Pharmacy Law, 1979 PHARMACY (POISONS AND

CAYMAN ISLANDS Pharmacy Law, 1979 PHARMACY (POISONS AND RESTRICTED PHARMACEUTICALS) REGULATIONS (2017 Revision) Supplement No. 24 published with Extraordinary Gazette No. 45 of 31st May, 2017. PUBLISHING DETAILS The Pharmacy (Poisons and Restricted Pharmaceuticals) Regulations, 1981 made the 8th December, 1981consolidated with the Pharmacy (Poisons and Restricted Pharmaceuticals) (Amendment) Regulations, 2016 made the 9th August, 2016. Revised under the authority of the Law Revision Law (1999 Revision). Consolidated and revised this 1st day of May, 2017. Note ( note forming part of the Regulations): This revision replaces the 1999 Revision which should now be discarded. Page 2 Revised as at 1st day of May, 2017 c Pharmacy (Poisons and Restricted Pharmaceuticals) Regulations Arrangement of Regulations CAYMAN ISLANDS Pharmacy Law, 1979 PHARMACY (POISONS AND RESTRICTED PHARMACEUTICALS) REGULATIONS (2017 Revision) Arrangement of Regulations Regulation Page 1. Citation ......................................................................................................................................5 2. Poisons......................................................................................................................................5 3. Restricted pharmaceuticals ........................................................................................................5 SCHEDULE 1 7 Poisons 7 SCHEDULE 2 8 Restricted Pharmaceuticals 8 c Revised as at 1st day of May, 2017 Page 3 Pharmacy (Poisons and Restricted Pharmaceuticals) Regulations Regulation 1 CAYMAN ISLANDS Pharmacy Law, 1979 PHARMACY (POISONS AND RESTRICTED PHARMACEUTICALS) REGULATIONS (2017 Revision) 1. Citation 1. These Regulations may be cited as the Pharmacy (Poisons and Restricted Pharmaceuticals) Regulations (2017 Revision). 2. Poisons 2. The chemical substances prescribed in Schedule 1 hereto are poisons for the purposes of the Law. 3. Restricted pharmaceuticals 3. The pharmaceuticals prescribed in Schedule 2 hereto are restricted pharmaceuticals for the purposes of the Law. c Revised as at 1st day of May, 2017 Page 5 Pharmacy (Poisons and Restricted Pharmaceuticals) Regulations SCHEDULE 1 SCHEDULE 1 regulation 2 Poisons Aldrin Arsensical substances Arsenious oxide Arsenic sulphides Calcium arsenates Calcium arsenites Copper acetoarsenite Copper arsenates Copper arsenites Lead arsenates Sodium arsenates Sodium thioarsanates Sodium arsenites Barium carbonate Dieldrin Dinitrocresols (DNOC): their compounds with a metal or a base Dinosam; its compound with a metal or a base. c Revised as at 1st day of May, 2017 Page 7 SCHEDULE 2 Pharmacy (Poisons and Restricted Pharmaceuticals) Regulations SCHEDULE 2 regulation 3 Restricted Pharmaceuticals Part I Acetanilide: alkyl acetanilides Acetohoexamide Acetylcarbronal Allylisopropylacetylurea Barbituric acid; its salts; derivatives of barbituric acid; their salts; compound of barbituric acid; its salts; its derivatives; their salts with any other substance Busulphan; its salts Cannabis extracts and tinctures of cannabis Demecarium bromide Digitalis and related substances or compounds Dinitrocresols (DNOC), their compounds with a metal or a base Dinitronaphthols; dinitrophenols; dinitrothynols Disulfuram Dithienylallylamines, dithienylalkylamines; their salts, except diethylthiambutene, dimethylthiambutene and ethylmethylthiambutene Fentanyl; its salts Gallamine; its salts; its quaternary compounds Mannomustine; its salts Mercaptopurine; its salts Mustine; and any N-substituted derivatives of di (2-cholorethyl) amine; their salts Phenacemide Phenylcinchoninic acid: salicylcinchoninic acid; their salts; their esters Polymethylenebistrimethylammonium salts Tretamine; its salts Tri-(1-aziridinyl)-1, 4 benzoquinone Amidopyrine; its salts; amidopyrine sulphonates; their salts-p-Aminoben- zenesulphonamide; its salts, derivatives of paminobenzenesulphonamide having any of the hydrogen atoms of the p-amino group or of the sulphonamide group substituted by another radical; their salts, except when contained in