Implementation of the Designer Anabolic Steroid Control Act of 2014, 50036-50041 [2023-15747]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 88, Number 146 (Tuesday, August 1, 2023)]
[Rules and Regulations]
[Pages 50036-50041]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-15747]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1300, 1302, and 1308

[Docket No. DEA-481]
RIN 1117-AB81


Implementation of the Designer Anabolic Steroid Control Act of 
2014

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Final rule.

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SUMMARY: On December 18, 2014, the Designer Anabolic Steroid Control 
Act of 2014 (DASCA) became law. The Act amended the Controlled 
Substances Act to revise and add specified substances to the definition 
of ``anabolic steroid.'' The Act provided a new mechanism for temporary 
and permanent scheduling of anabolic steroids, and added specific 
labeling requirements for products containing anabolic steroids. The 
Drug Enforcement Administration (DEA) is publishing this rule to amend 
and reorganize its regulations to make them consistent with DASCA 
regarding the updated definition, specific substances, criteria and 
timeframes applicable to temporary and permanent scheduling of anabolic 
steroids, and labeling requirements.

DATES: This final rule is effective August 1, 2023.

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

SUPPLEMENTARY INFORMATION: On December 18, 2014, the Designer Anabolic 
Steroid Control Act of 2014, Public Law 113-260 (128 Stat. 2929) 
(DASCA), became law. The purpose of this final rule is to codify in 
Drug Enforcement Administration (DEA) regulations the statutory 
amendments to the Controlled Substances Act (CSA) made by DASCA. This 
final rule merely conforms the DEA's regulations to the statutory 
amendments to the CSA that have already taken effect, and does not add 
additional requirements to the regulations. Thus, because this rule 
does no more than incorporate statutory amendments into DEA's 
regulations, publishing a notice of proposed rulemaking and soliciting 
public comment are unnecessary; and the rule is instead being issued as 
a final rule effective immediately.

DASCA's Changes to the CSA

    A House Report for DASCA stated that the purpose of the Act is ``to 
more effectively regulate anabolic steroids.'' H.R. Rep. No. 113-587, 
Part 2, at 4 (2014). DASCA makes four changes to the CSA: DASCA (1) 
revises and adds additional substances to the existing definition of 
``anabolic steroid'' in 21 U.S.C. 802(41); (2) provides a new mechanism 
for temporary and permanent scheduling of anabolic steroids in 21 
U.S.C. 811(i); (3) adds labeling requirements for anabolic steroids 
under 21 U.S.C. 825(e); and (4) provides new penalties for violating 
the labeling requirements under 21 U.S.C. 842(a)(16) and 842(c)(1)(C) 
and (D).
    It is evident from the enactment of DASCA that Congress believed 
the prior two public laws addressing steroids under the CSA (the 
Anabolic Steroids Control Act of 1990, Pub. L. 101-647, and the 
Anabolic Steroid Control Act of 2004, Pub. L. 108-358) had not 
sufficiently stemmed the misuse of anabolic steroids by athletes, 
students, and others. Among other things, Congress found that the prior 
statutory definition of an anabolic steroid was too narrow and that 
this narrowness was being exploited by some manufacturers and 
distributors. DASCA was designed to remedy this situation by: (1) 
expressly controlling under the CSA additional anabolic steroids that 
have emerged in the United States in recent years; and (2) expanding 
the definition of an anabolic steroid to allow other such steroids to 
be controlled as they emerged in the future. Indeed, the word 
``designer'' in DASCA's title reflects that Congress was targeting 
those who sought to circumvent the CSA by producing anabolic steroids 
that were slightly different in chemical structure from those 
substances specifically listed in the CSA but which were intended to 
cause the same effects--and thus were potentially harmful to users. The 
following statement by one of the sponsors of the legislation, Senator 
Whitehouse, illustrates these considerations:

    [A] loophole in current law allows for designer anabolic 
steroids to easily be found on the internet, in gyms, and even in 
retail stores.
    Designer steroids are produced by reverse engineering existing 
illegal steroids and then slightly modifying the chemical 
composition, so that the resulting product is not on [DEA's] list of 
controlled substances. When taken by consumers, designer steroids 
can cause serious medical consequences, including liver injury and 
increased risk of heart attack and stroke. They may also lead to 
psychological effects such as aggression, hostility, and addiction.


[[Page 50037]]


160 Cong. Rec. S891-892 (daily ed. Feb. 11, 2014) (statement of Sen. 
Whitehouse); accord 160 Cong. Rec. H7460 (daily ed. Sept. 15, 2014) 
(statement of Rep. Pitts); id. at H7461 (statement of Rep. 
Christensen); id. (statement of Rep. Waxman).

