[Federal Register Volume 83, Number 15 (Tuesday, January 23, 2018)]
[Rules and Regulations]
[Pages 3071-3075]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01173]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1301

[Docket No. DEA-450]
RIN 1117-AB42


Implementation of the Provision of the Comprehensive Addiction 
and Recovery Act of 2016 Relating to the Dispensing of Narcotic Drugs 
for Opioid Use Disorder

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

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SUMMARY: The Comprehensive Addiction and Recovery Act (CARA) of 2016, 
which became law on July 22, 2016, amended the Controlled Substances 
Act (CSA) to expand the categories of practitioners who may, under 
certain conditions on a temporary basis, dispense a narcotic drug in 
Schedule III, IV, or V for the purpose of maintenance treatment or 
detoxification treatment. Separately, the Department of Health and 
Human Services, by final rule effective August 8, 2016, increased to 
275 the maximum number of patients that a practitioner may treat for 
opioid use disorder without being separately registered under the CSA 
for that purpose. The Drug Enforcement Administration (DEA) is hereby 
amending its regulations to incorporate these statutory and regulatory 
changes.

DATES: Effective: January 22, 2018.

FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control 
Division, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.

SUPPLEMENTARY INFORMATION: It has been determined this is a major rule 
within the meaning of the Congressional Review Act (CRA). 5 U.S.C. 
804(2). Major rules generally cannot take effect until 60 days after 
the date on which the rule is published in the Federal Register. 5 
U.S.C. 801(a)(3). However, the CRA provides that ``any rule for which 
an agency for good cause finds (and incorporates the finding and a 
brief statement of reasons therefor in the rule issued) that notice and 
public procedure thereon are impracticable, unnecessary, or contrary to 
the public interest, shall take effect at such time as the Federal 
agency promulgating the rule determines.'' 5 U.S.C. 808. As is 
discussed below, DEA finds there is good cause to issue these 
amendments as a final rule without notice and comment, because these 
amendments merely conform the implementing regulations with recent 
amendments to the CSA contained in CARA that have already taken effect. 
Accordingly, DEA has determined this rule will take effect January 22, 
2018.

Background and Legal Authority

Pertinent Provisions of the CARA

    On July 22, 2016, the President signed the Comprehensive Addiction 
and Recovery Act (CARA) into law as Public Law 114-198. Section 303 of 
the CARA amended certain provisions of 21 U.S.C. 823(g)(2), which is 
the subsection of the Controlled Substance Act (CSA) that sets forth 
the conditions under which a practitioner may, without being separately 
registered under subsection 823(g)(1), dispense a narcotic drug in 
Schedule III, IV, or V for the purpose of maintenance treatment or 
detoxification treatment. Maintenance treatment is the dispensing of a 
narcotic drug, in excess of twenty-one days, for the treatment of 
dependence upon heroin or other morphine-like drugs (21 U.S.C. 
802(29)). A detoxification treatment is the term given when a narcotic 
drug is dispensed in decreasing doses, not exceeding one hundred and 
eighty days, ``to alleviate adverse physiological or psychological 
effects incident to withdrawal from the continuous or sustained use of 
a narcotic drug,'' with the ultimate goal of bringing a patient to a 
narcotic drug-free state (21 U.S.C. 802(30)).
    Specifically, section 303 of the CARA temporarily expands the types 
of practitioners who may dispense a narcotic drug in Schedule III, IV, 
or V for the purpose of maintenance treatment or detoxification 
treatment without being separately registered as a narcotic treatment 
program. Whereas prior to the CARA, only qualified physicians were 
permitted to dispense narcotic drugs in this manner, the CARA now 
temporarily permits certain nurse practitioners and physician 
assistants to qualify to do so. The CARA achieves this result by (1) 
inserting the term ``qualifying practitioner'' in place of ``qualifying 
physician'' in 21 U.S.C. 823(g)(2)(B)(i) and (2) defining ``qualifying 
practitioner'' to include not only a physician, but also (until October 
1, 2021) a ``qualifying other practitioner,'' which includes a nurse 
practitioner or physician assistant who meets certain qualifications 
set forth in paragraph 823(g)(2)(G)(iv). More precisely, section 303 of 
the CARA defines ``qualifying other practitioner'' as a nurse 
practitioner or physician assistant who satisfies each of the following 
criteria:
    (I) The nurse practitioner or physician assistant is licensed under 
State law to prescribe schedule III, IV, or V medications for the 
treatment of pain;
    (II) The nurse practitioner or physician assistant must complete 
not fewer than 24 hours of initial training.
    (III) The nurse practitioner or physician assistant is supervised 
by, or works in collaboration with, a qualifying physician, if the 
nurse practitioner or physician assistant is required by State law to 
prescribe medications for the treatment of opioid use disorder in 
collaboration with or under the supervision of a physician; and
    The Secretary determines in collaboration with, a qualifying 
physician, if the nurse practitioner or physician assistant is 
supervised by, or works in collaboration with, a qualifying physician, 
if the nurse practitioner can treat and manage opiate-dependent 
patients. The Secretary may, by regulation, revise the requirements for 
being qualifying other practitioner.
    This section of the CARA further provides that the Secretary of 
Health and Human Services (HHS) may, by regulation, revise the 
foregoing

