DEA response: For the reasons 

discussed in response to the previous 

comments, as of the effective date of the 

final rule, pursuant to 21 U.S.C. 821, 

825, and 958(e) and in accordance with 

21 CFR 1302.03, manufacturers are 

required to print upon the labeling of 

each commercial container of HCPs they 

distribute the designation of HCPs as 

‘‘C–II.’’ It shall be unlawful for 

commercial containers of HCPs to be 

distributed downstream without bearing 

the label properly identifying them as 

schedule II controlled substances in 

accordance with 21 CFR part 1302. As 

clearly stated in 21 CFR 1302.05, ‘‘[a]ll 

labels on commercial containers of, and 

all labeling of, a controlled substance 

which either is transferred to another 

schedule or is added to any schedule 

shall comply with the requirements of 

§ 1302.03, on or before the effective date 

established in the final order for the 

transfer or addition.’’ Accordingly, the 

DEA is requiring that commercial 

containers of HCPs distributed on or 

after 45 days from the date of 

publication of the final rule be labeled 

as ‘‘C–II’’ and be packaged in 

accordance with 21 CFR part 1302. 

A distribution of HCPs on or after the 

effective date of this final rule, is a 

distribution of a schedule II controlled 

substance, and a DEA Form 222 is 

required to be used to conduct the 

transfer in accordance with 21 CFR 

1305.03. A registrant may transfer 

commercial containers of HCPs labeled 

as ‘‘C–III’’ upstream on or after the 

effective date of the final rule, with 

utilization of a DEA Form 222 as 

required in accordance with 21 CFR 

1305.03. Utilization of the DEA Form 

222 ensures that schedule I and II 

controlled substances are accounted for, 

and allows for the detection and 

prevention of diversion. 

Additionally, as discussed previously 

in more detail in the Economic Impact 

Analysis, the DEA believes that any 

manufacturer or distributor that requires 

more than 45 days to sell HCP inventory 

under normal circumstances can make 

minor modifications to ordering and 

stocking procedure for a transitional 

period to meet the established effective 

date. Distributors also have the option of 

returning excess stock of HCPs labeled 

as ‘‘C–III’’ to the manufacturer, or the 

manufacturer’s authorized agent, as 

authorized by this final rule, or in 

accordance with 21 CFR 1307.12. 

The DEA takes this opportunity to 

clarify that the regulation pertaining to 

labeling of commercial containers 

applies to distributions by 

manufacturers and distributors. The 

DEA does not regulate the labeling and 

packing of commercial containers of 

controlled substance downstream of 

distributors. 

c. Exemption of Distributors and 

Manufacturers 

A national trade association 

comprised of distributors and an 

individual manufacturer of HCPs 

requested that the DEA provide an 

exemption from the schedule II 

controlled substance security 

requirements for manufacturers and 

distributors of HCPs. Both commenters 

based this request on the assertion that 

manufacturers and distributors are not a 

documented significant source of 

diversion. 

DEA response: Scheduling 

determinations are based on scientific 

determinations regarding the drug or 

other substance’s potential for abuse, its 

potential for psychological and physical 

dependence, and whether the drug or 

other substance has a currently accepted 

medical use in treatment in the United 

States. 21 U.S.C. 812(b). The DEA may 

not reschedule, or refuse to reschedule, 

a drug or other substance based on 

purported sources of diversion. One of 

the primary functions of the DEA 

Diversion Control Program is to ensure 

that registrants are in compliance with 

the safeguards inherent in the CSA. This 

proactive approach is designed to 

identify and prevent the large scale 

diversion of controlled substances and 

listed chemicals into the illicit market. 

