902 KAR 55:045. Exempt prescription products.

 

      RELATES TO: KRS 218A.020-218A.130, 21 C.F.R. 1308.31-1308.32

      STATUTORY AUTHORITY: KRS 194A.030, 194A.050, 211.090, 218A.020, 218A.250

      NECESSITY, FUNCTION, AND CONFORMITY: KRS 218A.020(3) provides that if a controlled substance is designated, rescheduled, or deleted as a controlled substance under federal law and notice is given to the Cabinet for Health Services, the Cabinet for Health Services may similarly control the substance under KRS Chapter 218A by administrative regulation. This administrative regulation exempts from the provisions of KRS Chapter 218A that stimulant or depressant products have been exempted pursuant to federal regulation.

 

      Section 1. Exempt Prescription Products. The Cabinet for Health Services exempts the following prescription products from the provisions of KRS 218A.150 - 218A.180 and 218A.200:

      (1) Acetaminophen 325mg/Butalbital 50 mg, tablet, NDC 00456-0674: butalbital 50 mg;

      (2) Acetaminophen 500mg/Butalbital 50 mg, tablet, NDC 00456-0671: butalbital 50 mg;

      (3) ALAGESIC Tablets, tablet, NDC 55726-0300: butalbital 50 mg;

      (4) Alkaloids of Belladonna and Phenobarbital, tablet, NDC 00377-0527: phenobarbital 16.20 mg;

      (5) Amaphen Capsules (reformulated), capsule, NDC 11311-0954: butalbital 50 mg;

      (6) Aminophylline and Phenobarbital, enteric coated tablet, NDC 00115-2156: phenobarbital 15 mg;

      (7) Aminophylline and Phenobarbital Tablets, tablet, NDC 00115-2154: phenobarbital 15 mg;

      (8) Anaspaz PB, tablet, NDC 00225-0300: phenobarbital 15 mg;

      (9) Anolor 300 Capsules, capsule, NDC 51674-0009: butalbital 50 mg;

      (10) Anoquan Modified Formula, capsule, NDC 00166-0881: butalbital 50 mg;

      (11) Anti-Spas Elixir, elixir, NDC 00719-4090: phenobarbital 3.24 mg/ml;

      (12) Anti-Spas Tablets, tablet, NDC 00719-1091: phenobarbital 16.20 mg;

      (13) Antispas, tablet, NDC 00377-0622: phenobarbital 16.20 mg;

      (14) Antispasmodic, tablet, NDC 00364-0020: phenobarbital 16 mg;

      (15) Antispasmodic, tablet, NDC 00367-4118: phenobarbital 16.20 mg;

      (16) Antispasmodic, tablet, NDC 03547-0777: phenobarbital 16.20 mg;

      (17) Antispasmodic Elixir, elixir, NDC 00182-0686: phenobarbital 3.24 mg/ml;

      (18) Antispasmodic Elixir, elixir, NDC 00364-7002: phenobarbital 3.20 mg/ml;

      (19) Antispasmodic Elixir, elixir, NDC 00832-8009: phenobarbital 3.24 mg/ml;

      (20) Antispasmodic Tablets, tablet, NDC 00182-0129: phenobarbital 16.20 mg;

      (21) Antispasmodic Tablets, tablet, NDC 47679-0158: phenobarbital 16.2 mg;

      (22) Antispasmodic Tablets, tablet, NDC 00839-5055: phenobarbital 16 mg;

      (23) Antrocol, capsule, NDC 00095-0041: phenobarbital 16 mg;

      (24) Antrocol Elixir, elixir, NDC 00095-0042: phenobarbital 3 mg/ml;

      (25) Antrocol Tablets, tablet, NDC 00095-0040: phenobarbital 16 mg;

      (26) Arco-Lase Plus, tablet, NDC code 00275-0045: phenobarbital 8 mg;

      (27) Atropine Sulfate with Phenobarbital, tablet, NDC 00463-6035: phenobarbital 15 mg;

      (28) Axotal, tablet, NDC 00013-1301: butalbital 50 mg;

      (29) Azpan, tablet, NDC 00172-3747: phenobarbital 8 mg;

      (30) B-A-C Tablets, tablet, NDC 00259-1256: butalbital 50 mg;

