[Federal Register Volume 85, Number 242 (Wednesday, December 16, 2020)]
[Rules and Regulations]
[Pages 81388-81390]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25288]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-671]


Schedules of Controlled Substances: Exempt Anabolic Steroid 
Products

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Order with opportunity for comment.

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SUMMARY: The Drug Enforcement Administration is denying applications to 
designate four in-process preparations containing trenbolone acetate as 
exempt anabolic steroid products under the Controlled Substances Act.

DATES: This order is effective December 16, 2020. Written comments must 
be postmarked, and electronic comments must be sent, on or before 
February 16, 2021.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-671'' on all electronic and written correspondence, 
including any attachments.
    Electronic comments: The Drug Enforcement Administration (DEA) 
encourages all comments be submitted electronically through the Federal 
eRulemaking Portal which provides the ability to type short comments 
directly into the comment field on the web page or 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: Paper comments that duplicate electronic 
submissions are not necessary and are discouraged. Should you wish to 
mail a paper comment in lieu of an electronic comment, it should be 
sent via regular or express mail to: Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Drug and Chemical 
Evaluation, Diversion Control Division, Drug Enforcement 
Administration; Mailing Address: 8701 Morrissette Drive, Springfield, 
Virginia 22152; Telephone: (571) 362-3249.

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

    Please note that all comments received are considered part of the 
public record. They will, unless reasonable cause is given, be made 
available by DEA for public inspection online at http://www.regulations.gov. Such information includes personal identifying 
information (such as your name, address, etc.) voluntarily submitted by 
the commenter. The Freedom of Information Act applies to all comments 
received. 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 made publicly available, 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 publicly available 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 made publicly available, 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 or personal identifying 
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

    Anabolic steroids are listed in schedule III of the Controlled 
Substances Act (CSA). 21 U.S.C. 802(41) and 812(c), Schedule III(e). 
The CSA further provides that the Attorney General may, by regulation, 
exempt from any or all CSA provisions any

[[Page 81389]]

``compound, mixture, or preparation which contains any anabolic 
steroid, which is intended for administration to a human being or an 
animal, and which, because of its concentration, preparation, 
formulation or delivery system, does not present any significant 
potential for abuse.'' 21 U.S.C. 811(g)(3)(C). The authority to exempt 
these products has been delegated from the Attorney General to the 
Administrator of the Drug Enforcement Administration (DEA) (28 CFR 
0.100(b)), who in turn, re-delegated this authority to the Assistant 
Administrator of Diversion Control (DC) (28 CFR part 0, Appendix to 
Subpart R, section 7(g)). The procedures for implementing this section 
are found at 21 CFR 1308.33.

