Date="03/31/93" Citation="58 FR 16772" Group="legal" Type="RULE" Department="DEPARTMENT OF JUSTICE" Agency="DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE" Subject="Schedules of Controlled Substances: Exempt Anabolic Steroid Products"

DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 Schedules of Controlled Substances: Exempt Anabolic Steroid Products AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Interim rule and request for comments.

DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 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 certain preparations as exempt anabolic steroid products. This action, as part of the ongoing implementation of the Anabolic Steroid Control Act of 1990, removes certain regulatory controls pertaining to Schedule III substances from the designated entities. DATES: Effective Date: March 31, 1993. Comments must be submitted on or before June 1, 1993. ADDRESSES: Comments and objections should be submitted to the Director, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537; Attention: DEA Federal Register Representative/CCR. FOR FURTHER INFORMATION CONTACT: Howard McClain, Jr., (Chief, Drug and Chemical Evaluation Section), 202-307-7183. SUPPLEMENTARY INFORMATION: Section 1903 of the Anabolic Steroids Control Act of 1990 (ASCA) (title XIX of Public Law 101-647) 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 was published by the DEA on Friday, August 30, 1991, (56 FR 42935). An order was published on Tuesday, November 24, 1992, (57 FR 55090) which identified certain products as being exempt anabolic steroid products. The purpose of this rule is to identify an additional five products which meet the exempt anabolic steroid product criteria. The Director, Office of Diversion Control, having reviewed the applications, the recommendations of the Secretary of the Department of Health and Human Services, 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. Interested persons are invited to submit their comments in writing in regard to this interim rule. The listing of these products in 21 CFR 1308.34 relieves persons who handle them in the course of legitimate business from the registration, records, reports, prescription, physical security, import, and export requirements associated with Schedule III substances. Accordingly, the Director certifies that this action will have no impact on the ability of small businesses to compete and he therefore determines that no regulatory flexibility analysis is required. This action has been analyzed in accordance with the principles and criteria contained in E.O. 12612, and it has been determined that this matter does not have sufficient federalism implications to require the preparation of a Federalism Assessment. It has been determined that drug control matters are not subject to review by the Office of Management and Budget (OMB) pursuant to the provisions of E.O. 12291. Accordingly, this action is not subject to those provisions of E.O. 12778 which are contingent upon review by OMB. Nevertheless, the Director has determined that this is not a "major rule," as that term is used in E.O. 12291, and that it would otherwise meet the applicable standards of sections 2(a) and 2(b)(2) of E.O. 12778. List of Subjects in 21 CFR Part 1308 Administrative practice and procedure, Drug traffic control, Narcotics, Prescription drugs. Under the authority vested in the Attorney General by title XIX of Public Law 101-647, as delegated to the Administrator of the DEA pursuant to 21 U.S.C. 871(a) and 28 CFR 0.100, the Director of the Office of Diversion Control hereby amends 21 CFR part 1308 as set forth below: PART 1308-[AMENDED] 1. The authority citation for 21 CFR part 1308 continues to read as follows: Authority: 21 U.S.C. 811, 812, 871(b) unless otherwise noted. sec1308.34 [Amended] 2. Section 1308.34 is amended by adding five new entries to the Table of Exempt Anabolic Steroid Products, to be placed in alphabetical order first by Trade Name and then by Company, to read as follows: sec1308.34 Exempt anabolic steroid products. * * * * * Table of Exempt Anabolic Stero id Products ------------------------------------------------------------------------------- ------------------------------------------------------------ Trade name Company NDC No. Form Ingredients Quality ------------------------------------------------------------------------------- ------------------------------------------------------------ * * * * * * * Synovex H Pellets in process...... Syntex Animal Health, Palo Dru m............. Testosterone propionate... 25 mg. Alto, CA Estradiol benzoate........ 2.5 mg. Synovex H Pellets in process Syntex Animal Health, Palo Dru m............. Testosterone propionate... 10 parts. granulation. Alto, CA Estradiol benzoate........ 1 part. Testagen.......................... Clint Pharmaceuticals, 55553-257 Via l............. Testosterone cypionate.... 50 mg/ml. Nashville, TN Estradiol cypionate....... 2 mg/ml. * * * * * * * Testosterone Cypionate-Estradiol Cypionate Injection. Testosterone Cypionate-Estradiol Goldline Labs, Ft. 0182-3069 Via l............. Testosterone cypionate.... 50 mg/ml. Cypionate Injection. Lauderdale, FL Estradiol cypionate....... 2 mg/ml. * * * * * * * Testosterone Enanthate-Estradiol Valerate Injection. Testosterone Enanthate-Estradiol Goldline Labs, Ft. 0182-3073 Via l............. Testosterone enanthate.... 90 mg/ml. Valerate Injection. Lauderdale, FL Estradiol valerate........ 4 mg/ml. * * * * * * * ------------------------------------------------------------------------------- ------------------------------------------------------------ Dated: March 26, 1993. Gene R. Haislip, Director, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 93-7463 Filed 3-30-93; 8:45 am] BILLING CODE 4410-09-M