[Federal Register Volume 65, Number 13 (Thursday, January 20, 2000)]
[Rules and Regulations]
[Pages 3124-3126]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-1347]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[DEA No. 187I]
RIN 1117-AA51


Schedules of Controlled Substances: Exempt Anabolic Steroid 
Products

AGENCY:  Drug Enforcement Administration, Department of Justice.

ACTION:  Interim rule and request for comments.

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SUMMARY:  The Drug Enforcement Administration (DEA) is designating six 
preparations as exempt anabolic steroid products. This action, as part 
of the ongoing implementation of the Anabolic Steroids Control Act of 
1990, removes certain regulatory controls pertaining to Schedule III 
substances from the designated entities.

DATES:  Effective date: January 20, 2000. Comments must be submitted on 
or before March 20, 2000.

ADDRESSES:  Comments and objections should be submitted to the Deputy 
Assistant Administrator, Office of Diversion Control, Drug Enforcement 
Administration, Washington, DC. 20537; Attention: DEA Federal Register 
Representative/CCR.

[[Page 3125]]


FOR FURTHER INFORMATION CONTACT:  Frank Sapienza, Chief, Drug and 
Chemical Evaluation Section, Drug Enforcement Administration, 
Washington, DC 20537; Telephone: (202) 307-7183.

SUPPLEMENTARY INFORMATION:

What Does This Rule Accomplish and by What Authority Is It Being 
Issued:

    Section 1903 of the Anabolic Steroids Control Act of 1990 (title 
XIX of Pub. L. 101-647) (ASCA) provides that the Attorney General may 
exempt products which contain anabolic steroids from all or any part of 
the Controlled Substances Act (CSA) (21 U.S.C. 801 et seq.) if the 
products have no significant potential for abuse. The procedure for 
implementing this section of the ASCA is described in 21 CFR 1308.33. 
The purpose of this rule is to identify six products for which 
applications were made and which the Deputy Assistant Administrator for 
the DEA Office of Diversion Control finds meet the exempt anabolic 
steroid product criteria.

Why Is DEA Adding Anabolic Steroid Products to the List of 
Exemptions?

    In accordance with 21 CFR 1308.33 applications for the exemption of 
six anabolic steroid products were submitted by the products' 
manufacturers to the Deputy Assistant Administrator for the DEA Office 
of Diversion Control. Each application delineated a set of facts which 
the applicant believed justified the exempt status of its product. The 
applicants provides data which they believed showed that because of the 
specific product preparation, concentration, mixture, or delivery 
system these products had no significant potential for abuse. Upon 
acceptance of these applications the Deputy Assistant Administrator 
requested from the Assistant Secretary for Health, Department of Health 
and Human Services (HHS) a recommendation as to whether these products 
which contain anabolic steroids should be considered for exemption from 
certain portions of the CSA. The Deputy Assistant Administrator has 
received the determination and recommendations of the Assistant 
Secretary for Health and Surgeon General, that there was sufficient 
evidence to establish that these products do not possess a significant 
potential for abuse.

Which Anabolic Steroid Products Are Affected?

    The Deputy Assistant Administrator, having reviewed the 
applications, the recommendations of the Assistant Secretary for Health 
and Surgeon General, and other relevant information, finds that each of 
the products described below has no significant potential for abuse 
because of its concentration, preparation, mixture, or delivery system.

What Action Can Individuals Take if They Are Concerned About the 
Impact of this Rule?

    Interested persons are invited to submit their comments in writing 
with regard to this interim rule. 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 
shall immediately suspend the effectiveness of this order until he may 
reconsider the application in light of the comments and objections 
filed. Thereafter, the Deputy Assistant Administrator shall reinstate, 
revoke, or amend his original order as he determines appropriate.

Miscellaneous Matter--Correction

    In a previously published rule, an exempt anabolic steroid product 
was identified in the list referred to in 21 CFR 1308.34 by its active 
ingredients rather than its trade name. See 62 FR 51776, October 3, 
1997. Exemptions are granted, in accordance with the ASCA and the 
implementing regulations, to specific products. Therefore, DEA is 
correcting the list referred to in 21 CFR 1308.34 to describe the 
product by its specific trade name, Depo-Testadiol. The corrected 
information for this product in the list referred to in 21 CFR 1308.34 
is:

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             Trade name                      Company           NDC No.           Form              Ingredients                     Quantity
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Depo-Testadiol.....................  The Upjohn Company,      0009-0253   Vial.............  Testosterone cypionate,  50 mg/ml, 2 mg.ml.
                                      Kalamazoo, MI.                                          Estradiol cypionate.
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Why is DEA making this rule immediately effective?

    This rule is being made immediately effective in order to provide a 
health benefit to the public by more expeditiously increasing the 
access to these anabolic steroid products and to reduce regulatory 
restrictions that DEA (in consultation with HHS) has determined to be 
an unnecessary burden on the businesses manufacturing these products.

Plain English

    The Drug Enforcement Administration makes every effort to write 
clearly. If you have suggestions as to how to improve the clarity of 
this regulation, call or write Patricia M. Good, Chief, Liaison and 
Policy Section, Office of Diversion Control, Drug Enforcement 
Administration, Washington, DC 20537, Telephone (202) 307-7297.