[[Page 3072]]

requirements for being a qualifying other practitioner.
    The CARA also makes some technical revisions to 21 U.S.C. 823(g)(2) 
that do not materially alter the meaning of this subsection. 
Nonetheless, because the DEA regulations currently contain the older 
statutory language, DEA is hereby revising this part of the regulations 
to reflect the new statutory language.

HHS Final Rule Increasing the Patient Limit for Purposes of 21 U.S.C. 
823(g)(2)

    Under the CSA, the Secretary of HHS may, by regulation, increase 
the maximum number of patients that a practitioner may treat pursuant 
to 21 U.S.C. 823(g)(2). 21 U.S.C. 823(g)(2)(B)(iii)(III). On July 8, 
2016, the Secretary issued a final rule increasing this number to 275. 
81 FR 44712. As stated therein, to be eligible for the patient limit of 
275, the practitioner must possess a current waiver to treat up to 100 
patients under 21 U.S.C. 823(g)(2) and meet additional criteria set 
forth in 42 CFR 8.610-8.625.\1\ DEA is hereby amending its regulations 
to reflect these new limits.
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    \1\ The HHS final rule further provides that the approval by HHS 
to treat up to 275 patients is for a term of three years and that 
the practitioner must submit a renewal request with HHS every three 
years to continue to treat up to 275 patients. 42 CFR 8.625-8.655.
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Good Cause for Issuing This Rule as a Final Rule Without Notice and 
Comment

    As indicated, this final rule amends the DEA regulations only to 
the extent necessary to be consistent with current federal law (as 
modified by the CARA) and current federal regulations issued by HHS. 
The qualifying practitioner amendments in the CARA alter the provisions 
of the CSA that DEA previously implemented in its regulations, and DEA 
is therefore obligated to update those regulations. With respect to the 
HHS regulations, the CSA gives sole authority to HHS to change the 
maximum number of patients per practitioner under 21 U.S.C. 823(g)(2), 
and where HHS does so, DEA is obligated to apply that number. As a 
result, DEA has no discretion not to amend its regulations as is being 
done in this final rule. Indeed, the new provisions issued under this 
final rule are already in effect by virtue of the CARA and the HHS 
final rule regarding patient limits. This final rule simply updates the 
DEA regulations to reflect these new provisions. Public comment on 
these amendments to the DEA regulations would therefore serve no 
purpose. Because notice and public comment are unnecessary, DEA finds 
there is good cause within the meaning of the Administrative Procedure 
Act (APA) to issue these amendments as a final rule without notice and 
comment, because these amendments merely conform the implementing 
regulations with recent amendments to the CSA contained in CARA that 
have already taken effect (see 5 U.S.C. 553(b)(B), relating to notice 
and comment procedures). ``[W]hen regulations merely restate the 
statute they implement, notice-and-comment procedures are 
unnecessary''. Gray Panthers Advocacy Committee v. Sullivan, 936 F.2d 
1284, 1291 (D.C. Cir. 1991); see also Komjathy v. Nat. Trans. Safety 
Bd., 832 F.2d 1294, 1296 (D.C. Cir. 1987) (when a rule ``does no more 
than repeat, virtually verbatim, the statutory grant of authority'' 
notice-and-comment procedures are not required). Therefore, we are 
issuing these amendments as a final rule, effective upon publication in 
the Federal Register. This rule constitutes final action on these 
changes under the APA (5 U.S.C. 553).

