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Rule

Schedules of Controlled Substances: Exempt Anabolic Steroids Products

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

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 Start Printed Page 43691comments were received. Therefore, the interim rule is being adopted without change.

EFFECTIVE DATE:

July 14, 2000.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

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

End Further Info End Preamble Start Supplemental Information

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 nameCompanyNDC No.FormIngredientsQuantity
Component E-H in process granulationIvy Laboratories, Inc., Overland Park, KSPail or drumTestosterone propionate10 parts
Estradiol benzoate1 part
Component E-H in process pelletsIvy Laboratories, Inc., Overland Parks, KSPailTestosterone propionate25 mg/
Estradiol benzoate2.5 mg/pellet
Component TE-S in process granulationIvy Laboratories, Inc., Overland Park, KSPail or drumTrenbolone acetate5 parts
Estradiol USP1 part
Component TE-S in process pelletsIvy Laboratories, Inc., Overland Parks, KSPailTrenbolone acetate120 mg/
Estradiol USP24 mg/pellet
Testoderm with Adhesive 4 mg/dAlza Corp., Palo Alto,CAExport onlyPatchTestosterone10 mg
Testosterone Ophthalmic SolutionsAllergan, Irvine, CAOphthalmic SolutionsTestosterone≤0.6% w/v

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 NameCompanyNDC No.FormIngredientsQuantity
Andro-Estro 90-4Rugby Laboratories, Rockville Centre, NY0536-1605VialTestosterone enanthate90 mg/ml
Estradiol valerate4 mg/ml
Androgyn L.A.Forest Pharmaceuticals, St. Louis, MO0456-1005VialTestosterone enanthate90 mg/ml
Estradiol valerate4 mg/ml
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Component E-H in process granulationIvy Laboratories, Inc., Overland Park, KSPail or drumTestosterone propionate10 parts
Estradiol benzoate1 part
Componenet E-H in process pelletsIvy Laboratories, Inc., Overland Park, KSPailTestosterone propionate25 mg/
Estradiol benzoate2.5 mg/pellet
Component TE-S in process granulationIvy Laboratories, Inc., Overland Park, KSPail or drumTrenbolone acetate5 parts
Estradiol USP1 part
Component TE-S in process pelletsIvy Laboratories, Inc., Overland Park, KSPailTrenbolone acetate120 mg/
Estradiol USP24 mg/pellet
depANDROGYNForest Pharmaceuticals, St. Louis, MO0456-1020VialTestosterone cypionate50 mg/ml
Estradiol cypionate2 mg/ml
DEPTO-T.E.Quality Research Pharm., Carmel, IN52765-257VialTestosterone cypionate50 mg/ml
Estradiol cypionate2 mg/ml
Depo-TestadiolThe Upjohn Company, Kalamazoo, MI0009-0253VialTestosterone cypionate50 mg/ml
Estradiol cypionate2 mg/ml
depTESTROGENMartica Pharmaceuticals, Phoenix, AZ51698-257VialTestosterone cypionate50 mg/ml
Estradiol cypionate2 mg/ml
DuomoneWintec Pharmaceutical, Pacific, MO52047-360VialTestosterone enanthate90 mg/ml
Estradiol valerate4 mg/ml
DUO-SPAN IIPrimedics Laboratories, Gardena, CA0684-0102VialTestosterone cypionate50 mg/ml
Estradiol cypionate2 mg/ml
DURATESTRINW. E. Hauck, Alpharetta, GA43797-016VialTestosterone cypionate50 mg/ml
Estradiol cypionate2 mg/ml
EstratestSolvay Pharmaceuticals, Marietta, GA0032-1026TBEsterifield estrogens1.25 mg
Methyltestosterone2.5 mg
Estratest HSSolvay Pharmaceuticals, Marietta, GA0032-1023TBEsterifield estrogens0.625 mg
Methyltestosterone1.25 mg
MenogenSage Pharmaceuticals, Shreveport, LA59243-570TBEsterifield estrogens1.25 mg
Methyltestosterone2.5 mg
Menogen HSSage Pharmaceutical, Shreveport, LA59243-560TBEsterifield estrogens.0625 mg
Methyltestosterone1.25 mg
PAN ESTRA TESTPan American Labs., Covington, LA0525-0175VialTestosterone cypionate50 mg/ml
Estradiol cypionate2 mg/ml
