81 FR 16892 - Exempt Chemical Preparations Under the Controlled Substances Act

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 58 (March 25, 2016)

The applications for exempt chemical preparations received by the Drug Enforcement Administration (DEA) between April 1, 2013, and December 31, 2015, as listed below, were accepted for filing and have been approved or denied as indicated.

[Federal Register Volume 81, Number 58 (Friday, March 25, 2016)]
[Notices]
[Pages 16892-17040]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-06624]



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Vol. 81

Friday,

No. 58

March 25, 2016

Part III

Book 3 of 3 Books

Pages 16891-17058





Department of Justice





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Drug Enforcement Administration



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Exempt Chemical Preparations Under the Controlled Substances Act; 
Notice

Federal Register / Vol. 81 , No. 58 / Friday, March 25, 2016 / 
Notices

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-372]


Exempt Chemical Preparations Under the Controlled Substances Act

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice of order with opportunity for comment.

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SUMMARY: The applications for exempt chemical preparations received by 
the Drug Enforcement Administration (DEA) between April 1, 2013, and 
December 31, 2015, as listed below, were accepted for filing and have 
been approved or denied as indicated.

DATES: Interested persons may file written comments on this order in 
accordance with 21 CFR 1308.23(e). Electronic comments must be 
submitted, and written comments must be postmarked, on or before May 
24, 2016. Commenters should be aware that the electronic Federal Docket 
Management System will not accept comments after 11:59 p.m. Eastern 
Time on the last day of the comment period.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-372'' on all correspondence, including any 
attachments. The Drug Enforcement Administration (DEA) encourages that 
all comments be submitted through the Federal eRulemaking Portal, which 
provides the ability to type short comments directly into the comment 
field on the Web page or to attach a file for lengthier comments. 
Please go to http://www.regulations.gov and follow the online 
instructions at that site for submitting comments. Upon completion of 
your submission you will receive a Comment Tracking Number for your 
comment. Please be aware that submitted comments are not 
instantaneously available for public view on Regulations.gov. If you 
have received a comment tracking number, your comment has been 
successfully submitted and there is no need to resubmit the same 
comment. Paper comments that duplicate the electronic submission are 
not necessary and are discouraged. Should you wish to mail a comment in 
lieu of an electronic comment, it should be sent via regular or express 
mail to: Drug Enforcement Administration, Attention: DEA Federal 
Register Representative/ODW, 8701 Morrissette Drive, Springfield, 
Virginia 22152.

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

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

    Please note that all comments received are considered part of the 
public record and made available for public inspection online at http://www.regulations.gov and in the DEA's public docket. Such information 
includes personal identifying information (such as your name, address, 
etc.) voluntarily submitted by the commenter.
    If you want to submit personal identifying information (such as 
your name, address, etc.) as part of your comment, but do not want it 
to be posted online or made available in the public docket, you must 
include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first 
paragraph of your comment. You must also place all the personal 
identifying information you do not want posted online or made available 
in the public docket in the first paragraph of your comment and 
identify what information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be posted online or made available 
in the public docket, you must include the phrase ``CONFIDENTIAL 
BUSINESS INFORMATION'' in the first paragraph of your comment. You must 
also prominently identify confidential business information to be 
redacted within the comment.
    Comments containing personal identifying information and 
confidential business information identified as directed above will 
generally be made publicly available in redacted form. If a comment has 
so much confidential business information that it cannot be effectively 
redacted, all or part of that comment may not be made publicly 
available. Comments posted to http://www.regulations.gov may include 
any personal identifying information (such as name, address, and phone 
number) included in the text of your electronic submission that is not 
identified as directed above as confidential.
    An electronic copy of this document is available at http://www.regulations.gov for easy reference.

