§ 1308.34 21 CFR Ch. II (4–1–96 Edition)
the date on which it will take effect. following the procedures set forth in The Administrator shall permit any in- paragraph (d) of this section for han- terested person to file written com- dling an application for an exemption ments on or objections to the order which has been accepted for filing. within 60 days of the date of publica- tion of his order in the FEDERAL REG- [56 FR 42936, Aug. 30, 1991; 57 FR 10815, Mar. 31, 1992] ISTER. If any such comments or objec- tions raise significant issues regarding § 1308.34 Exempt anabolic steroid any finding of fact or conclusion of law products. upon which the order is based, the Ad- ministrator shall immediately suspend The following anabolic steroid con- the effectiveness of the order until he taining compounds, mixtures, or may reconsider the application in light preparations have been exempted by of the comments and objections filed. the Administrator from application of Thereafter, the Administrator shall re- sections 302 through 309 and 1002 instate, revoke, or amend his original through 1004 of the Act (21 U.S.C. 822– order as he determines appropriate. 829 and 952–954) and §§ 1301.24, 1301.31, (e) The Administrator may revoke 1301.32, and 1301.71 through 1301.76 of any exemption granted pursuant to this chapter for administrative pur- section 1903(a) of Public Law 101–647 by poses only:
TABLE OF EXEMPT ANABOLIC STEROID PRODUCTS
Trade name Company NDC No. Form Ingredients Quantity
Androgyn L.A...... Forest Pharma- 0456±1005 ...... Vial ...... Testosterone enanthate 90 mg/ml ceuticals, St. Louis, Estradiol valerate ...... 4 mg/ml MO. Andro-Estro 90±4 ...... Rugby Laboratories, 0536±1605 ...... Vial ...... Testosterone enanthate 90 mg/ml Rockville Centre, NY. Estradiol valerate ...... 4 mg/ml depANDROGYN ...... Forest Pharma- 0456±1020 ...... Vial ...... Testosterone cypionate 50 mg/ml ceuticals, St. Louis, Estradiol cypionate ...... 2 mg/ml MO. DEPO±T.E...... Quality Research 52765±257 ...... Vial ...... Testosterone cypionate 50 mg/ml Pharm., Carmel, IN. Estradiol cypionate ...... 2 mg/ml depTESTROGEN ...... Martica Pharma- 51698±257 ...... Vial ...... Testosterone cypionate 50 mg/ml ceuticals, Phoenix, Estradiol cypionate ...... 2 mg/ml AZ. Duomone ...... Wintec Pharmaceutical, 52047±360 ...... Vial ...... Testosterone enanthate 90 mg/ml Pacific, MO. Estradiol valerate ...... 4 mg/ml DURATESTRIN ...... W.E. Hauck, 43797±016 ...... Vial ...... Testosterone cypionate 50 mg/ml Alpharetta, GA. Estradiol cypionate ...... 2 mg/ml DUO±SPAN II ...... Primedics Laboratories, 0684±0102 ...... Vial ...... Testosterone cyplonate 50 mg/ml Gardena, CA. Esterified cypionate ..... 2 mg/ml Estratest ...... Solvay Pharma- 0032±1026 ...... TB ...... Esterified estrogens ..... 1.25 mg ceuticals, Marletta, Methyltestosterone ...... 2.5 mg GA. Estratest HS ...... Solvay Pharma- 0032±1023 ...... TB ...... Esterified estrogens ..... 0.625 mg ceuticals, Marletta, Methyltestosterone ...... 1.25 mg GA. PAN ESTRA TEST ...... Pan American Labs, 0525±0175 ...... Vial ...... Testosterone cypionate 50 mg/ml Covington, LA. Estradiol cypionate ...... 2 mg/ml Premarin with Ayerst Labs. Inc., New 0046±0879 ...... TB ...... Conjugated estrogens 1.25 mg Methyltestosterone. York, NY. Methyltestosterone ...... 10.0 mg Premarin with Ayerst Labs. Inc., New 0046±0878 ...... TB ...... Conjugated estrogens 0.625 mg Methyltestosterone. York, NY. Methyltestosterone ...... 5.0 mg Synovex H Pellets in Syntex Animal Health, ...... Drum ...... Testosterone propio- 25 mg. process. Palo Alto, CA. nate. 2.5 mg. Estradiol benzoate ...... Synovex H Pellets in Syntex Animal Health, ...... Drum ...... Testosterone propio- 10 parts. process granulation. Palo Alto, CA. nate. 1 part. Estradiol benzoate ...... TEST±ESTRO Rugby Laboratories, 0536±9470 ...... Vial ...... Testosterone cypionate 50 mg/ml Cypionates. Rockville Centre, NY. Estradiol cypionate ...... 2 mg/ml Testagen ...... Clint Pharmaceuticals, 55553±257 ...... Vial ...... Testosterone cypionate 50 mg/ml. Nashville, TN. Estradiol cypionate ...... 2 mg/ml. Testosterone Cyp 50 I.D.E.-Interstate, Amity- 0814±7737 ...... Vial ...... Testosterone cypionate 50 mg/ml Estradiol Cyp 2. ville, NY. Estradiol cypionate ...... 2 mg/ml
