[Federal Register Volume 62, Number 104 (Friday, May 30, 1997)]
[Rules and Regulations]
[Pages 29288-29289]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14111]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[DEA No. 160I]


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 ten 
preparations as exempt anabolic steroid products. This action, as part 
of the ongoing implementation of the Anabolic Steroid Control Act of 
1990, removes certain regulatory controls pertaining to Schedules III 
substances from the designated entities.

DATES: Effective Date: May 30, 1997. Comments must be submitted on or 
before July 29, 1997.

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

FOR FURTHER INFORMATION CONTACT: Frank L. Sapienza, Chief, Drug and 
Chemical Evaluation Section, 202-307-7183.

SUPPLEMENTARY INFORMATION: Section 1903 of the Anabolic Steroids 
Control Act of 1990 (ASCA) (title XIX of Pub. L. 101-647) 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 Sec. 1308.33 of Title 21 Code of Federal Regulations. The 
purpose of this rule is to identify ten products for which applications 
were made and which the Acting Deputy Assistant Administrator finds 
meet the exempt anabolic steroid product criteria.
    The Acting Deputy Assistant Administrator, Office of Diversion 
Control, having reviewed the applications, the recommendations of the 
Secretary of the Department of Health and Human Services, 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. Therefore, pursuant to the 
authority vested in the Attorney General by title XIX of Public Law 
101-647 as delegated to the Administrator of the DEA pursuant to 21 
U.S.C. 871(a) and 28 CFR 0.100, the Acting Deputy Assistant 
Administrator hereby orders that the following anabolic steroid 
containing compounds, mixtures, or preparations 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 Secs. 1301.11, 1301.13, 1301.71 
through 1301.76 of Title 21 Code of Federal Regualtions for 
administrative purposes only and be included in the list of products 
described in 21 CFR 1308.34.

[[Page 29289]]



                                                            Exempt Anabolic Steroid Products                                                            
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          Trade name                 Company         NDC No.             Form                       Ingredients                        Quantity         
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Menogen.......................  Sage                 59243-570  TB....................  Esterified estrogens...............  1.25 mg.                   
                                 Pharmaceuticals,                                       Methyltestosterone.................  2.5 mg.                    
                                 Shreveport, LA.                                                                                                        
Menogen HS....................  Sage                 59243-560  TB....................  Esterified estrogens...............  0.625 mg.                  
                                 Pharmaceuticals,                                       Methyltestosterone.................  1.25 mg.                   
                                 Shreveport, LA.                                                                                                        
Synovex Plus, in-process,       Fort Dodge Animal  ...........  Drum..................  Trenbolone acetate.................  25 parts.                  
 granulation.                    Health, Fort                                           Estradiol benzoate.................  3.5 parts.                 
                                 Dodge, IA.                                                                                                             
Synovex Plus, in-process, bulk  Fort Dodge Animal  ...........  Drum..................  Trenbolone acetate.................  25.00 mg.                  
 pellets.                        Health, Fort                                           Estradiol benzoate.................  3.50 mg pellet.            
                                 Dodge, IA.                                                                                                             
Testoderm, 4 mg/d.............  Alza Corp., Palo    17314-4608  Patch.................  Testosterone.......................  10 mg.                     
                                 Alto, CA.                                                                                                              
Testoderm, 6 mg/d.............  Alza Corp., Palo    17314-4609  Patch.................  Testosterone.......................  15 mg.                     
                                 Alto, CA.                                                                                                              
Testoderm, with Adhesive, 6 mg/ Alza Corp., Palo    17314-2836  Patch.................  Testosterone.......................  15 mg.                     
 d.                              Alto, CA.                                                                                                              
Testoderm, in-process film....  Alza Corp., Palo   ...........  Sheet.................  Testosterone.......................  0.25 mg/cm \2\.            
                                 Alto, CA.                                                                                                              
Testoderm, with Adhesive, in-   Alza Corp., Palo   ...........  Sheet.................  Testosterone.......................  0.25 mg/cm \2\.            
 process film.                   Alto, CA.                                                                                                              
Tilapia Sex Reversal Feed       Rangen, Inc.,      ...........  Plastic Bags..........  Methyltesterone....................  60 mg/kg fish feed.        
 (Investigational).              Buhl, ID.                                                                                                              
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    Interested persons are invited to submit their comments in writing 
in 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 Acting 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, he shall reinstate, revoke, or amend his 
original order as he determines appropriate.
    This exemption relieves persons who handle the products in the 
course of legitimate business from the registration, records, reports, 
prescription, physical security, import, and export requirements 
associated with Schedule III substances. Accordingly, the Acting Deputy 
Assistant Administrator certifies that this action will have no impact 
on the ability of small businesses to compete and he therefore 
determines that no regulatory flexibility analysis is required.
    This action has been analyzed in accordance with the principles and 
criteria contained in E.O. 12612, and it has been determined that this 
matter does not have sufficient federalism implications to require the 
preparation of a Federalism Assessment.
    It has been determined that drug control matters are not subject to 
review by the Office of Management and Budget (OMB) pursuant to the 
provisions of E.O. 12866. Accordingly, this action is not subject to 
those provisions of E.O. 12778 which are contingent upon review by OMB. 
Nevertheless, the Acting Deputy Assistant Administrator has determined 
that this is not a ``major rule,'' as that term is used in E.O. 18866, 
and that it would otherwise meet the applicable standards of sections 
2(a) and 2(b)(2) of E.O. 12778.

    Dated: May 21, 1997.
Terrance W. Woodworth,
Acting Deputy Assistant Administrator, Office of Diversion Control, 
Drug Enforcement Administration.
[FR Doc. 97-14111 Filed 5-29-97; 8:45 am]
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