      (31) Bancap, capsule, NDC 00456-0546: butalbital 50 mg;

      (32) Barbeloid (Revised) Green, tablet, NDC 00377-0365: phenobarbital 16.20 mg;

      (33) Barbeloid Yellow, tablet, NDC 00377-0498: phenobarbital 16.20 mg;

      (34) Barbidonna Elixir, elixir, NDC 00037-0305: phenobarbital 3.20 mg/ml;

      (35) Barbidonna No 2, tablet, NDC 00037-0311: phenobarbital 32 mg;

      (36) Barbidonna Tablets, tablet, NDC 00037-0301: phenobarbital 16 mg;

      (37) Barophen, elixir, NDC 00472-0981: phenobarbital 3.24 mg/ml;

      (38) Bel-phen-ergot s Tablets, tablet, NDC 00182-1847: phenobarbital 40 mg;

      (39) Bel-Phen-Ergot-S Tablets, tablet, NDC 00719-1686: phenobarbital 40 mg;

      (40) Bel-Tabs, tablet, NDC 00677-1171: phenobarbital 40 mg;

      (41) Belladenal, tablet, NDC 00078-0028: phenobarbital 50 mg;

      (42) Belladenal-S, sustained release tablet, NDC 00078-0027: phenobarbital 50 mg;

      (43) Belladonna Alkaloids with Phenobarbital, elixir, NDC 00179-0045: phenobarbital 3.24 mg/ml;

      (44) Belladonna Alkaloids with Phenobarbital, elixir, NDC 00737-1283: phenobarbital 3 mg/ml;

      (45) Belladonna Alkaloids with Phenobarbital, tablet, NDC 51079-0168: phenobarbital 16.20 mg;

      (46) Belladonna Alkaloids and Phenobarbital, tablet, NDC 00143-1140: phenobarbital 16.20 mg;

      (47) Bellalphen, tablet, NDC 00223-0425: phenobarbital 16.20 mg;

      (48) Bellamine Tablets, tablet, NDC 00904-2548: phenobarbital 40 mg;

      (49) Bellamor Tablets, tablet, NDC 00839-7370: phenobarbital 40 mg;

      (50) Bellergal-S, sustained release tablet, NDC 00078-0031: phenobarbital 40 mg;

      (51) Bellophen, tablet, NDC 00115-2400: phenobarbital 16.20 mg;

      (52) Bilezyme Plus, tablet, NDC 00249-1112: phenobarbital 8 mg;

      (53) Bladder Mixture Plus Phenobarbital, liquid, NDC 11326-1624: phenobarbital 2.92 mg/ml;

      (54) Blue Cross Butalbital, APAP and Caffeine Tablets, tablet, NDC 00879-0567: butalbital 50 mg;

      (55) Broncholate, capsule, NDC 00563-0277: phenobarbital 8 mg;

      (56) Broncomar, elixir, NDC 12939-0128: butabarbital 1 mg/ml;

      (57) Bucet Capsules, capsule, NDC 00785-2307: butalbital 50 mg;

      (58) Bucet Tablets, tablet, NDC 00785-2307: butalbital 50 mg;

      (59) Butace, capsule, NDC code 00539-0906: butabarbital 50 mg;

      (60) Butacet Capsules, capsule, NDC 53121-0133: butalbital 50 mg;

      (61) Butalbital, Acetaminophen and Caffeine Capsules, capsule, NDC 46672-0228: butalbital 50 mg;

      (62) Butalbital, Acetaminophen and Caffeine Tablets, tablet, NDC 52555-0079: butalbital 50 mg;

      (63) Butalbital, Acetaminophen and Caffeine Tablets, tablet, NDC 54696-0513: butalbital 50 mg

      (64) Butalbital, Acetaminophen and Caffeine Tablets, tablet, NDC 00302-0490: butalbital 50 mg;

      (65) Butalbital, Acetaminophen and Caffeine Tablets, tablet, NDC 46672-0053: butalbital 50 mg;

      (66) Butalbital, Acetaminophen and Caffeine Tablets, tablet, NDC 46672-0059: butalbital 50 mg;

