Date="11/24/92" Citation="57 FR 55090" 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: Final rule.

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: Final rule. ------------------------------------------------------------ SUMMARY: The interim rule (57 FR 32423, July 22, 1992) which identified certain anabolic steroid products as being exempt from the regulatory provisions of the Controlled Substances Act (CSA) (21 U.S.C. 801 et seq.) is adopted with the addition of 14 products. EFFECTIVE DATE: November 24, 1992. FOR FURTHER INFORMATION CONTACT: Howard McClain, Jr., Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, Washington, DC 20537, Telephone: (202) 307-7183. SUPPLEMENTARY INFORMATION: The Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration (DEA), published in the Federal Register, an interim rule which identified six pharmaceuticals as being exempt anabolic steroid products (57 FR 32423, July 22, 1992). Comments were requested, four were received. The Chief Drug Inspector of the South Carolina Board of Pharmacy supported the interim rule. Steris Laboratories asked that the rule apply not only to products which bear the Steris label but also to those labeled for licensed distributors. The American Society of Hospital Pharmacists (ASHP) requested that the rule apply to formulations rather than to specific products. The ASHP argued that product specific exemptions placed a substantial and unnecessary burden on pharmacists who must assure compliance with the CSA. The U.S. Small Business Administration notified the Deputy Assistant Administrator that the analysis which is required by Regulatory Flexibility Act (5 U.S.C. 601, et seq.) was incomplete. In response to the submission of Steris Laboratories, the table of exempt anabolic steroid products has been changed to reflect the addition of the private label products. Inclusion of those products also addresses the concerns of the ASHP. Being product specific is consistent with past practice for other exempt products containing controlled substances as reflected in secsec1308.22, 1208.24 and 1308.32 of title 21 of the Code of Federal Regulations. A definitive status of the named products is important to the manufacturers, distributors, certain state governments, and DEA. In relation to the comments of the SBA, the rule was evaluated again in regard to the Regulatory Flexibility Act. That evaluation follows. The Anabolic Steroids Control Act of 1990 (title XIX of Pub. L. 101-647) requires that the Attorney General, upon the recommendation of the Secretary of Health and Human Services (HHS), exempt a compound, mixture, or preparation containing an anabolic steroid if, because of its concentration, preparation, mixture, or delivery system, it has no significant potential for abuse. 21 CFR 1308.33 establishes the procedures for such exemptions. The exemption of an anabolic steroid product follows from a factual determination and recommendation by the Secretary of HHS that the product has no significant potential for abuse. The exemption of an anabolic steroid product relieves persons who distribute and dispense such products from the registration, recordkeeping, reporting and other regulatory requirements normally associated with Schedule III controlled substances. All handlers of the product, irrespective of whether they are major pharmaceutical firms or small entities, benefit from the exemption. However, since pharmaceutical manufacturers must adhere to the strict recordkeeping requirements of the Food, Drug and Cosmetic Act, and since virtually all other handlers, such as distributors, pharmacies, hospitals and practitioners, keep records and inventories for business and other regulatory reasons, the beneficial impact on entities of all sizes is so small as to be insignificant. Accordingly, the Deputy Assistant Administrator concludes 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 Deputy Assistant Administrator 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, and redelegated to the Deputy Assistant Administrator, Office of Diversion Control in 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, the interim rule amending 21 CFR 1308.34 which was published at 57 FR 32423 on July 22, 1992, with the following changes: PART 1308-SCHEDULES OF CONTROLLED SUBSTANCES 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. 