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Drug Schedules Regulation B.C

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Pharmacy Operations and Drug Scheduling Act DRUG SCHEDULES REGULATION B.C. Reg. 9/98 Deposited and effective January 9, 1998 Last amended January 6, 2020 by B.C. Reg. 1/2020 Consolidated Regulations of British Columbia This is an unofficial consolidation. Consolidation current to January 27, 2020 B.C. Reg. 9/98 (O.C. 35/98), deposited and effective January 9, 1998, is made under the Pharmacy Operations and Drug Scheduling Act, S.B.C. 2003, c. 77, s. 22. This is an unofficial consolidation provided for convenience only. This is not a copy prepared for the purposes of the Evidence Act. This consolidation includes any amendments deposited and in force as of the currency date at the bottom of each page. See the end of this regulation for any amendments deposited but not in force as of the currency date. Any amendments deposited after the currency date are listed in the B.C. Regulations Bulletins. All amendments to this regulation are listed in the Index of B.C. Regulations. Regulations Bulletins and the Index are available online at www.bclaws.ca. See the User Guide for more information about the Consolidated Regulations of British Columbia. The User Guide and the Consolidated Regulations of British Columbia are available online at www.bclaws.ca. Prepared by: Office of Legislative Counsel Ministry of Attorney General Victoria, B.C. Consolidation current to January 27, 2020 Pharmacy Operations and Drug Scheduling Act DRUG SCHEDULES REGULATION B.C. Reg. 9/98 Contents 1 Alphabetical order 2 Sale of drugs 3 [Repealed] SCHEDULES Alphabetical order 1 (1) The drug schedules are printed in an alphabetical format to simplify the process of locating each individual drug entry and determining its status in British Columbia. (2) Each entry is preceded by a code noted as 1, 1A, 2, 3 or 4, in which 1 = Schedule I 1A = Triplicate/Duplicate Prescription Program 2 = Schedule II 3 = Schedule III 4 = Schedule IV. Sale of drugs 2 (1) Drugs listed in Schedules I, IA, II, III and IV must be sold from licensed pharmacies. (2) Unscheduled drugs may be sold from non-pharmacy outlets. (3) The various schedules are differentiated as follows: Schedule I (Prescription): Schedule I drugs require a prescription for sale and are provided to the public by a pharmacist following the diagnosis and professional intervention of a practitioner. The sale is controlled in a regulated environment as defined by provincial pharmacy legislation. Entries followed by a “V” superscript may be sold without having received a prescription if (a) the drug is in a form not suitable for human use, or (b) the main panel of the manufacturer’s inner label and the manufacturer’s outer label carry, in both official languages, the statement “For Veterinary Use Only” or “For Agricultural Use Only” immediately following or preceding the brand name, proper name or common name, in type size not less than one-half as large as the largest type on the label, and the product is sold in the original manufacturer’s container. Schedule IA (Triplicate/Duplicate Prescription Program): Drugs which may be sold by a pharmacist to a practitioner or on the prescription of a practitioner in Last amended January 6, 2020 1 Consolidation current to January 27, 2020 B.C. Reg. 9/98 PHARMACY OPERATIONS AND DRUG SCHEDULING ACT DRUG SCHEDULES REGULATION Schedules accordance with Bylaw 5 (31) (6) of the bylaws to the Pharmacists, Pharmacy Operations and Drug Scheduling Act. Schedule II (Professional Service Area): Drugs which may be sold by a pharmacist on a non-prescription basis and which must be retained within the Professional Service Area of the pharmacy where there is no public access and no opportunity for patient self-selection. Schedule III (Professional Products Area): Drugs which may be sold by a pharmacist to any person from the self-selection Professional Products Area of a licensed pharmacy. Schedule IV (Prescription by Pharmacist): Drugs which may be prescribed by a pharmacist in accordance with guidelines approved by the Council. Unscheduled (Non-pharmacy Sale): Drugs which may be sold by a non- pharmacist to any person. [am. B.C. Regs. 312/2001; 210/2002.] 