F A E R N A T F T Q U O U BERMUDA PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT) ORDER 2017 BR 111 / 2017 The Minister responsible for health, in exercise of the power conferred by section 48A(1) of the Pharmacy and Poisons Act 1979, makes the following Order: Citation This Order may be cited as the Pharmacy and Poisons (Third and Fourth Schedule Amendment) Order 2017. Repeals and replaces the Third and Fourth Schedule of the Pharmacy and Poisons Act 1979 The Third and Fourth Schedules to the Pharmacy and Poisons Act 1979 are repealed and replaced with— “THIRD SCHEDULE (Sections 25(6); 27(1))) DRUGS OBTAINABLE ONLY ON PRESCRIPTION EXCEPT WHERE SPECIFIED IN THE FOURTH SCHEDULE (PART I AND PART II) Note: The following annotations used in this Schedule have the following meanings: md (maximum dose) i.e. the maximum quantity of the substance contained in the amount of a medicinal product which is recommended to be taken or administered at any one time. 1 2 1
Transcript
FA E R NAT F
TQUO U
BERMUDA
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
BR 111 / 2017
The Minister responsible for health, in exercise of the power conferred by section48A(1) of the Pharmacy and Poisons Act 1979, makes the following Order:
CitationThis Order may be cited as the Pharmacy and Poisons (Third and Fourth Schedule
Amendment) Order 2017.
Repeals and replaces the Third and Fourth Schedule of the Pharmacy and Poisons Act1979
The Third and Fourth Schedules to the Pharmacy and Poisons Act 1979 arerepealed and replaced with—
“THIRD SCHEDULE
(Sections 25(6); 27(1)))
DRUGS OBTAINABLE ONLY ON PRESCRIPTION EXCEPT WHERESPECIFIED IN THE FOURTH SCHEDULE (PART I AND PART II)
Note: The following annotations used in this Schedule have the following meanings:
md (maximum dose) i.e. the maximum quantity of the substancecontained in the amount of a medicinal product which is recommended to be takenor administered at any one time.
1
2
1
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
mdd (maximum daily dose) i.e. the maximum quantity of thesubstance that is contained in the amount of a medicinal product which isrecommended to be taken or administered in any period of 24 hours.
mg milligram
ms (maximum strength) i.e. either or, if so specified, both of thefollowing:
the maximum quantity of the substance by weight or volume thatis contained in the dosage unit of a medicinal product; or
the maximum percentage of the substance contained in amedicinal product calculated in terms of w/w, w/v, v/w, or v/v,as appropriate.
external use means for application to the skin, teeth, mucosa of themouth, throat, nose, eye, ear, vagina or anal canal when a local action only isnecessary and extensive systemic absorption is unlikely to occur. Note: thefollowing are not regarded as for external use: throat sprays, throat pastilles, throatlozenges, throat tablets, nasal drops, nasal sprays, nasal inhalations or teethingpreparations.
parenteral use means administration by breach of the skin or mucousmembrane.