      (67) Butalbital, Acetaminophen and Caffeine Tablets, tablet, NDC 00832-1102: butalbital 50 mg;

      (68)Butalbital, Acetaminophen and Caffeine Tablets, tablet, NDC 52446-0544: butalbital 50 mg;

      (69) Butalbital and Acetaminophen Tablets, tablet, NDC 00879-0543: butalbital 50 mg;

      (70) Butalbital and Acetaminophen Tablets 50/325, tablet, NDC 46672-0099: butalbital 50 mg;

      (71) Butalbital and Acetaminophen Tablets 50/650, tablet, NDC 46672-0098: butalbital 50 mg;

      (72) Butalbital, APAP and Caffeine, tablet, NDC 00302-0490: butalbital 50 mg;

      (73) Butalbital, APAP and Caffeine Tablets, tablet, NDC 00182-1274: butalbital 50 mg;

      (74) Butalbital Compound Capsules, capsule, NDC 53506-0103: butalbital 50 mg;

      (75) Butalbital with Acetaminophen and Caffeine Tablets, tablet, NDC 00143-1787: butalbital 50 mg;

      (76) Butibel Elixir, elixir, NDC 00037-0044: butabarbital sodium 3 mg/ml;

      (77) Butibel Tablets, tablet, NDC 00037-0046: butabarbital sodium 15 mg;

      (78) Cafatine-PB Tablets, tablet, NDC 00904-1750: pentobarbital sodium 30 mg;

      (79) Cafergot P-B Suppository, suppository, NDC 00078-0035: pentobarbital 60 mg;

      (80) Cafergot P-B Tablets, tablet, NDC 00078-0036: pentobarbital sodium 30 mg;

      (81) C.D.P. Plus Capsules, capsule, NDC 00182-1856: chlordiazepoxide HCl 5 mg;

      (82) Cephadyn, tablet, NDC 95702-0650: butalbital 50 mg.;

      (83) Charspast, tablet, NDC 00377-0500: phenobarbital 16.20 (83) mg;

      (84) Chlordiazepoxide HCl and Clidinium Br., capsule, NDC 57247-1003: chlordiazepoxide 5 mg;

      (85) Chlordiazepoxide HCl 5 mg and Clidinium BR 2.5 mg, capsule, NDC 52446-0096: chlordiazepoxide HCL 5 mg;

      (86) Chlordiazepoxide Hydrochloride + Clidinium Bromide, capsule, NDC 47679-0268: chlordiazepoxide HCl 5 mg;

      (87) Chlordiazepoxide with Clidinium Bromide, capsule, NDC 46193-0948: chlordiazepoxide HCl 5 mg;

      (88) Chlordinium, capsule, NDC 00719-1208: chlordiazepoxide HCl 5 mg;

      (89) Chlordinium Sealets, capsule, NDC 00580-0084: chlordiazepoxide HCl 5 mg;

      (90) Clindex, capsule, NDC 00536-3490: chlordiazepoxide HCL 5 mg;

      (91) Clinibrax Capsules, capsule, NDC 00832-1054: chlordiazepoxide HCl 5 mg;

      (92) Clinoxide, capsule, NDC 00879-0501: chlordiazepoxide HCl 5 mg;

      (93) CON-TEN, capsule, NDC 11584-1029: butalbital 50 mg;

      (94) Digestokraft, tablet, NDC 00796-0237: butabarbital sodium 8 mg;

      (95) Digestokraft, tablet, NDC 00377-0460: butabarbital sodium 8 mg;

      (96) Dilantin with Phenobarbital 1/2,capsule, NDC 00071-0531: phenobarbital 32 mg;

      (97) Dilantin with Phenobarbital 1/4, capsule, NDC 00071-0375: phenobarbital 16 mg;

      (98) Dolmar, capsule, NDC 12939-0812: butalbital 50 mg;

      (99) Donalixir, elixir, NDC 00471-0095: phenobarbital 3.24 mg/ml;

      (100) Donna-Sed, elixir, NDC 00298-5054: phenobarbital 3.24 mg/ml;

      (101) Donnatal Capsules, capsule, NDC 00031-4207: phenobarbital 16.20 mg;

      (102) Donnatal Elixir, elixir, NDC 00031-4221: phenobarbital 3.24 mg/ml;