Manufacturers and distributors pose the 

greatest potential for large-scale 

diversion. As discussed in the final rule, 

‘‘Controlled Substances and List I 

Chemical Registration and 

Reregistration Fees,’’ there is great risk 

and grave consequences associated with 

the quantity and purity of controlled 

substances and/or chemicals with each 

manufacturer at this point in the closed 

system. 77 FR 15234, 15241, March 15, 

2012. Accordingly, non-practitioners 

such as manufacturers and distributors 

must adhere to very stringent physical 

security requirements. The DEA has 

determined that there is a high potential 

for abuse of HCPs, and this, inter alia, 

requires that HCPs be controlled in 

schedule II. The physical security 

requirements applicable to schedule II 

controlled substances will provide 

secure controls to detect and prevent 

diversion of HCPs. Accordingly, the 

DEA declines to exempt manufacturers 

or distributors from the physical 

security requirements applicable to 

HCPs upon control in schedule II. 

However, the DEA encourages 

manufacturers and distributors to work 

closely with their local DEA office 

regarding submission of materials, 

storage containers, all applicable 

security requirements, and any 

necessary modifications due to 

compliance with this rule. 21 CFR 

1301.71(d); see also 21 CFR 1307.03. 

10. Economic Impact 

a. Cost to Ultimate Users 

Several commenters stated that the 

DEA had failed to fully take into 

account costs and impacts to ultimate 

users in its economic impact analysis. 

DEA response: Scheduling decisions 

are based on scientific determinations 

regarding the drug or other substance’s 

potential for abuse, its potential for 

psychological and physical dependence, 

and whether the drug or other substance 

has a currently accepted medical use in 

treatment in the United States. 21 U.S.C. 

812(b). The DEA may not reschedule, or 

refuse to reschedule, a drug or other 

substance based on the population it is 

intended or approved to treat, or 

potential impacts thereon. However, as 


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discussed above, scheduling or 

rescheduling a drug does not hinder 

legitimate access to needed medication. 

For the reasons discussed earlier in this 

document, the DEA does not believe 

that there will be significant impacts, if 

any, on ultimate users associated with 

this rulemaking. 

b. Cost of Physical Security 

Several commenters suggested that it 

would cost millions of dollars for 

distributors and retail pharmacies to 

obtain new vaults or increase the size of 

their vaults to accommodate for the 

influx of HCPs. Another commenter 

suggested that only a limited number of 

firms can build vaults that meet the 

requirements of the DEA and because of 

this, constructing a vault would be time 

consuming and costly. 

DEA response: Scheduling 

determinations are based on scientific 

determinations regarding the drug or 

other substance’s potential for abuse, its 

potential for psychological and physical 

dependence, and whether the drug or 

other substance has a currently accepted 

medical use in treatment in the United 

States. 21 U.S.C. 812(b). The DEA may 

not reschedule, or refuse to reschedule, 

a drug or other substance based on 

economic impacts. 

Retail pharmacies are not required by 

the CSA or DEA regulations to place 

schedule II controlled substances in a 

vault or safe. In accordance with 21 CFR 

1301.75(b), pharmacies may disperse 

schedule II controlled substances 

throughout their stock of noncontrolled 

substances in such a manner as to 

obstruct the theft or diversion of the 

controlled substances. 

11. Proposed Alternatives 

a. Establishment of a National 

Prescription Drug Monitoring Program 

(PDMP) 

Several commenters requested the 

implementation of a national 

prescription drug monitoring program 

(PDMP) either as an alternative to 

rescheduling HCPs, or possibly in 

addition thereto, as a means of 

curtailing doctor shopping and 

preventing abuse. For example, one 

commenter noted that ‘‘Despite broad 

consensus that prescribers and public 

health officials need these essential 

tools modernized to support clinical 

decision-making and identify state and 

regional patterns of abuse and diversion, 

state-based PDMPs continue to have 

limited financial resources and 

interoperability * * *.’’ Another 

commenter stated that PDMPs ‘‘can be 

improved by creating incentives for 

inter-state connectivity, making data 

available in a more timely fashion and 

unifying standard submissions.’’ 

