[Federal Register Volume 62, Number 192 (Friday, October 3, 1997)]
[Rules and Regulations]
[Pages 51774-51776]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25973]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[DEA No. 161F]


Schedules of Controlled Substances: Excluded Veterinary Anabolic 
Steroid Implant Products

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

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SUMMARY: The interim rule (62 FR 29289, May 30, 1997) which identified 
eight veterinary anabolic steroid implant products as being excluded

[[Page 51775]]

from the Controlled Substances Act (CSA) (21 U.S.C. 801 et seq.) is 
adopted without change.

DATES: Effective Date: October 3, 1997.

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

SUPPLEMENTARY INFORMATION: The Acting Deputy Assistant Administrator, 
Office of Diversion Control, Drug Enforcement Administration (DEA), 
published in the Federal Register, an interim rule which identified 
eight products as being excluded veterinary anabolic steroid implant 
products (62 FR 29289, May 30, 1997). Comments were requested, none 
were received.
    Therefore, pursuant to the authority 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 Drug 
Enforcement Administration Office of Diversion Control, pursuant to 28 
CFR 0.104, appendix to subpart R, section 7(g), the Deputy Assistant 
Administrator of the Office of Diversion Control hereby adopts as a 
final rule, without change, the interim rule amending the products 
which are described in 21 CFR 1308.26 which was published at 62 FR 
29289 on May 30, 1997.
    The veterinary anabolic steroid implant products which are 
described in 21 CFR 1308.26 are excluded from application of the CSA in 
relation to their production, distribution, and use in animals only. If 
any person distributes, dispenses or otherwise diverts these products 
to use in humans, he/she shall be deemed to have distributed a Schedule 
III controlled substance and may be prosecuted for CSA violations. The 
veterinary anabolic steroid implants products which are excluded from 
application of the CSA are as follows:

                                                  Excluded Veterinary Anabolic Steroid Implant Products                                                 
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        Trade name                Company         NDC or DIN No.    Delivery system                  Ingredients                        Quantity        
--------------------------------------------------------------------------------------------------------------------------------------------------------
Component E-H.............  Vetlife, Inc.,            021641-002  20 implant belt, 8   Testosterone propionate...............  200 mg/implant           
                             Norcross, GA.                         pellets/implant.                                            (25 mg/pellet)           
                                                                                       Estradiol benzoate....................  20 mg/implant            
                                                                                                                               (2.5 mg/pellet)          
Component E-H.............  Elanco,                     01968327  20 implant belt, 8   Testosterone propionate...............  200 mg/implant           
                             Scarborough, ON.                      pellets/implant.                                            (25 mg/pellet)           
                                                                                       Estradiol benzoate....................  20 mg/implant            
                                                                                                                               (2.5 mg/pellet)          
Component TE-S............  VetLife, Inc.,            021641-004  20 implant belt, 6   Trenbolone acetate....................  120 mg/implant           
                             Norcross, GA.                         pellets/implant.                                            (20 mg/pellet)           
                                                                                       Estradiol.............................  24 mg/implant            
                                                                                                                               (4 mg/pellet)            
Component T-H.............  VetLife, Inc.,            021641-006  20 implant belt, 10  Trenbolone acetate....................  200 mg/implant           
                             Norcross, GA.                         pellets/implant.                                            (20 mg/pellet)           
Component T-S.............  VetLife, Inc.,            021641-005  20 implant belt, 7   Trenbolone acetate....................  140 mg/implant           
                             Norcross, GA.                         pellets/implant.                                            (20 mg/pellet)           
F-TO......................  Animal Health,              00093351  20 implant           Testosterone propionate...............  200 mg/implant           
                             Upjohn                                cartridge belt, 8                                           (25 mg/pellet)           
                             International,                        pellets/implant.    Oestradiol benzoate...................  20 mg/implant            
                             Kalamazoo, MI.                                                                                    (2.5 mg/pellet)          
Finaplix-H................  Hoechst Roussel         12799-807-10  10 implant           Trenbolone acetate....................  200 mg/implant           
                             Vet, Somerville,                      cartridge, 10                                               (20 mg/pellet)           
                             NJ.                                   pellets/implant.                                                                     
Finaplix-S................  Hoechst Roussel         12799-807-07  10 implant           Trenbolone acetate....................  140 mg/implant           
                             Vet, Somerville,                      cartridge, 7                                                (20 mg/pellet)           
                             NJ.                                   pellets/implant.                                                                     
Heifer-oid................  Anchor Division,     ...............  Single & 20 implant  Testosterone propionate...............  200 mg/implant           
                             Boehringer                            cartridge belts, 8                                          (25 mg/pellet)           
                             Ingelheim, St.                        pellets/implant.    Estradiol benzoate....................  20 mg/implant            
                             Joseph, MO.                                                                                       (2.5 mg/pellet)          
Heifer-oid................  Bio-Ceutic           ...............  20 implant           Testosterone propionate...............  200 mg/implant           
                             Division,                             cartridge belt, 8                                           (25 mg/pellet)           
                             Boehringer                            pellets/implant.    Estradiol benzoate....................  20 mg/implant            
                             Ingelheim, St.                                                                                    (2.5 mg/pellet)          
                             Joseph, MO.                                                                                                                
Heifer-oid................  Ivy Laboratories,    ...............  Single & 20 implant  Testosterone propionate...............  200 mg/implant           
                             Inc., Overland                        cartridge belts, 8                                          (25 mg/pellet)           
                             Park, KS.                             pellets/implant.    Estradiol benzoate....................  20 mg/implant            
                                                                                                                               (2.5 mg/pellet)          
Implus-H..................  The Upjohn Co.,         0009-0434-01  20 implant           Testosterone propionate...............  200 mg/implant           
                             Kalamazoo, MI.                        cartridge belt, 8                                           (25 mg/pellet)           
                                                                   pellets/implant.    Estradiol benzoate....................  20 mg/implant            
                                                                                                                               (2.5 mg/pellet)          
Implus-H..................  Upjohn Co., Animal        06-0434-01  20 implant           Testosterone propionate...............  200 mg/implant           
                             Health Div.,               01968327   cartridge belt, 8                                           (25 mg/pellet)           
                             Orangeville, ON.                      pellets/implant.    Estradiol benzoate....................  20 mg/implant            
                                                                                                                               (2.5 mg/pellet)          
Revalor-G.................  Hoechst Roussel            12799-811  10 implant           Trenbolone acetate....................  40 mg/implant            
                             Vet, Somerville,                      cartridge 2                                                 (20 mg/pellet)           
                             NJ.                                   pellets/implant.    Estradiol.............................  4 mg/implant             
                                                                                                                               (2 mg/pellet)            