Changes to the Definition of an Anabolic Steroid

    To curtail the foregoing activity, DASCA amended the CSA definition 
of ``anabolic steroid'' by adding 22 new substances to the prior 
statutory list of anabolic steroids. See 21 U.S.C. 802(41)(A)(i)-
(lxxiv). While the statute lists 25 substances, two of these substances 
are duplicates of substances previously listed in the regulatory 
definition of anabolic steroid, and one substance is included twice on 
the statutory list, bringing the actual number to 22 new specific 
substances. In particular, methasterone and prostanozol were included 
in the statute but were already listed, albeit under alternative 
chemical names, in the regulatory definition of anabolic steroid.\1\ 4-
Chloro-17[alpha]-methyl-androsta-1,4-diene-3,17[beta]-diol is listed 
twice in the statute. See id. 802(41)(A)(liii), (lvii).
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    \1\ Methasterone is currently identified as 2[alpha],17[alpha]-
dimethyl-5[alpha]-androstan-17[beta]-ol-3-one in 21 CFR 
1300.01(b)(``anabolic steroid'')(32), but as 2[alpha],17[alpha]-
dimethyl-17[beta]-hydroxy-5[alpha]-androstan-3-one in 21 U.S.C. 
802(41)(A)(lviii). Prostanozol is currently identified as 17[beta]-
hydroxy-5[alpha]-androstano[3,2-c]pyrazole in 21 CFR 
1300.01(b)(``anabolic steroid'')(58), but as [3,2-c]pyrazole-
5[alpha]-androstan-17[beta]-ol in 21 U.S.C. 802(41)(A)(lxxiv). This 
rule revises the regulatory list of anabolic steroids to include all 
these variations of the chemical names of methasterone and 
prostanozol.
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    This rule revises the existing regulatory definition of ``anabolic 
steroid'' in 21 CFR 1300.01(b) to incorporate the revised statutory 
standard, moves the list of specifically named anabolic steroids from 
21 CFR 1300.01(b) to 21 CFR 1308.13(f), and adds the 22 new substances 
included in DASCA to the relocated list at 21 CFR 1308.13(f).\2\ In 
addition to incorporating the language of the statutory amendments of 
DASCA into DEA's regulations, this rule relocates and makes a number of 
organizational and typographical changes to the regulatory list of 
anabolic steroids to improve the list's clarity. These changes, 
however, do not add or remove any substances from this list beyond the 
22 new substances added by DASCA or otherwise alter DASCA's language. 
DASCA expanded the definition of ``anabolic steroid'' to include a drug 
or hormonal substance (other than estrogens, progestins, 
corticosteroids, and dehydroepiandrosterone) that is not listed and is 
derived from, or has a chemical structure substantially similar to a 
listed anabolic steroid or steroids, if it: (1) has been created or 
manufactured with the intent of producing a substance that either 
promotes muscle growth or otherwise causes a pharmacological effect 
similar to that of testosterone; or (2) has been, or is intended to be, 
marketed or otherwise promoted in any manner suggesting that consuming 
it will promote muscle growth or any pharmacological effect similar to 
that of testosterone. 21 U.S.C. 802(41)(C)(i). Unless otherwise 
excepted or listed in another schedule, all substances meeting the 
definition of ``anabolic steroid'' are controlled under schedule III of 
the CSA. See id. 812(c), Schedule III, (e); 21 CFR 1300.01(b), 
1308.13(f). Thus, other substances that meet DASCA's revised definition 
of an anabolic steroid are also considered schedule III substances, 
even if they are not specifically listed in Sec.  1308.13(f).
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    \2\ Although the list is being relocated from 21 CFR 1300.01(b) 
to 21 CFR 1308.13(f), all listed or defined anabolic steroids will 
maintain the same Controlled Substance Code Number, 4000.
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    Under this modified definition, a substance shall not be considered 
to be a drug or hormonal substance if it: (1) is an herb or other 
botanical, a concentrate, metabolite, or extract of, or a constituent 
isolated directly from, an herb or other botanical, or a combination of 
two or more such substances; (2) is a dietary ingredient for purposes 
of the Federal Food, Drug and Cosmetic Act (FD&C Act); and (3) is not 
anabolic or androgenic. 21 U.S.C. 802(41)(C)(ii). Any person claiming 
the benefit of exemption or exception under this definition shall bear 
the burden in administrative or judicial proceedings of going forward 
with evidence with respect to such exemption or exception in accordance 
with 21 U.S.C. 885(a). 21 U.S.C. 802(41)(C)(iii).

