[Federal Register Volume 85, Number 115 (Monday, June 15, 2020)]
[Rules and Regulations]
[Pages 36148-36150]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-11318]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-601]


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 designating two 
pharmaceutical preparations containing esterified estrogens and 
methyltestosterone as exempt anabolic steroid products under the 
Controlled Substances Act.

DATES: This order is effective June 15, 2020. Written comments must be 
postmarked, and electronic comments must be sent, on or before August 
14, 2020.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-601'' on all electronic and written correspondence, 
including any attachments.
     Electronic comments: The Drug Enforcement Administration 
(DEA) encourages that 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

[[Page 36149]]

are not necessary. 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/Regulatory Drafting and Policy Support Section, 8701 
Morrissette Drive, Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting 
and Policy Support Section, Diversion Control Division, Drug 
Enforcement Administration; Mailing Address: 8701 Morrissette Drive, 
Springfield, Virginia 22152; Telephone: (571) 362-3261.

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

    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 ``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

    On September 30, 2015, DEA received an application from ECI 
Pharmaceuticals, LLC, seeking to exempt two products combining 
esterified estrogens and methyltestosterone in tablets from control 
under the CSA. Letter from ECI Pharmaceuticals to DEA Office of 
Diversion Control (Sept. 30, 2015), at 1. Specifically, the products 
were Esterified Estrogens and Methyltestosterone 0.625/1.25mg tablets 
H.S. (half strength) and Esterified Estrogens and Methyltestosterone 
1.25/2.5mg tablets D.S. (full strength). Id.
    ECI based its application on the ground that DEA had previously 
exempted from control other tablet products combining esterified 
estrogens and methyltestosterone and that its products ``contain the 
same active drug substances in the same quantities . . . and most of 
the same excipients as many of the'' products that have been granted 
exemptions. Id. at 3. ECI's application further stated that ``[t]he 
deterrent effects of Esterified Estrogen when taken in combination with 
Methyltestosterone will not give the desired effect of one trying to 
abuse an anabolic steroid.'' Id. at Attachment 1, at 2. While noting 
that methyltestosterone had been controlled in schedule III because of 
its abuse by ``young and middle aged males,'' ECI explained that ``in 
combination with Esterified Estrogens, abuse of the substance would 
give counter effects of its intended use, causing a significant raise 
in the Estrogen level in males abusing the product.'' Id.
    Upon review of the application, DEA accepted it for filing. On 
November 2, 2015, DEA provided a copy of ECI's application to the 
Secretary of Health and Human Services (HHS) and requested an 
evaluation and a recommendation.
    On September 30, 2019, the Assistant Secretary for Health (ASH) 
provided HHS's evaluation and recommendation to DEA. Letter from 
Assistant Secretary for Health, HHS, to Acting Administrator, DEA, at 1 
(Sept. 30, 2019) (ASH Letter). HHS found that ``[r]eports and evidence 
of the abuse of steroids have involved topically applied testosterone 
formulations and transdermal testosterone products,'' which are 
``treatment replacement therapies for deficiency of endogenous 
testosterone.'' Id. at Attachment (HHS Evaluation), at 3. HHS found 
that ``[t]hese formulations contain only testosterone or testosterone 
esters, including methyltestosterone,'' but not estrogens which 
``generally lack anabolic effects.'' Id. HHS also found that abusers of 
steroids seek testosterone because of ``its strong anabolic effects 
that lead to increased muscle mass and strength and enhance athletic 
endurance.'' Id. By contrast, HHS found that ``bodybuilding internet 
forums advise users to avoid estrogen and anabolic steroid-estrogen 
combination products like Esterified Estrogens and Methyltestosterone 
H.S. and D.S. tablets because of the undesirable side effects induced 
by estrogen,'' which include ``gynecomastia'' and ``water and fat 
retention under the skin.'' Id. at 3-4.
    HHS further noted that ECI's two products contain the same active 
drug substance in the same amounts and most of the same excipients as 
eight different products which had previously been exempted from 
control. Id. at 4-5. HHS also performed a search of published 
literature databases, internet drug-user forums, and national drug 
reporting documents and found no ``new evidence for significant abuse'' 
of androgen/estrogen combination products. Id. at 6. HHS thus found 
that ``[f]rom an abuse potential perspective, it is reasonable to 
conclude that the mixture itself is undesirable,'' as the mixture 
contains ``estrogen, a hormone that lacks anabolic steroid properties 
sought by abusers.'' Id. Based on ``the similarity in formulation, 
route of administration and dosage strength''

