Schedules of controlled substances: Republication,

[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

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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

Company

NDC No.

Form

Ingredients

Quantity

Component E-H in process

Ivy Laboratories, Inc., .................... Pail or drum........ Testosterone propionate. 10 parts granulation.

Overland Park, KS. Estradiol benzoate...... 1 part Component E-H in process pellets. Ivy Laboratories, Inc., .................... Pail................ Testosterone propionate. 25 mg/ Overland Parks, KS. Estradiol benzoate...... 2.5 mg/pellet Component TE-S in process

Ivy Laboratories, Inc., .................... Pail or drum........ Trenbolone acetate...... 5 parts granulation.

Overland Park, KS. Estradiol USP........... 1 part Component TE-S in process pellets Ivy Laboratories, Inc., .................... Pail................ Trenbolone acetate...... 120 mg/ Overland Parks, KS. Estradiol USP........... 24 mg/pellet Testoderm with Adhesive 4 mg/d... Alza Corp., Palo Alto,CA. Export only......... Patch............... Testosterone............ 10 mg Testosterone Ophthalmic Solutions Allergan, Irvine, CA..... .................... Ophthalmic Solutions Testosterone............ 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 Name

Company

NDC No.

Form

Ingredients

Quantity

Andro-Estro 90-4................. Rugby Laboratories,

0536-1605

Vial............... Testosterone enanthate.. 90 mg/ml Rockville Centre, NY. Estradiol valerate...... 4 mg/ml Androgyn L.A..................... Forest Pharmaceuticals, 0456-1005

Vial............... Testosterone enanthate.. 90 mg/ml St. Louis, MO. Estradiol valerate...... 4 mg/ml

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Component E-H in process

Ivy Laboratories, Inc.,

Pail or drum....... Testosterone propionate. 10 parts granulation.

Overland Park, KS. Estradiol benzoate...... 1 part Componenet E-H in process pellets Ivy Laboratories, Inc.,

Pail............... Testosterone propionate. 25 mg/ Overland Park, KS. Estradiol benzoate...... 2.5 mg/pellet Component TE-S in process

Ivy Laboratories, Inc.,

Pail or drum....... Trenbolone acetate...... 5 parts granulation.

Overland Park, KS. Estradiol USP........... 1 part Component TE-S in process pellets Ivy Laboratories, Inc.,

Pail............... Trenbolone acetate...... 120 mg/ Overland Park, KS. Estradiol USP........... 24 mg/pellet depANDROGYN...................... Forest Pharmaceuticals, 0456-1020

Vial............... Testosterone cypionate.. 50 mg/ml St. Louis, MO. Estradiol cypionate..... 2 mg/ml DEPTO-T.E........................ Quality Research Pharm., 52765-257

Vial............... Testosterone cypionate.. 50 mg/ml Carmel, IN. Estradiol cypionate..... 2 mg/ml Depo-Testadiol................... The Upjohn Company,

0009-0253

Vial............... Testosterone cypionate.. 50 mg/ml Kalamazoo, MI. Estradiol cypionate..... 2 mg/ml depTESTROGEN..................... Martica Pharmaceuticals, 51698-257

Vial............... Testosterone cypionate.. 50 mg/ml Phoenix, AZ. Estradiol cypionate..... 2 mg/ml Duomone.......................... Wintec Pharmaceutical, 52047-360

Vial............... Testosterone enanthate.. 90 mg/ml Pacific, MO. Estradiol valerate...... 4 mg/ml DUO-SPAN II...................... Primedics Laboratories, 0684-0102

Vial............... Testosterone cypionate.. 50 mg/ml Gardena, CA. Estradiol cypionate..... 2 mg/ml DURATESTRIN...................... W. E. Hauck, Alpharetta, 43797-016

Vial............... Testosterone cypionate.. 50 mg/ml GA. Estradiol cypionate..... 2 mg/ml Estratest........................ Solvay Pharmaceuticals, 0032-1026

TB................. Esterifield estrogens... 1.25 mg Marietta, GA. Methyltestosterone...... 2.5 mg Estratest HS..................... Solvay Pharmaceuticals, 0032-1023

TB................. Esterifield estrogens... 0.625 mg Marietta, GA. Methyltestosterone...... 1.25 mg Menogen.......................... Sage Pharmaceuticals, 59243-570

TB................. Esterifield estrogens... 1.25 mg Shreveport, LA. Methyltestosterone...... 2.5 mg Menogen HS....................... Sage Pharmaceutical, 59243-560

TB................. Esterifield estrogens... .0625 mg Shreveport, LA. Methyltestosterone...... 1.25 mg PAN ESTRA TEST................... Pan American Labs.,