Changes to the Provisions Governing the Administrative Scheduling of 
Anabolic Steroids

    To further diminish the ability of illicit manufacturers of 
anabolic steroids to circumvent the law by producing new designer 
substances with similar effects, DASCA also made it easier for DEA to 
add such substances to the list of anabolic steroids on a temporary and 
permanent basis. Specifically, DASCA added a new subsection to the CSA 
(21 U.S.C. 811(i)), which gives the Attorney General (and thus the 
Administrator of DEA by delegation) the authority to issue a temporary 
order adding a drug or substance to the definition of ``anabolic 
steroid'' upon the finding that: (A) the substance satisfies the 
criteria for being considered an anabolic steroid but is not already 
listed in 21 U.S.C. 802(41) or in the regulations of the Attorney 
General (in practice, the regulatory definition of ``anabolic steroid'' 
in 21 CFR 1300.01); and (B) such addition will assist in preventing 
abuse or misuse of the substance. 21 U.S.C. 811(i)(1). Such a temporary 
control order may last up to 24 months after the effective date, with a 
possible extension of 6 months, and may not take effect until 30 days 
after the date of the publication by the Attorney General of a notice 
in the Federal Register of the intention to issue such an order and the 
grounds upon which such an order is to be issued. 21 U.S.C. 811(i)(2). 
The Attorney General shall also transmit notice of a proposed order to 
the Secretary of Health and Human Services and take into consideration 
any comments submitted by the Secretary in response to that notice. 21 
U.S.C. 811(i)(3). DASCA also gives the DEA the authority to issue, by 
rule, a permanent order adding a drug or other substance to the 
definition of an anabolic steroid if that drug or other substance 
satisfies the criteria for being considered an anabolic steroid under 
21 U.S.C. 802(41). 21 U.S.C. 811(i)(6).
    Unlike scheduling under 21 U.S.C. 811(a), nothing in DASCA requires 
this rulemaking to take place on the record after opportunity for a 
hearing, and thus these permanent orders may be issued pursuant to the 
informal rulemaking procedures prescribed by subchapter II of chapter 5 
of Title 5 of the United States Code. See 5 U.S.C. 553(c).

New Labeling Requirements for Anabolic Steroids

    To protect potential consumers from unknowingly ingesting anabolic 
steroids, and to ensure that all persons in the distribution chain 
identify those items that contain anabolic steroids, DASCA also added a 
labeling requirement to the CSA. This labeling provision states that it 
is unlawful to import, export, manufacture, distribute, or dispense--or 
possess with intent to manufacture, distribute, or dispense--an 
anabolic steroid or product containing an anabolic steroid, unless the 
product bears a label clearly identifying the anabolic steroid or 
product containing an anabolic steroid by the nomenclature used by the 
International Union of Pure and Applied Chemistry (IUPAC). 21 U.S.C. 
825(e)(1). DASCA makes an exception to the IUPAC labeling requirement 
where the product is labeled in the manner required under the CSA and 
the FD&C Act; that is, the product is the subject of an approved 
application as described in 21 U.S.C. 355(b) or (j), or the product is

[[Page 50038]]

exempt from the provisions of 21 U.S.C. 355 because it is intended 
solely for investigational use as described in 21 U.S.C. 355(i) and it 
is being used exclusively for the purposes of a clinical trial that is 
the subject of an effective investigational new drug application. Id. 
825(e)(2).
    DASCA also added new civil fine provisions for failure to comply 
with the labeling requirements:
     For a violation by an importer, exporter, manufacturer, or 
distributor (except as provided in the subsequent paragraph), up to 
$500,000 per instance of importation, exportation, manufacturing, 
distribution, or possession with intent to manufacture or distribute. 
21 U.S.C. 842(c)(1)(C).
     In the case of a distribution, dispensing, or possession 
with intent to distribute or dispense in violation of the labeling 
requirements at the retail level, up to $1,000 per violation. ``At the 
retail level'' refers to products sold, or held for sale, directly to 
the consumer for personal use. Each package, container, or other 
separate unit containing an anabolic steroid that is distributed, 
dispensed, or possessed with intent to distribute or dispense at the 
retail level is a separate violation. 21 U.S.C. 842(c)(1)(D). Failure 
to comply with labeling requirements may be taken into account by DEA 
when issuing or revoking a registration.\3\
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    \3\ See 21 U.S.C. 823(a), 824(a).
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    These penalty provisions are discussed here for the sake of 
completeness and given their close connection with other DASCA 
provisions. DEA is not amending its regulations to incorporate these 
civil fine provisions, as DEA's regulations do not address civil fines 
in general, making such amendment unnecessary.

