[Title 21 CFR 1308.34]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter II - DRUG ENFORCEMENT]
[Part 1308 - SCHEDULES OF CONTROLLED SUBSTANCES]
[Sec. 1308.34 - Exempt anabolic steroid products.]
[From the U.S. Government Publishing Office]




  21
  FOOD AND DRUGS
  9
  1996-04-01
  1996-04-01
  false
  Exempt anabolic steroid products.
  1308.34
  Sec. 1308.34
  
    FOOD AND DRUGS
    DRUG ENFORCEMENT
    SCHEDULES OF CONTROLLED SUBSTANCES
  


Sec. 1308.34  Exempt anabolic steroid products.

    The following anabolic steroid containing compounds, mixtures, or 
preparations have been exempted by the Administrator from application of 
sections 302 through 309 and 1002 through 1004 of the Act (21 U.S.C. 
822-829 and 952-954) and Secs. 1301.24, 1301.31, 1301.32, and 1301.71 
through 1301.76 of this chapter for administrative purposes only:

                                    Table of Exempt Anabolic Steroid Products                                   
----------------------------------------------------------------------------------------------------------------
          Trade name                Company           NDC No.           Form       Ingredients       Quantity   
----------------------------------------------------------------------------------------------------------------
Androgyn L.A.................  Forest            0456-1005........  Vial.......  Testosterone     90 mg/ml      
                                Pharmaceuticals                                   enanthate.      4 mg/ml       
                                , St. Louis, MO.                                 Estradiol                      
                                                                                  valerate.                     
Andro-Estro 90-4.............  Rugby             0536-1605........  Vial.......  Testosterone     90 mg/ml      
                                Laboratories,                                     enanthate.      4 mg/ml       
                                Rockville                                        Estradiol                      
                                Centre, NY.                                       valerate.                     
depANDROGYN..................  Forest            0456-1020........  Vial.......  Testosterone     50 mg/ml      
                                Pharmaceuticals                                   cypionate.      2 mg/ml       
                                , St. Louis, MO.                                 Estradiol                      
                                                                                  cypionate.                    
DEPO-T.E.....................  Quality Research  52765-257........  Vial.......  Testosterone     50 mg/ml      
                                Pharm., Carmel,                                   cypionate.      2 mg/ml       
                                IN.                                              Estradiol                      
                                                                                  cypionate.                    
depTESTROGEN.................  Martica           51698-257........  Vial.......  Testosterone     50 mg/ml      
                                Pharmaceuticals                                   cypionate.      2 mg/ml       
                                , Phoenix, AZ.                                   Estradiol                      
                                                                                  cypionate.                    
Duomone......................  Wintec            52047-360........  Vial.......  Testosterone     90 mg/ml      
                                Pharmaceutical,                                   enanthate.      4 mg/ml       
                                Pacific, MO.                                     Estradiol                      
                                                                                  valerate.                     
DURATESTRIN..................  W.E. Hauck,       43797-016........  Vial.......  Testosterone     50 mg/ml      
                                Alpharetta, GA.                                   cypionate.      2 mg/ml       
                                                                                 Estradiol                      
                                                                                  cypionate.                    
DUO-SPAN II..................  Primedics         0684-0102........  Vial.......  Testosterone     50 mg/ml      
                                Laboratories,                                     cyplonate.      2 mg/ml       
                                Gardena, CA.                                     Esterified                     
                                                                                  cypionate.                    
Estratest....................  Solvay            0032-1026........  TB.........  Esterified       1.25 mg       
                                Pharmaceuticals                                   estrogens.      2.5 mg        
                                , Marletta, GA.                                  Methyltestoster                
                                                                                  one.                          
Estratest HS.................  Solvay            0032-1023........  TB.........  Esterified       0.625 mg      
                                Pharmaceuticals                                   estrogens.      1.25 mg       
                                , Marletta, GA.                                  Methyltestoster                
                                                                                  one.                          
PAN ESTRA TEST...............  Pan American      0525-0175........  Vial.......  Testosterone     50 mg/ml      
                                Labs,                                             cypionate.      2 mg/ml       
                                Covington, LA.                                   Estradiol                      
                                                                                  cypionate.                    
Premarin with                  Ayerst Labs.      0046-0879........  TB.........  Conjugated       1.25 mg       
 Methyltestosterone.            Inc., New York,                                   estrogens.      10.0 mg       
                                NY.                                              Methyltestoster                
                                                                                  one.                          
Premarin with                  Ayerst Labs.      0046-0878........  TB.........  Conjugated       0.625 mg      
 Methyltestosterone.            Inc., New York,                                   estrogens.      5.0 mg        
                                NY.                                              Methyltestoster                
                                                                                  one.                          
Synovex H Pellets in process.  Syntex Animal     .................  Drum.......  Testosterone     25 mg.        
                                Health, Palo                                      propionate.     2.5 mg.       
                                Alto, CA.                                        Estradiol                      
                                                                                  benzoate.                     
Synovex H Pellets in process   Syntex Animal     .................  Drum.......  Testosterone     10 parts.     
 granulation.                   Health, Palo                                      propionate.     1 part.       
                                Alto, CA.                                        Estradiol                      
                                                                                  benzoate.                     
TEST-ESTRO Cypionates........  Rugby             0536-9470........  Vial.......  Testosterone     50 mg/ml      
                                Laboratories,                                     cypionate.      2 mg/ml       
                                Rockville                                        Estradiol                      
                                Centre, NY.                                       cypionate.                    
Testagen.....................  Clint             55553-257........  Vial.......  Testosterone     50 mg/ml.     
                                Pharmaceuticals                                   cypionate.      2 mg/ml.      
                                , Nashville, TN.                                 Estradiol                      
                                                                                  cypionate.                    
Testosterone Cyp 50 Estradiol  I.D.E.-           0814-7737........  Vial.......  Testosterone     50 mg/ml      
 Cyp 2.                         Interstate,                                       cypionate.      2 mg/ml       
                                Amityville, NY.                                  Estradiol                      
                                                                                  cypionate.                    