Regulatory Analysis

    As explained above, DEA is obligated to issue this final rule to 
revise its regulations so that they are consistent with the provisions 
of the CSA that were amended by the CARA and the HHS final rule 
increasing the patient limit under 21 U.S.C. 823(g)(2). In issuing this 
final rule, DEA has not gone beyond the statutory text enacted by 
Congress or the final rule issued by HHS. Thus, DEA would have to issue 
this final rule regardless of the outcome of the agency's regulatory 
analysis. Nonetheless, DEA conducted this analysis as discussed below.

Executive Orders 12866 (Regulatory Planning and Review) and 13563, 
(Improving Regulation and Regulatory Review)

    This final rule was developed in accordance with the principles of 
Executive Orders 12866 and 13563. Executive Order 12866 directs 
agencies to assess all costs and benefits of available regulatory 
alternatives and, if regulation is necessary, to select regulatory 
approaches that maximize net benefits (including potential economic, 
environmental, public health, and safety effects; distributive impacts; 
and equity). Executive Order 13563 is supplemental to and reaffirms the 
principles, structures, and definitions governing regulatory review as 
established in Executive Order 12866. Executive Order 12866 classifies 
a ``significant regulatory action,'' requiring review by the Office of 
Management and Budget (OMB), as any regulatory action that is likely to 
result in a rule that may: (1) Have an annual effect on the economy of 
$100 million or more or adversely affect in a material way the economy, 
a sector of the economy, productivity, competition, jobs, the 
environment, public health or safety, or State, local, or tribal 
governments or communities; (2) create a serious inconsistency or 
otherwise interfere with an action taken or planned by another agency; 
(3) materially alter the budgetary impact of entitlements, grants, user 
fees, or loan programs or the rights and obligations of recipients 
thereof; or (4) raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
the Executive Order.
    1. The DEA expects that this final rule will have an annual effect 
on the economy of $100 million or more in at least one year and 
therefore is an economically significant regulatory action. The 
analysis of benefits and costs is below.
    2. This regulatory action is not likely to result in a rule that 
may create a serious inconsistency or otherwise interfere with an 
action taken or planned by another agency. This final rule amends the 
DEA regulations only to the extent necessary to be consistent with 
current federal law (as modified by the CARA) and current federal 
regulations issued by HHS. The qualifying practitioner amendments in 
the CARA alter the provisions of the CSA that DEA previously 
implemented in its regulations, and DEA is therefore obligated to 
update those regulations. With respect to the HHS regulations, the CSA 
gives sole authority to HHS to change the maximum number of patients 
per practitioner under 21 U.S.C. 823(g)(2), and where HHS does so, DEA 
is obligated to apply that number.
    3. This regulatory action is not likely to result in a rule that 
may materially alter the budgetary impact of entitlements, grants, user 
fees, or loan programs or the rights and obligations of recipients 
thereof. The Diversion Control Fee Account, which the DEA administers 
and which involves registration fees, is not directly affected. This 
regulatory action temporarily expanding the types of practitioners and 
increasing the maximum number of patients that a practitioner may treat 
as described in detail above represents a minor modification to the 
registration procedures within the Diversion Control Program and does 
not necessitate a change in registration fees.
    4. This regulatory action is not likely to result in a rule that 
may raise novel

[[Page 3073]]