Certifications

Regulatory Flexibility Act

    The Deputy Assistant Administrator, for the DEA Office of Diversion 
Control, in accordance with the Regulatory Flexibility Act (5 U.S.C. 
605(b)), has reviewed this rule and by approving it, certifies that it 
will not have a significant economic impact on a substantial number of 
small business entities. The granting of exempt status relieves persons 
who handle the exempt products in the course of legitimate business 
from the registration, labeling, records, reports, prescription, 
physical security, and import and export restrictions imposed by the 
CSA.

Administrative Procedure Act 5 U.S.C. 553

    This rule provides a health benefit to the public by more 
expeditiously increasing the access to these anabolic steroid products 
and reducing regulatory restrictions that DEA and HHS have determined 
to be unnecessary. Therefore DEA has determined that it is contrary to 
the public interest to delay the effectiveness of this rule by 
requiring notice of proposed rulemaking and delay the effective date.
    The relief from these administrative restrictions will provide 
monetary savings to each of the three pharmaceutical manufacturers who 
applied for these exemptions. In addition to the economic gain to the 
pharmaceutical industry, these exemptions provide significant benefits 
to the general public by increasing the availability of these drug 
products for the legitimate medical treatment for which they were 
intended.

[[Page 3126]]

Executive Order 12866

    This interim rule has been drafted and reviewed in accordance with 
Executive Order 12866, section 1(b), Principles of Regulation. The 
Deputy Assistant Administrator, Office of Diversion Control, has 
determined that this rule is a significant regulatory action under 
Executive Order 12866, section 3(f), Regulatory Planning and Review, 
and accordingly this rule has been reviewed by the Office of Management 
and Budget. This regulation exempts those who handle the affected 
products in the course of legitimate business from the restrictions 
associated with Schedule III allowing for a more efficient and cost 
effective means of doing business. These exemptions will provide direct 
economic relief and financial savings to the three manufacturer 
applicants requesting these actions. This regulation is in the public 
interest and provides more expedient access to these products which, in 
turn, has the potential to improve the health benefits to the public.

Executive Order 13132

    This rule will not have substantial direct effects on the United 
States, on the relationship between the national government and the 
United States, or on the distribution of power and responsibilities 
among the various levels of government. Therefore, in accordance with 
Executive Order 13132, it is determined that this rule does not have 
sufficient federalism implications to warrant the preparation of a 
Federalism Assessment.

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 in any one year, and it will not significantly or 
uniquely affect small governments. Therefore, no actions were deemed 
necessary under provisions of the Unfunded Mandates Reform Act of 1995.

Small Business Regulatory Enforcement Fairness Act of 1996

    This rule is not a major rule, as defined by Section 804 of the 
Small Business Regulatory Enforcement Fairness Act of 1996. This rule 
will not result in an annual effect on the economy of $100,000,000 or 
more; 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.

PART 1308--[AMENDED]

    Pursuant to the authority vested in the Attorney General by section 
1903 of the ASCA, delegated to the Administrator of the DEA pursuant to 
21 U.S.C. 871(a) and 28 CFR 0.100, and redelegated to the Deputy 
Assistant Administrator of the DEA Office of Diversion Control pursuant 
to 28 CFR 0.104, Appendix to Subpart R, section 7(g), the Deputy 
Assistant Administrator hereby orders that the following compounds, 
mixtures, or preparations containing anabolic steroids be exempted from 
application of sections 302 through 309 and 1002 through 1004 of the 
CSA (21 U.S.C. 822-829 and 952-954) and 21 CFR 1301.11, 1301,13, 
1301.71 through 1301.76 for administrative purposes only and be 
included in the list of products described in 21 CFR 1308.34.


Sec. 1308.34  Amended

                                                            Exempt Anabolic Steroid Products
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           Trade name                   Company               NDC No.                   Form               Ingredients                 Quality
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Component E-H in Process Pellets  Ivy Laboratories,    .....................  Pail...................  Testosterone         25 mg/pellet, 2.5 mg/pellet.
                                   Inc. Overland                                                        propionate,
                                   Park, KS.                                                            Estradiol benzoate.
Component E-H in Process          Ivy Laboratories,    .....................  Pail or Drum...........  Testosterone         10 parts, 1 part.
 Granulation.                      Inc. Overland                                                        propionate,
                                   Park, KS.                                                            Estradiol benzoate.
Component TE-S in Process         Ivy Laboratories,    .....................  Pail...................  Trenbolone acetate,  120 mg/pellet, 24 mg/pellet.
 Pellets.                          Inc. Overland                                                        Estradiol USP.
                                   Park, KS.
Component TE-S in Process         Ivy Laboratories,    .....................  Pail or Drum...........  Trenbolone acetate,  5 parts, 1 part.
 Granulation.                      Inc. Overland                                                        Estradiol USP.
                                   Park, KS.
Testoderm with Adhesive 4 mg/d..  Alza Corp, Palo      Export only..........  Patch..................  Testosterone.......  10 mg.
                                   Alto, CA.
Testosterone Ophthalmic           Allergan, Irvine,    .....................  Ophthalmic Solutions...  Testosterone.......  0.6 w/v.
 Solutions.                        CA.
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    Dated: January 11, 2000.
John H. King,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc 00-1347 Filed 1-19-00; 8:45 am]
BILLING CODE 4410-09-M