Premarin with MethyltestosteroneAyerst Labs. Inc,. New York, NY0046-0878TBConjugated estrogens0.625 mg
Methyltestosterone5.0 mg
Premarin with MethyltestosteroneAyerst Labs. Inc., New York, NY0046-0879TBConjugated estrogens1.25 mg
Methyltestosterone10.0 mg
Synovex H in-process bulk pelletsSyntex Animal health, Palo Alto, CADrumTestosterone propionate25 mg
Estradiol benzoate2.5 mg/pellet
Synovex H in-process granulationSyntex Animal Health, Palo Alto, CADrumTestosterone propionate10 part
Estradiol benzoate1 part
Synovex Plus in-process bulk pelletsFort Dodge Animal Health, Fort Dodge, IADrumTrenbolone acetate25 mg/
Estradiol benzoate3.50 mg/pellet
Synovex Plus in-process granulationFort Dodge Animal Health, Fort Dodge, IADrumTrenbolone acetate 25 parts
Estradiol benzoate3.5 parts
TestagenClint Pharmaceuticals, Nashville, TN55553-257VialTestosterone cypionate50 mg/ml
Estradiol cypionate2 mg/ml
TEST-ESTRO CypionatesRugby Laboratories Rockvill Centre, NY0536-9470VialTestosterone cypionate50 mg/ml
Estradiol cypionate2 mg/ml
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Testoderm 4 mg/dAlza Copr., Palo Alto, CA17314-4608PatchTestosterone10 mg
Testoderm 6 mg/dAlza Corp., Palo Alto, CA17314-4609PatchTestosterone15 mg
Testoderm with Adhesive 4 mg/dAlza Corp., Palo Alto, CAExport onlyPatchTestosterone10 mg
Testoderm with Adhesive 6 mg/dAlza Corp., Palo Alto, CA17314-2836PatchTestosterone15 mg
Testoderm in-process filmAlza Corp, Palo Alto, CASheetTestosterone0.25 mg/cm2
Testoderm with Adhesive in-process filmAlza Corp., Palo Alto, CASheetTestosterone0.25 mg/cm2
Testosterone Cypionate/Estradiol Cypionate InjectionBest Generics, No. Miami Beach, FL54274-530VialTestosterone cypionate50 mg/ml
Estradiol cypionate2 mg/ml
Testosterone Cypionate/Estradiol Cypionate InjectionGoldline Labs, Ft. Lauderdale, Fl0182-3069VialTestosterone cypionate50 mg/ml
Estradiol cypionate2mg/ml
Testosterone Cyp 50 Estradiol Cyp 2I.D.E.-Interstate, Amityville, NY0814-7737VialTestosterone cypionate50 mg/ml
Estradiol cypionate2 mg/ml
Testosterone Cypionate/Estradiol Cypionate InjectionSchein Pharmaceuticals, Port Washington, NY0364-6611VialTestosterone cypionate50 mg/ml
Estradiol cypionate2mg/ml
Testosterone Cypionate/Estradiol Cypionate InjectionSteris Labs. Inc., Phoenix, AZ0402-0257VialTestosterone cypionate50 mg/ml
Estradiol cypionate2 mg/ml
Testosterone Enanthate/Estradiol Valerate InjectionGoldline Labs, Ft. Lauderdale, Fl0182-3073VialTestosterone enanthate90 mg/ml
Estradiol valerate4 mg/ml
Testosterone Enanthate/Estradiol Valerate InjectionSchein Pharmaceuticals, Port Washington, NY0364-6618VialTestosterone enanthate90 mg/ml
Estradiol valerate4 mg/ml
Testosterone Enanthate/Estradiol Valerate InjectionSteris Labs. Inc., Phoenix, AZ0402-0360VialTestosterone enanthate90 mg/ml
Estradiol valerate4 mg/ml
Testosterone Ophthalmic SolutionsAllergan, Irvine, CAOphthalmic solutionsTestosterone≤0.6% w/v
Tilapia Sex Reversal Feed (Investigational)Rangen, Inc., Buhl, IDPlastic bagsMethyltestosterone60 mg/kg fish feed
Tilapia Sex Reversal Feed (Investigational)Ziegler Brothers, Inc., Gardners, PAPlastic bagsMethyltestosterone60 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 Start Printed Page 43694result 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.

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PART 1308—[AMENDED]

End Part Start Amendment Part

Pursuant to the authority delegated to the Administrator of the DEA pursuant to

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Dated: July 3, 2000.

John H. King,

Deputy Assistant Administrator, Office of Diversion Control.

End Signature End Supplemental Information

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

BILLING CODE 4410-09-M