††††† 902 KAR 55:090. Exempt anabolic steroid products.

 

††††† RELATES TO: KRS 218A.010-218A.030, 218A.080-218A.090, 21 C.F.R. 1308.13, 1308.33-1308.34, 21 U.S.C. 801, 812

††††† STATUTORY AUTHORITY: KRS 218A.020

††††† NECESSITY, FUNCTION, AND CONFORMITY: KRS 218A.020 authorizes the Cabinet for Health Services to add, delete, or reschedule substances enumerated in KRS Chapter 218A. This administrative regulation exempts certain anabolic steroid products from the licensing, distribution, and recordkeeping provisions of KRS Chapter 218A.

 

††††† Section 1. Exempt Anabolic Steroid Products. The Cabinet for Health Services exempts the following anabolic steroid containing compounds, mixtures, or preparations from the provisions of KRS 218A.150 - 218A.180 and 218A.200:

††††† (1) Androgyn L.A., vial, NDC number 0456-1005: testosterone enanthate 90 mg/ml, estradiol valerate 4 mg/ml;

††††† (2) Andro-Estro 90-4, vial, NDC number 0536-1605: testosterone enanthate 90 mg/ml, estradiol valerate 4 mg/ml;

††††† (3) Component E-H in process granulation, pail or drum: testosterone propionate 10 parts, estradiol benzoate 1 part;

††††† (4) Component E-H in process pellets, pail: testosterone propionate 25 mg, estradiol benzoate 2.5 mg/pellet;

††††† (5) Component TE-S in process granulation, pail or drum: trenbolone acetate 5 parts, estradiol USP 1 part;

††††† (6) Component TE-S in process pellets, pail: trenbolone acetate 120 mg, estradiol USP 24 mg/pellet;

††††† (7) DepANDROGYN, vial, NDC number 0456-1020: testosterone cypionate 50 mg/ml, estradiol cypionate 2 mg/ml;

††††† (8) DEPO-T.E., vial, NDC number 52765-257: testosterone cypionate 50 mg/ml, estradiol cypionate 2 mg/ml;

††††† (9) Depo-Testadiol, vial, NDC number 0009-0253; testosterone cypionate 50 mg/ml, estradiol cypionate 2 mg/ml;

††††† (10) depTESTROGEN, vial, NDC number 51698-257: testosterone cypionate 50 mg/ml, estradiol cypionate 2 mg/ml;

††††† (11) Duomone, vial, NDC number 52047-360: testosterone enanthate 90 mg/ml, estradiol valerate 4 mg/ml;

††††† (12) DURATESTRIN, vial, NDC number 43797-016: testosterone cypionate 50 mg/ml, estradiol cypionate 2 mg/ml;

††††† (13) DUO-SPAN II, vial, NDC number 0684-0102: testosterone cypionate 50 mg/ml, estradiol cypionate 2 mg/ml;

††††† (14) Estratest, tablet, NDC number 0032-1026: esterified estrogens 1.25 mg, methyltestosterone 2.5 mg;

††††† (15) Estratest HS, tablet, NDC number 0032-1023: esterified estrogens 0.625 mg, methyltestosterone 1.25 mg;

††††† (16) Menogen, tablet, NDC number 59243-0570: esterified estrogens 1.25 mg, methyltestosterone 2.5 mg.;

††††† (17) Menogen HS, tablet, NDC number 59243-0560: esterified estrogens 0.625 mg, methyltestosterone 1.25 mg.;

††††† (18) PAN ESTRA TEST, vial, NDC number 0525-0175: testosterone cypionate 50 mg/ml, estradiol cypionate 2 mg/ml;

††††† (19) Premarin with Methyltestosterone, tablet, NDC number 0046-0879: conjugated estrogens 1.25 mg, methyltestosterone 10.0 mg;

††††† (20) Premarin with Methyltestosterone, tablet, NDC number 0046-0878: conjugated estrogens 0.625 mg, methyltestosterone 5.0 mg;

