Pharmacy and Poisons (Third and Fourth Schedule Amendment) Order 2019 (BR 69/2019)

FA E R N AT F TQUO U BERMUDA PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT) ORDER 2019 BR 69 / 2019 The Minister responsible for health, in exercise of the power conferred by section 48A of the Pharmacy and Poisons Act 1979, makes the following Order: Citation This order, which amends the Pharmacy and Poisons Act 1979 (“the Act”), may be cited as the Pharmacy and Poisons (Third and Fourth Schedule Amendment) Order 2019. Amends Third Schedule The Third Schedule to the Act is amended— by inserting the following in their appropriate alphabetical and chronological place— “ Adalimumab Aflibercept Anakinra Apixaban Apremilast Asparaginase Astemizole Bevacizumab Botulinum Toxin Brexpiprazole Canagliflozin Ceftolozane 1 2 (a) 1 PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT) ORDER 2019 Crisaborole Daclizumab Dalteparin Dapagliflozin Denosumab Desoximetasone, Desoxymethasone Dexlansoprazole Dextroamphetamine, Dexamphetamine Dicyloverine, Dicyclomine Dolutegravir Dulaglutide Edoxaban Eluxadoline Empagliflozin Enoxaparin Estrogens, conjugated Etanercept Etonorgestrel Etoricoxib Evolocumab Glecaprevir Glycopyrrolate Guanfacine Hydroquinone - ms 4% and above Ibogaine Infliximab Ivermectin Ixekizumab Ledipasvir Linagliptin Linaglotide Liraglutide Lisdexamphetamine, Lisdexamfetamine Lurasidone Meclizine, Meclozine if sold or recommended for the prevention of nausea of pregnancy Methoxy Polyethylene Glycol Epoetin Beta 2 PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT) ORDER 2019 Nicotinoyldihydrocodeine, Nicodicodine Nitroglycerin, Glyceryl Trinitrate Nordiazepam, Nordazepam Obeticholic Acid Ocrelizumab Oseltamivir Palbociclib Pancreatin Pancrelipase Pembrolizumab Peramivir Pibrentasvir Piperacillin Propiverine Hydrochloride’ Ranibizumab Rifaximin Rilpivirine Rituximab Rupatadine Sarilumab Secukinumab Sevelamer Hydrochloride Sofosubir Somatrophin, Somatotropin Sulfamethoxazole, Sulphamethoxazole Sulfamethoxazole / Trimethoprim, Co-trimoxazole Sulfonamide, Sulphonamide Tazobactam Terfenadine Teriflunomide Ticagrelor Thioguanine, Tioguanine Tinzaparin Tofacitinib Ustekinumab Vedolizumab Velpatasvir Vernakalant 3 PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT) ORDER 2019 Vilanterol Vitamin D 50,000 units and above Vortioxetine Voxilaprevir 5-FU, Fluorouracil 6-MP, Mercaptopurine ”; by deleting the following— “ Asparaginase, L-Atenolol Clotrimazole Desloratadine Fexofenadine Miconazole Procainamide Durules Pyrantel Quinine and Urea Rauwolfia (Serpentina and Vomitoria) Valerian Preparations Veratrum (green and white) ”; by correcting the drugs listed in the First Column with the drugs provided in the Second Column— “ First Column Second Column Aconite Belladonna and Chloroform Liniment BPC 1968 Aconite Belladonna and Chloroform Liniment BP 1968 Adiciilin Adicillin Albuterol Albuterol, Salbutamol Amoxycillin Amoxycillin, Amoxicillin Amyl Nitrite Vitrellae BPC Amyl Nitrite Vitrellae BP Bendrofluazide Bendrofluazide, Bendroflumethazide CCNU Capsules CCNU, Lomustine Chlorodyne BPC Chlorodyne BP Chloroform and Morphine Tincture BPC Chloroform and Morphine Tincture BP Cocillana Compound Syrup BPC 1949 Cocillana Compound Syrup BP 1949 Codeine - for non-parental use with ms greater than 8mg calculated as base Codeine - for non-parenteral use with ms greater than 8mg calculated as base (b) (c) 4 PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT) ORDER 2019 Colocynth and Jalap Compound Tablets BPC 1963 Colocynth and Jalap Compound Tablets BP 1963 Co-trimoxazole Co-trimoxazole, Sulfamethoxazole/ Trimethoprim Desoxymethasone Desoxymethasone, Desoximetasone Dexamphetamine (Dextroamphetamine, Dexamfetamine) Dexamphetamine, Dextroamphetamine Dicyclomine Dicyclomine, Dicyloverine Diethyl Propion Diethylpropion Dihydrallazine Sulphate