00-1347. Schedules of Controlled Substances: Exempt Anabolic Steroid Products

AGENCY:

Drug Enforcement Administration, Department of Justice.

ACTION:

Interim rule and request for comments.

SUMMARY:

The Drug Enforcement Administration (DEA) is designating six preparations as exempt anabolic steroid products. This action, as part of the ongoing implementation of the Anabolic Steroids Control Act of 1990, removes certain regulatory controls pertaining to Schedule III substances from the designated entities.

DATES:

Effective date: January 20, 2000. Comments must be submitted on or before March 20, 2000.

ADDRESSES:

Comments and objections should be submitted to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, Washington, DC. 20537; Attention: DEA Federal Register Representative/CCR.

FOR FURTHER INFORMATION CONTACT:

Frank Sapienza, Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, Washington, DC 20537; Telephone: [phone].

SUPPLEMENTARY INFORMATION:

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

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 Controlled Substances Act (CSA) (21 U.S.C. 801 et seq.) 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. The purpose of this rule is to identify six products for which applications were made and which the Deputy Assistant Administrator for the DEA Office of Diversion Control finds meet the exempt anabolic steroid product criteria.

Why Is DEA Adding Anabolic Steroid Products to the List of Exemptions?

In accordance with 21 CFR 1308.33 applications for the exemption of six anabolic steroid products were submitted by the products' manufacturers to the Deputy Assistant Administrator for the DEA Office of Diversion Control. Each application delineated a set of facts which the applicant believed justified the exempt status of its product. The applicants provides data 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 these 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 which contain anabolic steroids should be considered for exemption from certain portions of the CSA. The Deputy Assistant Administrator has received the determination and recommendations of the Assistant Secretary for Health and Surgeon General, that there was sufficient evidence to establish that these products do not possess a significant potential for abuse.

Which Anabolic Steroid Products Are Affected?

The Deputy Assistant Administrator, having reviewed the applications, the recommendations of the Assistant Secretary for Health and Surgeon General, and other relevant information, finds that each of the products described below has no significant potential for abuse because of its concentration, preparation, mixture, or delivery system.

What Action Can Individuals Take if They Are Concerned About the Impact of this Rule?

Interested persons are invited to submit their comments in writing with regard to this interim rule. If any comments or objections raise significant issues regarding any finding of fact or conclusion of law upon which this order is based, the Deputy Assistant Administrator shall immediately suspend the effectiveness of this order until he may reconsider the application in light of the comments and objections filed. Thereafter, the Deputy Assistant Administrator shall reinstate, revoke, or amend his original order as he determines appropriate.

Miscellaneous Matter—Correction

In a previously published rule, an exempt anabolic steroid product was identified in the list referred to in 21 CFR 1308.34 by its active ingredients rather than its trade name. See 62 FR 51776, October 3, 1997. Exemptions are granted, in accordance with the ASCA and the implementing regulations, to specific products. Therefore, DEA is correcting the list referred to in 21 CFR 1308.34 to describe the product by its specific trade name, Depo-Testadiol. The corrected information for this product in the list referred to in 21 CFR 1308.34 is:

Trade name	Company	NDC No.	Form	Ingredients	Quantity
Depo-Testadiol	The Upjohn Company, Kalamazoo, MI	0009-0253	Vial	Testosterone cypionate, Estradiol cypionate	50 mg/ml, 2 mg.ml.

Why is DEA making this rule immediately effective?

This rule is being made immediately effective 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.

Plain English

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, DC 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 a 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.

Administrative Procedure Act 5 U.S.C. 553

This rule provides a health benefit to the public by more expeditiously increasing the access to these anabolic steroid products and reducing regulatory restrictions that DEA and HHS have determined to be unnecessary. Therefore DEA has determined that it is contrary to the public interest to delay the effectiveness of this rule by requiring notice of proposed rulemaking and delay the effective date.

The relief from these administrative restrictions will provide monetary savings to each of the three pharmaceutical manufacturers who applied for these exemptions. In addition to the economic gain to the pharmaceutical industry, these exemptions provide significant benefits to the general public by increasing the availability of these drug products for the legitimate medical treatment for which they were intended.

Executive Order 12866

This interim rule has been drafted and reviewed in accordance with Executive Order 12866, section 1(b), Principles of Regulation. The Deputy Assistant Administrator, Office of Diversion Control, has determined that this rule is a significant regulatory action under Executive Order 12866, section 3(f), Regulatory Planning and Review, and accordingly this rule has been reviewed by the Office of Management and Budget. This regulation exempts those who handle the affected products in the course of legitimate business from the restrictions associated with Schedule III allowing for a more efficient and cost effective means of doing business. These exemptions will provide direct economic relief and financial savings to the three manufacturer applicants requesting these actions. This regulation is in the public interest and provides more expedient access to these products which, in turn, has the potential to improve the health benefits to the public.

Executive Order 13132

This rule will not have substantial direct effects on the United States, on the relationship between the national government and the United States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, it is 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 the United States based companies to compete with foreign-based companies in domestic and export markets.

PART 1308—[AMENDED]

Pursuant to the authority vested in the Attorney General by section 1903 of the ASCA, 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 DEA Office of Diversion Control pursuant to 28 CFR 0.104, Appendix to Subpart R, section 7(g), the Deputy Assistant Administrator hereby orders that the following compounds, mixtures, or preparations containing anabolic steroids be exempted from application of sections 302 through 309 and 1002 through 1004 of the CSA (21 U.S.C. 822-829 and 952-954) and 21 CFR 1301.11, 1301,13, 1301.71 through 1301.76 for administrative purposes only and be included in the list of products described in 21 CFR 1308.34.

§ 1308.34

Amended

Exempt Anabolic Steroid Products

Trade name	Company	NDC No.	Form	Ingredients	Quality
Component E-H in Process Pellets	Ivy Laboratories, Inc. Overland Park, KS		Pail	Testosterone propionate, Estradiol benzoate	25 mg/pellet, 2.5 mg/pellet.
Component E-H in Process Granulation	Ivy Laboratories, Inc. Overland Park, KS		Pail or Drum	Testosterone propionate, Estradiol benzoate	10 parts, 1 part.
Component TE-S in Process Pellets	Ivy Laboratories, Inc. Overland Park, KS		Pail	Trenbolone acetate, Estradiol USP	120 mg/pellet, 24 mg/pellet.
Component TE-S in Process Granulation	Ivy Laboratories, Inc. Overland Park, KS		Pail or Drum	Trenbolone acetate, Estradiol USP	5 parts, 1 part.
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.

Dated: January 11, 2000.

John H. King,

Deputy Assistant Administrator, Office of Diversion Control.