DEA response: One of the best ways 

to combat the rising tide of prescription 

drug abuse is the implementation and 

use of PDMPs. PDMPs help prevent and 

detect the diversion and abuse of 

pharmaceutical controlled substances, 

particularly at the retail level where no 

other automated information collection 

system exists. PDMPs are valuable tools 

for prescribers, pharmacists, and law 

enforcement agencies to identify, detect, 

and prevent prescription drug abuse and 

diversion. 

The DEA supports and encourages the 

development and maintenance of 

PDMPs at the State level. Currently, 48 

States have an operational PDMP 

(meaning collecting data from 

dispensers and reporting information 

from the database to authorized users). 

One State has enacted legislation 

enabling the program to come online; 

Missouri has no state PDMP. As of 

February, 2014, only 16 States mandate 

usage of PDMP. Of those 16 States, 6 

States mandate its usage in designated 

circumstances and 10 mandate its use in 

broader circumstances. Currently, 26 

States have adopted the Interconnect 

platform for data sharing. 

The DEA agrees with these 

commenters that the use of PDMPs is 

challenging across State lines because 

interconnectivity is limited. 

Interconnectivity or a nationwide 

system would help deter and detect 

drug traffickers and drug seekers, many 

of whom willingly travel hundreds of 

miles to gain easy access to 

unscrupulous pain clinics and 

physicians. 

The Department has supported the 

development of PDMPs through the 

Harold Rogers Prescription Drug 

Monitoring grant program, distributing a 

total of over $87 million from FY 2002 

to FY 2014, including $7 million in FY 

2014. The purpose of this program is to 

enhance the capacity of regulatory and 

law enforcement agencies to collect and 

analyze controlled substance 

prescription data. It focuses on 

providing help for States that want to 

establish a PDMP or expand an existing 

PDMP. In 2012, the Department 

provided further policy guidance on 

data sharing efforts among State PDMPs, 

a critical aspect of the program. 

b. Better Utilization of Currently 

Established State PDMPs Already in 

Existence 

One commenter suggested that State 

monitoring systems should be used in a 

way to specifically identify usage of 

HCPs in the respective State. The 

commenter stated that this would allow 

each State to develop its own methods 

for handling the abuse of HCPs problem 

rather than making a nationwide rule 

rescheduling HCPs to schedule II. 

Another commenter suggested that 

practitioners should use State 

prescription monitoring programs more 

to prevent unnecessary refills and 

prescriptions, thereby preventing abuse. 

Another commenter suggested that 

States should be mandated to 

implement a PDMP if they don’t already 

have one in existence. 

DEA response: As mentioned above, 

States are free to implement their own 

PDMP. Moreover, States may customize 

their PDMP in a way that is most 

beneficial to that State. The States can 

do this so long as the laws governing the 

program do not conflict with the CSA, 

DEA regulations, or other federal law. 

However, the DEA, as required by the 

CSA, has an obligation to control drugs 

or other substances that have a potential 

for abuse. Once the DEA controls a drug 

or substance, it must apply the 

provisions of the CSA to that newly 

controlled drug or substance. As stated, 

scheduling determinations are based on 

scientific determinations regarding the 

drug or other substance’s potential for 

abuse, its potential for psychological 

and physical dependence, and whether 

the drug or other substance has a 

currently accepted medical use in 

treatment in the United States. 21 U.S.C. 

812(b). 

c. Establishment of a List of ‘‘Vetted 

Patients’’ 

One commenter suggested ‘‘that 

people who genuinely need the 

medication * * * be listed in the state 

monitoring system as patients who have 

been vetted and should be prescribed 

the medication without [schedule II] 

requirements.’’ The commenter 

proposed that such vetting could be 

done on a six month renewal basis. 