Findings of Fact

    DEA received an application from Ivy Animal Health, Inc. (Ivy), 
dated March 27, 2015, seeking to exempt two anabolic steroid-containing 
product preparations containing trenbolone acetate from control under 
the CSA. Letter from Ivy Animal Health, Inc. to DEA (Mar. 27, 2015), at 
1. Specifically, the product preparations were Component TE-H in-
process granulation and Component TE-H in-process pellets in bulk 
containers. Id.
    Ivy based its application on the grounds that DEA had previously 
exempted other in-process granulations and pellets containing 
trenbolone acetate, and the Component TE-H ``product formulations 
contain the same active ingredients Trenbolone acetate and Estradiol'' 
as the other in-process materials that are currently exempt. Id. Ivy's 
application further stated that ``[t]he presence of Estradiol in the 
formulation with Trenbolone acetate renders the Component TE-H in 
process granulation and pellets unusable for anabolic steroid abuse.'' 
Id. at 4-5. Ivy noted that DEA has ``previously identified Component 
TE-S in process granulation and in process pellets as exempt from the 
CSA as the presence of Estradiol in the formulation prevented 
significant potential for abuse.'' Id. at 5.
    Upon review of the application, DEA accepted it for filing. On 
April 29, 2015, DEA provided a copy of Ivy's application to the 
Secretary of Health and Human Services (HHS) and requested an 
evaluation and a recommendation.
    DEA also received an application from Ivy Animal Health, Inc., 
dated April 30, 2015, seeking to exempt two anabolic steroid-containing 
product preparations containing trenbolone acetate from control under 
the CSA. Letter from Ivy Animal Health, Inc. to DEA (Apr. 30, 2015), at 
1. Specifically, the product preparations were Component T-H in-process 
granulation and Component T-H in-process pellets in bulk containers. 
Id.
    Ivy based its application on the grounds that DEA had ``previously 
identified Component TE-S in process granulation and in process pellets 
as exempt from the CSA as the formulation prevented significant 
potential for abuse.'' Id. The application noted that the ``combination 
of [trenbolone acetate] with the excipient materials under the 
manufacturing process conditions removes significant potential for 
abuse of the anabolic steroid in the granulation mixture and resultant 
in process pellets.'' Id. Ivy further noted that this formulation ``is 
identical to that of the Component[supreg] T-H packaged product pellets 
and presents no more potential for abuse than that of the excluded 
packaged implant product.'' Id. at 4. Ivy claimed that for Component T-
H in-process granulation and Component T-H in-process pellets, 
``[c]omplicated manipulation of the material, including dissolution, 
separation, and reconstituting, would be required to convert the in 
process material to Trenbolone acetate and prepare it for injection or 
some other delivery method.'' Id. at 5.
    Upon review of the application, DEA accepted it for filing. On June 
4, 2015, DEA provided a copy of Ivy's application to the Secretary of 
HHS and requested an evaluation and a recommendation.
    On October 8, 2019, the Assistant Secretary for Health (ASH) 
provided HHS's evaluation and recommendation to DEA for both 
applications. Letter from Assistant Secretary for Health, HHS, to 
Acting Administrator, DEA, at 1 (Oct. 8, 2019) (ASH Letter). HHS found 
that ``[a]lthough there is no evidence that trenbolone is being 
obtained from in-process materials there is evidence that it is being 
abused.'' Id. HHS noted the availability of ``protocols or kits to 
purify trenbolone from marketed cattle pellets'' and concluded that 
these ``do-it-yourself kits'' makes the ``in-process materials easy to 
abuse.'' Id.
    With respect to the inclusion of estradiol in Component TE-H in-
process granulation and Component TE-H in-process pellets, HHS found 
that ``protocols and kits have been developed to purify trenbolone from 
estradiol.'' Id. Although HHS had previously ``recommended that DEA 
exempt in-process substances containing trenbolone and estradiol'' on 
the basis that ``inclusion of estradiol deterred abuse,'' because these 
kits and protocols are now available, ``it can no longer be concluded 
that the addition of estradiol to a substance containing trenbolone 
acetate deters the abuse of trenbolone acetate.'' Id.
    HHS thus concluded ``that the products Component T-H in-process 
granulation and Component T-H in-process pellets, and Component TE-H 
in-process granulation and Component TE-H in-process pellets do not fit 
into the category of having no significant potential for abuse based on 
concentration, preparation, formulation, or delivery system.'' Id. The 
ASH thus recommended that Ivy's ``products be denied exemption from 
scheduling under the CSA.'' Id.
    Further, after a review of the available kits and protocols, DEA 
finds this information credible, easy to understand, and requires no 
specialized skill or experience to carry out the required steps. Thus, 
DEA concludes that trenbolone acetate can be easily separated from 
estradiol and other excipient materials used to make Component TE-H in-
process granulation, Component TE-H in-process pellets, Component T-H 
in-process granulation, and Component T-H in-process pellets. The 
composition of these in-process materials containing significant 
quantities of trenbolone acetate does not prevent significant potential 
for abuse.

Conclusions of Law

    Based on the evaluation and recommendation of the ASH, as well as 
DEA's review of available evidence of diversion of these types of 
products, the Assistant Administrator does not find that ``because of 
[their] concentration, preparation, formulation, or delivery system,'' 
Ivy's Component TE-H in-process granulation, Component TE-H in-process 
pellets, Component T-H in-process granulation, and Component T-H in-
process pellets ``ha[ve] no significant potential for abuse.'' 21 CFR 
1308.33(a).
    Therefore, the Assistant Administrator, Diversion Control Division, 
hereby orders that the above products containing anabolic steroids not 
be exempted from application of any section of the CSA, and they are 
not to be included in the list of products described in 21 CFR 1308.34. 
These in-process materials remain controlled as an anabolic steroid in 
schedule III. Unless specifically excepted, to the extent Ivy handles 
trenbolone acetate in the manufacturing process, Ivy must comply with 
all applicable registration, security and recordkeeping requirements 
set forth in the CSA and DEA regulations. Exemptions granted or denied 
under 21 CFR 1308.33 are

[[Page 81390]]

product- and manufacturer-specific, and the present order does not 
address any other product currently listed in 21 CFR 1308.34.
    This order does not apply to the final, packaged, and labeled 
products ``containing an anabolic steroid, that are expressly intended 
for administration through implants to cattle or other nonhuman 
species'' where the products ``have been approved by the Secretary of 
Health and Human Services for such administration.'' 21 CFR 1308.26(a). 
Under 21 U.S.C. 802(41)(B)(i), such products are excepted from the 
definition of an anabolic steroid without undergoing the exemption 
process described in 21 CFR 1308.33, and without any evaluation or 
determination of their abuse potential.

Opportunity for Comment

    Pursuant to 21 CFR 1308.33, any interested person may submit 
written comments on, or objections to, the denial of an exemption for 
any product listed in this order, within 60 days of the date of 
publication of this order, as specified above. If any comments or 
objections raise significant issues regarding any finding of fact or 
conclusion of law upon which this order is based, the Assistant 
Administrator, Diversion Control Division, may reconsider the 
application in light of the comments and objections filed. 21 CFR 
1308.33. Thereafter, the Assistant Administrator shall amend his 
original order as he determines appropriate. Id.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-25288 Filed 12-15-20; 8:45 am]
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