Impact of Statutory Changes on Regulatory Requirements

    In enacting DASCA and expanding the scope of substances that fall 
within the CSA definition of an anabolic steroid, Congress increased 
the number of substances that are schedule III controlled substances 
and subject to the corresponding provisions of the CSA. This law added 
22 new substances to the list of schedule III controlled substances, 
which are included in 21 CFR 1308.13(f).
    Since December 18, 2014, the manufacture, import, export, 
distribution, or sale of a newly listed anabolic steroid or a substance 
meeting the revised definition of an anabolic steroid, except by DEA 
registrants, has been a violation of the CSA that may result in 
imprisonment and fines. 21 U.S.C. 841, 960. Possession of the steroids 
unless legally obtained is also subject to criminal penalties. 21 
U.S.C. 844. Importation of these schedule III steroids is illegal 
unless the person importing the steroids is registered with DEA as an 
importer or researcher and files the required declaration for each 
shipment. Illegal importation of a schedule III anabolic steroid is a 
violation of the CSA that may result in imprisonment and fines. 21 
U.S.C. 960(a)(1).

Disposal of Anabolic Steroids

    Persons who possess substances defined as anabolic steroids and who 
wish to dispose of them rather than becoming registered to handle them 
should contact their local DEA Diversion field office for assistance in 
disposing of these substances legally. The DEA Diversion field office 
will provide the person with instructions regarding the disposal. A 
list of local DEA Diversion field offices may be found at https://apps2.deadiversion.usdoj.gov/contactDea/spring/fullSearch.

Good Cause for Issuing This Rule as a Final Rule Without Notice and 
Comment

    An agency may find good cause to exempt a rule from certain 
provisions of the Administrative Procedure Act (APA), 5 U.S.C. 553, 
including notice of proposed rulemaking and the opportunity for public 
comment, if such actions are determined to be unnecessary, 
impracticable, or contrary to the public interest. DEA finds there is 
good cause within the meaning of the APA to issue these amendments as a 
final rule without notice and comment, because these amendments, as 
explained above, merely conform the implementing regulations with 
recent amendments to the CSA 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 Comm. v. 
Sullivan, 936 F.2d 1284, 1291 (D.C. Cir. 1991); see also United States 
v. Cain, 583 F.3d 408, 420 (6th Cir. 2009) (contrasting legislative 
rules, which require notice-and-comment procedures, ``with regulations 
that merely restate or interpret statutory obligations,'' which do 
not); Komjathy v. Nat'l Transp. Safety Bd., 832 F.2d 1294, 1296-97 
(D.C. Cir. 1987) (per curiam) (when a rule ``does no more than repeat, 
virtually verbatim, the statutory grant of authority,'' notice-and-
comment procedures are not required).
    As DEA is simply incorporating the terms of DASCA into its 
regulations and making organizational and technical changes, publishing 
a notice of proposed rulemaking and soliciting public comment is 
unnecessary. The revised definition of ``anabolic steroid,'' the 
identification of 22 new specific substances as anabolic steroids, the 
new mechanism for temporary and permanent scheduling of anabolic 
steroids, and the revised labeling requirements for anabolic steroids 
have already been in effect since December 18, 2014. Moreover, while 
the list of anabolic steroids has been moved to Sec.  1308.13(f), this 
change is a technical one; it imposes no new or substantive requirement 
on the public or DEA registrants. For the reasons discussed above, DEA 
also finds good cause exists to make this rule effective immediately 
upon publication. 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 issuing this final rule to revise its 
regulations so that they are consistent with the provisions of the CSA 
that were amended by the DASCA. In issuing this final rule, DEA has not 
gone beyond the statutory text enacted by Congress. DEA's regulatory 
analysis is 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

[[Page 50039]]

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. This rule is not a ``significant regulatory action'' under 
Executive Order 12866.
    On December 18, 2014, the Designer Anabolic Steroid Control Act of 
2014 (DASCA) became law. The Act amended the Controlled Substances Act 
(CSA) to expand the general definition of ``anabolic steroid'' to 
include a broader range of substances, and to add 22 new specific 
substances to the list of named substances in the definition. The Act 
further provided a new mechanism for temporary and permanent scheduling 
of anabolic steroids as schedule III controlled substances, and added 
new labeling requirements for anabolic steroids, with penalties for 
violation of such requirements. These provisions of DASCA were self-
implementing, and did not require any amendments to the Code of Federal 
Regulations in order to be effective. The 22 new specific substances 
that were not previously controlled and the other unnamed substances 
that meet DASCA's revised definition of anabolic steroid became 
schedule III substances with the passage of DASCA.
    As stated above, the DEA is simply updating its regulations to be 
consistent with the exact terms of DASCA; this final rule does not 
change the legal status of these substances. Because the placement of 
these substances in schedule III, the revised general definition of 
``anabolic steroid,'' the criteria and timeframes applicable to 
temporary and permanent scheduling of anabolic steroids, and the 
labeling requirements for anabolic steroids (with penalties for 
violation) have already been in effect since December 18, 2014, any 
economic impact of DASCA has already been absorbed by the economy.
    Therefore, this final rule will have no economic impact. 
Accordingly, the DEA does not anticipate that this rulemaking will 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.

