[Federal Register Volume 79, Number 163 (Friday, August 22, 2014)]
[Rules and Regulations]
[Pages 49661-49682]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-19922]


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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.

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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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    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.
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    \1\ Hydrocodone 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.
    \2\ As 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.
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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\
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    \3\ Specifically: (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 
Zohydro\TM\ ER, a single-entity, extended release schedule II 
product. Zohydro\TM\ 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.''
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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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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.
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    \5\ The DEA presentation is available at http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/drugsafetyandriskmanagmentadvisorycommittee/ucm346941.pdf.
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    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).
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    \6\ The 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).
    \7\ Comments 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.
    \8\ The 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).
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    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. 
Fifty-six 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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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

[[Page 49665]]

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[supreg], Lortab[supreg]). Currently marketed HCPs approved as 
cough suppressants include Hycodan[supreg], Mycodone[supreg], 
Tussionex[supreg], Pennkinetic[supreg], Tussigon[supreg], 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

[[Page 49666]]

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

[[Page 49667]]

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.
---------------------------------------------------------------------------

    \9\ Centers 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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \10\ Laxmaiah 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).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \11\ As 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.
---------------------------------------------------------------------------

    ``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

[[Page 49668]]

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 Eight-Factor 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.

[[Page 49669]]

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.
---------------------------------------------------------------------------

    \12\ United States v. Rosen, 582 F.2d 1032, 1036 (5th Cir. 
1978).
---------------------------------------------------------------------------

    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'').

[[Page 49670]]

    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 up-scheduling ``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.

[[Page 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 triplicate-
prescription 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 self-
medicating. 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

[[Page 49672]]

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 
large-volume 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, un-registered, relatively unsecure environment, where the 
disabled and elderly cannot defend themselves or adequately report what 
has happened.
---------------------------------------------------------------------------

    \13\ The 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).
    \15\ Marti 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).
    \16\ Comment 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.
    \17\ U.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.
---------------------------------------------------------------------------

    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

[[Page 49673]]

painkillers--such as HCPs.\19\ These medication thefts occurred in both 
large nursing homes and small adult foster homes.\20\
---------------------------------------------------------------------------

    \18\ Mac McLean, Drug Theft Affects Care, The Bulletin, Sept. 8, 
2013, available at http://www.bendbulletin.com/news/1340250-153/drug-theft-affects-care.
    \19\ Id.
    \20\ Id.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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-drug-theft. 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 wide-spread 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.
---------------------------------------------------------------------------

    \23\ Wes Bledsoe, Criminal Offenders Residing in Long-Term Care 
Facilities, 2(3) J Forensic Nurs. 142 (2006).
---------------------------------------------------------------------------

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).
---------------------------------------------------------------------------

    \24\ E.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.
---------------------------------------------------------------------------

    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 e-
prescribing 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

[[Page 49674]]

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

[[Page 49675]]

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/committeesmeetingmaterials/drugs/drugsafetyandriskmanagmentadvisorycommittee/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. Seventy-five 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.
---------------------------------------------------------------------------

    \25\ SAMHSA, 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-use-2013.htm.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \26\ Hedegaard 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.
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    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.

[[Page 49676]]

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.
---------------------------------------------------------------------------

    \27\ NAICS 424210--Drugs and druggists' sundries merchant 
wholesalers; Merchant wholesalers, except manufacturers' sales 
branches and offices.
    \28\ The 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.
---------------------------------------------------------------------------

    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).
---------------------------------------------------------------------------

    \29\ IMS Health, National Sales Perspective TM (NSP).
---------------------------------------------------------------------------

    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 non-physical security controls. The DEA believes that a 45-day 
period will provide handlers of HCPs a reasonable amount of time to 
implement any one-time 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.

[[Page 49677]]

    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 Sec.  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

[[Page 49678]]

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

[[Page 49679]]

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).

[[Page 49680]]

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

[[Page 49681]]

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.
---------------------------------------------------------------------------

    \30\ For 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.
---------------------------------------------------------------------------

    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

[[Page 49682]]

standards. 5 U.S.C. 601(6); 15 U.S.C. 632.
---------------------------------------------------------------------------

    \31\ The 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.
---------------------------------------------------------------------------

    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

0
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.


Sec.  1308.13  [Amended]

0
2. Amend Sec.  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