CABINET FOR HEALTH AND FAMILY SERVICES

Office of Inspector General

Division of Audits and Investigations

(Amended After Comments)

 

      902 KAR 55:045. Exempt prescription products.

 

      RELATES TO: KRS 218A.020-218A.250[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 and Family Services, the Cabinet for Health and Family Services may similarly control the substance under KRS Chapter 218A by administrative regulation. This administrative regulation exempts prescription products from the licensing, distribution, recordkeeping, and reporting provisions of KRS Chapter 218A if the products have received approval as an exempt prescription product pursuant to 21 C.F.R. 1308.32[from the provisions of KRS Chapter 218A that stimulant or depressant products have been exempted pursuant to federal regulation].

 

      Section 1. Exempt Prescription Products. (1) Except as provided by [for] subsection (2) of this section, the Cabinet for Health and Family Services exempts prescription products from the licensing, distribution, recordkeeping, and reporting provisions of KRS 218A.150 – 218A.172, 218A.180, 218A.200, and 218A.202 if the products have received approval as exempt prescription products pursuant to 21 C.F.R. 1308.32.

      (2) All products containing butalbital shall:

      (a) Be reported to the Kentucky All-Schedule Prescription Electronic Reporting System in accordance with the requirements established in 902 KAR 55:110; and

      (b) Not be exempt from the licensing, distribution, and recordkeeping provisions of KRS 218A.150 – 218A.172, 218A.180, and 218A.200[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].

 

MARYELLEN B. MYNEAR, Inspector General

AUDREY TAYSE HAYNES,      Secretary

      APPROVED BY AGENCY: July 8, 2014

      FILED WITH LRC: July 9, 2014 at 4 p.m.

      CONTACT PERSON: Tricia Orme, Office of Legal Services, 275 East Main Street 5 W-B, Frankfort, Kentucky 40621, phone (502) 564-7905, fax (502) 564-7573, email tricia.orme@ky.gov.

 

REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT

 

Contact Persons: Maryellen B. Mynear, Stephanie Hold, Stephanie Brammer-Barnes

      (1) Provide a brief summary of:

      (a) What this administrative regulation does: This administrative regulation exempts prescription products from the licensing, distribution, and recordkeeping provisions of KRS Chapter 218A if the products have been exempted by the Drug Enforcement Administration (DEA) from the application of certain provisions of the federal Controlled Substances Act pursuant to 21 C.F.R. 1308.32.

      (b) The necessity of this administrative regulation: This administrative regulation is necessary to exempt certain prescription products from the licensing, distribution, and recordkeeping provisions of KRS Chapter 218A.

      (c) How this administrative regulation conforms to the content of the authorizing statutes: This administrative regulation conforms to the content of KRS 218A.020 by establishing Kentucky’s exempt prescription products.

      (d) How this administrative regulation currently assists or will assist in the effective administration of the statutes: This administrative regulation assists in the effective administration of the statutes by establishing Kentucky’s exempt prescription products.

      (2) If this is an amendment to an existing administrative regulation, provide a brief summary of:

      (a) How the amendment will change this existing administrative regulation: This amended after comments regulation deletes the obsolete list of exempt prescription products in Kentucky and adds language to clarify that prescription products which are exempt from the licensing, distribution, recordkeeping, and reporting provisions of KRS Chapter 218A shall be the same products that have received approval from the DEA for exemption from the application of certain provisions of the federal Controlled Substances Act pursuant to 21 C.F.R. 1308.32. Further, in response to concerns raised by the Kentucky Board of Pharmacy regarding butalbital, the amended after comments regulation clarifies that all products containing butalbital shall be reported to the Kentucky All Schedule Prescription Electronic Reporting (KASPER) System and not be exempt from the provisions of this administrative regulation.

      (b) The necessity of the amendment to this administrative regulation: This amended after comments regulation is necessary to ensure consistency between state and federal regulations which exempt certain prescription products from the licensing, distribution, recordkeeping, and reporting provisions of the state and federal Controlled Substances Acts.

      (c) How the amendment conforms to the content of the authorizing statutes: This amended after comments regulation conforms to the content of the authorizing statutes by ensuring consistency between state and federal regulations related to exempt prescription products.

      (d) How the amendment will assist in the effective administration of the statutes: This amended after comments regulation assists in the effective administration of the statutes by ensuring consistency between this administrative regulation and 21 C.F.R 1308.32.