Executive Order 12988, Civil Justice Reform

    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 ambiguity, minimize litigation, establish clear 
legal standards, and reduce burden.

Executive Order 13132, Federalism

    This rulemaking does not preempt or modify any provision of State 
law, impose enforcement responsibilities on any State, or diminish the 
power of any State to enforce its own laws. Accordingly, this 
rulemaking does not have federalism implications warranting the 
application of Executive Order 13132.

Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments

    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 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.

Paperwork Reduction Act of 1995

    This rule does not involve a collection of information within the 
meaning of the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3521.

Unfunded Mandates Reform Act of 1995

    This 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 annually for inflation) in any one year, 
and will not significantly or uniquely affect small governments. 
Therefore, no actions were deemed necessary under the provisions of the 
Unfunded Mandates Reform Act of 1995. 2 U.S.C. 1532.

Congressional Review Act

    This final rule is not a major rule as defined by the Congressional 
Review Act (CRA), 5 U.S.C. 804. However, pursuant to the CRA, the DEA 
is submitting a copy of this final rule to both Houses of Congress and 
to the Comptroller General.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
July 18, 2023, by Administrator Anne Milgram. That document with the 
original signature and date is maintained by DEA. For administrative 
purposes only, and in compliance with requirements of the Office of the 
Federal Register, the undersigned DEA Federal Register Liaison Officer 
has been authorized to sign and submit the document in electronic 
format for publication, as an official document of DEA. This 
administrative process in no way alters the legal effect of this 
document upon publication in the Federal Register.

List of Subjects

21 CFR Part 1300

    Chemicals, Drug traffic control.

21 CFR Part 1302

    Drug traffic control, Exports, Imports, Labeling, Packaging and 
containers.

21 CFR Part 1308

    Administrative practice and procedure, Drug traffic control, 
Reporting and recordkeeping requirements.

    For the reasons set forth above, 21 CFR parts 1300, 1302, and 1308 
are amended as follows:

PART 1300--DEFINITIONS

0
1. The authority citation for part 1300 continues to read as follows:


    Authority: 21 U.S.C. 802, 821, 822, 829, 871(b), 951, 958(f).


0
2. Section 1300.01 is amended in paragraph (b) by revising the 
definition of ``Anabolic steroid'' as follows:


Sec.  1300.01  Definition relating to controlled substances.

* * * * *
    (b) * * *
    Anabolic steroid means any drug or hormonal substance, chemically 
and pharmacologically related to testosterone (other than estrogens, 
progestins, corticosteroids, and dehydroepiandrosterone), and includes 
(but is not limited to) those substances listed in Sec.  1308.13(f) of 
this chapter.
    (1)(i) Except as provided in paragraph (1)(ii) of this definition, 
such term does not include an anabolic steroid that is expressly 
intended for administration

[[Page 50040]]

through implants to cattle or other nonhuman species and that has been 
approved by the Secretary of Health and Human Services for such 
administration.
    (ii) If any person prescribes, dispenses, or distributes such 
steroid for human use, the person shall be considered to have 
prescribed, dispensed, or distributed an anabolic steroid within the 
meaning of this definition.
    (2)(i) Subject to paragraph (2)(ii) of this definition, a drug or 
hormonal substance (other than estrogens, progestins, corticosteroids, 
and dehydroepiandrosterone) that is not listed in Sec.  1308.13(f) of 
this chapter and is derived from, or has a chemical structure 
substantially similar to, one or more anabolic steroids listed in Sec.  
1308.13(f) of this chapter shall be considered to be an anabolic 
steroid for purposes of this chapter if--
    (A) The drug or substance has been created or manufactured with the 
intent of producing a drug or other substance that either--
    (1) Promotes muscle growth; or
    (2) Otherwise causes a pharmacological effect similar to that of 
testosterone; or
    (B) The drug or substance has been, or is intended to be, marketed 
or otherwise promoted in any manner suggesting that consuming it will 
promote muscle growth or any other pharmacological effect similar to 
that of testosterone.
    (ii) A substance shall not be considered to be a drug or hormonal 
substance for purposes of this definition if it--
    (A) Is--
    (1) An herb or other botanical;
    (2) A concentrate, metabolite, or extract of, or a constituent 
isolated directly from, an herb or other botanical; or
    (3) A combination of 2 or more substances described in paragraph 
(2)(ii)(A)(1) or (2) of this definition;
    (B) Is a dietary ingredient for purposes of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.); and
    (C) Is not anabolic or androgenic.
    (iii) In accordance with 21 U.S.C. 885(a), any person claiming the 
benefit of an exemption or exception under paragraph (2)(ii) of this 
definition shall bear the burden of going forward with the evidence 
with respect to such exemption or exception.
* * * * *

PART 1302--LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED 
SUBSTANCES

0
3. The authority citation for part 1302 continues to read as follows:

    Authority:  21 U.S.C. 821, 825, 871(b), 958(e).


