Diversion Control Division, US Department of Justice, Drug Enforcement Administration

RESOURCES > Federal Register Notices > Rules - 2000 > Exempt Anabolic Steroids Products

Rules - 2000

[Federal Register: July 14, 2000 (Volume 65, Number 136)] 
[Rules and Regulations] 
[Page 43690-43694] 
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14jy00-11]


DEPARTMENT OF JUSTICE  

Drug Enforcement Administration  

21 CFR Part 1308  

[DEA-187F]
RIN 1117-AA51  

Schedules of Controlled Substances: Exempt Anabolic Steroids Products  

AGENCY: Drug Enforcement Administration, Department of Justice.  

ACTION: Final rule.


SUMMARY: The Drug Enforcement Administration (DEA) published an interim rule with request for comments (65 FR 3124, Jan. 20, 2000, as corrected at 65 FR 5024, Feb. 2, 2000) which identified six anabolic steroid products as being exempt from certain regulatory provisions of the Controlled Substances Act (21 U.S.C. 801 et seq.) (CSA). No

[[Page 43691]]

comments were received. Therefore, the interim rule is being adopted without change.

EFFECTIVE DATE: July 14, 2000.

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

SUPPLEMENTARY INFORMATION: 

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

This rule finalizes an interim rule (65 FR 3124, Jan. 20, 2000, as corrected at 65 FR 5024, Feb. 2, 2000) which identified six products as being exempt from certain portions of the Controlled Substances Act (21 U.S.C. 801 et seq.) (CSA). 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 CSA 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. Exempt status removes each product from application of the registration, labeling, records, reports, prescription, physical security, and import and export restrictions associated with Schedule III substances.  

Why Did DEA Add Six Products to the List of Exempt Anabolic Steroids Products?

Manufacturers of six anabolic steroid products submitted exempt status applications to the Deputy Assistant Administrator for the DEA Office of Diversion Control in accordance with 21 CFR 1308.33. Each application delineated a set of facts which the applicant believed justified the exempt status of its product. The applicants provided information 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 the 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 should be considered for exemption from certain portions of the CSA. The Deputy Assistant Administrator received the determination and recommendation of the Assistant Secretary for Health and Surgeon General that there was sufficient evidence to establish that each product does not possess a significant potential for abuse. 

Which Anabolic Steroid Products Are Effected and When Does the Rule Become Affective?  

In the interim rule, the Deputy Assistant Administrator identified the following six products as being exempt from application of sections 302 and through 309 and 1002 through 1004 of the CSA (21 U.S.C. 822-829 and 952-954) and 21 CFR 1301.13, 1301.22, and 1301.71 through 1301.76:

Exempt Anabolic Steroid Products

Trade name Component E-H in process granulation.
Company Ivy Laboratories, Inc., Overland Park, KS.
NDC No.  
Form Pail or drum
Ingredients Testosterone propionate  Quantity 10 parts
 
Trade name Component E-H in process pellets.
Company Ivy Laboratories, Inc. Overland Park, KS.
NDC No.  
Form Pail
Ingredients Estradiol benzoate Quantity 1 part
Ingredients Testosterone propionate  Quantity 25mg
 
Trade name Component TE-S in process granulation.
Company Ivy Laboratories, Inc. Overland Park, KS.
NDC No.  
Form Pail or drum
Ingredients Estradiol benzoate Quantity 2.5 mg/pellet
Ingredients Trenbolone acetate Quantity 5 parts
 
Trade name Component TE-S in process pellets.
Company Ivy Laboratories, Inc. Overland Park, KS.
NDC No.  
Form Pail
Ingredients Estradiol USP Quantity 1 part
Ingredients Trenbolone acetate Quantity 120 mg
 
Trade name Testoderm with Adhesive 4 mg/d.
Company Alza Corp., Palo Alto, CA
NDC No. Export only
Form Patch
Ingredients Estradiol benzoate Quantity 2.5 mg/pellet
Ingredients Trenbolone acetate Quantity 5 parts
 
Trade name Testosterone Ophthalmic Solutions.
Company Allergan, Irvine, CA
NDC No.  
Form Ophthalmic Solutions.
Ingredients Testosterone Quantity ≤0.6% w/v
Ingredients Trenbolone acetate Quantity 5 parts

The interim rule became immediately effective on publication in the Federal Register, January 20, 2000, 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.

What Comments to the Interim Rule Were Received?

Comments to the interim rule were requested, none were received.