2. In sec1308.34 the table is revised to read as follows: sec1308.34 Exempt anabolic steroid products. Table of Exempt Anabolic Steroid Products -----------------------------------+------------------------------------+------ -------------+--------------+--------------------+------------------- Trade name | Company | NDC No. | Form | Ingredients | Quantity -----------------------------------+------------------------------------+------ -------------+--------------+--------------------+------------------- | | | | | Androgyn L.A. .................... | Forest Pharmaceuticals, St. Louis, | 0456- 1005 ....... | Vial ....... | Testosterone | 90 mg/ml | MO | | | enanthate | 4 mg/ml | | | | Estradiol valerate | Andro-Estro 90-4 ................. | Rugby Laboratories, Rockville | 0536- 1605 ....... | Vial ....... | Testosterone | 90 mg/ml | Centre, NY | | | enanthate | 4 mg/ml | | | | Estradiol valerate | depANDROGYN ...................... | Forest Pharmaceuticals, St. Louis, | 0456- 1020 ....... | Vial ....... | Testosterone | 50 mg/ml | MO | | | cypionate | 2 mg/ml | | | | Estradiol | | | | | cypionate | DEPO-T.E. ........................ | Quality Research Pharm., Carmel, | 52765 -257 ....... | Vial ....... | Testosterone | 50 mg/ml | IN | | | cypionate | 2 mg/ml | | | | Estradiol | | | | | cypionate | depTESTROGEN ..................... | Martica Pharmaceuticals, Phoenix, | 51698 -257 ....... | Vial ....... | Testosterone | 50 mg/ml | AZ | | | cypionate | 2 mg/ml | | | | Estradiol | | | | | cypionate | Duomone .......................... | Wintec Pharmaceutical, Pacific, MO | 52047 -360 ....... | Vial ....... | Testosterone | 90 mg/ml | | | | enanthate | 4 mg/ml | | | | Estradiol valerate | DURATESTRIN ...................... | W.E. Hauck, Alpharetta, GA ....... | 43797 -016 ....... | Vial ....... | Testosterone | 50 mg/ml | | | | cypionate | 2 mg/ml | | | | Estradiol | | | | | cypionate | DUO-SPAN II ...................... | Primedics Laboratories, Gardena, | 0684- 0102 ....... | Vial ....... | Testosterone | 50 mg/ml | CA | | | cyplonate | 2 mg/ml | | | | Esterified | | | | | cypionate | Estratest ........................ | Solvay Pharmaceuticals, Marletta, | 0032- 1026 ....... | TB ......... | Esterified | 1.25 mg | GA | | | estrogens | 2.5 mg | | | | Methyltestosterone | Estratest HS ..................... | Solvay Pharmaceuticals, Marletta, | 0032- 1023 ....... | TB ......... | Esterified | 0.625 mg | GA | | | estrogens | 1.25 mg | | | | Methyltestosterone | PAN ESTRA TEST ................... | Pan American Labs, Covington, LA . | 0525- 0175 ....... | Vial ....... | Testosterone | 50 mg/ml | | | | cypionate | 2 mg/ml | | | | Estradiol | | | | | cypionate | Premarin with Methyltestosterone . | Ayerst Labs. Inc., New York, NY .. | 0046- 0879 ....... | TB ......... | Conjugated | 1.25 mg | | | | estrogens | 10.0 mg | | | | Methyltestosterone | Premarin with Methyltestosterone . | Ayerst Labs. Inc., New York, NY .. | 0046- 0878 ....... | TB ......... | Conjugated | 0.625 mg | | | | estrogens | 5.0 mg | | | | Methyltestosterone | TEST-ESTRO Cypionates ............ | Rugby Laboratories, Rockville | 0536- 9470 ....... | Vial ....... | Testosterone | 50 mg/ml | Centre, NY | | | cypionate | 2 mg/ml | | | | Estradiol | | | | | cypionate | Testosterone Cyp 50 Estradiol Cyp | I.D.E.-Interstate, Amityville, NY | 0814- 7737 ....... | Vial ....... | Testosterone | 50 mg/ml 2. | | | | cypionate | 2 mg/ml | | | | Estradiol | | | | | cypionate | Testosterone Cypionate-Estradiol | Best Generics, No. Miami Beach, FL | 54274 -530 ....... | Vial ....... | Testosterone | 50 mg/ml Cypionate Injection. | | | | cypionate | 2 mg/ml | | | | Estradiol | | | | | cypionate | Testosterone Cypionate-Estradiol | Schein Pharmaceuticals, Port | 0364- 6611 ....... | Vial ....... | Testosterone | 50 mg/ml Cypionate Injection. | Washington, NY | | | cypionate | 2 mg/ml | | | | Estradiol | | | | | cypionate | Testosterone Cypionate-Estradiol | Steris Labs. Inc., Phoenix, AZ ... | 0402- 0257 ....... | Vial ....... | Testosterone | 50 mg/ml Cypionate Injection. | | | | cypionate | 2 mg/ml | | | | Estradiol | | | | | cypionate | Testosterone Enanthate-Estradiol | Schein Pharmaceuticals, Port | 0364- 6618 ....... | Vial ....... | Testosterone | 90 mg/ml Valerate Injection. | Washington, NY | | | enanthate | 4 mg/ml | | | | Estradiol valerate | Testosterone Enanthate-Estradiol | Steris Labs. Inc., Phoenix, AZ ... | 0402- 0360 ....... | Vial ....... | Testosterone | 90 mg/ml Valerate Injection. | | | | enanthate | 4 mg/ml | | | | Estradiol valerate | -----------------------------------+------------------------------------+------ -------------+--------------+--------------------+------------------- * * * * * Dated: November 16, 1992. Gene R. Halslip, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 92-28494 Filed 11-23-92; 8:45 am] BILLING CODE 4410-09-M