Exempt Anabolic Steroids (21 CFR § 1308.33 and 21 CFR § 1308.34)

Home , Esterified estrogens, Estradiol benzoate, Methyltestosterone, Testosterone cypionate, Testosterone enanthate, Testosterone propionate

November 5, 2020

Drug Enforcement Administration Diversion Control Division Drug and Chemical Evaluation Section Telephone: (571) 362-3249 E-mail: [email protected] Exempt Anabolic Steroids

Trade Name Company NDC # Form Ingredients Quantity Andro-Estro 90-4 Rugby Laboratories, 0536-1605 Vial Testosterone enanthate; Estradiol valerate 90 mg/mL; 4 mg/mL Rockville Centre, NY Androgyn L.A. Forest Pharmaceuticals, St. 0456-1005 Vial Testosterone enanthate; Estradiol valerate 90 mg/mL; 4 mg/mL Louis, MO Component E-H in process Ivy Laboratories, Inc., Pail or drum Testosterone propionate; Estradiol benzoate 10 parts; 1 part granulation Overland Park, KS Component E-H in process Ivy Laboratories, Inc., Pail Testosterone propionate; Estradiol benzoate 25 mg/2.5 mg/pellet pellets Overland Park, KS Component TE-S in process Ivy Laboratories, Inc., Pail or drum Trenbolone acetate; Estradiol USP 5 parts; 1 part granulation Overland Park, KS Component TE-S in process Ivy Laboratories, Inc., Pail Trenbolone acetate; Estradiol USP 120 mg/24 mg/pellet pellets Overland Park, KS depANDROGYN Forest Pharmaceuticals, St. 0456-1020 Vial Testosterone cypionate; Estradiol cypionate 50 mg/mL; 2 mg/mL Louis, MO Depo-Testadiol The Upjohn Company, 0009-0253 Vial Testosterone cypionate; Estradiol cypionate 50 mg/mL; 2 mg/mL Kalamazoo, MI depTESTROGEN Martica Pharmaceuticals, 51698-257 Vial Testosterone cypionate; Estradiol cypionate 50 mg/mL; 2 mg/mL Phoenix, AZ DEPTO-T.E. Quality Research Pharm., 52765-257 Vial Testosterone cypionate; Estradiol cypionate 50 mg/mL; 2 mg/mL Carmel, IN Duomone Wintec Pharmaceutical, 52047-360 Vial Testosterone enanthate; Estradiol valerate 90 mg/mL; 4 mg/mL Pacific, MO DUO-SPAN II Primedics Laboratories, 0684-0102 Vial Testosterone cypionate; Estradiol cypionate 50 mg/mL; 2 mg/mL Gardena, CA DURATESTRIN W. E. Hauck, Alpharetta, GA 43797-016 Vial Testosterone cypionate; Estradiol cypionate 50 mg/mL; 2 mg/mL Essian Pharmaceutics International TB Esterified estrogens; Methyltestosterone 1.25 mg; 2.5 mg Inc., Hunt Valley, MD Essian H.S. Pharmaceutics International TB Esterified estrogens; Methyltestosterone 0.625 mg; 1.25 mg Inc., Hunt Valley, MD Esterified Estrogens and ECI Pharmaceuticals LLC TB Esterified estrogens; Methyltestosterone 1.25 mg; 2.5 mg Methyltestosterone 1.25 mg/2.5 mg D.S.

Page 1 Drug Enforcement Administration Last exemption granted on June 15, 2020 (85 FR 36148)

Exempt Anabolic Steroids

Trade Name Company NDC # Form Ingredients Quantity Esterified Estrogens and ECI Pharmaceuticals LLC TB Esterified estrogens; Methyltestosterone 0.625 mg; 1.25 mg Methyltestosterone 0.625mg/1.25mg H.S. Esterified Estrogens and Interpharm, Inc., TB Esterified estrogens; Methyltestosterone 0.625 mg; 1.25 mg Methyltestosterone, USP (0.625 mg/1.25mg) Esterified Estrogens and Interpharm, Inc. TB Esterified estrogens; Methyltestosterone 1.25 mg; 2.5 mg Methyltestosterone, USP (1.25 mg/2.5 mg) Esterified Estrogens/ ANDAPharm, LLC TB Esterified estrogens; Methyltestosterone 0.625 mg; 1.25 mg Methyltestosterone, (0.625 mg/1.25 mg) Tablet Esterified Estrogens/ ANDAPharm, LLC TB Esterified estrogens; Methyltestosterone 1.25 mg; 2.5 mg Methyltestosterone, (1.25 mg/2.5 mg) Tablet Estratest Solvay Pharmaceuticals, 0032-1026 TB Esterified estrogens; Methyltestosterone 1.25 mg; 2.5 mg Marietta, GA Estratest H.S. Solvay Pharmaceuticals, 0032-1023 TB Esterified estrogens; Methyltestosterone 0.625 mg; 1.25 mg Marietta, GA Menogen Sage Pharmaceuticals, 59243-570 TB Esterified estrogens; Methyltestosterone 1.25 mg; 2.5 mg Shreveport, LA Menogen HS Sage Pharmaceuticals, 59243-560 TB Esterified estrogens; Methyltestosterone 0.625 mg; 1.25 mg Shreveport, LA Methyltestosterone and Lannett Company, Inc. TB Esterified estrogens; Methyltestosterone 1.25 mg; 2.5 mg Esterified Estrogens (2.5 mg/1.25 mg) Methyltestosterone and Lannett Company, Inc. TB Esterified estrogens; Methyltestosterone 0.625 mg; 1.25 mg Esterified Estrogens (Half Strength) (1.25 mg/0.625 mg) PAN ESTRA TEST Pan American Labs; 0525-0175 Vial Testosterone cypionate; Estradiol cypionate 50 mg/mL; 2 mg/mL Covington, LA Premarin with Ayerst Labs Inc., New York, 0046-0878 TB Conjugated estrogens; Methyltestosterone 0.625 mg; 5.0 mg Methyltestosterone NY Premarin with Ayerst Labs Inc., New York, 0046-0879 TB Conjugated estrogens; Methyltestosterone 1.25 mg; 10.0 mg Methyltestosterone NY Page 2 Drug Enforcement Administration Last exemption granted on June 15, 2020 (85 FR 36148)