What Exempt Anabolic Steroid Products are Included in the List Referred to in 21 CFR 1308.34?

With the publication of this final rule, the complete list of products referred to in 21 CFR 1308.34 is as follows:

 Exempt Anabolic Steroid Products

Trade name Andro-Estro 90-4
Company Rugby Laboratories, Rockville Centre, NY
NDC No.  0536-1605
Form Vial
Ingredients Testosterone enanthate Quantity 90 mg/ml
 
Trade name Androgyn L.A
Company Forest Pharmaceuticals, St. Louis, MO
NDC No.  0456-1005
Form Vial
Ingredients Estradiol valerate Quantity 4 mg/ml
Ingredients Testosterone enanthate Quantity 90 mg/ml
   
Trade name Component E-H in process granulation.
Company  Ivy Laboratories, Inc., Overland Park, KS.
NDC No.  
Form Pail or drum
Ingredients Testosterone propionate. Quantity 10 parts
       
Trade name Componenet E-H in process pellets
Company Ivy Laboratories, Inc., Overland Park, KS.
NDC No.  
Form Pail
Ingredients Estradiol benzoate Quantity 1 part
Ingredients Testosterone propionate Quantity 25 mg/
   
Trade name Component TE-S in process granulation
Company Ivy Laboratories, Inc., Overland Park, KS.
NDC No.  
Form Pail or drum
Ingredients Estradiol benzoate Quantity 2.5 mg/pellet
Ingredients Trenbolone acetate Quantity 5 parts
   
Trade name Component TE-S in process pellets.
Company Ivy Laboratories, Inc., Overland Park, KS.
NDC No.  
Form Pail
Ingredients Estradiol USP Quantity 1 part
Ingredients Trenbolone acetate Quantity 120 mg/
   
Trade name depANDROGYN
Company Forest Pharmaceuticals,  St. Louis, MO.
NDC No. 0456-1020
Form Vial
Ingredients Estradiol USP Quantity 24 mg/pellet
Ingredients Testosterone cypionate Quantity 50 mg/ml
   
Trade name Component TE-S in process granulation
Company Ivy Laboratories, Inc., Overland Park, KS.
NDC No.  
Form Pail or drum
Ingredients Estradiol benzoate Quantity 2.5 mg/pellet
Ingredients Trenbolone acetate Quantity 5 parts
   
Trade name DEPTO-T.E
Company Quality Research Pharm.,  Carmel, IN.
NDC No. 52765-257
Form Vial
Ingredients Estradiol cypionate Quantity 2 mg/ml
Ingredients Testosterone cypionate Quantity 50 mg/ml
   
Trade name Depo-Testadiol
Company The Upjohn Company,  Kalamazoo, MI.
NDC No. 0009-0253
Form Vial
Ingredients Estradiol cypionate Quantity 2 mg/ml
Ingredients Testosterone cypionate Quantity 50 mg/ml
   
Trade name depTESTROGEN
Company Martica Pharmaceuticals,  Phoenix, AZ.
NDC No. 51698-257
Form Vial
Ingredients Estradiol cypionate Quantity 2 mg/ml
Ingredients Testosterone cypionate Quantity 50 mg/ml
   
Trade name Duomone
Company Wintec Pharmaceutical,  Pacific, MO.
NDC No. 52047-360
Form Vial
Ingredients Estradiol cypionate Quantity 2 mg/ml
Ingredients Testosterone enanthate Quantity 90 mg/ml
   
Trade name DUO-SPAN II
Company Primedics Laboratories, Gardena, CA.
NDC No. 0684-0102
Form Vial
Ingredients Estradiol valerate Quantity 4 mg/ml
Ingredients Testosterone cypionate Quantity 50 mg/ml
   
Trade name DURATESTRIN
Company W. E. Hauck, Alpharetta,  GA.
NDC No. 43797-016
Form Vial
Ingredients Estradiol cypionate Quantity 2 mg/ml
Ingredients Testosterone cypionate Quantity 50 mg/ml
   
Trade name Estratest
Company Solvay Pharmaceuticals,  Marietta, GA.
NDC No. 0032-1026
Form TB
Ingredients Estradiol cypionate Quantity 2 mg/ml
Ingredients Esterifield estrogens Quantity 1.25 mg
   
Trade name Estratest HS
Company Solvay Pharmaceuticals,  Marietta, GA.
NDC No. 0032-1023
Form TB
Ingredients Methyltestosterone Quantity 2.5 mg
Ingredients Esterifield estrogens Quantity 0.625 mg
   