DEA response: The CSA does not 

prevent the States from enacting laws 

related to controlled substances or 

prevent States from creating stricter 

laws. See 21 U.S.C. 903. However, 

States cannot create rules that are more 

relaxed than the CSA, and its 

implementing regulations, as this would 

be a conflict. See Id. Creating a list of 

vetted patients who do not have to 

comply with schedule II requirements 

would be in direct conflict with the CSA 

and schedule II prescription 

requirements. An individual 

practitioner must determine if an 

individual has a legitimate medical 

purpose to be issued a prescription for 

a controlled substance each time a 

prescription is issued. There is no 


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mechanism to ‘‘vet’’ a patient in the 

CSA. 

d. Monitoring and/or Enforcement 

One commenter stated that ‘‘I believe 

more effort should go into the 

monitoring the narcotics registry and 

targeting [of] patients or doctors that are 

suspicious for abuse rather than trying 

to restrict the narcotics given.’’ Another 

suggested to ‘‘vet the patients by 2 

different doctor evaluations, vetting to 

extend for 6 months. Register the vetted 

patients in the state drug monitoring 

programs as ‘OK’ to obtain 90-day 

supplies. Patients not vetted get a very 

limited supply.’’ 

DEA response: The DEA actively 

pursues administrative action and civil 

and criminal prosecution of DEA 

registrants and individuals who divert 

controlled substances. One of the 

primary functions of the DEA Diversion 

Control Program is to ensure that all 

DEA registrants are in compliance with 

the safeguards inherent in the CSA. This 

proactive approach is designed to 

identify and prevent diversion of 

controlled substances and listed 

chemicals into the illicit market. Insofar 

as the issuance of and the filling of 

controlled substance prescriptions is 

concerned, prescribers and pharmacies, 

have an obligation to ensure that they 

do not prescribe or dispense controlled 

substances to individuals with no 

legitimate medical purpose for the 

controlled substance. 

e. Change of Prescription Requirements 

While Retaining Schedule III Status 

Several commenters suggested that 

the DEA change prescription 

requirements for HCPs while keeping 

them as schedule III controlled 

substances instead of transferring them 

to schedule II of the CSA. For example, 

some commenters suggested that 

subcategories be created for specific 

categories of practitioners, such as 

oncologists or emergency practitioners. 

Other commenters suggested that the 

DEA should limit the quantity of HCPs 

prescribed or number of refills 

authorized instead of rescheduling 

HCPs. As an example, one commenter 

suggested that any HCP prescriptions of 

30 tablets and under should remain as 

a schedule III controlled substance and 

prescriptions for over 30 tablets of HCPs 

should be a schedule II controlled 

substance. 

DEA response: The DEA cannot retain 

schedule III status for HCPs, as the DEA 

has determined that HCPs satisfy the 

criteria for control in schedule II of the 

CSA. 21 U.S.C. 812(b). 

The Assistant Secretary of the HHS 

provided a scientific and medical 

evaluation and a scheduling 

recommendation to control HCPs as a 

schedule II controlled substance. In 

accordance with 21 U.S.C. 811(c), the 

DEA conducted its own analysis of the 

eight factors determinative of control. 

Besides published literature, various 

other data as detailed in the supporting 

documents were considered in making 

the scheduling determination for HCPs. 

Thus, the scheduling determination is 

based on a comprehensive evaluation of 

all available data as related to the 

required eight factors. The summary of 

each factor as analyzed by the HHS and 

the DEA, and as considered by the DEA 

in this scheduling action, was provided 

in the proposed rule. Both the DEA and 

the HHS analyses have been made 

available in their entirety under 

‘‘Supporting and Related Material’’ of 

the public docket for this rule at http:// 

www.regulations.gov under Docket No. 

DEA–389. Based on the review of the 

HHS evaluation and scheduling 

recommendation and all other relevant 

data, the DEA found that HCPs have an 

abuse potential and meets the 

requirements for schedule II controls 

under the CSA. 

f. Education of Prescribing Practitioners 

Several commenters suggested that 

prescribing practitioners should receive 

education about the problems of HCP 

abuse, addiction, and prevention of 

diversion rather than rescheduling 

HCPs. 