legal or policy issues arising out of legal mandates, the President's 
priorities, or the principles set forth in the Executive Order. This 
final rule amends the DEA regulations only to the extent necessary to 
be consistent with current federal law (as modified by the CARA) and 
current federal regulations issued by HHS. The qualifying practitioner 
amendments in the CARA alter the provisions of the CSA that DEA 
previously implemented in its regulations, and DEA is therefore 
obligated to update those regulations. With respect to the HHS 
regulations, the CSA gives sole authority to HHS to change the maximum 
number of patients per practitioner under 21 U.S.C. 823(g)(2), and 
where HHS does so, DEA is obligated to apply that number. This 
regulatory action therefore does not raise novel legal or policy 
issues.
    The economic, interagency, budgetary, legal, and policy 
implications of this final rule have been examined and it has been 
determined to be a significant regulatory action under Executive Order 
12866, and therefore, has been submitted to the OMB for review.
I. Need for the Rule
    On July 22, 2016, the Comprehensive Addiction and Recovery Act of 
2016 (CARA) became law. One section of the CARA amended the Controlled 
Substances Act (CSA) to expand the categories of practitioners who may, 
under certain conditions on a temporary basis, dispense a narcotic drug 
in Schedule III, IV, or V for the purpose of maintenance treatment or 
detoxification treatment. Separately, the Department of Health and 
Human Services (HHS), by final rule effective August 8, 2016, increased 
to 275 the maximum number of patients that a practitioner may treat for 
opioid use disorder without being separately registered under the CSA 
for that purpose. The DEA is amending its regulations to incorporate 
these statutory and regulatory changes.
    In addition to the legal requirement to implement the statute, this 
rule also implements one of the objectives of the statute; expand 
availability of medication-assisted treatment (MAT) for opioid 
addiction. As supported by research, there is a gap between those who 
need treatment for opioid addition and treatment providers (``treatment 
gap''). An increase in treatment availability is expected to result in 
more patients treated.
    Substance Abuse and Mental Health Services Administration (SAMHSA) 
independently researched the issue of the treatment gap in its recent 
rule: Medication Assisted Treatment for Opioid Use Disorders, 81 FR 
44712, 44729 (July 8, 2016). SAMHSA found that ``. . . there is 
significant unmet need for MAT treatment among individuals with opioid 
use disorders . . . Evidence suggests that utilization of buprenorphine 
is limited directly by the existence of treatment limits.'' A research 
article in American Journal of Public Health concluded that there are 
significant gaps between treatment need and capacity at the state and 
national levels, with 96% of states and District of Columbia having 
opioid abuse or dependence rates higher than their buprenorphine 
treatment capacity rates.\2\ According to research by The Pew 
Charitable Trust, ``[i]n the U.S. only 49 percent of people with an 
opioid dependence can potentially receive treatment because too few 
doctors prescribe the medicine, and those that do can serve only a 
limited number of patients because of federal restrictions.'' \3\ Also, 
patients located in rural areas are negatively impacted by the limits 
because there are fewer doctors certified to prescribe 
buprenorphine.\4\ One research article examined the availability of MAT 
by U.S. counties and determined that more than 30 million persons live 
in counties without access to buprenorphine treatment.\5\
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    \2\ Christopher M. Jones, PharmD, MPH, Melinda Campopiano, MD, 
Grant Baldwin, Ph.D., MPH, and Elinore McCance-Katz, MD, Ph.D., 
``National and State Treatment Need and Capacity for Opioid Agonist 
Medication-Assisted Treatment,'' Am J Public Health, August 2015. 
Vol 105. No. 8.
    \3\ Christine Vestal, ``Few Doctors Are Willing, Able to 
Prescribe Powerful Anti-Addiction Drugs,'' January 15, 2016.
    \4\ The Coming Economic Bonanza In Addiction Treatment, Anson, 
Pat, (May 25, 2016), https://www.painnewsnetwork.org/stories/2016/5/25/the-coming-economic-bonanza-in-addiction-treatment.
    \5\ Roger A. Rosenblatt, MD, MPH, MFR1, C. Holly A. Andrilla, 
MS, Mary Catlin, BSN, MPH, Eric H. Larson, Ph.D. ``Geographic and 
Specialty Distribution of U.S. Physicians Trained to Treat Opioid 
Use Disorder,'' Annals of Family Medicine, Vol. 13, No. 1, January/
February 2015.
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II. Alternative Approaches
    This final rule amends the DEA regulations only to the extent 
necessary to be consistent with current federal law (as modified by the 
CARA) and current federal regulations issued by HHS. The qualifying 
practitioner amendments in the CARA alter the provisions of the CSA 
that DEA previously implemented in its regulations, and DEA is 
therefore obligated to update those regulations. With respect to the 
HHS regulations, the CSA gives sole authority to HHS to change the 
maximum number of patients per practitioner under 21 U.S.C. 823(g)(2), 
and where HHS does so, DEA is obligated to apply that number. As a 
result, DEA has no discretion not to amend its regulations as is being 
done in this final rule. Indeed, the new provisions issued under this 
final rule are already in effect by virtue of the CARA and the HHS 
final rule regarding patient limits. This final rule simply updates the 
DEA regulations to reflect these new provisions; thus, no alternative 
approaches are possible.
III. Analysis of Benefits and Costs
    This analysis is limited to the provisions associated with the 
section of the CARA that amended the CSA to expand the categories of 
practitioners who may, under certain conditions on a temporary basis, 
dispense a narcotic drug in schedule III, IV, or V for the purpose of 
maintenance treatment or detoxification treatment. The HHS rule that 
increased to 275 the maximum number of patients that a practitioner may 
treat for opioid use disorder without being separately registered under 
the CSA was promulgated under HHS' authority; therefore, that section 
of the CARA was excluded from this analysis. This is a summary; a 
detailed economic analysis of the proposed rule can be found in the 
rulemaking docket at http://www.regulations.gov.
    Benefits, in the form of economic burden (health care costs, 
criminal justice costs, and lost productivity costs) reductions, are 
expected to be generated from the expansion of the categories of 
practitioners who may dispense a narcotic drug in schedule III, IV, or 
V for the purpose of maintenance treatment or detoxification treatment. 
The DEA anticipates the expansion of the categories of practitioners 
will lead to an increase in the number of treatment providers, which 
will lead to an increase in the number of patients (who did not have 
access to treatment prior to this rule) treated, resulting in the 
reduction in the economic burden due to opioid abuse.
    Cost of the rule is associated with treatment cost and the cost to 
practitioners of obtaining authority to dispense a narcotic drug in 
schedule III, IV, or V for the purpose of maintenance treatment or 
detoxification treatment. While these costs are not directly 
attributable to this rule, obtaining dispensing authority and treating 
patients are required to generate the benefits of the rule, and thus, 
included in this analysis. Although the new treatment providers in the 
expanded category, qualifying other practitioners, will also need to 
comply with treatment-specific recordkeeping requirements, the cost of 
compliance is included in the estimated cost of treatment. Finally, 
there is potential for added risk of diversion from more