      (3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation: This administrative regulation affects Kentucky’s pharmacists who rely on state and federal regulations for information regarding exempt prescription products.

      (4) Provide an analysis of how the entities identified in question (3) will be impacted by either the implementation of this administrative regulation, if new, or by the change, if it is an amendment, including:

      (a) List the actions that each of the regulated entities identified in question (3) will have to take to comply with this administrative regulation or amendment: Under this amendment and amended after comments regulation, Kentucky’s pharmacists will use the DEA’s most current Exempt Prescription Products List to ensure compliance with both this administrative regulation and federal regulations.

      (b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3): No costs will be incurred by any pharmacies for compliance with this amendment.

      (c) As a result of compliance, what benefits will accrue to the entities identified in question (3): By making Kentucky’s exempt prescription products list consistent with the DEA’s exempt prescription products list, this amendment reduces confusion for pharmacists who rely on state and federal regulations for such information.

      (5) Provide an estimate of how much it will cost the administrative body to implement this administrative regulation:

      (a) Initially: No costs are necessary to implement this amendment.

      (b) On a continuing basis: No costs are necessary to implement this amendment.

      (6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation: No additional funding is necessary to implement this administrative regulation.

      (7) Provide an assessment of whether an increase in fees or funding will be necessary to implement this administrative regulation, if new, or by the change if it is an amendment: No fees or funding will be necessary to implement this administrative regulation.

      (8) State whether or not this administrative regulation established any fees or directly or indirectly increased any fees: This administrative regulation does not establish or increase any fees.

      (9) TIERING: Is tiering applied? Tiering is not applicable as compliance with this administrative regulation applies equally to all individuals or entities who elect to be regulated by it.

 

FISCAL NOTE ON STATE OR LOCAL GOVERNMENT

 

      1. What units, parts or divisions of state or local government (including cities, counties, fire departments, or school districts) will be impacted by this administrative regulation? This administrative regulation affects Kentucky’s pharmacists who rely on state and federal regulations for information regarding exempt prescription products.

      2. Identify each state or federal statute or federal regulation that requires or authorizes the action taken by the administrative regulation. KRS 218A.020, 21 C.F.R. 1308.31-1308.32

      3. Estimate the effect of this administrative regulation on the expenditures and revenues of a state or local government agency (including cities, counties, fire departments, or school districts) for the first full year the administrative regulation is to be in effect.

      (a) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for the first year? This amendment will not generate additional revenue for state or local government during the first year.

      (b) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for subsequent years? This amendment will not generate additional revenue for state or local government during subsequent years.

      (c) How much will it cost to administer this program for the first year? No additional costs are necessary to administer this program during the first year.

      (d) How much will it cost to administer this program for subsequent years? No additional costs are necessary to administer this program for subsequent years.

      Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.

      Revenues (+/-):

      Expenditures (+/-):

      Other Explanation

 

FEDERAL MANDATE ANALYSIS COMPARISON

 

      1. Federal statute or regulation constituting the federal mandate.

21 C.F.R. 1308.31-1308.32

      2. State compliance standards. KRS 218A.020(3)

      3. Minimum or uniform standards contained in the federal mandate. 21 C.F.R. 1308.31 provides an application procedure whereby any person may      apply for exemption for nonnarcotic prescription products which meet certain      criteria. 21 C.F.R. 1308.31(a) further states that any person seeking to have any compound, mixture, or preparation containing any nonnarcotic controlled substance listed in 21 C.F.R. 1308.12(e), or in 21 C.F.R. 1308.13(b) or (c), or in 21 C.F.R. 1308.14, or in 21 C.F.R. 1308.15, exempted from application of all or any part of the federal Controlled Substances Act may apply to the Administrator of DEA for such exemption. 21 C.F.R. 1308.32 provides for a list of "exempted prescription products", which are prescription drugs that contain certain nonnarcotic controlled substances yet are exempt from certain provisions of the federal Controlled Substances Act.

      4. Will this administrative regulation impose stricter requirements, or additional or different responsibilities or requirements, than those required by the federal mandate? This administrative regulation does not impose stricter requirements that those required by federal mandate.

      5. Justification for the imposition of the stricter standard, or additional or different responsibilities or requirements. Not applicable.