      (103) Donnatal Extentabs, sustained release tablet, NDC 00031-4235: phenobarbital 48.60 mg;

      (104) Donnatal No 2, tablet, NDC 00031-4264: phenobarbital 32.40 mg;

      (105) Donnatal Tablets, tablet, NDC 00031-4250: phenobarbital 16.20 mg;

      (106) Donnazyme, enteric coated tablet, NDC 00031-4649: phenobarbital 8.10 mg;

      (107) Donphen, tablet, NDC 00093-0205: phenobarbital 15 mg;

      (108) E-Caff PB Tablets, tablet, NDC 00185-0982: pentobarbital 30 mg;

      (109) Endolar, capsule, NDC 00588-7777: butalbital 50 mg;

      (110) Ephedrine and Sodium Phenobarbital, tablet, NDC 00377-0109: phenobarbital sodium 16.20 mg;

      (111) Ephedrine with Phenobarbital, tablet, NDC 00463-6086: phenobarbital 15 mg;

      (112) EQUI-CET Tablets, tablet, NDC 57779-0111: butalbital 50 mg;

      (113) Ergocaff-PB Tablets, tablet, NDC 00536-3801: pentobarbital sodium 30 mg;

      (114) Esgic Capsules, capsule, NDC 00456-0631: butalbital 50 mg;

      (115) ESGIC-PLUS, NDC 00456-0676, tablet, contains butalbital 50 mg;

      (116) Esgic Tablets, tablet, NDC 0456-0630: butalbital 50 mg;

      (117) Espasmotex, tablet, NDC code 11475-0835: phenobarbital 20 mg;

      (118) Ezol, capsule, NDC 45985-0578: butalbital 50 mg;

      (119) Fabophen Tablets, tablet, NDC 00904-3280: butalbital 50 mg;

      (120) Febridyne Plain Capsules, capsule, NDC 05383-0001: butalbital 50 mg;

      (121) FEMCET Capsules, capsule, NDC 50474-0703: butalbital 50 mg;

      (122) Fioricet, capsule, NDC 00078-0084: butalbital 50 mg;

      (123) G-1 Capsules, capsule, NDC 43797-0244: butalbital 50 mg;

      (124) G.B.S., tablet, NDC 00456-0281: phenobarbital 8 mg;

      (125) Gustase Plus, tablet, NDC 00249-1121: phenobarbital 8 mg;

      (126) Hybephen, tablet, NDC 00029-2360: phenobarbital 15 mg;

      (127) Hyosital White, tablet, NDC 00361-2131: phenobarbital 16.20 mg;

      (128) Hyosophen Capsules, capsule, NDC 00536-3926: phenobarbital 16 mg;

      (129) Hyosophen Tablets, tablet, NDC 00536-3920: phenobarbital 16.20 mg;

      (130) Hypnaldyne, tablet, NDC 00298-1778: phenobarbital 16.20 mg;

      (131) Hytrophen, tablet, NDC 00917-0244: phenobarbital 16.20 mg;

      (132) IDE-Cet Tablets, tablet, NDC 00814-3820: butalbital 50 mg;

      (133) ISOCET Tablets, tablet, NDC 00536-3951: butalbital 50 mg;

      (134) Isolate Compound, elixir, NDC 00472-0929: phenobarbital 0.40 mg/ml;

      (135) Isolate Compound Elixir, elixir, NDC 00364-7029: phenobarbital 0.40 mg/ml;

      (136) Isopap Capsules, capsule, NDC 11735-0400: butalbital 50 mg;

      (137) Isophed, liquid, NDC 00298-5680: phenobarbital 0.40 mg/ml;

      (138) Isuprel, elixir, NDC 00024-0874: phenobarbital 0.40 mg/ml;

      (139) Isuprel Compound, elixir, NDC 00057-0874: phenobarbital 0.40 mg/ml;

      (140) Kinesed, tablet, NDC 00038-0220: phenobarbital 16 mg;

      (141) Levsin with Phenobarbital Elixir, elixir, NDC 00091-4530: phenobarbital 3 mg/ml;

      (142) Levsin with Phenobarbital Tablets, tablet, NDC 00091-3534: phenobarbital 15 mg;