AerosoxacinAesculinAgomelatineAlbamycin preparationsAlbamycin T preparationsAlbumin HumanAlbumin Microspheres Human (3M)AlbuterolAlclofenacAlcuronium ChlorideAldosteroneAlendronateAlfacalcidolAlfentanilAlfuzosinAlgestone
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PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
Algestone AcetonideAlgestone AcetophenideAliskirenAlitretinoinAlkavervirAllobarbitoneAllopurinolAllyloestrenolAllylprodineAlmotriptanAlphacetylmethadolAlphadolone AcetateAlphameprodineAlphamethadolAlphaprodineAlphaxaloneAlprazolamAlprenololAlprostadilAlseroxylonAmantadineAmbenonium ChlorideAmbrisentanAmbusideAmbutonium BromideAmcinonideAmetazoleAmethocaine - for local ophthalmic use
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
AmitriptylineAmlodipineAmmonium BromideAmmonium Chloride - in inhalersAmoxycillinAmoxycillin TrihydrateAmphetamineAmphomycinAmphotericinAmpicillinAmpicillin TrihydrateAmyl Nitrite Vitrellae BPCAmylobarbitoneAmylocaine - in preparations for local ophthalmic useAnaesthetics - all inhalationalAnagrelideAnastrozoleAncrodAndrosterone
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
AsparaginaseAsparaginase, L-AtenololAtamestaneAtazanavirAtenololAtomoxetineAtorvastatinAtovaquoneAtracurium BesylateAtropine Eye Drops B.P. - in preparations for local opthalmic useAtropine Eye Ointment B.P. - in preparations for local opthalmic useAtropine - in inhalersAtropine Methobromide - in preparations for local ophthalmic useAtropine Methobromide - in inhalersAtropine Oxide - in preparations for local ophthalmic useAtropine Oxide - in inhalersAzacyclonolAzaperoneAzapropazoneAzaribineAzathioprineAzelaic AcidAzidocillinAzithromycinBacampicillinBacitracin Methylene DisalicylateBaclofenBalsalazideBambermycinBamipineBarbitoneBarbituric Acid - and derivativesBarium CarbonateBarium ChlorideBarium SulphateBarium SulphideBeclamideBeclomethasoneBelladonna Herb
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PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
Belladonna RootBemegrideBenactyzineBenapryzineBenazeprilBendazacBendrofluazideBenethamine PenicillinBenoxaprofenBenperidolBenserazideBenzafibrateBenzathine PenicillinBenzbromaroneBenzestrolBenzethidineBenzhexolBenzilonium BromideBenzocaine - for local ophthalmic useBenzoctamine
Benzoyl Peroxide - in concentrations greater than 10%Benzoylsuphanilamide, N-BenzphetamineBenzquinamideBenzthiazideBenztrone InjectionsBenztropine MesylateBenzylmorphineBenzylpenicillinBetacetylmethadolBetahistineBetameprodineBetamethadolBetamethasoneBetaprodineBetaxololBethanechol ChlorideBethanidineBexarotene
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PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
BezafibrateBezitramideBicalutamideBimatoprostBiorphen Oral SolutionBiperidenBismuth GlycollylarsanilateBisoprololBleomycin SulphateBolandiolBolasteroneBolazineBoldenone UndecylenateBolenolBolmantalateBosentanBretylium TosylateBrimonidineBrinzolamideBromazepamBromhexineBromocriptineBromvaletoneBrotizolamBudesonideBufexamacBufotenineBumetanideBuphenineBupivacaine - in preparations for local ophthalmic useBuprenorphineBupropionBuspironeBusulphanButacaine - in preparations for local ophthalmic useButalbitalButanilicaine - in preparations for local ophthalmic useButaperazine
Butobarbitone
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PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
Chymotrypsin - for parenteral or opthalmic useCiclacillinCiclopiroxCilazaprilCimetidineCinacalcetCinchocaine - in preparations for local ophthalmic useCinchophenCinoxacinCiprofloxacinCisplatinCitalopramCitrated Calcium CarbimideClarithromycinClavulanic AcidClemizoleClenbuterolClidinium BromideClindamycinClioquinolClobazamClobetasol 17-propionateClobetasone ButyrateClofazimineClofibrateClomiphene CitrateClomipramineClomocyclineClonazepamClonidineClonitazeneClopamideClopenthixolClopidogrel