[[Page 3074]]

practitioners having the authority to dispense narcotic drug in 
schedule III, IV, or V for the purpose of maintenance treatment or 
detoxification treatment.
    The DEA estimates the total benefit (economic burden reduction) is 
$208 million, $374 million, $467 million, $560 million, and $654 
million in years 1, 2, 3, 4, and 5, respectively; the total cost of 
treatment is $133 million, $238 million, $298 million, $358 million, 
and $417 million in years 1, 2, 3, 4, and 5, respectively; and the 
total cost of obtaining DATA-waived status is $7 million and $4 million 
in years 1 and 2, respectively; resulting in a net benefit of $68 
million, $132 million, $169 million, $202 million, and $237 million in 
years 1, 2, 3, 4, and 5, respectively. The table below contains the 
summary of benefits and costs.

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                                      Year 1          Year 2          Year 3          Year 4          Year 5
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Total economic burden reduction              208             374             467             560             654
 ($MM)..........................
Cost of treatment ($MM).........             133             238             298             358             417
Cost of obtaining DATA-waived                  7               4  ..............  ..............  ..............
 status ($MM)...................
Total cost ($MM)................             140             242             298             358             417
Annual net benefit ($MM)........              68             132             169             202             237
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Figures are rounded.

    At 3% discount rate, the present value of benefits is $2,044 
million, the present value of costs is $1,315 million and the net 
present value (NPV) is $729 million. At 7% discount rate, the present 
value of benefits is $1,796 million, the present value of costs is 
$1,156 million and the NPV is $640 million.\6\ The net benefits in 
years 1 to 5 equate to an annualized net benefit of $159 million at 3% 
and $156 million at 7% over five years. The table below summarizes the 
present value and annualized benefit calculations.
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    \6\ See Office of Mgmt. & Budget, Exec. Office of the President, 
OMB Circular A-4, Regulatory Analysis (2003).

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                                                            3%      7%
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Present value of benefits ($MM).........................   2,044   1,796
Present value of costs ($MM)............................   1,315   1,156
                                                         ---------------
  Net present value ($MM)...............................     729     640
Annualized net benefit--5 years ($MM)...................     159     156
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Figures are rounded.

Executive Order 12988, Civil Justice Reform

    This final rule meets the applicable standards set forth in 
sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice 
Reform to eliminate ambiguity, minimize litigation, establish clear 
legal standards, and reduce burden.

Executive Order 13132, Federalism

    This rulemaking does not have federalism implications warranting 
the application of Executive Order 13132. The final 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, Consultation and Coordination With Indian Tribal 
Governments

    This final 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 between the 
Federal Government and Indian tribes.