3 Repealed. [B.C. Reg. 418/98.] SCHEDULES [am. B.C. Regs. 9/98; 141/98; 418/98; 247/99; 31/2000; 355/2000; 377/2000; 378/2000; 132/2001; 211/2001; 312/2001; 21/2002; 210/2002; 232/2002; 233/2002; 288/2002; 19/2003; 303/2003; 142/2006; 169/2006; 137/2007; 200/2008; 45/2009; 46/2009; 286/2009; 2/2011; 64/2011; 189/2011; 190/2011; 192/2012; 180/2015; 181/2015; 83/2016; 160/2016; 230/2016; 279/2016; 6/2017, s. (b); 137/2018; 261/2018; 9/2019; 135/2019; 1/2020.] 1 Abacavir and its salts 1 Abatacept 1Abciximab 1 Acamprosate and its salts 1 Acarbose and its derivatives 1 Acebutolol and its salts 1 Acepromazine and its saltsV 1 Acetaminophen, when recommended for administration by intravenous injection 3 Acetaminophen (in sustained-release formulations containing greater than 650 mg per unit or in package sizes greater than 50 units) 1 AcetanilideV 2Acetarsol 1 Acetazolamide 1 Acetohexamide 1 Acetylcarbromal 1 Acetylcholine Chloride 2 Acetylcysteine 1 Acetylsalicylic acid and its salts (in oral preparations containing 80 mg or less per dosage unit in containers with more than 24 dosage units per container) 2 Acetylsalicylic acid and its salts (in oral preparations containing 80 mg or less per dosage unit in child-resistant containers with 24 or less dosage units per container or rectal preparations containing 150 mg or less per dosage unit) V Prescription not required if sold for veterinary use, provided that the product is labelled by the manufacturer “for agricultural use only” or “for veterinary use only” 2 Last amended January 6, 2020 Consolidation current to January 27, 2020 PHARMACY OPERATIONS AND DRUG SCHEDULING ACT B.C. Reg. 9/98 DRUG SCHEDULES REGULATION Schedules 3 Acetylsalicylic acid and its salts (in products intended for oral use by adults in strengths of 81 mg per dosage unit and 650 mg or greater per dosage unit and in rectal preparations containing more than 150 mg per dosage unit) 1 Acitretin and its salts and derivatives 1 Aconiazide and its salts 1 Acyclovir and its salts 1 Adalimumab 1 Adapalene and its salts and derivatives 1 Adefovir and its salts and derivatives 1 Adenosine or its salts when sold or recommended for administration by intravenous injection 2 Adiphene and its salts for parenteral use 1 Adrenocortical hormones and their salts and derivativesV, including but not limited to betamethasone dipropionate, betamethasone phosphate, betamethasone sodium, betamethasone valerate, budesonide, ciclesonide, clobetasone, cortisone, dexamethasone acetate, dexamethasone phosphate, dexamethasone sodium, difluprednate, fludrocortisone acetate, flunisolide, fluticasone furoate, fluticasone propionate, hydrocortisone aceponate, hydrocortisone acetate, hydrocortisone sodium, methylprednisolone acetate, methylprednisolone, methylprednisolone sodium, methylprednisolone succinate, mometasone furoate, prednisolone acetate, prednisolone phosphate, prednisolone sodium, prednisone, triamcinolone acetonide, triamcinolone hexacetonide (except (a) hydrocortisone or hydrocortisone acetate, when sold as a single medicinal ingredient in a concentration that provides 1% or less hydrocortisone in preparations for topical use on the skin, (b) hydrocortisone or hydrocortisone acetate, when