ointments or surgical dressings or in preparations for the prevention and treatment of diseases in poultry. Page 8 Revised as at 1st day of May, 2017 c Pharmacy (Poisons and Restricted Pharmaceuticals) Regulations SCHEDULE 2 B-Aminopropylbenzene and B-aminoispropylbenzene and any compound structurally derived from either of those substances by substitutions in the side chain or by ring closure therein (or by both such substitutions and closure), except ephedrine, N- methylephedrine, N-Diethylamineothylephedrine, phenylopropanolamine and prenalymine; any salt of any substance falling within this item Amitriptyline and other antidepressant compounds Androgenic, oestrogenic and progestational substances, the following- Benzoestrol Derivatives of stilbene, dibenzyl or naphthalene with oestrogenic activity; their esters Steroid compounds with androgenic or oestrogenic or progestational activity; their esters Azacyclonol; its salts Benactyzine; its salts Benzhexol; its salts Benztropine and its homologues; their salts Bronvaletone Captodiame; its salts Cabromal Carisoprodol Chloral; its addition and its condensation products; their molecular compounds Chlordiazepoxide; its salts 2-p-Chlorophynyl-3-Methylbutane-2; 3 diol Chlorothiazide and other derivatives of benzo-1,2,4 -thiadiazine-7 sulphonamide 1, 1- dioxide, whether hydrogenated or not Chlorphentermine; its salts Chlorphenoxamine Chlorpropamide; its salts Chlorprothixene Chlorthalidone Cyclarbamate Cycrimine (l-cyclopentyl-1-1-phenyl-3 piperidinopropran-0-01); its salts Desipramine; its salts Diazepam and related compounds Diphenoxlate and its salts contained in (a) pharmaceutical preparations in solid or liquid form containing not more than 2.5 millg. of diphenoxylate calculated as base and not less than 25 microgrammes of atropine calculated as atropine sulphate per dosage unit or (b) liquid preparation containing 0.5 milligrammes diphenoxylate hydrochloride, 0.005 millg. atropine sulphate, 0.16 millilitres ethyl alcohol, 0.002 millilitres imitation cherry flavour, 0.45 millilitres glycerine, 0.4 millilitres sorbital solution (70 per cent), 0.01 c Revised as at 1st day of May, 2017 Page 9 SCHEDULE 2 Pharmacy (Poisons and Restricted Pharmaceuticals) Regulations milligrammes red dye colour index No. 14700 (F.D. 4C. Red No. 4), 0.008 millilitres water. Ectylurea Emylcamate Ethchlorvynol Ethinamate Ethopheptazine; its salts Glutethimide; its salts Haloperidol Hexapropymate Hydrazines, benzyl phenethyl of phenoxy-ethyl; their a-methyl derivatives; acyl derivatives of any of the foregoing substances comprised in this item; salts of any compounds comprised in this item 4-hydroxymethyl-2, 2-disopropyl 1-1, 3-dioxalan Hydroxyzine; its salts Imipramine; its salts Mephenesin; its esters Meprobamate Metaxalone Metformin; its salts Methaqualone; its salts Methixene; its salts Methocarbamol Methosxalen Methylpentynol; its esters and other derivatives Methylprylone Modecate (Fluphenazine Decanoate) and related substances or compounds Nortryptyline; its salts Orphenadrine; its salts Oxethazaine Oxyphenbutazone and related compounds Paramethadione Pargyline; its salts Pemoline; its salts Phenaglycodol Page 10 Revised as at 1st day of May, 2017 c Pharmacy (Poisons and Restricted Pharmaceuticals) Regulations SCHEDULE 2 Phenbutrazate Phenetidylphenacetin Phenformin; its salts Phenothiazine, derivatives of: their salts, except dimethozanate, its salts and premethazine, its salts and molecular compounds Phenylbutezone; its salts 5-Phenylhydantoin; its alkyl and aryl derivatives; their salts Pituitary gland, the active principals of: except when containing preparation intended for external application only, or except in case of Lysinevasopressin or oxytocin, in inhalants Procyclidine; its salts Propranolol and related compounds Prothipendyl; its salts Quinethazone Rauwolfia, alkaloids of: their salts, derivates of the alkaloids of rauwolfia; their salts Styramate Sulphimpyrazone Sulphonal; alky sulphonals Suprarenal gland medulla, the active principles of; their salts except when contained in preparations intended for