DEA response: The DEA fully 

supports efforts by medical 

professionals, acting alone and as part of 

professional organizations, as well as 

industry associations, to educate 

members of their profession/industry on 

the risks associated with prescription 

opioid use and on ways to prevent 

misuse, abuse, and diversion of 

prescription opioid products. These 

efforts are an important and integral part 

of tackling the problem of prescription 

opioid abuse. 

However, as recognized by the CDC, 

the United States is in the midst of a 

public health crisis regarding 

prescription painkiller overdose. 

Individuals, families, and society are 

suffering the effects of abuse and 

addiction. People are dying. In their 

2011 report, the CDC estimated that 75 

opioid-related deaths occur each day. 

That equates to over 27,000 people each 

year. As a society, America simply 

cannot afford to wait for self-initiated 

educational programs and measures by 

medical professionals and industry to 

solve the problem on their own. As 

acknowledged by commenters 

advocating solely for an educational 

approach, opioid consumption in the 

United States continues to increase 

despite self-initiated professional 

educational endeavors such as symposia 

and scientific articles. 

One physician who wrote in support 

of rescheduling asserted that only a 

limited number of practitioners have 

paid attention to the warnings issued 

regarding the risk of addiction, 

overdose, and death associated with use 

of HCPs. It was this physician’s belief 

that: ‘‘The opioid epidemic has mainly 

resulted from a large volume of 

misinformed doctors failing to 

understand the risks and limited 

benefits of these drugs, especially for 

chronic noncancer pain, one of the most 

common reasons why patients seek 

medical care.’’ This concern has been 

echoed by the HHS. The HHS has noted 

‘‘Multiple studies have shown that a 

small percentage of prescribers are 

responsible for prescribing the majority 

of opioids.’’ Behavioral Health 

Coordinating Committee, Prescription 

Drug Abuse Subcommittee, HHS. 

Addressing Prescription Drug Abuse in 

the United States: Current Activities and 

Future Opportunities. 2013. (internal 

citations omitted). The HHS points out, 

however, that ‘‘Providers who are not 

high-volume prescribers may also 

contribute to opioid abuse and overdose 

because of a lack of education and 

awareness about appropriate opioid 

prescribing * * *.’’ The HHS 

additionally stated, ‘‘Even when 

sufficient information exists, studies 

show that some providers do not follow 

risk mitigation strategies even for 

patients known to be at high risk for 

abuse.’’ Id. The physician-commenter 

asserted that ‘‘Upscheduling 

hydrocodone combination products 

will, at the very least, send a clear 

message to these providers that 

hydrocodone is a narcotic in the same 

class as oxycodone, morphine and 

heroin, which should be prescribed and 

refilled with the utmost of selectivity, 

caution and close patient follow-up.’’ 

The problem must be addressed both 

nationally and locally by using all 

available legal and social measures at 

hand. At the Federal level, this includes 

following the legal path directed by 

Congress to address issues of substance 

abuse and trafficking. As part of a 

comprehensive approach involving 

multiple Federal and State actors to 

address these concerns, Congress has 

charged the DEA with the responsibility 

to implement and enforce, to the fullest 

extent of the law, the requirements of 

the CSA. This includes ensuring that 

drugs and other substances are 

appropriately scheduled concordant 

with the factors for each schedule under 

21 U.S.C. 812(b). 


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g. Education and Rehabilitation of 

Ultimate Users 

Several commenters suggested that 

patient education and/or rehabilitation 

was the proper route to address abuse of 

HCPs rather than rescheduling. 

DEA response: A multi-pronged 

approach, one that includes education, 

treatment, monitoring, and law 

enforcement is needed to combat this 

epidemic. The DEA supports all efforts 

to educate patients about the risks 

associated with use of substances with 

abuse potential. As discussed above, an 

analysis of the eight factors 

determinative of control demonstrates 

that HCPs warrant control II of the CSA. 

