[Federal Register Volume 62, Number 192 (Friday, October 3, 1997)]
[Rules and Regulations]
[Pages 51776-51778]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25972]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[DEA No. 160F]


Schedules of Controlled Substances: Exempt Anabolic Steroid 
Products

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

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SUMMARY: The interim rule (62 FR 29288, May 30, 1997) which identified 
ten anabolic steroid products as being exempt from certain regulatory 
provisions of 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 ten 
products as being exempt anabolic steroid products (62 FR 29288, 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)9, the Deputy Assistant 
Administrator of the Office of Diversion Control, hereby adopts as a 
final rule, without change, the interim rule amending 21 CFR 1308.34 
which was published at 62 FR 29288 on May 30, 1997.
    The anabolic steroid containing compounds, mixtures, or 
preparations which are described in 21 CFR 1308.34 are as follows:

[[Page 51777]]



                                                            Exempt Anabolic Steroid Products                                                            
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           Trade name                   Company           NDC No.           Form                      Ingredients                        Quantity       
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Andro-Estro 90-4................  Rugby                    0536-1605  Vial...........  Testosterone enanthate..................  90 mg/ml               
                                   Laboratories,                                       Estradiol valerate......................  4 mg/ml                
                                   Rockville Centre,                                                                                                    
                                   NY.                                                                                                                  
Androgyn L.A....................  Forest                   0456-1005  Vial...........  Testosterone enanthate..................  90 mg/ml               
                                   Pharmaceuticals,                                    Estradiol valerate......................  4 mg/ml                
                                   St. Louis, MO.                                                                                                       
depANDROGYN.....................  Forest                   0456-1020  Vial...........  Testosterone cypionate..................  50 mg/ml               
                                   Pharmaceuticals,                                    Estradiol cypionate.....................  2 mg/ml                
                                   St. Louis, MO.                                                                                                       
DEPO-T.E........................  Quality Research         52765-257  Vial...........  Testosterone cypionate..................  50 mg/ml               
                                   Pharm., Carmel,                                     Estradiol cypionate.....................  2 mg/ml                
                                   IN.                                                                                                                  
depTESTROGEN....................  Martica                  51698-257  Vial...........  Testosterone cypionate..................  50 mg/ml               
                                   Pharmaceuticals,                                    Estradiol cypionate.....................  2 mg/ml                
                                   Phoenix, AZ.                                                                                                         
Duomone.........................  Wintec                   52047-360  Vial...........  Testosterone enanthate..................  90 mg/ml               
                                   Pharmaceutical,                                     Estradiol valerate......................  4 mg/ml                
                                   Pacific, MO.                                                                                                         
DUO-SPAN II.....................  Primedics                0684-0102  Vial...........  Testosterone cypionate..................  50 mg/ml               
                                   Laboratories,                                       Estradiol cypionate.....................  2 mg/ml                
                                   Gardena, CA.                                                                                                         
DURATESTRIN.....................  W.E. Hauck,              43797-016  Vial...........  Testosterone cypionate..................  50 mg/ml               
                                   Alpharetta, GA.                                     Estradiol cypionate.....................  2 mg/ml                
Estratest.......................  Solvay                   0032-1026  TB.............  Esterified estrogens....................  1.25 mg                
                                   Pharmaceuticals,                                    Methyltestosterone......................  2.5 mg                 
                                   Marietta, GA.                                                                                                        
Estratest HS....................  Solvay                   0032-1023  TB.............  Esterified estrogens....................  0.625 mg               
                                   Pharmaceuticals,                                    Methyltestosterone......................  1.25 mg                
                                   Marietta, GA.                                                                                                        
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,                                    Mrethyltestosterone.....................  1.25 mg                
                                   Shreveport, LA.                                                                                                      
PAN ESTRA TEST..................  Pan American             0525-0175  Vial...........  Testosterone cypionate..................  50 mg/ml               
                                   Labs., Covington,                                   Estradiol cypionate.....................  2 mg/ml                
                                   LA.                                                                                                                  
Premarin with Methyltestosterone  Ayerst Labs. Inc.,       0046-0879  TB.............  Conjugated estrogens....................  1.25 mg                
                                   New York, NY.                                       Methyltestosterone......................  10.0 mg                
Premarin with Methyltestosterone  Ayerst Labs. Inc.,       0046-0878  TB.............  Conjugated estrogens....................  0.625 mg               
                                   New York, NY.                                       Methyltestosterone......................  5.0 mg                 