††††† (21) Synovex H in-process bulk pellets, drum: testosterone propionate 25 mg., estradiol benzoate 2.5 mg.;

††††† (22) Synovex H Pellets in-process granulation, drum: testosterone propionate 10 parts, estradiol benzoate 1 part;

††††† (23) Synovex Plus, in-process bulk pellets, drum: trenbolone acetate 25 mg., estradiol benzoate 3.5 mg/pellet;

††††† (24) Synovex Plus, in-process ganulation, drum: trenbolone acetate 25 parts, estradiol benzoate 3.5 parts;

††††† (25) TEST-ESTRO Cypionates, vial, NDC number 0536-9470: testosterone cypionate 50 mg/ml, estradiol cypionate 2 mg/ml;

††††† (26) Testagen, vial, NDC number 55553-257: testosterone cypionate 50 mg/ml, estradiol cypionate 2 mg/ml;

††††† (27) Testoderm, 4 mg/d, patch, NDC number 17314-4608: testosterone 10 mg.;

††††† (28) Testoderm, 6 mg/d, patch, NDC number 17314-4609: testosterone 15 mg.;

††††† (29) Testoderm, with Adhesive, 4 mg/d, patch, export only: testosterone 10 mg;

††††† (30) Testoderm, with Adhesive, 6 mg/d, patch, NDC number 17314-2836: testosterone 15 mg.;

††††† (31) Testoderm, in-process film, sheet: testosterone 0.25 mg/cm≤;

††††† (32) Testoderm, with Adhesive, in-process film, sheet: testosterone 0.25 mg/cm≤;

††††† (33) Testosterone Cyp 50 Estradiol Cyp 2, vial, NDC number 0814-7737: testosterone cypionate 50 mg/ml, estradiol cypionate 2 mg/ml;

††††† (34) Testosterone Cypionate-Estradiol Cypionate Injection, vial, NDC number 54274-530: testosterone cypionate 50 mg/ml, estradiol cypionate 2 mg/ml;

††††† (35) Testosterone Cypionate-Estradiol Cypionate Injection, vial, NDC number 0182-3069: testosterone cypionate 50 mg/ml, estradiol cypionate 2 mg/ml;

††††† (36) Testosterone Cypionate-Estradiol Cypionate Injection, vial, NDC number 0364-6611: testosterone cypionate 50 mg/ml, estradiol cypionate 2 mg/ml;

††††† (37) Testosterone Cypionate-Estradiol Cypionate Injection, vial, NDC number 0402-0257: testosterone cypionate 50 mg/ml, estradiol cypionate 2 mg/ml;

††††† (38) Testosterone Enanthate-Estradiol Valerate Injection, vial, NDC number 0182-3073: testosterone enanthate 90 mg/ml, estradiol valerate 4 mg/ml;

††††† (39) Testosterone Enanthate-Estradiol Valerate Injection, vial, NDC number 0364-6618: testosterone enanthate 90 mg/ml, estradiol valerate 4 mg/ml;

††††† (40) Testosterone Enanthate-Estradiol Valerate Injection, vial, NDC number 0402-0360: testosterone enanthate 90 mg/ml, estradiol valerate 4 mg/ml;

††††† (41) Testosterone Ophthalmic Solutions, ophthalmic solutions: testosterone £0.6%w/v;

††††† (42) Tilapia Sex Reversal Feed (Investigational), Rangen, Inc., plastic bags: methyltestosterone 60 mg/kg fish feed; and

††††† (43) Tilapia Sex Reversal Feed (Investigational), Zeigler Brothers, Inc, plastic bags: methyltestosterone 60 mg/kg fish feed. (19 Ky.R. 2207; eff. 4-21-93; Am. 21 Ky.R. 1395; eff. 1-9-95; 23 Ky.R. 3986; eff. 7-16-97; 26 Ky.R. 907; 1174; eff. 12-15-99; 29 Ky.R. 820; 1278; eff. 10-16-02.)