external application only or in inhalants, rectal preparations or preparations intended for use in the eye Syrosingopine Tetrabenazine; its salts Thyroid gland, the active principles of: their salts Tolbutamide Tribromethyl alcohol Trimipramine; its salts Troxidone Zoxazolamine; its salts 2,2,2 Trichloroethyl alcohol, esters of: their salts Part II Morphine and its salts, and any solution or dilution of morphine or its salts in an inert substance whether liquid or solid containing any proportion of morphine, and any preparation, admixture, extract or other substance (not being such solution or dilution as aforesaid) containing not less than one-fifth of one per cent morphine (calculated in respect of anhydrous morphine) c Revised as at 1st day of May, 2017 Page 11 SCHEDULE 2 Pharmacy (Poisons and Restricted Pharmaceuticals) Regulations Cocaine (including synthetic cocaine) and ecgonine and their respective salts, and any solution or dilution of cocaine or its salts in an inert substance, whether liquid or solid, containing any proportion of cocaine, and any preparation, admixture, extract or other substance (not being such a solution or dilution as aforesaid) containing not less than one- tenth of one per cent of cocaine or any proportion of ecgonine Acetyldihydrocodeinone Alphaprodine Alphameprodine Benzylmorphine Betameprodine Betaprodine Diethylthiambutene Dioxaphetyl butyrate (4-morpholino-2: 2-diphenyl ethyl butyrate) Didipanone Ethylmethylthiambutene Hydrocodone (also known as dihydrocodeinone or dicodide) Hyrdomorphone (also known as dihydromorphinone or dilaudide) Hydroxypethidine Isomethadone (also known as isoamidone) Ketobemidone Levomethorphan Levorphanol Methadol Methadone (also known as amidone) Methadyl acetate Methyldesomorphine (6-methyl-6-desoxymorphine) 1-Methyl-4-phenylpiperidine-4- carboxylic acid isopropyl ester Metopon (also known as methyldihydromorphinone) Morphine-N-oxide (also known as genormorphine) Normethadone Omnopon Osycodone (also known as dihydrohydroxcodeinone or eucodal) Pethidine (Demerol) Phenzdoxone Phenomorphan (3-hydroxy-N-phenethylmorphinan) Page 12 Revised as at 1st day of May, 2017 c Pharmacy (Poisons and Restricted Pharmaceuticals) Regulations SCHEDULE 2 Propoxyphene Racemethorphan Racemorphan Thebaine The esters of morphine (other than diacetylmorphine), ecogonine, Oxycodone, hydrocodone, hydromorphone, acetyldihydrocodeinone and dihydromorphine; the ethers of morphine (other than benzylmorphine, codeine, ethylmorphine and pholcodine); the morphine-N-oxide derivatives and any other pentavalent nitrogen morphine derivatives. Part III Amphotericin B Bacitracin Cephaloridine Cefoxitin Chloramphenicol Chloramphenicol and its salts Colistin Sulphate Cycloserine Erythromycin Framycetin Griseofulvin Kanamycin sulphate Lincomycin hydrochloride Neomycin Novobiocin Nystatin Paromomycin sulphate Penicillin G Benzyl penicillin sodium or potassium salt Procaine penicillin Fortified procaine, penicillin and other long-acting preparations Benzathine penicillin Phenoxymethyl penicillin Penicillin V, free base or potassium salt or calcium salt Phenbenicillin Phenoxybenzyl penicillin c Revised as at 1st day of May, 2017 Page 13 SCHEDULE 2 Pharmacy (Poisons and Restricted Pharmaceuticals) Regulations Phenethicillin potassium Cloxacillin sodium Methicillin sodium Ampicillin Polymyxin- B- sulphate Ristocetin Spectinomycin Spiramycin Streptomycin sulphate Streptomycin penicillin mixtures Dihydrostreptomycin Sulphomyxin sodium Tetracyclines Chlortetracycline Oxytetracyline Tetracycline Demethylchlortetracyline Lymecycline Methacycline Triacetyloleandomycin Tyrothricin Vancomycin Viomycin pantothenate and sulphate Viomycin sulphate All other antibiotics and chemotherapeutic agents. Part IV Chenopodium Oil Coumarin Dinitrobenzene Lysergic Acid Diethylamide Tetrahydrocannabinoe Page 14 Revised as at 1st day of May, 2017 c Pharmacy (Poisons and Restricted Pharmaceuticals) Regulations SCHEDULE 2 Publication in revised form authorised by the Cabinet this 22nd day of May, 2017. Clerk of Cabinet c Revised as at 1st day of May, 2017 Page 15