[[Page 51776]]

                                                                                                                                                        
Revalor-H.................  Hoechst Roussel            12799-810  10 implant           Trenbolone acetate....................  140 mg/implant           
                             Vet, Somerville,                      cartridge, 7                                                (20 mg/pellet)           
                             NJ.                                   pellets/implant.    Estradiol.............................  14 mg/implant            
                                                                                                                               (2 mg/pellet)            
Revalor-S.................  Hoechst Roussel            12799-809  10 implant           Trenbolone acetate....................  120 mg/implant           
                             Vet, Somerville,                      cartridge, 6                                                (20 mg/pellet)           
                             NJ.                                   pellets/implant.    Estradiol.............................  24 mg/implant            
                                                                                                                               4 mg/pellet)             
Synovex H.................  Fort Dodge Labs,           0856-3901  10 implant clip, 8   Testosterone propionate...............  200 mg/implant           
                             Fort Dodge, IA.                       pellets/implant.                                            (25 mg/pellet)           
                                                                                       Estradiol benzoate....................  20 mg/implant            
                                                                                                                               (2.5 mg/pellet)          
Synovex H.................  Syntex               ...............  10 implant clip, 8   Testosterone propionate...............  200 mg/implant           
                             Laboratories, Palo                    pellets/implant.                                            (25 mg/pellet)           
                             Alto, CA.                                                 Estradiol benzoate....................  20 mg/implant            
                                                                                                                               (2.5 mg/pellet)          
Synovex Plus..............  Fort Dodge Labs,           0856-3904  10 implant clip, 8   Trenbolone acetate....................  200 mg/implant           
                             Fort Dodge, IA.                       pellets/implant.                                            (25 mg/pellet)           
                                                                                       Estradiol.............................  28 mg/implant            
                                                                                                                               (3.5 mg/pellet)          
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In accordance with the provisions of 21 U.S.C. 811(a) of the CSA, 
this action is a formal rulemaking ``on the record after opportunity 
for a hearing.'' Such proceedings are conducted pursuant to the 
provisions of 5 U.S.C. 556 and 557 and, as such, are exempt from review 
by the Office of Management and Budget pursuant to Executive Order 
(E.O.) 12866, section 3(d)(1).
    The Deputy Assistant Administrator, 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 inclusion of a product in 21 CFR 1308.26 relieves persons 
who handle the product in the course of legitimate business from the 
requirements imposed by the CSA.
    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.
    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 have significant adverse 
effects on competition, employment, investment, productivity, 
innovation, or on the ability of the United States-based companies to 
complete with foreign-based companies in domestic and export markets.
    This rule will not have substantial direct effects on the States, 
on the relationship between the national government and the States, or 
on the distribution of power and responsibilities among the various 
levels of government. Therefore, in accordance with E.O. 12612, it is 
determined that this rule will not have sufficient federalism 
implications to warrant the preparation of a Federalism Assessment.

    Dated: September 8, 1997.
John H. King,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 97-25973 Filed 10-2-97; 8:45 am]
BILLING CODE 4410-09-M