Legal Authority

    The Drug Enforcement Administration (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 purpose of this 
action. 21 U.S.C. 801-971. The DEA published the implementing 
regulations for these statutes in title 21 of the Code of Federal 
Regulations (CFR), chapter II.
    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 ensuring an adequate supply is 
available 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.
    Section 201 of the CSA (21 U.S.C. 811) authorizes the Attorney 
General, by regulation, to exempt from certain provisions of the CSA 
certain compounds, mixtures, or preparations containing a controlled 
substance, if she finds that such compounds, mixtures, or preparations 
meet the requirements detailed in 21 U.S.C. 811(g)(3)(B).\1\ DEA 
regulations 21 CFR 1308.23 and 1308.24 further detail the criteria by 
which the DEA Deputy Assistant Administrator may exempt a chemical 
preparation or mixture from certain provisions of the CSA. The Deputy 
Assistant Administrator may, pursuant to 21 CFR 1308.23(f), modify or 
revoke the criteria by which exemptions are granted and modify the 
scope of exemptions at any time.
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    \1\ This authority has been delegated from the Attorney General 
to the Administrator of the DEA by 28 CFR 0.100, and subsequently 
redelegated to the Deputy Assistant Administrator pursuant to 
section 7 of 28 CFR 0.104, appendix to subpart R.
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Exempt Chemical Preparation Applications Submitted Between April 1, 
2013, and September 17, 2015

    The Deputy Assistant Administrator received applications between 
April 1, 2013, and September 17, 2015, requesting exempt chemical 
preparation status detailed in 21 CFR 1308.23. Pursuant to the criteria 
stated in 21 U.S.C. 811(g)(3)(B) and in 21 CFR 1308.23, the Deputy 
Assistant Administrator has found that each of the compounds, mixtures, 
and preparations described in Chart I below is intended for laboratory, 
industrial, educational, or special research purposes and not for 
general administration to a human being or animal and either: (1) 
Contains no narcotic controlled substance and is packaged in such a 
form or concentration that the packaged

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quantity does not present any significant potential for abuse; or (2) 
contains either a narcotic or non-narcotic controlled substance and one 
or more adulterating or denaturing agents in such a manner, 
combination, quantity, proportion, or concentration that the 
preparation or mixture does not present any potential for abuse; if the 
preparation or mixture contains a narcotic controlled substance, it 
must be formulated in such a manner that it incorporates methods of 
denaturing or other means so that the preparation or mixture is not 
liable to be abused or have ill effects if abused, and so that the 
narcotic substance cannot in practice be removed.
    Accordingly, pursuant to 21 U.S.C. 811(g)(3)(B), and in accordance 
with 21 CFR 1308.23 and 21 CFR 1308.24, the Deputy Assistant 
Administrator has determined that each of the chemical preparations or 
mixtures generally described in Chart I below and specifically 
described in the application materials received by the DEA, are exempt, 
to the extent described in 21 CFR 1308.24, from application of sections 
302, 303, 305, 306, 307, 308, 309, 1002, 1003, and 1004 (21 U.S.C. 822-
823, 825-829, and 952-954) of the CSA, and 21 CFR 1301.74, as of the 
date that was provided in the approval letters to the individual 
requesters.
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    The Deputy Assistant Administrator has found that each of the 
compounds, mixtures, and preparations described in Chart II below is 
not consistent with the criteria stated in 21 U.S.C. 811(g)(3)(B) and 
in 21 CFR 1308.23. Accordingly, the Deputy Assistant Administrator has 
determined that the chemical preparations or mixtures generally 
described in Chart II below and specifically described in the 
application materials received by the DEA, are not exempt from 
application of any part of the CSA or from application of any part of 
the CFR, with regard to the requested exemption pursuant to 21 CFR 
1308.23, as of the date that was provided in the determination letters 
to the individual requesters.