Executive Order 13771, Reducing Regulation and Controlling Regulatory 
Costs

    This final rule is considered an E.O. 13771 deregulatory action. 
The rule is an enabling rule which expands the options for opioid 
treatment. Details on the expected economic effects of this rule can be 
found in the rule's economic impact analysis.

Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to 
rules that are subject to notice and comment under section 553(b) of 
the APA. As explained above, the DEA determined that there was good 
cause to exempt this final rule from notice and comment. Consequently, 
the RFA does not apply to this final rule.

Unfunded Mandates Reform Act of 1995

    This final rule will not 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, and will 
not significantly or uniquely affect small governments. Therefore, no 
actions were deemed under the provisions of the Unfunded Mandates 
Reform Act of 1995, 2 U.S.C. 1532.

Congressional Review Act

    This rule is a major rule as defined by the Congressional Review 
Act. 5 U.S.C. 804. This rule will result in an annual effect on the 
economy of $100 million or more as a result of economic burden 
reductions. However, it will not cause a major increase in costs or 
prices; or significant adverse effects on competition, employment, 
investment, productivity, innovation, or on the ability of the United 
States-based companies to compete with foreign based companies in 
domestic and export markets. The DEA has submitted a copy of this final 
rule to both Houses of Congress and to the Comptroller General.

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

List of Subjects in 21 CFR Part 1301

    Administrative practice and procedure, Drug traffic control, 
Exports, Imports, Security measures.

    For the reasons set out above, the DEA amends 21 CFR part 1301 as 
follows:

PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS AND 
DISPENSERS OF CONTROLLED SUBSTANCES

0
1. The authority citation for 21 CFR part 1301 is revised to read as 
follows:

    Authority: 21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877, 
886a, 951, 952, 956, 957, 958, 965 unless otherwise noted.

0
2. In Sec.  1301.28, revise paragraphs (b)(1)(i), (ii), and (iii) to 
read as follows:


Sec.  1301.28   Exemption from separate registration for practitioners 
dispensing or prescribing Schedule III, IV, or V narcotic controlled 
drugs approved by the Food and Drug Administration specifically for use 
in maintenance or detoxification treatment.

* * * * *
    (b)(1) * * *
    (i) The individual practitioner is registered under Sec.  1301.13 
as an individual practitioner and is a ``qualifying physician'' as 
defined in section 303(g)(2)(G)(ii) of the Act (21

[[Page 3075]]

U.S.C. 823(g)(2)(G)(ii)), or during the period beginning on July 22, 
2016 and ending on October 1, 2021, a ``qualifying other practitioner'' 
as defined in section 303(g)(2)(G)(iv) of Act (21 U.S.C. 
823(g)(2)(G)(iv)). The Secretary of Health and Human Services may, by 
regulation, revise the requirements for being a qualifying other 
practitioner.
    (ii) With respect to patients to whom the practitioner will provide 
such drugs or combinations of drugs, the individual practitioner has 
the capacity to provide directly, by referral, or in such other manner 
as determined by the Secretary of Health and Human Services:
    (A) All drugs approved by the Food and Drug Administration for the 
treatment of opioid use disorder, including for maintenance, 
detoxification, overdose reversal, and relapse prevention; and
    (B) Appropriate counseling and other appropriate ancillary 
services.
    (iii)(A) The total number of patients to whom the individual 
practitioner will provide narcotic drugs or combinations of narcotic 
drugs under this section at any one time will not exceed the applicable 
number. Except as provided in paragraphs (b)(1)(iii)(B) and (C) of this 
section, the applicable number is 30.
    (B) The applicable number is 100 if, not sooner than 1 year after 
the date on which the practitioner submitted the initial notification, 
the practitioner submits a second notification to the Secretary of 
Health and Human Services of the need and intent of the practitioner to 
treat up to 100 patients.
    (C) The applicable number is 275 for a practitioner who has been 
approved by the Secretary of Health and Human Services under 42 CFR 
part 8 to treat up to 275 patients at any one time, and provided 
further that the practitioner has renewed such approval to the extent 
such renewal is required under this part of the HHS regulations.
* * * * *

    Dated: January 18, 2018.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2018-01173 Filed 1-22-18; 8:45 am]
BILLING CODE 4410-09-P