CocaineCocculus IndicusCocillana Compound Syrup BPC 1949Codeine - for non-parental use with ms greater
than 8mg calculated as baseCo-dergocrine MesylateColchicineColesevelamColestipolColistinCollagen preparations - if for implantation under the skinCollagenase - when sold or recommended as a
debriding agentColocynth and Jalap CompoundTablets BPC 1963
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
Diethyl Carbamazine CitrateDiethyl PropionDiethylamide Ethyl BenzilateDiethylamine AcetarsolDiethylstilboestrol - and derivatives if for medicinal useDiethylthiambutene
DiltiazemDimenoxadoleDimepheptanolDimepregnenDimercaprolDimethisoquin - in preparations for local ophthalmic useDimethisteroneDimethothiazine
Dimethyl SulphoxideDimethylthiambutene
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PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
DimethytubocurarineDinitrodiphenylsulphonylethylenediamineDinitrophenol, 2,4- - and derivatives if for medicinal useDinoprostDinoprostoneDioxaphetyl ButyrateDiphenhydramine - for parenteral useDiphenidolDiphenoxylateDiphetarsoneDiphyllineDipipanoneDipivefrinDiprenorphineDiprophyllineDipropyltryptamineDipyridamoleDipyroneDisodium Etidronate
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
DrostanoloneDrotebanolDuloxetineDutasterideDydrogesteroneDyflosEcgonine - any derivative of ecgonine which is
convertible to ecgonine or to cocaineEconazoleEcothiopate IodideEctyl ureaEdogestroneEdrophonium ChlorideEfavirenzEflornithineEletriptanEltrombopagEmbutramideEmepronium BromideEmeside preparationsEmetineEmtricitabineEmylcamateEnalaprilEnestebolEnflurane - for inhalational useEntacaponeEntecavirEphedrineEphedrine - in inhalersEpicillinEpinastineEpioestriolEpithiazideEpitiostanolEplerenoneEpoprostenolErgometrine MaleateErgot - prepared
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PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
ErgotamineErgotoxineErlotinibErythrityl TetranitrateErythromycinEscitalopramEsomeprazoleEstazolamEstradiolEstramustine PhosphateEtafedrineEtamiphyllineEthacrynic AcidEthambutolEthamivanEthamsylateEthanolamine OleateEthchlorvynolEthebenecidEther - for inhalational useEthiazideEthinamateEthinyloestradiolEthionamideEthisteroneEthoglucidEthoheptazine CitrateEthopropazineEthosuximideEthotoinEthuloseEthyl AcetanilideEthyl Alcohol - for internal use 45%Ethyl BiscoumacetateEthyl loflazepateEthyl N-heptyloxyacetate - if for internal use
EthylmethylthiambuteneEthylmorphine - if for non-parenteral use and (a) in
undivided preparations with ms 2.5%
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PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
(calculated as base); or(b) in single-dosepreparations with ms per dosage unit100mg (calculated as base)
EthyloestrenolEthylstibamineEthynodiol DiacetateEtidronate DisodiumEtodolacEtomidateEtonitazeneEtoposideEtorphineEtoxeridineEtravirineEtretinateEtymemazineEverolimusExemestaneExenatideEzetimibeFactor XIII ConcentrateFactorateFamciclovirFamotidineFamprofazoneFazadinium BromideFebuxostatFelodipineFencamfaminFenclofenacFenethylline
Fenfluramine (not in combinationwith Phentermine)FenofibrateFenoprofenFenoterolFenpipramideFenpipraneFentanyl
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PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