21 U.S.C. 812(b). 

h. Strict Enforcement/Sanctions 

Several commenters voiced an 

opinion that there should be strict 

enforcement against those that have 

diverted and illegally sold prescription 

HCPs. These commenters stated it 

would be a good idea to ban these 

offenders from receiving HCPs or reduce 

limits on how much HCPs an offender 

can receive. In addition, several 

commenters suggested tougher 

sanctions and enforcement should be 

applied to providers who are not 

lawfully practicing their trade rather 

than punishing those who are obeying 

the laws. 

DEA response: The DEA mission is to 

implement and enforce the CSA and 

corresponding regulations to the fullest 

extent of the law. The DEA actively 

pursues administrative action and civil 

and criminal prosecution of DEA 

registrants and other individuals who 

divert controlled substances. One of the 

primary functions of the DEA Diversion 

Control Program is to ensure that 

registrants are in compliance with the 

safeguards inherent in the CSA. The 

DEA supports State and local law 

enforcement, and State professional and 

regulatory boards in their efforts to 

prevent diversion and enforce the 

controlled substances laws. 

V. Scheduling Conclusion 

Based on consideration of all 

comments, 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 

potential for abuse of HCPs. As such, 

the DEA is rescheduling HCPs as a 

schedule II controlled substance under 

the CSA. 

VI. 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. The abuse potential of HCPs is 

comparable to the schedule II controlled 

substance oxycodone; 

2. HCPs have a currently accepted 

medical use in treatment in the United 

States. Several pharmaceutical products 

containing hydrocodone in combination 

with acetaminophen, aspirin, other 

NSAIDs, and homatropine are approved 

by the 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. 

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). 

VII. Requirements for Handling HCPs 

Upon the effective date of this final 

rule, any person who handles HCPs will 

be subject to the CSA’s schedule II 

regulatory controls and administrative, 

civil, and criminal sanctions applicable 

to the manufacture, distribution, 

dispensing, importing, exporting, 

engaging in research, conducting 

instructional activities, and conducting 

chemical analysis, of schedule II 

controlled substances, including the 

following: 

Registration. Any person who handles 

(manufactures, distributes, dispenses, 

imports, exports, engages in research, 

conducts instructional activities with, or 

conducts chemical analysis with) HCPs, 

or who desires to handle HCPs, must be 

registered with the DEA to conduct such 

activities pursuant to 21 U.S.C. 822, 

823, 957, and 958, and in accordance 

with 21 CFR parts 1301 and 1312 as of 

October 6, 2014. 

Security. HCPs are subject to schedule 

II security requirements and must be 

handled and stored pursuant to 21 

U.S.C. 821 and 823, and in accordance 

with 21 CFR 1301.71–1301.93 as of 

October 6, 2014. 

Labeling and Packaging. All labels, 

labeling, and packaging for commercial 

containers of HCPs must comply with 

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

accordance with 21 CFR part 1302 as of 

October 6, 2014, except with respect to 

exchanges for purposes of relabeling/ 

repackaging as provided below under 

‘‘Quotas.’’ 

Quotas. A quota assigned pursuant to 

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

CFR part 1303 is required in order to 

manufacture HCPs as of October 6, 

2014. Registrants required to obtain an 

individual manufacturing quota shall 

not manufacture HCPs on or after 

October 6, 2014, unless an individual 

manufacturing quota is granted for such 

quantities of HCP to be manufactured. 

Registrants required to obtain a 

procurement quota shall not procure 

HCPs on or after October 6, 2014, unless 

a procurement quota is granted for such 

quantities of HCP to be procured. 

Except, registrants authorized to 

manufacture schedule II and III 

controlled substances may relabel/ 

repackage HCPs labeled as ‘‘CIII’’ or ‘‘C– 

III’’ without obtaining procurement 

quota for such activity, under the 

following conditions: 

(1) The manufacturing activity occurs 

before December 8, 2014; 

(2) if the manufacturer is relabeling/ 

repackaging HCPs that were returned to 

the manufacturer, the manufacturer 

returns the same quantity and strength 

of HCPs labeled as ‘‘CII’’ or ‘‘C–II’’ back 

to the registrant that returned HCPs 

labeled as ‘‘CIII’’ or ‘‘C–III’’ to the 

manufacturer; and 

(3) an invoice or the DEA Form 222 

(whichever is applicable) records the 

transfer and reflects that the transfer 

occurred pursuant to the authority 

contained in this final rule. 