0
4. Section 1302.08 is added to read as follows:


Sec.  1302.08  False labeling of anabolic steroids.

    (a) It shall be unlawful to import, export, manufacture, 
distribute, dispense, or possess with intent to manufacture, 
distribute, or dispense, an anabolic steroid or product containing an 
anabolic steroid, unless the steroid or product bears a label clearly 
identifying an anabolic steroid or product containing an anabolic 
steroid by the nomenclature used by the International Union of Pure and 
Applied Chemistry (IUPAC).
    (b)(1) A product described in paragraph (b)(2) of this section is 
exempt from the International Union of Pure and Applied Chemistry 
nomenclature requirement of this section if such product is labeled in 
the manner required under the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.).
    (2) A product is described in this paragraph (b)(2) if the 
product--
    (i) Is the subject of an approved application as described in 
section 505(b) or (j) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(b), (j)); or
    (ii) Is exempt from the provisions of section 505 of the Federal 
Food, Drug, and Cosmetic Act relating to new drugs because--
    (A) It is intended solely for investigational use as described in 
section 505(i) of the Federal Food, Drug, and Cosmetic Act; and
    (B) Such product is being used exclusively for purposes of a 
clinical trial that is the subject of an effective investigational new 
drug application.

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
5. The authority citation for part 1308 continues to read as follows:

    Authority:  21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise 
noted.


0
6. Section 1308.13 is amended by revising paragraph (f) to read as 
follows:


Sec.  1308.13  Schedule III.

* * * * *
    (f) Anabolic steroids. Unless specifically excepted or unless 
listed in another schedule, any substance meeting the definition of 
anabolic steroid as set forth in Sec.  1300.01 of this chapter, 
including any material, compound, mixture or preparation containing any 
quantity of the following substances, including its salts, esters and 
ethers (4000):
    (1) 5[alpha]-androstan-3,17-dione;
    (2) 5[alpha]-androstan-3,6,17-trione;
    (3) 1-androstenediol (3[beta],17[beta]-dihydroxy-5[alpha]-androst-
1-ene);
    (4) 1-androstenediol (3[alpha],17[beta]-dihydroxy-5[alpha]-androst-
1-ene);
    (5) 4-androstenediol (3[beta],17[beta]-dihydroxy-androst-4-ene);
    (6) 5-androstenediol (3[beta],17[beta]-dihydroxy-androst-5-ene);
    (7) 1-androstenedione (5[alpha]-androst-1-en-3,17-dione);
    (8) 4-androstenedione (androst-4-en-3,17-dione);
    (9) 5-androstenedione (androst-5-en-3,17-dione);
    (10) bolasterone (7[alpha],17[alpha]-dimethyl-17[beta]-
hydroxyandrost-4-en-3-one);
    (11) boldenone (17[beta]-hydroxyandrost-1,4-diene-3-one);
    (12) boldione (androsta-1,4-diene-3,17-dione);
    (13) 6-bromo-androsta-1,4-diene-3,17-dione;
    (14) 6-bromo-androstan-3,17-dione;
    (15) calusterone (7[beta],17[alpha]-dimethyl-17[beta]-
hydroxyandrost-4-en-3-one);
    (16) 4-chloro-17[alpha]-methyl-androsta-1,4-diene-3,17[beta]-diol;
    (17) 4-chloro-17[alpha]-methyl-androst-4-ene-3[beta],17[beta]-diol;
    (18) 4-chloro-17[alpha]-methyl-17[beta]-hydroxy-androst-4-en-3-one;
    (19) 4-chloro-17[alpha]-methyl-17[beta]-hydroxy-androst-4-ene-3,11-
dione;
    (20) clostebol (4-chloro-17[beta]-hydroxyandrost-4-en-3-one);
    (21) dehydrochloromethyltestosterone (4-chloro-17[beta]-hydroxy-
17[alpha]-methyl-androst-1,4-dien-3-one);
    (22) desoxymethyltestosterone (17[alpha]-methyl-5[alpha]-androst-2-
en-17[beta]-ol) (a.k.a. ``madol'');
    (23) 4-dihydrotestosterone (17[beta]-hydroxy-androstan-3-one);
    (24) [Delta]1-dihydrotestosterone (a.k.a. ``1-testosterone'') 
(17[beta]-hydroxy-5[alpha]-androst-1-en-3-one);
    (25) 3[beta],17[beta]-dihydroxy-5[alpha]-androstane;
    (26) 3[alpha],17[beta]-dihydroxy-5[alpha]-androstane;
    (27) 2[alpha],17[alpha]-dimethyl-17[beta]-hydroxy-5[beta]-
androstan-3-one;
    (28) drostanolone (17[beta]-hydroxy-2[alpha]-methyl-5[alpha]-
androstan-3-one);
    (29) 2[alpha],3[alpha]-epithio-17[alpha]-methyl-5[alpha]-androstan-
17[beta]-ol;
    (30) estra-4,9,11-triene-3,17-dione;
    (31) 13[beta]-ethyl-17[beta]-hydroxygon-4-en-3-one;
    (32) ethylestrenol (17[alpha]-ethyl-17[beta]-hydroxyestr-4-ene);
    (33) fluoxymesterone (9-fluoro-17[alpha]-methyl-11[beta],17[beta]-
dihydroxyandrost-4-en-3-one);
    (34) formebolone (2-formyl-17[alpha]-methyl-11[alpha],17[beta]-
dihydroxyandrost-1,4-dien-3-one);