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BILLING CODE 4410-09-C

Scope of Approval

    The exemptions are applicable only to the precise preparation or 
mixture described in the application submitted to DEA in the form(s) 
listed in this order and only for those sections of the CSA and the CFR 
that are specifically identified. In accordance with 21 CFR 1308.24(h), 
any change in the quantitative or qualitative composition of the 
preparation or mixture, or change in the trade name or other 
designation of the preparation or mixture after the date of application 
requires a new application. In accordance with 21 CFR 1308.24(g), the 
DEA may prescribe requirements other than those set forth in 21 CFR 
1308.24 (b) through (e) on a case-by-case basis for materials exempted 
in bulk quantities. Accordingly, in order to limit opportunity for 
diversion from the larger bulk quantities, the DEA has determined that 
each of the exempted bulk products listed in this order may only be 
used in-house by the manufacturer, and may not be distributed for any 
purpose, or transported to other facilities.
    Additional exempt chemical preparation requests received between 
April 1, 2013, and December 31, 2015, and not otherwise referenced in 
this order may remain under consideration until the DEA receives 
additional information required, in accordance with 21 CFR 1308.23(d), 
as detailed in separate correspondence to individual requesters. The 
DEA's order on such requests will be communicated to the public in a 
future Federal Register publication.
    The DEA also notes that these exemptions are limited to exemption 
from only those sections of the CSA and the CFR that are specifically 
identified in 21 CFR 1308.24(a). All other requirements of the CSA and 
the CFR apply, including registration as an importer as required by 21 
U.S.C. 957.

Chemical Preparations Containing Newly Controlled Substances

    The statutory authority for exempt chemical preparations is based 
on the control status of substances contained within a preparation, the 
intended administration of a preparation, and the packaged form of a 
preparation. The DEA conducts a case-by-case analysis of each 
application for exemption to determine whether exemption of a 
preparation from certain provisions of the CSA is appropriate pursuant 
to the specified statutory and regulatory requirements.
    Most exempt chemical preparations have remained effective until the 
holder of a specific exempt chemical preparation specifically requested 
that the exemption be terminated. The CSA allows for modifications to 
the controlled substances schedules to add, remove, or change the 
schedule of substances thus resulting in periodic modifications to the 
control status of various substances. 21 U.S.C. 811(a). Since the CSA 
was enacted in 1970, the DEA has on several occasions added to, removed 
from, or modified the schedules of controlled substances in accordance 
with the CSA. Such changes may result in the non-compliance of exempt 
chemical preparations with current statutes or regulations if chemical 
preparations that have already obtained exempt status contain newly 
controlled substances. For example, although an exempt chemical 
preparation may continue to be packaged in the same manner as when it 
was approved, non-controlled substances in the preparation may become 
controlled, thus prompting the need for a new application for exemption 
of the chemical preparation to ensure continued compliance. Other 
preparations that previously contained no controlled substances may 
contain newly controlled substances and thus would require an 
application for exemption.
    The DEA reviews applications for chemical preparation exemptions 
based on the statutes and regulations that are in place at the time of 
the application, including the control status of substances included in 
the preparation. The DEA must remain vigilant to ensure that exempt 
chemical preparations remain consistent with the standards set

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forth in the CSA and its implementing regulations. As such, the DEA 
reminds the public that any chemical preparation, regardless of whether 
it was previously exempt, that contains a newly controlled substance 
will require a new application for exemption pursuant to 21 U.S.C. 
811(g)(3)(B) and 21 CFR 1308.23-1308.24.

Opportunity for Comment

    In accordance with 21 CFR 1308.23, any interested person may submit 
written comments on or objections to any chemical preparation in this 
order that has been approved or denied as exempt. If any comments or 
objections raise significant issues regarding any finding of fact or 
conclusion of law upon which this order is based, the Deputy Assistant 
Administrator will immediately suspend the effectiveness of any 
applicable part of this order until he may reconsider the application 
in light of the comments and objections filed.

Approved Exempt Chemical Preparations Are Posted on DEA's Web Site

    A list of all current exemptions, including those listed in this 
order, is available on the DEA's Web site at http://www.DEAdiversion.usdoj.gov/schedules/exempt/exempt_chemlist.pdf. The 
dates of applications of all current exemptions are posted for easy 
reference.

    Dated: March 16, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-06624 Filed 3-24-16; 8:45 am]
 BILLING CODE 4410-09-P