For example, if before October 6, 

2014, distributor A transfers 5 packages 

of 100-bottle 5/325 HCPs labeled as CIII/ 

C–III to manufacturer B, solely for the 

purpose of relabeling, the invoice would 

reflect that the transfer occurred 

pursuant to the authority in this final 

rule. If the return occurs after October 

6, 2014, the DEA Form 222 would 

reflect that the transfer occurred 

pursuant to the authority contained in 

this final rule. When the manufacturer 

distributes HCPs labeled as ‘‘CII’’ or C– 

II’’ back to the registrant that returned 

the HCPs labeled as ‘‘CIII’’ or ‘‘C–III,’’ 

the manufacturer must return the same 

quantity and strength that was originally 

received for relabeling/repackaging. The 

DEA Form 222 will, again, reflect that 

the transfer occurred pursuant to the 

authority contained in this final rule. 

In the above example, the 

manufacturer would not be required to 

obtain a procurement quota in order to 

relabel/repackage 5 packages of 100- 

bottle 5/325 HCPs, so long as 


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Federal Register / Vol. 79, No. 163 / Friday, August 22, 2014 / Rules and Regulations 49681 

30For 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 

course of professional practice, but does not include 

a pharmacist, pharmacy, or hospital (or other 

person other than an individual). For the purposes 

of performing regulatory analysis, ‘‘mid-level 

practitioner’’ means an individual registered with 

the DEA as a ‘‘mid-level practitioner’’ but does not 

include practitioners as defined above. Examples of 

mid-level practitioners include, but are not limited 

to, health care providers such as nurse 

practitioners, nurse midwives, nurse anesthetists, 

clinical nurse specialists and physician assistants. 

31The estimated break-down is as follows: 50 

manufacturers; 4 exporters; 683 distributors; 50,774 

pharmacies; and 314,840 persons registered as or 

employing practitioners/mid-level practitioners/ 

hospitals/clinics. 

manufacturer B subsequently transfers 

to distributor A 5 packages of 100-bottle 

5/325 HCPs labeled as CII/C–II, unless 

the relabel/repackage activity occurs 

after December 8, 2014. 

Registrants may continue to return 

HCPs pursuant to 21 CFR 1307.12. 

Inventory. Any person who becomes 

registered with the DEA on or after the 

effective date of the final rule must 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 

and 958, and in accordance with 21 CFR 

1304.03, 1304.04, and 1304.11(a) and (b) 

as of October 6, 2014. 

After the initial inventory, every DEA 

registrant must take a new inventory of 

all stocks of controlled substances 

(including HCPs) on hand every two 

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

and in accordance with 21 CFR 1304.03, 

1304.04, and 1304.11. 

Records and Reports. Every DEA 

registrant must maintain records and 

submit reports with respect to HCPs 

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

in accordance with 21 CFR parts 1304 

and 1312 as of October 6, 2014. Each 

pharmacy with a modified registration 

under 21 U.S.C. 823(f) that authorizes 

the dispensing of controlled substances 

by means of the Internet must submit 

reports to the DEA regarding HCPs 

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

accordance with 21 CFR 1304.55 as of 

October 6, 2014. 

Orders for HCPs. Every DEA registrant 

who distributes HCPs must comply with 

order form requirements, pursuant to 21 

U.S.C. 821, 828, 871 and in accordance 

with 21 CFR parts 1305 and 1307 as of 

October 6, 2014. 

Prescriptions. All prescriptions for 

HCPs must comply with 21 U.S.C. 

