[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.
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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\
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\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.
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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.
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\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.
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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.
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\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.
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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