[[Page 50041]]

    (35) furazabol (17[alpha]-methyl-17[beta]-hydroxyandrostano[2,3-
c]furazan);
    (36) [3,2-c]furazan-5[alpha]-androstan-17[beta]-ol;
    (37) 18a-homo-3-hydroxy-estra-2,5(10)-dien-17-one;
    (38) 4-hydroxy-19-nortestosterone (4,17[beta]-dihydroxy-estr-4-en-
3-one);
    (39) 4-hydroxy-androst-4-ene-3,17-dione;
    (40) 17[beta]-hydroxy-androstano[2,3-d]isoxazole;
    (41) 17[beta]-hydroxy-androstano[3,2-c]isoxazole;
    (42) 3[beta]-hydroxy-estra-4,9,11-trien-17-one;
    (43) 4-hydroxytestosterone (4,17[beta]-dihydroxy-androst-4-en-3-
one);
    (44) mestanolone (17[alpha]-methyl-17[beta]-hydroxy-5[alpha]-
androstan-3-one);
    (45) mesterolone (1[alpha]-methyl-17[beta]-hydroxy-5[alpha]-
androstan-3-one);
    (46) methandienone (17[alpha]-methyl-17[beta]-hydroxyandrost-1,4-
dien-3-one);
    (47) methandriol (17[alpha]-methyl-3[beta],17[beta]-
dihydroxyandrost-5-ene);
    (48) methasterone (2[alpha],17[alpha]-dimethyl-5[alpha]-androstan-
17[beta]-ol-3-one or 2[alpha],17[alpha]-dimethyl-17[beta]-hydroxy-
5[alpha]-androstan-3-one);
    (49) methenolone (1-methyl-17[beta]-hydroxy-5[alpha]-androst-1-en-
3-one);
    (50) 17[alpha]-methyl-androsta-1,4-diene-3,17[beta]-diol;
    (51) 17[alpha]-methyl-5[alpha]-androstan-17[beta]-ol;
    (52) 17[alpha]-methyl-androstan-3-hydroxyimine-17[beta]-ol;
    (53) 6[alpha]-methyl-androst-4-ene-3,17-dione;
    (54) 17[alpha]-methyl-androst-2-ene-3,17[beta]-diol;
    (55) 17[alpha]-methyl-3[beta],17[beta]-dihydroxy-5[alpha]-
androstane;
    (56) 17[alpha]-methyl-3[alpha],17[beta]-dihydroxy-5[alpha]-
androstane;
    (57) 17[alpha]-methyl-3[beta],17[beta]-dihydroxyandrost-4-ene;
    (58) 17[alpha]-methyl-4-hydroxynandrolone (17[alpha]-methyl-4-
hydroxy-17[beta]-hydroxyestr-4-en-3-one);
    (59) methyldienolone (17[alpha]-methyl-17[beta]-hydroxyestra-
4,9(10)-dien-3-one);
    (60) 17[alpha]-methyl-[Delta]1-dihydrotestosterone (17[beta]-
hydroxy-17[alpha]-methyl-5[alpha]-androst-1-en-3-one) (a.k.a. ``17-
[alpha]-methyl-1-testosterone'');
    (61) methyltestosterone (17[alpha]-methyl-17[beta]-hydroxyandrost-
4-en-3-one);
    (62) methyltrienolone (17[alpha]-methyl-17[beta]-hydroxyestra-
4,9,11-trien-3-one);
    (63) mibolerone (7[alpha],17[alpha]-dimethyl-17[beta]-hydroxyestr-
4-en-3-one);
    (64) nandrolone (17[beta]-hydroxyestr-4-en-3-one);
    (65) 19-nor-4-androstenediol (3[beta],17[beta]-dihydroxyestr-4-
ene);
    (66) 19-nor-4-androstenediol (3[alpha],17[beta]-dihydroxyestr-4-
ene);
    (67) 19-nor-5-androstenediol (3[beta],17[beta]-dihydroxyestr-5-
ene);
    (68) 19-nor-5-androstenediol (3[alpha],17[beta]-dihydroxyestr-5-
ene);
    (69) 19-nor-4,9(10)-androstadienedione (estra-4,9(10)-diene-3,17-
dione);
    (70) 19-nor-4-androstenedione (estr-4-en-3,17-dione);
    (71) 19-nor-5-androstenedione (estr-5-en-3,17-dione);
    (72) norbolethone (13[beta],17[alpha]-diethyl-17[beta]-hydroxygon-
4-en-3-one);
    (73) norclostebol (4-chloro-17[beta]-hydroxyestr-4-en-3-one);
    (74) norethandrolone (17[alpha]-ethyl-17[beta]-hydroxyestr-4-en-3-
one);
    (75) normethandrolone (17[alpha]-methyl-17[beta]-hydroxyestr-4-en-
3-one);
    (76) oxandrolone (17[alpha]-methyl-17[beta]-hydroxy-2-oxa-5[alpha]-
androstan-3-one);
    (77) oxymesterone (17[alpha]-methyl-4,17[beta]-dihydroxyandrost-4-
en-3-one);
    (78) oxymetholone (17[alpha]-methyl-2-hydroxymethylene-17[beta]-
hydroxy-5[alpha]-androstan-3-one);
    (79) prostanozol (17[beta]-hydroxy-5[alpha]-androstano[3,2-
c]pyrazole or [3,2-c]pyrazole-5[alpha]-androstan-17[beta]-ol);
    (80) [3,2-c]pyrazole-androst-4-en-17[beta]-ol;
    (81) stanozolol (17[alpha]-methyl-17[beta]-hydroxy-5[alpha]-
androst-2-eno[3,2-c]-pyrazole);
    (82) stenbolone (17[beta]-hydroxy-2-methyl-5[alpha]-androst-1-en-3-
one);
    (83) testolactone (13-hydroxy-3-oxo-13,17-secoandrosta-1,4-dien-17-
oic acid lactone);
    (84) testosterone (17[beta]-hydroxyandrost-4-en-3-one);
    (85) tetrahydrogestrinone (13[beta],17[alpha]-diethyl-17[beta]-
hydroxygon-4,9,11-trien-3-one); and
    (86) trenbolone (17[beta]-hydroxyestr-4,9,11-trien-3-one).
* * * * *