sold in combination with any other non- prescription medicinal ingredient that provides 1% or less hydrocortisone in preparations for topical use on the skin, (c) clobetasone butyrate, when sold in a concentration of 0.05% in cream preparations for topical use on the skin, (d) fluticasone propionate, when sold for the treatment of allergic rhinitis in a nasal spray that delivers 50 mcg per metered spray for individuals 18 years of age and older), (e) mometasone furoate for the treatment of allergic rhinitis in a nasal spray that delivers 50 mcg per spray for those 12 years of age and older, and (f) triamcinolone acetonide in a nasal spray that delivers 55 mcg per spray for adults and children 12 years of age and older 1 Agalsidase alfa 1 Alatrofloxacin and its salts and derivatives 1 Aldesleukin 1Alefacept 1 Alemtuzumab 1 Alendronic acid and its salts 1 Alfacalcidol 1A Alfentanil 1 Alfuzosin and its salts 1 Aliskiren and its salts 1 Alkyl nitrites 1 Allergy serums 2 Allethrins (pyrethrins) V Prescription not required if sold for veterinary use, provided that the product is labelled by the manufacturer “for agricultural use only” or “for veterinary use only” Last amended January 6, 2020 3 Consolidation current to January 27, 2020 B.C. Reg. 9/98 PHARMACY OPERATIONS AND DRUG SCHEDULING ACT DRUG SCHEDULES REGULATION Schedules 1 Allopurinol 1 Allylisopropylacetylurea 1 Almotriptan and its salts 3 Aloe vera latex, its extracts and derivatives (except aloin) (dosage forms for systemic use containing more than 300 mg per dosage unit) 1 Alpha-chloralose 1 Alphadolone and its salts 1 Alphaxalone 1 Alprazolam 1 Alteplase and its salts and derivatives 1 Altrenogest 1 Altretamine 3 Aluminum oxide 1 Alverine and its salts (for parenteral use) 1 Amantadine and its salts 1 Ambenonium chloride 1Ambrisentan 1 Amifostine and its salts 1 Amikacin and its salts and derivatives 1 Amiloride and its salts 1 4-Amino-pteroyl aspartic acid and its salts 1 Amino acid solutions (for parenteral use) 1 Aminocaproic acid 1 Aminoglutethimide 1 Aminolevulinic acid and its salts and derivatives 1 Aminophylline 1 Aminopromazine [proquamezine] and its salts 1 Aminopterin and its salts 1 Aminopyrine
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    付表ⅠA 指定を受けた医薬の有効成分 Annex ⅠA Designated Pharmaceutical Active Ingredients 号(Sub-heading) 品名 Description 2818.30 アルゲルドラート algeldrate 2833.22 アルスルフ alusulf 2842.10 アルマシラート almasilate 2842.10 シマルドラート simaldrate 2842.90 硫酸アルマドラ ート almadrate sulfate 2842.90 アルマガート almagate 2842.90 カルバルドラード carbaldrate 2842.90 ヒドロタルシト hydrotalcite 2842.90 マガルドラート magaldrate 2843.30 オーラノフィン auranofin 2843.30 金チオグリカニド aurothioglycanide 2843.30 金チオりんご酸ナトリウム sodium aurothiomalate 2843.30 金チオ硫酸ナトリウム sodium aurotiosulfate 2843.90 カルボプラチン carboplatin 2843.90 シスプラチン cisplatin 2843.90 デキソルマプラチン dexormaplatin 2843.90 エンロプラチン enloplatin 2843.90 イプロプラチン iproplatin 2843.90 ロバプラチン lobaplatin 2843.90 ミボプラチン miboplatin 2843.90 ネダプラチン nedaplatin 2843.90 オルマプラチン ormaplatin 2843.90 オキサリプラチン oxaliplatin 2843.90 セブリプラチン sebriplatin 2843.90 スピロプラチン spiroplatin 2843.90 ゼニプラチン zeniplatin 2844.40 アルツモマブ altumomab 2844.40 塩化セシウム(131Cs) cesium (131 Cs) chloride 2844.40 クロルメロドリン(197Hg) chlormerodrin (197 Hg) 2844.40 シアノコバラミン(57Co) cyanocobalamin (57 Co) 2844.40 シアノコバラミン(58Co) cyanocobalamin (58 Co) 2844.40 シアノコバラミン(60Co) cyanocobalamin (60 Co) 2844.40 エチオダイズド油(131I) ethiodized oil (131 I) 2844.40 くえん酸第二鉄(59Fe)注射液 ferric (59 Fe) citrate in 2844.40 フィブリノゲン(125I) fibrinogen (125 I) 2844.40 フルデオキシグルコー ス(18F) fludeoxyglucose ( 18 F) 2844.40 フルオロドパ(18F) fluorodopa (18 F) 2844.40 くえん酸ガリウム(67Ga) gallium (67 Ga) citrate 2844.40 金コロイド(198Au) gold (198 Au), colloidal 2844.40 イオベングアン(131I) iobenguane (131 I) 2844.40 よう化人血清アルブミン(125I) iodinated (125 I) human serum albumin 2844.40 よう化人血清アルブミン(131I) iodinated