Trade name Menogen
Company Sage Pharmaceuticals,  Shreveport, LA.
NDC No. 59243-570
Form TB
Ingredients Methyltestosterone Quantity 1.25 mg
Ingredients Esterifield estrogens Quantity 1.25 mg
   
Trade name Menogen HS
Company Sage Pharmaceutical,  Shreveport, LA.
NDC No. 59243-560
Form TB
Ingredients Methyltestosterone Quantity 2.5 mg
Ingredients Esterifield estrogens Quantity .0625 mg
   
Trade name PAN ESTRA TEST
Company Pan American Labs.,  Covington, LA.
NDC No. 0525-0175
Form Vial
Ingredients Methyltestosterone Quantity 1.25 mg
Ingredients Testosterone cypionate Quantity 50 mg/ml
   
Trade name Premarin with Methyltestosterone.
Company Ayerst Labs. Inc,. New  York, NY.
NDC No. 0046-0878
Form TB
Ingredients Estradiol cypionate Quantity 2 mg/ml
Ingredients Conjugated estrogens Quantity 0.625 mg
   
Trade name Premarin with Methyltestosterone.
Company Ayerst Labs. Inc., New  York, NY.
NDC No. 0046-0879
Form TB
Ingredients Methyltestosterone Quantity 5.0 mg
Ingredients Conjugated estrogens Quantity 1.25 mg
   
Trade name Synovex H in-process bulk pellets.
Company Syntex Animal health,  Palo Alto, CA.
NDC No.  
Form Drum
Ingredients Methyltestosterone Quantity 10.0 mg
Ingredients Testosterone propionate Quantity 25 mg
   
Trade name Synovex H in-process granulation.
Company Syntex Animal Health,  Palo Alto, CA.
NDC No.  
Form Drum
Ingredients Estradiol benzoate Quantity 2.5 mg/pellet
Ingredients Testosterone propionate Quantity 10 part
   
Trade name Synovex Plus in-process bulk pellets.
Company Fort Dodge Animal Health, Fort Dodge, IA.
NDC No.  
Form Drum
Ingredients Estradiol benzoate Quantity 1 part
Ingredients Trenbolone acetate Quantity 25 mg/
   
Trade name Synovex Plus in-process granulation.
Company Fort Dodge Animal Health,  Fort Dodge, IA.
NDC No.  
Form Drum
Ingredients Estradiol benzoate Quantity 3.50 mg/pellet
Ingredients Trenbolone acetate 25 parts
   
Trade name Testagen
Company Clint Pharmaceuticals,  Nashville, TN.
NDC No. 55553-257
Form Vial
Ingredients Estradiol benzoate Quantity 3.5 parts
Ingredients Testosterone cypionate Quantity 50 mg/ml
   
Trade name TEST-ESTRO Cypionates
Company Rugby Laboratories  Rockvill Centre, NY.
NDC No. 0536-9470
Form Vial
Ingredients Estradiol cypionate Quantity 2 mg/ml
Ingredients Testosterone cypionate Quantity 50 mg/ml
   
Trade name Testoderm 4 mg/d
Company Alza Copr., Palo Alto, CA
NDC No. 17314-4608
Form Patch
Ingredients Estradiol cypionate Quantity 2 mg/ml
Ingredients Testosterone Quantity 10 mg
   
Trade name Testoderm 6 mg/d
Company Alza Corp., Palo Alto, CA
NDC No. 17314-4609
Form Patch
Ingredients Testosterone Quantity 15 mg
   
Trade name Testoderm with Adhesive 4 mg/d
Company Alza Corp., Palo Alto, CA
NDC No. Export only
Form Patch
Ingredients Testosterone Quantity 10 mg
   
Trade name Testoderm with Adhesive 6 mg/d
Company Alza Corp., Palo Alto, CA
NDC No. 17314-2836
Form Patch
Ingredients Testosterone Quantity 15 mg
   
Trade name Testoderm in-process film
Company Alza Corp, Palo Alto, CA
NDC No.  
Form Sheet
Ingredients Testosterone Quantity 0.25 mg/cm2
   
Trade name Testoderm with Adhesive in-process film.
Company Alza Corp., Palo Alto, CA
NDC No.  
Form Sheet
Ingredients Testosterone Quantity 0.25 mg/cm2
   