182
VerDate 14
TABLE OF EXEMPT ANABOLIC STEROID PRODUCTSÐContinued
Trade name Company NDC No. Form Ingredients Quantity
Testosterone Best Generics, No. 54274±530 ...... Vial ...... Testosterone cypionate 50 mg/ml CypionateÐEstradiol Miami Beach, FL. Estradiol cypionate ...... 2 mg/ml Cypionate Injection. Testosterone Goldline Labs, Ft. Lau- 0182±3069 ...... Vial ...... Testosterone cypionate 50 mg/ml. CypionateÐEstradiol derdale, FL. Estradiol cypionate ...... 2 mg/ml. Cypionate Injection. Testosterone Schein Pharma- 0364±6611 ...... Vial ...... Testosterone cypionate 50 mg/ml CypionateÐEstradiol ceuticals, Port Wash- Estradiol cypionate ...... 2 mg/ml Cypionate Injection. ington, NY. Testosterone Steris Labs. Inc., Phoe- 0402±0257 ...... Vial ...... Testosterone cypionate 50 mg/ml CypionateÐEstradiol nix, AZ. Estradiol cypionate ...... 2 mg/ml Cypionate Injection. Testosterone The Upjohn Co., Kala- 0009±0253 ...... Vial ...... Testosterone cypionate 50 mg/ml. CypionateÐEstradiol mazoo, MI. Estradiol cypionate ...... 2 mg/ml. Cypionate Injection. Testosterone Goldline Labs, Ft. Lau- 0182±3073 ...... Vial ...... Testosterone enanthate 90 mg/ml. EnanthateÐEstradiol derdale, FL. Estradiol valerate ...... 4 mg/ml. Valerate Injection. Testosterone Schein Pharma- 0364±6618 ...... Vial ...... Testosterone enanthate 90 mg/ml EnanthateÐEstradiol ceuticals, Port Wash- Estradiol valerate ...... 4 mg/ml Valerate Injection. ington, NY. Testosterone Steris Labs. Inc., Phoe- 0402±0360 ...... Vial ...... Testosterone enanthate 90 mg/ml EnanthateÐEstradiol nix, AZ. Estradiol valerate ...... 4 mg/ml Valerate Injection. Tilapia Sex Reversal Zeigler Brothers, Inc., ...... Plastic Methyltestosterone fish 60 mg/1 kg. Feed (Investigational). Gardners, PA. Bags. feed.
[56 FR 42937, Aug. 30, 1991, as amended at 57 FR 55091, Nov. 24, 1992; 58 FR 16773, Mar. 31, 1993; 58 FR 34708, June 29, 1993]
HEARINGS § 1308.43 Waiver or modification of Rules. § 1308.41 Hearings generally. The Administrator or the presiding In any case where the Administrator officer (with respect to matters pend- shall hold a hearing on the issuance, ing before him) may modify or waive amendment, or repeal of rules pursuant any rule in this part by notice in ad- to section 201 of the Act, the proce- vance of the hearing, if he determines dures for such hearing and accompany- that no party in the hearing will be un- ing proceedings shall be governed gen- duly prejudiced and the ends of justice erally by the rulemaking procedures will thereby be served. Such notice of set forth in the Administrative Proce- modification or waiver shall be made a dure Act (5 U.S.C. 551–559) and specifi- part of the record of the hearing. cally by section 201 of the Act (21 U.S.C. 811), by §§ 1308.42–1308.51, and by § 1308.44 Initiation of proceedings for §§ 1316.41–1316.67 of this chapter. rulemaking. § 1308.42 Purpose of hearing. (a) Any interested person may sub- mit a petition to initiate proceedings If requested by any interested person for the issuance, amendment, or repeal after proceedings are initiated pursu- of any rule or regulation issuable pur- ant to § 1308.44, the Administrator shall hold a hearing for the purpose of re- suant to the provisions of section 201 of ceiving factual evidence and expert the Act. opinion regarding the issues involved (b) Petitions shall be submitted in in the issuance, amendment or repeal quintuplicate to the Administrator in of a rule issuable pursuant to section the following form: 201(a) of the Act (21 U.S.C. 811(a)). Ex- ———————————————————————— tensive argument should not be offered (Date) into evidence but rather presented in ADMINISTRATOR, DRUG ENFORCEMENT opening or closing statements of coun- ADMINISTRATION sel or in memoranda or proposed find- Department of Justice, ings of fact and conclusions of law. Washington, DC 20537.
183
VerDate 14