0525-0175

Vial............... Testosterone cypionate.. 50 mg/ml Covington, LA. Estradiol cypionate..... 2 mg/ml Premarin with Methyltestosterone. Ayerst Labs. Inc,. New 0046-0878

TB................. Conjugated estrogens.... 0.625 mg York, NY. Methyltestosterone...... 5.0 mg Premarin with Methyltestosterone. Ayerst Labs. Inc., New 0046-0879

TB................. Conjugated estrogens.... 1.25 mg York, NY. Methyltestosterone...... 10.0 mg Synovex H in-process bulk pellets Syntex Animal health,

Drum............... Testosterone propionate. 25 mg Palo Alto, CA. Estradiol benzoate...... 2.5 mg/pellet Synovex H in-process granulation. Syntex Animal Health,

Drum............... Testosterone propionate. 10 part Palo Alto, CA. Estradiol benzoate...... 1 part Synovex Plus in-process bulk Fort Dodge Animal Health,

Drum............... Trenbolone acetate...... 25 mg/ pellets.

Fort Dodge, IA. Estradiol benzoate...... 3.50 mg/pellet Synovex Plus in-process

Fort Dodge Animal Health,

Drum............... Trenbolone acetate 25 granulation.

Fort Dodge, IA.

parts. Estradiol benzoate...... 3.5 parts Testagen......................... Clint Pharmaceuticals, 55553-257

Vial............... Testosterone cypionate.. 50 mg/ml Nashville, TN. Estradiol cypionate..... 2 mg/ml TEST-ESTRO Cypionates............ Rugby Laboratories

0536-9470

Vial............... Testosterone cypionate.. 50 mg/ml Rockvill Centre, NY. Estradiol cypionate..... 2 mg/ml

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Testoderm 4 mg/d................. Alza Copr., Palo Alto, CA 17314-4608

Patch.............. Testosterone............ 10 mg Testoderm 6 mg/d................. Alza Corp., Palo Alto, CA 17314-4609

Patch.............. Testosterone............ 15 mg Testoderm with Adhesive 4 mg/d... Alza Corp., Palo Alto, CA Export only

Patch.............. Testosterone............ 10 mg Testoderm with Adhesive 6 mg/d... Alza Corp., Palo Alto, CA 17314-2836

Patch.............. Testosterone............ 15 mg Testoderm in-process film........ Alza Corp, Palo Alto, CA.

Sheet.............. Testosterone............ 0.25 mg/cm2 Testoderm with Adhesive in-

Alza Corp., Palo Alto, CA

Sheet.............. Testosterone............ 0.25 mg/cm2 process film. Testosterone Cypionate/Estradiol Best Generics, No. Miami 54274-530

Vial............... Testosterone cypionate.. 50 mg/ml Cypionate Injection.

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..... 2mg/ml Testosterone Cyp 50 Estradiol Cyp I.D.E.-Interstate,

0814-7737

Vial............... Testosterone cypionate.. 50 mg/ml 2.

Amityville, NY. Estradiol cypionate..... 2 mg/ml Testosterone Cypionate/Estradiol Schein Pharmaceuticals, 0364-6611

Vial............... Testosterone cypionate.. 50 mg/ml Cypionate Injection.

Port Washington, NY. Estradiol cypionate..... 2mg/ml Testosterone Cypionate/Estradiol Steris Labs. Inc.,

0402-0257

Vial............... Testosterone cypionate.. 50 mg/ml Cypionate Injection.

Phoenix, AZ. 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 Pharmaceuticals, 0364-6618

Vial............... Testosterone enanthate.. 90 mg/ml Valerate Injection.

Port Washington, NY. Estradiol valerate...... 4 mg/ml Testosterone Enanthate/Estradiol Steris Labs. Inc.,

0402-0360

Vial............... Testosterone enanthate.. 90 mg/ml Valerate Injection.

Phoenix, AZ. Estradiol valerate...... 4 mg/ml Testosterone Ophthalmic Solutions Allergan, Irvine, CA.....

Ophthalmic

Testosterone............ 0.6% w/v solutions. Tilapia Sex Reversal Feed

Rangen, Inc., Buhl, ID...

Plastic bags....... Methyltestosterone...... 60 mg/kg fish feed (Investigational). Tilapia Sex Reversal Feed

Ziegler Brothers, Inc.,

Plastic bags....... Methyltestosterone...... 60 mg/kg fish feed (Investigational).

Gardners, PA.

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

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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. 00-17915Filed7-13-00; 8:45 am]

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