0
7. Section 1308.50 is added to read as follows:


Sec.  1308.50  Temporary and permanent scheduling of recently emerged 
anabolic steroids.

    (a) The Administrator may issue a temporary order adding a drug or 
other substance to the definition of anabolic steroids if the 
Administrator finds that--
    (1) The drug or other substance satisfies the criteria for being 
considered an anabolic steroid under 21 U.S.C. 802(41) but is not 
listed in that section or by regulation of the Attorney General as 
being an anabolic steroid; and
    (2) Adding such drug or other substance to the definition of 
anabolic steroids will assist in preventing abuse or misuse of the drug 
or other substance.
    (b) An order issued under paragraph (a) of this section shall not 
take effect until 30 days after the date of the publication by the 
Administrator of a notice in the Federal Register of the intention to 
issue such order and the grounds upon which such order is to be issued. 
The order shall expire not later than 24 months after the date it 
becomes effective, except that the Administrator may, during the 
pendency of proceedings under paragraph (f) of this section, extend the 
temporary scheduling order for up to 6 months.
    (c) The Administrator shall transmit notice of an order proposed to 
be issued under paragraph (a) of this section to the Secretary of 
Health and Human Services. In issuing an order under paragraph (a), the 
Administrator shall take into consideration any comments submitted by 
the Secretary in response to a notice transmitted pursuant to this 
paragraph (c).
    (d) A temporary scheduling order issued under paragraph (a) of this 
section shall be vacated upon the issuance of a permanent scheduling 
order under paragraph (f) of this section.
    (e) An order issued under paragraph (a) of this section is not 
subject to judicial review.
    (f) The Administrator may, by rule, issue a permanent order adding 
a drug or other substance to the definition of anabolic steroids if 
such drug or other substance satisfies the criteria for being 
considered an anabolic steroid under 21 U.S.C. 802(41). Such rulemaking 
may be commenced simultaneously with the issuance of the temporary 
order issued under paragraph (a) of this section.

Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2023-15747 Filed 7-31-23; 8:45 am]
BILLING CODE 4410-09-P