Exempt Anabolic Steroids

Trade Name Company NDC # Form Ingredients Quantity Synovex H in-process bulk Syntex Animal Health, Palo Drum Testosterone propionate; Estradiol benzoate 25 mg; 2.5 mg/pellet pellets Alto, CA Synovex H in-process Syntex Animal Health, Palo Drum Testosterone propionate; Estradiol benzoate 10 part; 1 part granulation Alto, CA Synovex Plus in-process bulk Fort Dodge Animal Health, Drum Trenbolone acetate; Estradiol benzoate 25 mg; 3.5 mg/pellet pellets Fort Dodge, IA Synovex Plus in-process Fort Dodge Animal Health, Drum Trenbolone acetate; Estradiol benzoate 25 parts; 3.5 parts granulation Fort Dodge, IA Syntest D.S. Syntho Pharmaceuticals, Inc. 66576-231 TB Esterified estrogens; Methyltestosterone 1.25 mg; 2.5 mg

Syntest H.S. Syntho Pharmaceuticals, Inc. 66576-230 TB Esterified estrogens; Methyltestosterone 0.625 mg; 1.25 mg

TEST-ESTRO Cypionates Rugby Laboratories, 0536-9470 Vial Testosterone cypionate; Estradiol cypionate 50 mg/mL; 2 mg/mL Rockville Centre, NY Testoderm 4 mg/d Alza Corp., Palo Alto, CA 17314- Patch Testosterone 10 mg 4608 Testoderm 6 mg/d Alza Corp., Palo Alto, CA 17314- Patch Testosterone 15 mg 4609 Testoderm in-process film Alza Corp., Palo Alto, CA Sheet Testosterone 0.25 mg/cm2

Testoderm with Adhesive 4 Alza Corp., Palo Alto, CA Export only Patch Testosterone 10 mg mg/d Testoderm with Adhesive 6 Alza Corp., Palo Alto, CA 17314- Patch Testosterone 15 mg mg/d 2836 Testoderm with Adhesive in- Alza Corp., Palo Alto, CA Sheet Testosterone 0.25 mg/cm2 process film Testosterone Cyp 50 Estradiol I.D.E.-Interstate, 0814-7737 Vial Testosterone cypionate; Estradiol cypionate 50 mg/mL; 2 mg/mL Cyp 2 Amityville, NY Testosterone Best Generics, North Miami 54274-530 Vial Testosterone cypionate; Estradiol cypionate 50 mg/mL; 2 mg/mL Cypionate/Estradiol Cypionate Beach, FL Injection Testosterone Goldline Labs, Ft. 0182-3069 Vial Testosterone cypionate; Estradiol cypionate 50 mg/mL; 2 mg/mL Cypionate/Estradiol Cypionate Lauderdale, FL Injection

Page 3 Drug Enforcement Administration Last exemption granted on June 15, 2020 (85 FR 36148)

Exempt Anabolic Steroids

Trade Name Company NDC # Form Ingredients Quantity Testosterone Schein Pharmaceuticals, Port 0364-6611 Vial Testosterone cypionate; Estradiol cypionate 50 mg/mL; 2 mg/mL Cypionate/Estradiol Cypionate Washington, NY Injection Testosterone Steris Labs Inc. Phoenix, AZ 0402-0257 Vial Testosterone cypionate; Estradiol cypionate 50 mg/mL; 2 mg/mL Cypionate/Estradiol Cypionate Injection Testosterone Goldline Labs, Ft. 0182-3073 Vial Testosterone enanthate; Estradiol valerate 90 mg/mL; 4 mg/mL Enanthate/Estradiol Valerate Lauderdale, FL Injection Testosterone Schein Pharmaceuticals, Port 0364-6618 Vial Testosterone enanthate; Estradiol valerate 90 mg/mL; 4 mg/mL Enanthate/Estradiol Valerate Washington, NY Injection Testosterone Steris Labs Inc. Phoenix, AZ 0402-0360 Vial Testosterone enanthate; Estradiol valerate 90 mg/mL; 4 mg/mL Enanthate/Estradiol Valerate Injection Testosterone Ophthalmic Allergan, Irvine, CA Ophthalmic Testosterone ≤0.6% w/v Solutions solution Tilapia Sex Reversal Feed Wilbur-Ellis Nutrition LLC, Plastic Bags Methyltestosterone 60 mg/kg fish feed (Investigational) Buhl, ID

Page 4 Drug Enforcement Administration Last exemption granted on June 15, 2020 (85 FR 36148)