HexachlorophaneHexamethoniumHexamineHexobarbitoneHexoestrolHistidine, L-Homatropine - in preparations for local ophthalmic useHomatropine HydrobromideHomatropine MethylbromideHyaluronidaseHydralazineHydrargaphenHydrobromic AcidHydrochlorothiazideHydrocodoneHydrocortamateHydrocortisoneHydroflumethiazideHydrogen cyanideHydromorphinolHydromorphoneHydroxy-3-nitrophenylarsonic Acid,4-HydroxychloroquineHydroxycholecalciferol, 1,a-HydroxymethylgramicidinHydroxypethidineHydroxyprogesteroneHydroxyureaHydroxyzineHygromycine BHyoscine - in preparations for local ophthalmic useHyoscine Butylbromide - in inhalersHyoscine Hydrobromide - in inhalersHyoscine Methobromide - in inhalersHyoscyamine - in inhalersHypnomidate ConcentrateIbandronateIbuprofen
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PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
IdarubicinIdoxuridineIfosfamideImatinibImipramineImiquimodImmunoglobulinsIndapamide HemihydrateIndinavirIndomethacinInjectables - allInjections - all preparations for human useInosine PranobexIntra-uterine contraceptive devicesIntravenous Fluids - allIodoxamic AcidIopanoic AcidIpratropium BromideIprindoleIproniazidIrbesartanIsoaminileIsocarboxazidIsoconazole preparationsIsoetharineIsoflurane - if for inhalational use
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
IvabradineJaborandiKanamycin SulphateKetamineKetazolamKetobemidoneKetoconazoleKetoprofenKetorolac TrometamolKetotifenKhellinLabetololLacosamideLamivudineLamotrigineLanatosideLansoprazoleLanthanumLapatinibLatamoxefLatanoprost - in preparations for local ophthalmic useLead and Opium Lotion BPC 1959Lead ArsenateLefetamineLeflunomideLetrozoleLeuprolideLevallorphanLevetiracetamLevocetirizineLevodopaLevofloxacinLevomethorphanLevomoramideLevonorgestrelLevophenacylmorphanLevorphanolLevothyroxineLidoflazine
26
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
Lignocaine - in preparations for local ophthalmic useLincomycinLinezolidLiothyronineLisdexamfetamine(Lisdexamphetamine)LisinoprilLithium CarbonateLithium SulphateLobelineLodoxamideLofentanilLofepramineLomustineLoperamideLopinavirLoprazolamLorazepamLorcaserinLormetazepamLosartanLoteprednol EtabonateLoxapineLuteinising hormoneLynoestrenolLypressin
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
MebolazineMecamylamineMechlorethamineMecillinamMeclofenamic AcidMeclofenoxateMecloqualoneMeclozine - if sold or recommended for the
prevention of nausea of pregnancyMedazepamMedicinal Opium - if in preparations from which the opium
cannot be readily recovered in amountswhich constitute a risk to health and,also if in liquid preparations with ms0.2% (calculated as anhydrousmorphine base); in solid preparationswith ms 0.2% (calculated as anhydrousmorphine base)
MedigoxinMedrogestoneMedroxyprogesterone AcetateMefenamic AcidMefenorexMefloquineMefrusideMegestrolMeglumine DiatrizoateMelarsonyl PotassiumMelarsoprolMelengestrolMeloxicamMelphalanMemantineMenadiol - if for parenteral routeMenotrophinMepazineMepenzolateMephenesinMephenoxoloneMephentermine
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PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
MepitiostaneMepivacaine - in preparations for local ophthalmic useMeprobamateMeptazinolMepyramineMequitazineMercaptorpurineMercuderamideMesaboloneMersalyl AcidMesalamineMescalineMesnaMesoridazineMestanoloneMesteroloneMestranolMetabutethamine - in preparations for local ophthalmic useMetaldehyde - if for medicinal useMetaraminolMetaxalone
MetoprololMetriboloneMetronidazoleMetyraponeMexiletineMezlocillinMianserinMiboleroneMiconazoleMidazolamMidodrineMifepristoneMinocyclineMinoxidilMirtazapineMisoprostolMithramycinMitobronitolMitomycin CMitopodozideMitotaneMoclobemideModafinilMoexiprilMolindoneMometasoneMonensinMonosulfiram - for internal useMontelukastMorazoneMorpheridineMorphine - in liquid preparations with ms 0.2%
(calculated as anhydrous morphinebase); in solid preparations with ms
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PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
0.2% (calculated as anhydrousmorphine base); in pentavalent nitrogenderivatives