Synovex H in-process bulk         Syntex Animal       ..............  Drum...........  Testosterone propionate.................  25 mg/                 
 pellets.                          Health, Palo                                        Estradiol benzoate......................  2.5 mg/pellet          
                                   Alto, CA.                                                                                                            
Synovex H in-process granulation  Syntex Animal       ..............  Drum...........  Testosterone propionate.................  10 parts               
                                   Health, Palo                                        Estradiol benzoate......................  1 part                 
                                   Alto, CA.                                                                                                            
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 mg/                 
 pellets.                          Health, Fort                                        Estradiol benzoate......................  3.50 mg/pellet         
                                   Dodge, IA.                                                                                                           
Testagen........................  Clint                    55553-257  Vial...........  Testosterone cypionate..................  50 mg/ml               
                                   Pharmaceuticals,                                    Estradiol cypionate.....................  2 mg/ml                
                                   Nashville, TN.                                                                                                       
TEST-ESTRO Cypionates...........  Rugby                    0536-9470  Vial...........  Testosterone cypionate..................  50 mg/ml               
                                   Laboratories,                                       Estradiol cypionate.....................  2 mg/ml                
                                   Rockville Centre,                                                                                                    
                                   NY.                                                                                                                  
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/d..  Alza Corp., Palo        17314-2836  Patch..........  Testosterone............................  15 mg                  
                                   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.                                                                                                            
Testosterone Cypionate/Estradiol  Best Generics, No.       54274-530  Vial...........  Testosterone cypionate..................  50 mg/ml               
 Cypionate Injection.              Miami Beach, FL.                                    Estradiol cypionate.....................  2 mg/ml                
Testosterone Cypionate/Estradiol  Goldline Labs, Ft.       0182-3069  Vial...........  Testosterone cypionate..................  50 mg/ml               
 Cypionate Injection.              Lauderdale, FL.                                     Estradiol cypionate.....................  2 mg/ml                
Testosterone Cyp 50 Estradiol     I.D.E.-Interstate,       0814-7737  Vial...........  Testosterone cypionate..................  50 mg/ml               
 Cyp 2.                            Amityville, NY.                                     Estradiol cypionate.....................  2 mg/ml                
Testosterone Cypionate/Estradiol  Schein                   0364-6611  Vial...........  Testosterone cypionate..................  50 mg/ml               
 Cypionate Injection.              Pharmaceuticals,                                    Estradiol cypionate.....................  2 mg/ml                
                                   Port Washington,                                                                                                     
                                   NY.                                                                                                                  
Testosterone Cypionate/Estradiol  Steris labs, Inc.,       0402-0257  Vial...........  Testosterone cypionate..................  50 mg/ml               
 Cypionate Injection.              Phoenix, AZ.                                        Estradiol cypionate.....................  2 mg/ml                
Testosterone Cypionate/Estradiol  The Upjohn Co.,          0009-0253  Vial...........  Testosterone cypionate..................  50 mg/ml               
 Cypionate Injection.              kalamazoo, MI.                                      Estradiol cypionate.....................  2 mg/ml                
Testosterone Enanthate/Estradiol  Goldline Labs, Ft.       0182-3073  Vial...........  Testosterone enanthate..................  90 mg/ml               
 Valerate Injection.               Lauderdale, FL.                                     Estradiol valerate......................  4 mg/ml                
Testosterone Enanthate/Estradiol  Schein                   0364-6618  Vial...........  Testosterone enanthate..................  90 mg/ml               
 Valerate Injection.               Pharmaceuticals,                                    Estradiol valerate......................  4 mg/ml                
                                   Port Washington,                                                                                                     
                                   NY.                                                                                                                  
Testosterone Enanthate/Estradiol  Steris Labs. Inc.,       0402-0360  Vial...........  Testosterone enanthate..................  90 mg/ml               
 Valerate Injection.               Phoenix, AZ.                                        Estradiol valerate......................  4 mg/ml                
Tilapia Sex Reversal Feed         Rangen, Inc.,       ..............  Plastic Bags...  Methyltestosterone......................  60 mg/kg fish feed     
 (Investigational).                Buhl, ID.                                                                                                            
Tilapia Sex Reversal Feed         Zeigler Brothers,   ..............  Plastic Bags...  Methyltestosterone......................  60 mg/kg fish feed     
 (Investigational.                 Inc., Gardners,                                                                                                      
                                   PA.                                                                                                                  
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[[Page 51778]]

    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 1308.34 relieves persons 
who handle the product in the course of legitimate business from the 
registration, records, reports, prescription, physical security, import 
and export requirements associated with Schedule III controlled 
substances under the CSA. Specifically, the products are 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, and 
1301.71 through 1301.76 of Title 21 Code of Federal Regulations.
    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 
compete 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. 97-25972 Filed 10-2-97; 8:45 am]
BILLING CODE 4410-09-M