  • Pharmaceuticals and Medical Devices Safety Information No

    Pharmaceuticals and Medical Devices Safety Information No

    Pharmaceuticals and Medical Devices Safety Information No. 203 July 2004 Table of Contents 1. Serious skin disorders caused by pharmaceuticals ···················3 2. Effects of electromagnetic waves from antitheft devices, etc. on medical devices ······································7 3. Important Safety Information ··························································· 13 .1. Monoethanolamine Oleate ······························································· 13 .2. Clarithromycin ··················································································16 .3. Tegafur/Gimeracil/Oteracil Potassium ·············································· 22 .4. Melphalan (injectable dosage form) ················································· 25 4. Revision of PRECAUTIONS (No. 157) Milnacipran Hydrochloride (and 6 others) ···················································30 This Pharmaceuticals and Medical Devices Safety Information (PMDSI) is issued based on safety information collected by the Ministry of Health, Labour and Welfare. It is intended to facilitate safer use of pharmaceuticals and medical devices by healthcare providers. PMDSI is available on the Pharmaceuticals and Medical Devices Agency website (http://www.pmda.go.jp/english/index.html) and on the MHLW website (http://www.mhlw.go.jp/, Japanese only). Published by Translated by Pharmaceutical and Food Safety Bureau, Pharmaceuticals and Medical Devices Agency Ministry of Health, Labour and Welfare Pharmaceutical and Food Safety Bureau, Office of Safety, Ministry
  • Medicinal Product No Longer Authorised

    Medicinal Product No Longer Authorised

    III SCIENTIFIC DISCUSSION 1. INTRODUCTION Pruban contains resocortol butyrate and is a corticosteroid preparation for cutaneous use in dogs. Pruban is indicated for the treatment of acute localised moist dermatitis. Most cases of acute moist dermatitis are complications of flea bite hypersensitivity, although allergic skin diseases, other ectoparasites, anal sac problems, or foreign bodies can also initiate the trauma. Once the skin is irritated, an itch-scratch cycle is initiated and the intense trauma may produce severe lesions in a few hours. Dogs with heavy hair coats are particularly predisposed to this problem. A typical lesion is red, moist and exudative. It can extend rapidly if adequate therapy does not start. These lesions are not skin infections, even though they can be colonised by bacteria secondarily (mainly Staphylococcus) and have to be differentiated from pyotraumatic folliculitis. Recommended therapy consists in cleaning the lesion (sedation may be necessary) with antiseptics. Clipping the hair is also useful. Most cases necessitate a treatment with a topical or/and oral corticosteroid. Beside symptomatic treatment, it is important to identify the primary cause, if possible. authorised The anti-inflammatory activity (including local vasoconstriction) of resocortol butyrate was demonstrated on non-target species. Pharmacodynamic activity responsible for side effects was demonstrated after systemic administration. These effects were reduced after topical administration. Radiometric pharmacokinetic studies in rats indicated that resocortol butyrate administered topically via ethanolic solution is greatly absorbed. The major excretion routes are urine and faeces; resocortol butyrate was weakly metabolised in the skin and plasma but highly metabolised in the liver. The formulation is an oil-in-water emulsion in which the active substance (resocortol butyrate) is suspended.