00-17915. 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 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 [phone].

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

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 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.