      (143) Levsin-PB, drops, NDC 00091-4536: phenobarbital 15 mg/ml;

      (144) Levsinex with Phenobarbital, sustained release capsule, NDC 00091-3539: phenobarbital 45 mg;

      (145) Librax, capsule, NDC 00140-0007: chlordiazepoxide HCl 5 mg;

      (146) Lufyllin-EPG Elixir, elixir, NDC 00037-0565: phenobarbital 1.60 mg/ml;

      (147) Lufyllin-EPG Tablets, tablet, NDC 00037-0561: phenobarbital 16 mg;

      (148) Malatal, tablet, NDC 00166-0748: phenobarbital 16.20 mg;

      (149) Margesic Capsules, capsule, NDC 00682-0804: butalbital 50 mg;

      (150) Medigesic Tablets, tablet, NDC 52747-0311: butalbital 50 mg;

      (151) Menrium 5-2, tablet, NDC 00140-0023: chlordiazepoxide 5 mg;

      (152) Menrium 5-4, tablet, NDC 00140-0024: chlordiazepoxide 5 mg;

      (153) Menrium 10-4, tablet, NDC 00140-0025: chlordiazepoxide 10 mg;

      (154) Micomp-PB Tablets, tablet, NDC 55053-0525: pentobarbital sodium 30 mg;

      (155) Milprem-200, tablet, NDC 00037-5501: meprobamate 200 mg;

      (156) Milprem-400, tablet, NDC 00037-5401: meprobamate 400 mg;

      (157) Mudrane, tablet, NDC 00095-0050: phenobarbital 8 mg;

      (158) Mudrane GG Elixir, elixir, NDC 00095-0053: phenobarbital 0.50 mg/ml;

      (159) Mudrane GG Tablets, tablet, NDC 00095-0051: phenobarbital 8 mg;

      (160) Pacaps Capsules, capsule, NDC 10892-0116: butalbital 50 mg;

      (161) Pacaps Modified Formula, capsule, NDC 48534-0884: butalbital 50 mg;

      (162) Panzyme, tablet, NDC 00377-0491: phenobarbital 8.10 mg;

      (163) Panzyme, tablet, NDC 00314-0310: phenobarbital 8.10 mg;

      (164) PB Phe-Bell, tablet, NDC 12908-7006: phenobarbital 16.20 mg;

      (165) Phedral C.T., tablet, NDC 00298-1173: phenobarbital 8.10 mg;

      (166) Phenerbel-S Tablets, tabelt, NDC 00536-4234: phenobarbital 40 mg;

      (167) Phenobarbital, Ergotamine and Belladonna Tablets, tablet, NDC 00781-1701: phenobarbital 40 mg;

      (168) Phenobarbital and Hyoscyamine Sulfate, tablet, NDC 00764-2057: phenobarbital 16.20 mg;

      (169) Phrenilin, tablet, NDC 00086-0050: butalbital 50 mg;

      (170) Phrenilin Forte, capsule, NDC 00086-0056: butalbital 50 mg;

      (171) PMB-200, tablet, NDC 00046-0880: meprobamate 200 mg;

      (172) PMB-400, tablet, NDC 00046-0881: meprobamate 400 mg;

      (173) Private Formula No 3095, tablet, NDC 00252-3095: phenobarbital sodium 15 mg;

      (174) Pulsaphen, tablet, NDC 00377-0652: phenobarbital 15 mg;

      (175) Pulsaphen Gray, tablet, NDC 00917-0113: phenobarbital 15 mg;

      (176) Quadrinal Suspension, suspension, NDC 00044-4580: phenobarbital 2.40 mg/ml;

      (177) Quadrinal Tablets, tablet, NDC 00044-4520: phenobarbital 24 mg;

      (178) Quibron Plus Capsules, capsule, NDC 00087-0518: butabarbital 20 mg;

      (179) Quibron Plus Elixir, elixir, NDC 00087-0511: butabarbital 1.33 mg/ml;

      (180) Repan Capsules, capsule, NDC 00642-0163: butalbital 50 mg;

      (181) Repan Tablets, tablet, NDC 00642-0162: butalbital 50 mg;

      (182) Rexatal Tablets, tablet, NDC 00478-5477: phenobarbital 16.52 mg;