Morphine Methobromide - morphine N-Oxide and otherpentavalent nitrogen morphinederivatives
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
Nepafenac - in preparations for local ophthalmic useNepenthe Oral SolutionNetilmycinNevirapineNialamideNicardipineNicocodineNicodicodineNicodicodine (6-nicotinoyldihydrocodeine)NicomorphineNicotinaldehyde Thio-semicarbazoneNicotine - for human use (except in natural
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
NorethisteroneNorethynodrelNorfloxacinNorgestrel (d-Norgestrel)NorlevorphanolNormethadoneNormorphineNorpipanoneNortriptylineNovobiocinNux Vomica SeedNux Vomica Tincture BPNystatin OctacosactrinOestradiolOestriolOestrogenic substances, conjugatedOestroneOfloxacinOlanzepineOleandomycinOlmesartanOlopatadine - in preparations for local ophthalmic useOmeprazoleOndansetronOpipramolOpium, rawOpium, Tincture BPOral Contraceptives - allOrciprenalineOrlistatOrphenadrineOrthocaine - in preparations for local ophthalmic useOseltamivirOuabainOvandrotoneOvarian Gland, driedOxabolone
34
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
OxacillinOxamniquineOxanamideOxandroloneOxantel PamoateOxatomideOxazepamOxazolamOxcarbazepineOxedrineOxethazaineOxolinic AcidOxophenarsineOxprenololOxtriphyllineOxybuprocaine - except in preparations for local
ophthalmic useOxybutyninOxycodoneOxymesteroneOxymetholoneOxymorphoneOxypertineOxyphenbutazoneOxyphencyclimineOxyphenonium BromideOxytetracyclineOxytetracycline DihydrateOxytocins - natural and synthetic PaliperidonePancrelipasePancuronium BromidePantoprazolePapaverinePapaverine - in inhalersPapaverolineParadione CapsulesParaldehyde
35
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
Phenacaine - except in preparations for localophthalmic use
PhenacemidePhenadoxonePhenaglycodolPhenampromide
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PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
Phenarsone SulphoxylatePhenazocinePhenazonePhenazone and Caffeine CitratePhenazone SalicylatePhenbenicillin PotassiumPhenbutrazatePhencyclidinePhendimetrazinePhenelzine SulphatePhenethicillin PotassiumPhenethylamine - derivatives formed by substitution in the
ring to any extentwith alkyl, alkoxy,alkylenedioxy or halide substitutes,whether or not further substituted in thering by one or more other univalentsubstituents with alkyl, alkoxy,alkylenedioxy or halide substitutes,whether or not further substituted in thering by one or more other univalentsubstituents
PheneturidePhenglutarimidePhenindionePheniprazinePhenmetrazinePhenobarbitonePhenol - for parenteral usePhenomorphanPhenoperidinePhenoxybenzaminePhenoxymethylpenicillinPhenprocoumonPhensuximidePhenterminePhentermine Resin Complex
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
Phenylephrine - if for ophthalmic or nasaladministration; above 1%w/v
Phenylindanedione - and its derivativesPhenylmethylbarbituric Acid
PhenylpropanolaminePhenytoinPhenytoin SodiumPholcodine - if for non-parenteral use and in
undivided preparations with ms 2.5%(calculated as base) if for non-parenteraluse and in single-dose preparations withms per dosage unit 100 mg (calculatedas base)
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
PiritramidePiroxicamPituitary extractPituitary Gland (whole dried)- if in inhalersPituitary powdered (posterior lobe) - if in inhalersPivampicillinPivmecillinamPizotifenPodophyllotoxinPodophyllumPodophyllum IndianPodophyllum ResinPoldine MethylsulphatePolidexidePoliovaccines - allPolymyxin B Sulphate - if for parenteral usePolynoxylinPolyoestradiol PhosphatePolysaccharide Iron ComplexPolythiazide
PosaconazolePotassium AminosalicylatePotassium ArsenitePotassium BromidePotassium Chloride - if for non-parenteral medicinal usePotassium ClorazepatePotassium GluconatePotassium HydroxyquinolonePotassium PerchloratePractololPralidoximePramipexolePrasteronePravastatinPrazepamPrazosinPrednisolonePrednisonePregabalin