Trade name Testosterone Cypionate/Estradiol Cypionate Injection.
Company Best Generics, No. Miami Beach, FL.
NDC No. 54274-530
Form Vial
Ingredients Testosterone cypionate Quantity 50 mg/ml
Ingredients   Quantity  
   
Trade name Testosterone Cypionate/Estradiol Cypionate Injection.
Company Goldline Labs, Ft.  Lauderdale, Fl.
NDC No. 0182-3069
Form Vial
Ingredients Estradiol cypionate Quantity 2 mg/ml
Ingredients Testosterone cypionate Quantity 50 mg/ml
   
Trade name Testosterone Cyp 50 Estradiol Cyp 2.
Company I.D.E.-Interstate,  Amityville, NY.
NDC No. 0814-7737
Form Vial
Ingredients Estradiol cypionate Quantity 2mg/ml
Ingredients Testosterone cypionate Quantity 50 mg/ml
   
Trade name Testosterone Cypionate/Estradiol Cypionate Injection.
Company Schein Pharmaceuticals,  Port Washington, NY.
NDC No. 0364-6611
Form Vial
Ingredients Estradiol cypionate Quantity 2 mg/ml
Ingredients Testosterone cypionate Quantity 50 mg/ml
   
Trade name Testosterone Cypionate/Estradiol Cypionate Injection.
Company Steris Labs. Inc.,  Phoenix, AZ.
NDC No. 0402-0257
Form Vial
Ingredients Estradiol cypionate Quantity 2mg/ml
Ingredients Testosterone cypionate Quantity 50 mg/ml
   
Trade name Testosterone Enanthate/Estradiol Valerate Injection.
Company Goldline Labs, Ft. Lauderdale, Fl.
NDC No. 0182-3073
Form Vial
Ingredients Estradiol cypionate Quantity 2 mg/ml
Ingredients Testosterone enanthate Quantity 90 mg/ml
   
Trade name Testosterone Enanthate/Estradiol Valerate Injection.
Company Schein Pharmaceuticals,  Port Washington, NY.
NDC No. 0364-6618
Form Vial
Ingredients Estradiol valerate Quantity 4 mg/ml
Ingredients Testosterone enanthate Quantity 90 mg/ml
   
Trade name Testosterone Enanthate/Estradiol Valerate Injection.
Company Steris Labs. Inc.,  Phoenix, AZ.
NDC No. 0402-0360
Form Vial
Ingredients Estradiol valerate Quantity 4 mg/ml
Ingredients Testosterone enanthate Quantity 90 mg/ml
   
Trade name Testosterone Ophthalmic Solutions.
Company Allergan, Irvine, CA
NDC No.  
Form Ophthalmic  solutions.
Ingredients Estradiol valerate Quantity 4 mg/ml
Ingredients Testosterone Quantity ≤0.6% w/v
   
Trade name Tilapia Sex Reversal Feed (Investigational).
Company Rangen, Inc., Buhl, ID
NDC No.  
Form Plastic bags
Ingredients Methyltestosterone Quantity 60 mg/kg fish feed
   
Trade name Tilapia Sex Reversal Feed (Investigational).
Company Ziegler Brothers, Inc.,  Gardners, PA.
NDC No.  
Form Plastic bags
Ingredients Methyltestosterone Quantity 60 mg/kg fish feed

Additional copies of this list may be obtained by submitting a written request to the Drug and Chemical Evaluation Section, Office of Diversion Control, Drug Enforcement Administration, Washington, D.C. 20537.

Plain Language Instructions

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, D.C. 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 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.

Executive Order 12866

The Deputy Assistant Administrator further certifies that this rulemaking has been drafted in accordance with the principles in Executive Order 12866, section 1(b). The Office of Management and Budget (OMB) reviewed the interim rule as a significant action; the DEA received no comments regarding the interim rule. This final rule falls into a category of regulatory actions which OMB has determined are exempt from regulatory review. Therefore, this action has not been reviewed by the OMB.

Executive Order 13132

This action has been analyzed in accordance with the principles and criteria in Executive Order 13132 and it has been 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

[[Page 43694]]

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 United States-based companies to compete with foreign-based companies in domestic and export markets.

PART 1308--[AMENDED]

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 which was published at 65 FR 3124 on Jan. 20, 2000 and corrected at 65 FR 5024, on Feb. 2, 2000, amending the list described in 21 CFR 1308.34.

Dated: July 3, 2000.

John H. King,
Deputy Assistant Administrator, Office of Diversion Control.

[FR Doc. 00-17915 Filed 7-13-00; 8:45 am]
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