      (183) Rogesic Capsules, capsule, NDC 31190-0008: butalbital 50 mg;

      (184) Sangesic, tablet, NDC 00511-1627: butalbital 30 mg;

      (185) Sedapap-10 Tablets, tablet, NDC 00259-1278: butalbital 50 mg;

      (186) Sedapar Elixir, elixir, NDC 00349-4100: phenobarbital 3.24 mg/ml;

      (187) Sedapar Tablets, tablet, NDC 00349-2355: phenobarbital 16.20 mg;

      (188) Sedarex No 3, tablet, NDC 00144-1575: phenobarbital 16.20 mg;

      (189) Seds, tablet, NDC 00418-4072: phenobarbital 16.20 mg;

      (190) Soniphen, enteric coated tablet, NDC 0456-0429: phenobarbital 16 mg;

      (191) Spaslin, tablet, NDC 00165-0029: phenobarbital 16.20 mg;

      (192) Spasmalones, tablet, NDC 00653-0002: phenobarbital 16 mg;

      (193) Spasmolin, tablet, NDC 00115-4652: phenobarbital 15 mg;

      (194) Spastemms Elixir, elixir, NDC 00463-9023: phenobarbital 3.24 mg/ml;

      (195) Spastemms Tablets, tablet, NDC 0463-6181: phenobarbital 15 mg;

      (196) Spastolate, tablet, NDC 00814-7088: phenobarbital 16.20 mg;

      (197) Spastrin Tablets, tablet, NDC 54580-0124: phenobarbital 40 mg;

      (198) Susano, elixir, NDC 00879-0059: phenobarbital 3.24 mg/ml;

      (199) Susano, tablet, NDC 00879-0058: phenobarbital 16.20 mg;

      (200) Tedral SA, sustained release tablet, NDC 00071-0231: phenobarbital 25 mg;

      (201) Tencet, tablet, NDC 47649-0370: butalbital 50 mg;

      (202) Tencet Capsules, capsule, NDC 47649-0560: butalbital 50 mg;

      (203) T-E-P, tablet, NDC 00364-0266: phenobarbital 8.10 mg;

      (204) T.E.P., tablet, NDC 00157-0980: phenobarbital 8 mg;

      (205) Theodrine Tablets, tablet, NDC 00536-4648: phenobarbital 8 mg;

      (206) Theophen, tablet, NDC code 12634-0101: phenobarbital 8 mg;

      (207) Theophenyllin, tablet, NDC 00839-5111: phenobarbital 8 mg;

      (208) Theophylline Ephedrine and Phenobarbital, tablet, NDC 00143-1695: phenobarbital 8 mg;

      (209) Triad, tablet, NDC 00785-2306: butalbital 50 mg;

      (210) Triad Capsules, capsule, NDC 00785-2305: butalbital 50 mg;

      (211) Triaprin, capsule, NDC 00217-2811: butalbital 50 mg;

      (212) Truxaphen, tablet, NDC 00377-0541: phenobarbital 16.20 mg;

      (213) Two-Dyne Revised, tablet, NDC 00314-2229: butalbital 50 mg;

      (214) Wescophen-S, tablet, NDC 00917-0135: phenobarbital 30 mg;

      (215) Wescophen S-II, tablet, NDC 00377-0628: phenobarbital 30 mg;

      (216) Wesmatic Forte, tablet, NDC 00917-0845: phenobarbital 8 mg;

      (217) Wesmatic Forte, tablet, NDC 00377-0426: phenobarbital 8.10 mg; and

      (218) Zebutal, capsule, NDC 59630-0170: butalbital 50. (Recodified from 901 KAR 1:041, 4-14-82; Am. 11 Ky.R. 1680; eff. 6-4-85; 18 Ky.R. 1472; eff. 2-7-92; 19 Ky.R. 1666; 2251; eff. 3-17-93; 20 Ky.R. 864; eff. 12-6-93; 21 Ky.R. 1394; eff. 1-9-95; 23 Ky.R. 4228; eff. 7-16-97; 25 Ky.R. 629; 1631; eff. 1-19-99; 26 Ky.R. 903; 1171; eff. 12-15-99.)