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PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
Prenylamine LactatePrethcamidePrilocaine - except in preparations for local
ophthalmic usePrimaquine PhosphatePrimidoneProbenecidProbucolProcainamideProcainamide DurulesProcaine - except in preparations for local
ProdilidineProgesteroneProguanilProheptazineProlactinProligestoneProlintanePromazinePromethazine - if for parenteral usePropafenonePropanididPropantheline BromideProparacaine - in preparations for oral, parenteral and
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
SulphinpyrazoneSulphomyxinSulphonalSulphonamides - allSulpirideSulthiameSumatriptanSunitinibSuprofenSutilains - when sold or recommended as a
debriding agentSuxamethonium BromideSuxamethonium ChlorideSuxethonium Bromide TacrineTacrolimusTadalafilTalampicillinTamoxifenTamsulosinTapentadolTazaroteneTeclothiazide PotassiumTelithromycinTelmisartanTemazepamTemozolomideTenofovirTerazosinTerbutalineTestosteroneTestosterone 17B Chloral HemiacetalTetrabenazineTetracaine - if for parenteral or ophthalmic useTetracosactrinTetracyclineTetracycline Phosphate ComplexTetrasodium Fostestrol
46
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
TetrazepamThalidomideThallium AcetateThebacon - and its saltsThebaineTheobromineTheophyllineThiambutosineThiethylperazineThiocarlideThioguanineThiomesteroneThiopropazateThioproperazineThioridazineThiosinamineThiosinamine and Ethyl IodideThiotepaThiothixeneThiouracilThrombin preparationsThymoxamineThyroidThyrotrophinThyrotrophin releasing hormoneThyroxine SodiumTiagabineTianulinTiaprofenic AcidTicarcillinTigloidineTilidateTimololTinidazoleTioguanine/ThioguanineTiotropiumTipranavirTizanidineTobramycin
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PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
Triiodothyronine InjectionTriiodothyroproprionic AcidTrilostaneTrimeperidineTrimeprazineTrimetaphanTrimetazidineTrimethadioneTrimethoprimTrimipramineTrimustineTrioxsalenTripsin - if for internal useTrometamolTropicamideTrospiumTroxidoneTryptamine - Tryptamine or ring-hydroxy tryptamine
derivatives formed by substitution at thenitrogen atom of the sidechain with oneor more alkyl substituents; their salts;their esters and ethers; their salts (Noneof these derivatives specified above isthought to be commercially available)
Tryptophan, L-TrypureTubocurarine ChlorideTybamateTylosinTylosin PhosphateTylosin TartrateTyrothricin UramustineUmeclidiniumUrea - if for medicinal useUrea StibamineUredofosUrethaneUridine-5-triphosphoric Acid
49
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
UrokinaseUrsodeoxycholic Acid Vaccines - allValacyclovirValerian preparationsValproic AcidValsartanVancomycinVardenafilVareniclineVenlafaxineVerapamilVeratrineVeratrum (green and white)VidarbineVigabatrinViloxazineVinbarbitoneVinblastineVincristineVindesineViomycinVirginiamycinVitamin B12 - with intrinsic Factor ConcentrateVitamin D - above 50,000 I.U. per dosage unitVoriconazole WarfarinXantinol NicotinateXipanideXylazineYohimbine ZafirlukastZaleplonZeranolZidovudineZimelidine
50
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
ZipeprolZinc Sulphate - if for oral use with md greater than
Any ester or ether of a substance for the time being specified in paragraph1.
Any salt of a substance for the time being specified in paragraph 1 or 2.SCHEDULE 4
(Sections 28(1); 28(2))
PART I
DRUGS OBTAINABLE ONLY AT REGISTERED PHARMACIES
Note: The following annotations used in this Schedule have the followingmeanings:md (maximum dose) i.e. the maximum quantity of the substance
contained in the amount of a medicinal productwhich is recommended to be taken oradministered at any one time.