829(a) and must be issued in accordance 

with 21 CFR part 1306 and subpart C of 

21 CFR part 1311 as of October 6, 2014. 

No prescription for HCPs issued on or 

after October 6, 2014 shall authorize any 

refills. Any prescriptions for HCPs that 

are issued before October 6, 2014, and 

authorized for refilling, may be 

dispensed in accordance with 21 CFR 

1306.22–1306.23, 1306.25, and 1306.27, 

if such dispensing occurs before April 8, 

2015. 

Importation and Exportation. All 

importation and exportation of HCPs 

must be in compliance with 21 U.S.C. 

952, 953, 957, and 958, and in 

accordance with 21 CFR part 1312 as of 

October 6, 2014. 

Liability. Any activity involving HCPs 

not authorized by, or in violation of, the 

CSA or its implementing regulations, 

occurring as of October 6, 2014, is 

unlawful, and may subject the person to 

administrative, civil, and/or criminal 

action. 

VIII. Regulatory Analyses 

Executive Orders 12866 and 13563 

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

this 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 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 rulemaking does not have 

federalism implications warranting the 

application of Executive Order 13132. 

The 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 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 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 rule is to place HCPs into schedule 

II of the CSA. No less restrictive 

measures (i.e., non-control 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.30 It is possible 

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 

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 31 are ‘‘small 

entities’’ in accordance with the RFA 

and Small Business Administration size 


rmajette on DSK2TPTVN1PROD with RULES
49682 Federal Register / Vol. 79, No. 163 / Friday, August 22, 2014 / Rules and Regulations 

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

632. 

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 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) as a result of this 

rule being 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 rule 

to reschedule HCPs as schedule II 

controlled substances will not have a 

significant economic impact on a 

substantial number of small entities. 

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. 

Congressional Review Act 

This rule is not a major rule as 

defined by section 804 of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (Congressional 

Review Act (CRA)). This rule will not 

result in: an annual effect on the 

economy of $100,000,000 or more; a 

major increase in costs or prices for 

consumers, individual industries, 

Federal, State, or local government 

agencies, or geographic regions; or 

significant adverse effects on 

competition, employment, investment, 

productivity, innovation, or on the 

ability of United States-based 

companies to compete with foreign 

based companies in domestic and 

export markets. However, pursuant to 

the CRA, the DEA has submitted a copy 

of this final rule to both Houses of 

Congress and to the Comptroller 

General. 

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 amended 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 (vi), 

respectively. 

Dated: August 15, 2014. 

Michele M. Leonhart, 

Administrator. 

[FR Doc. 2014–19922 Filed 8–21–14; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[TD 9676] 

RIN 1545–BJ59 

Allocation and Apportionment of 

Interest Expense; Correction 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Correcting amendment. 

SUMMARY: This document contains 

corrections to final regulations (TD 

9676) that were published in the 

Federal Register on Wednesday, July 

16, 2014 (79 FR 41424) providing 

guidance concerning the allocation and 

apportionment of interest expense by 

corporations owning a 10 percent or 

greater interest in a partnership, as well 

as the allocation and apportionment of 

interest expense using the fair market 

value method. These regulations also 

update the interest allocation 

regulations to conform to the statutory 

changes made by section 216 of the 

legislation commonly referred to as the 

Education Jobs and Medicaid Assistance 

Act (EJMAA), enacted on August 10, 

2010, affecting the affiliation of certain 

foreign corporations for purposes of 

section 864(e). These regulations affect 

taxpayers that allocate and apportion 

interest expense. 

DATES: This correction is effective on 

August 22, 2014, and is applicable July 

16, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Jeffrey L. Parry at (202) 317–6936 (not 

a toll-free number). 

SUPPLEMENTARY INFORMATION: 

Background and Explanation of 

Provisions 

The final regulations that are the 

subject of this document are under 

section 864(e) of the Internal Revenue 

Code. 

Need for Correction 

As published, final regulations (TD 

9676) contain errors that may prove to 

be misleading and are in need of 

clarification. 


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