[[Page 183]]

                                                                                                                
Testosterone Cypionate--       Best Generics,    54274-530........  Vial.......  Testosterone     50 mg/ml      
 Estradiol Cypionate            No. Miami                                         cypionate.      2 mg/ml       
 Injection.                     Beach, FL.                                       Estradiol                      
                                                                                  cypionate.                    
Testosterone Cypionate--       Goldline Labs,    0182-3069........  Vial.......  Testosterone     50 mg/ml.     
 Estradiol Cypionate            Ft. Lauderdale,                                   cypionate.      2 mg/ml.      
 Injection.                     FL.                                              Estradiol                      
                                                                                  cypionate.                    
Testosterone Cypionate--       Schein            0364-6611........  Vial.......  Testosterone     50 mg/ml      
 Estradiol Cypionate            Pharmaceuticals                                   cypionate.      2 mg/ml       
 Injection.                     , Port                                           Estradiol                      
                                Washington, NY.                                   cypionate.                    
Testosterone Cypionate--       Steris Labs.      0402-0257........  Vial.......  Testosterone     50 mg/ml      
 Estradiol Cypionate            Inc., Phoenix,                                    cypionate.      2 mg/ml       
 Injection.                     AZ.                                              Estradiol                      
                                                                                  cypionate.                    
Testosterone Cypionate--       The Upjohn Co.,   0009-0253........  Vial.......  Testosterone     50 mg/ml.     
 Estradiol Cypionate            Kalamazoo, MI.                                    cypionate.      2 mg/ml.      
 Injection.                                                                      Estradiol                      
                                                                                  cypionate.                    
Testosterone Enanthate--       Goldline Labs,    0182-3073........  Vial.......  Testosterone     90 mg/ml.     
 Estradiol Valerate Injection.  Ft. Lauderdale,                                   enanthate.      4 mg/ml.      
                                FL.                                              Estradiol                      
                                                                                  valerate.                     
Testosterone Enanthate--       Schein            0364-6618........  Vial.......  Testosterone     90 mg/ml      
 Estradiol Valerate Injection.  Pharmaceuticals                                   enanthate.      4 mg/ml       
                                , Port                                           Estradiol                      
                                Washington, NY.                                   valerate.                     
Testosterone Enanthate--       Steris Labs.      0402-0360........  Vial.......  Testosterone     90 mg/ml      
 Estradiol Valerate Injection.  Inc., Phoenix,                                    enanthate.      4 mg/ml       
                                AZ.                                              Estradiol                      
                                                                                  valerate.                     
Tilapia Sex Reversal Feed      Zeigler           .................  Plastic      Methyltestoster  60 mg/1 kg.   
 (Investigational).             Brothers, Inc.,                      Bags.        one fish feed.                
                                Gardners, PA.                                                                   
----------------------------------------------------------------------------------------------------------------


[56 FR 42937, Aug. 30, 1991, as amended at 57 FR 55091, Nov. 24, 1992; 
58 FR 16773, Mar. 31, 1993; 58 FR 34708, June 29, 1993]

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