2
3
51
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
mdd (maximum dailydose)
i.e. the maximum quantity of the substance thatis contained in the amount of a medicinalproduct which is recommended to be taken oradministered in any period of 24 hours.
mg milligram
ms (maximumstrength) i.e. either or, if so specified, both of the following:
(a) the maximum quantity of the substance byweight or volume that is contained in the dosageunit of a medicinal product; or(b) the maximum percentage of the substancecontained in a medicinal product calculated interms of w/w, w/v, v/w, or v/v, as appropriate.
externaluse
means for application to the skin, teeth, mucosaof the mouth, throat, nose, eye, ear, vagina oranal canal when a local action only is necessaryand extensive systemic absorption is unlikely tooccur. Note: the following are not regarded as forexternal use: throat sprays, throat pastilles,throat lozenges, throat tablets, nasal drops,nasal sprays, nasal inhalations or teethingpreparations.
parenteraluse
means administration by breach of the skin ormucous membrane.
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
Aluminiumoxide -
for human use
AlverineAmbucetamideAmethocaine - in all other preparations for non-parenteral useAminacrine - in preparations for non-parenteral useAmylocaineAntazoline - if for nasal or ophthalmic administrationAspirin - if enteric coated or formulated in any other way so
as to delay absorptionAzatadine BamethanBelladonna herb - in preparations for external use, in preparations for
internal use and mdd 1mg of the alkaloidsBelladonna root - in preparations for external use, in preparations for
internal use and mdd 1mg of the alkaloidsBenorylateBenzamine lactateBenzocaine - if in preparations for non-parenteral use with ms
more than 1%Benzoyl peroxide - in concentrations of 10% or lessBenzydamine preparationsBenzyl BenzoatepreparationsBetaineBorax BPBoric Acid BPBromelainsBromodiphenhydramineBrompheniramineBuclizineBuclosamideBuphenine - in preparations for internal use with md 6mg and
mdd 18mgBupivacaine - in preparations for non-parenteral useButacaine - in preparations for non-parenteral useButanilicaine - in preparations for non-parenteral useButethamideButoxyethyl nicotinateButylaminobenzoate - for topical use only
53
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
CalciumGlucogalactogluconate -
if for oral administration
Calcium polystyrenesulphonateCalcium resoniumCalcium with Vitamin Dtablets BPCCannabidiol withtetrahydrocannabinol lessthan 1%Cantharidin - in preparations for external use and ms 0.01%Caramiphen - in liquid preparations and ms 0.1% (calculated as
base), in tablet preparation and ms 7.5mg(calculated as base)
Carbaryl preparationsCarbenoxolone - in gels and ms 2%, in pellets with md 5mg and mdd
25mgCarbetapentane citrateCarbinoxamineCastor oil - if for ophthalmic useCetylpyridium chloride - if for internal useCharcoal - if for internal useChloral hydrate - in preparations for external useChlorcyclizineChlordantoinChlorhexidine - if for administration into the nasal or oral cavities, - if for use specifically as a bath additive,Chlorpheniramine if impregnated onto gauze dressing for direct
application to a woundChlorphenoxyethanolChlorprenalineChlorpyriline CitrateChlorxylenol - for application to the skinCholebrin tabletsCholine magnesiumtrisalicylateCholine salicylateChymotrypsinCinchocaine - in preparations for non-parenteral use and ms 3%
(calculated as base)CineoleCinnarizine
54
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
Clioquinol - in preparations for external use, in preparations forinternal use for treatment of mouth ulcers with ms35mg and mdd 250mg
Coal tar - in preparations Conium leaf in preparations forexternal use and ms 7% of the crude drug
Creosote - if for medicinal useCrotamitonCyanocobalamin - if in a formulation in which it is the sole active