[[Page 36150]]

with previously exempted products, HHS concluded that there are ``no 
meaningful differences in the abuse potential for this specific mixture 
of active ingredients.'' Id.
    HHS thus concluded that ECI's ``Esterified Estrogen and 
Methyltestosterone H.S. and D.S. tablets have no abuse potential and 
therefore may be exempted from CSA regulation.'' Id. The ASH thus 
recommended that ECI's ``products be exempted from scheduling under the 
CSA.'' ASH Letter, at 2. Further, after reviewing several law 
enforcement databases, DEA has found no evidence of significant abuse 
or trafficking of these types of products.

Conclusions of Law

    Based on the evaluation and recommendation of the ASH, as well as 
DEA having found no evidence of significant abuse or trafficking of 
these types of products, the Assistant Administrator finds that 
``because of [their] concentration, preparation, formulation, or 
delivery system,'' ECI's Esterified Estrogens and Methyltestosterone 
0.625/1.25mg tablets H.S. and Esterified Estrogens and 
Methyltestosterone 1.25/2.5mg tablets D.S., ``ha[ve] no significant 
potential for abuse.'' 21 CFR 1308.33(a). Information on these products 
is given below.

                                        Exempt Anabolic Steroid Products
----------------------------------------------------------------------------------------------------------------
            Trade name                  Company            Form          Ingredients             Quantity
----------------------------------------------------------------------------------------------------------------
Esterified Estrogens and           ECI                Tablets.......  Esterified         1.25 mg/Tablet.
 Methyltestosterone 1.25 mg/2.5     Pharmaceuticals                    Estrogens.        2.5 mg/Tablet.
 mg D.S.                            LLC.                              Methyltestosteron
                                                                       e.
Esterified Estrogens and           ECI                Tablets.......  Esterified         0.625 mg/Tablet.
 Methyltestosterone 0.625mg/        Pharmaceuticals                    Estrogens.        1.25 mg/Tablet.
 1.25mg H.S.                        LLC.                              Methyltestosteron
                                                                       e.
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    Therefore, the Assistant Administrator, Diversion Control Division, 
hereby orders that the above products containing anabolic steroids be 
exempted from application of sections 302, 303, 305, 307, 309, 1002, 
1003, 1004 of the CSA (21 U.S.C. 822-823, 825, 827, 829, a 952-954) and 
21 CFR 1301.13, 1301.22 and 1301.71 through 1301.76, and be included in 
the list of products described in 21 CFR 1308.34. These exemptions 
apply only with respect to the finished products. To the extent ECI 
handles methyltestosterone in the manufacturing process, because such 
material remains a controlled anabolic steroid, ECI must comply with 
all applicable registration, security and recordkeeping requirements 
set forth in the CSA and DEA regulations.

Opportunity for Comment

    Pursuant to 21 CFR 1308.33, any interested person may submit 
written comments on, or objections to, the exemption of either product 
listed in this order, within 60 days of the date of publication of 
this, 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, shall immediately suspend the effectiveness of this 
order until he may reconsider the application in light of the comments 
and objections filed. 21 CFR 1308.33. Thereafter, the Assistant 
Administrator shall reinstate, revoke, or amend his original order as 
he determines appropriate. Id.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-11318 Filed 6-12-20; 8:45 am]
 BILLING CODE 4410-09-P