Dihydralazine Dronabinol (Marinol) Dronabinol Factorate Factor VIII Fluorouracil Fluorouracil, 5-FU Folic Acid Folic acid - md greater than 1mg Frusemide Frusemide, Furosemide Furosemide Furosemide, Frusemide Glyceryl Trinitrate Glyceryl Trinitrate, Nitroglycerin Histidine, L- Histidine Ibuprofen Ibuprofen - md greater than 400mg Injectables - all Injectables - except insulins Injections - all preparations for human use Injections - except insulins Lead and Opium Lotion BPC 1959 Lead and Opium Lotion BP 1959 Levonorgestrel Levonorgestrel - except levonorgestrel 1.5mg Lisdexamfetamine (Lisdexamphetamine) Lisdexamfetamine, Lisdexamphetamine Lomustine Lomustine, CCNU Meclozine Meclozine, Meclizine Mercaptorpurine Mercaptopurine, 6-MP Nabiximols (Sativex) Nabiximols Nicodicodine (6 Nicotinoyldihydrocodeine) Nicodicodine, Nicotinoyldihydrocodeine Nordazepam aka nordiazepam Nordazepam, Nordiazepam Norgestrel (d-Norgestrel) Norgestrel Nystatin Nystatin - except for topical use Omeprazole Omeprazole - ms greater than 10mg 5 PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT) ORDER 2019 Oral contraceptives - all Oral contraceptives - except for levonorgestrel 1.5mg Orlistat Orlistat - ms greater than 60mg Paregoric B.P. Paregoric BP Phytomenadione Phytomenadione, Phytonadione Phytonadione Phytonadione, Phytomenadione Potassium chloride - if for non parenteral medicinal use Potassium chloride - ms greater than 99mg Pyroglutamyl, L-histidyl-L-proline Amide, L Pyroglutamyl Salbutamol Salbutamol, Albuterol Somatotropin (Somatrophin) Somatotropin, Somatrophin Sulfasalazine Sulfasalazine, Sulphasalazine Sulphasalazine Sulphasalazine, Sulfasalazine Sulphonamides - all Sulphonamide, Sulfonamide Sulphamethoxazole Sulphamethoxazole, Sulfamethoxazole Tioguanine/Thioguanine Tioguanine, Thioguanine Tripsin - if for internal use Trypsin ”. Amends the Fourth Schedule The Fourth Schedule to the Act is amended— in Part I by inserting the following in their proper alphabetical place— “ Clotrimazole - for topical use Desloratadine Diabetic Diagnostic Reagents and Tests Diclofenac - for topical use Fexofenadine Flurbiprofen oral lozenges Hydroquinone - ms 2% Ibuprofen - for topical use and md 400mg orally Iodoquinol, Di iodohydroxyquinoline for topical use Isoconazole for topical use Itraconazole - for topical use Ketoprofen in oral preparations with ms 75 mg, in preparations for external use 3 (a) 6 PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT) ORDER 2019 Miconazole - for topical use Minoxidil topical use, ms 2% Meclizine, Meclozine Naproxen Sodium - ms 220mg Permethrin Polyethylene glycol - for oral use Pyrantel Ranitidine - ms 75mg Scopolamine, Hyoscine - in preparations for external use, in preparations for internal use with ms 0.15% Terbinafine - for external use only Thimerosal, Thiomersal when used as a skin antiseptic ”; in Part I by deleting the following— “ Aspirin Calcium with Vitamin D tablets BPC Castor oil Cyanocobalamin Halibut liver oil capsules Hyoscine butylbromide Lithium carbonate Lithium sulphate Phenylpropanolamine Senna ”; in Part I by correcting the drugs listed in the First Column with the drugs provided in the Second Column— “ First Column Second Column Aconitine - Eye drops, neutral BPC in preparations for external use Aconitine - Eye drops, neutral BP in preparations for external use Alkaline Eye Drops BPC Alkaline Eye Drops BP Chlorhexidine - if for administration into the nasal or oral cavities, if for use specifically as a bath additive, Chlorhexidine - if for administration into the nasal or oral cavities, for use specifically as a bath additive, if impregnated onto gauze dressing for direct application to a wound (b) (c) 7 PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT) ORDER 2019 Chlorpheniramine if impregnated onto gauze dressing for direct application to a wound Chlorpheniramine Di-iodohydroxyquinoline - for topical preparations for the skin Diabetic Diagnostic Reagents all Diabetic diagnostic tests Di-iodohydroxyquinoline, iodoquinol for topical use Folic Acid - if in preparations for internal use and md 500 micrograms Folic Acid - ms 1 mg Gamma Benzene Hexachloride Gamma Benzene Hexachloride, Lindane Histidine, L- Histidine Hyoscine Hyoscine, Scopolamine Kaolin Poultice BPC Kaolin Poultice BP Lachesine Eye Drops BPC Lachesine Eye Drops BP Lead Subacetate Solution, Dilute BPC Lead Subacetate Solution, Dilute BP Lead Subacetate Solution, Strong BPC Lead Subacetate Solution, Strong BP Lignocaine - in preparations for external use and ms 0.7% in preparations for non-parenteral use Lignocaine - in preparations for external use and ms 4% in preparations for non-parenteral use Lindane Lindane, Gamma Benzene Hexachloride Meclozine Meclozine, Meclizine Pholcodine - if for non-parenteral use and in undivided preparations with ms 1.5% (calculated as base) and md 20 mg (calculated as base) if for non-parenteral use and in single-dose preparations with ms per dosage unit 1.5% (calculated as base) and md 20 mg (calculated as base) Pholcodine - 5mg/5ml Linctus BP Phytomenadione Phytomenadione, Phytonadione Resorcinal Resorcinol Thiomersal Thiomersal, Thimerosal Tyloxapol Tyrothricin Tyrothricin 8 PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT) ORDER 2019 Vitamin D 1000-50,000 I.U. per dosage unit Vitamin D- 1,000 - 49,999 IU per dosage unit Zinc Sulphate Eye Drops BPC Zinc Sulphate Eye Drops BP ”; in Part II paragraph 1 by inserting the following in their proper alphabetical place— “ Chloramphenicol - for ophthalmic use Codeine - for non-parenteral use and ms 8mg calculated as base Epinephrine, Adrenaline Esomeprazole - ms 20mg Fluconazole - ms 150mg and mdd 150mg Hyoscine butylbromide - in preparations for external use in preparations for internal use (other than inhalers) with md 10 mg Lansoprazole ms 15mg Minoxidil for topical use ms 5% Nitroglycerin, Glyceryl Trinitrate tablets and sublingual spray Nystatin - for topical use only Omeprazole - ms 10mg Orlistat - ms 60mg Ranitidine - ms 150mg Terconazole - for vaginal use Triamcinolone Acetonide - nasal spray ms 55 mcg/spray ”; in Part II paragraph 1 by deleting the following— “ Astemizole Folic Acid Ibuprofen Injections Isoconazole Preparations Phenylpropanolamine Terfenadine ”; in Part II paragraph 1 by correcting the drugs listed in the First Column with the drugs provided in the Second Column— “ Adrenaline Adrenaline, Epinephrine Bacitracin - in topical preparations for auricular or local ophthalmic use Bacitracin - for topical use (d) (e) (f) 9 PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT) ORDER 2019 Clotrimazole - if in preparations for external or vaginal use Clotrimazole - if in preparations for external or vaginal use Hyaluronidase - if in preparations for external use Hydrocortisone in preparations for topical use ms 0.5% in preparations for external use and ms 1% Hyaluronidase - for external use Hydrocortisone - in preparations for topical use ms 0.5% in preparations for external use and ms 1% Hydrocortisone - for external use and ms 1% Isoconazole - if in preparations for external or vaginal use Isoconazole - if in preparations for external or vaginal use Itraconazole - if in preparations for external or vaginal use Itraconazole - if in preparations for external or vaginal use Levamizole Levamisole Levonorgestrel - if for use as an emergency contraception Levonorgestrel - ms 1.5mg if for use as an emergency contraception Miconazole - for external application to the skin, or for oral use or vaginal use Miconazole - if in preparations for external or vaginal use Neomycin - in preparations for external use with ms 3.5 mg per gram Neomycin - for topical use only ”. Made this 29th day of May 2019 Minister of Health [Operative Date: 07 June 2019] 10