ingredient and is for internal useCyclizine - if in preparations 1% and lessCyclomethacaine - if for nasal administrationCyclopentamine - if for oral administration and maximum dose 15mgCyclopropaneCyteal DanthronDeanol - in preparations for internal use and mdd 26 mgDequalinium - chloride in external paint preparations and ms 1%
in throat lozenges or throat pastilles and ms 0.25mgDexbrompheniramineDexchlorpheniramineDextromethorphan - in preparations for internal use with md 15 mg
(calculated as base) and mdd 75 mg (calculated asbase)
Di-iodohydroxyquinoline - for topical preparations for the skin DiabeticDiagnostic Reagents all Diabetic diagnostic tests
Diatrizoate sodium - for non-parenteral useDibromopropamidine - for ophthalmic useDichlorophenDicophaneDihydrotachysterolDimenhydrinateDimethindeneDimethisoquin - in preparations for non-parenteral useDimethylaminoethanoltartrateDioctylsodiumsulphosuccinateDiphenhydramineDiphenylpyralineDithranol preparationDocusate sodiumDomiphen Bromide - if for oral use
55
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
Doxylamine Embramine - in preparations for internal or external use and ms
1%EmetineEphedrine - in nasal sprays or nasal drops and ms 2%, in
preparations for external use, in preparations forinternal use (except nasal sprays or nasal drops)with md 30 mg and mdd 60 mg
Ethyl alcohol - for medicinal use Famotidine - in preparations for internal use with ms 10 mgFerrous salts - for internal use where the ferrous salt is the sole
active ingredientFluoresceinFluothaneFolic Acid - if in preparations for internal use and mdd 500
microgramsFrangula preparationsGamma BenzenehexachlorideGelsemine - in preparations for internal or external use and ms
0.1%Gelsemium - in preparations for internal use with md 25mg of the
crude drug and mdd 75mg of the crude drugGlutaraldehydeGlycopyrronium bromide - in preparations for internal use with md 1 mg and
mdd 2 mgGrindelia liquid extractGuaiacolGuar gumGynominHalibut-Liver Oil CapsulesHeparin - in preparations for external useHeparinoidHexachlorophane - if in preparations for external use in:
(a) soaps with ms more than 0.1% but not morethan 2%(b) products other than soaps or aerosols with msmore than 0.1% but not more than 0.75%
Hexamidine isethionateHistapyrrodine
56
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
Histidine, L- - if for use as an ingredient in dietary or nutritionalproducts as an aminoacid
Homatropine hydrobromide-
if in preparations for internal use with md 0.2mgand mdd 0.6mg
Hydrargaphen - in preparations for local application to the skinHydroxymethylgramicidin - if in throat lozenges or throat pastillesHyoscine - in preparations for external use, in preparations for
internal use with ms 0.15%Hyoscine butylbromide - in preparations for external use, in preparations for
internal use (other than inhalers) with md 3mg andmdd 9mg; or
Hyoscine hydrobromide - in preparations for external use, in preparations forinternal use with md 300 micrograms and mdd 900micrograms
Hyoscine methobromide - in preparations for external use, in preparations forinternal use with md 2.5 mg and mdd 7.5 mg
Hypromellose - for ophthalmic use Inositol nicotinateIocetamic acid - if for oral administrationIodinated glycerinIpecacuanhaIsopropamide iodide - in preparations for internal use with md 2.5 mg (as
isopropamide ion) and mdd 5 mg (as isopropamideion)
IsothipendylIspagula husk Jaborandi - in preparations for external use and ms more than
0.025% of the alkaloids in the medicinal product; Kaolin Poultice BPC Lachesine Eye Drops BPCLactuloseLead Subacetate Solution,Dilute BPCLead Subacetate Solution,Strong BPCLevonorgestrel - if for use as an emergency contraceptionLignocaine - in preparations for external use and ms 0.7% in
preparations for non-parenteral useLindane
57
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
Lithium carbonate - in preparations for internal use with md 5mg(calculated as base) and mdd 15 mg (calculated asbase)
Lithium sulphate - in preparations for internal use with md 5mg(calculated as base) and mdd 15 mg (calculated asbase)
Lobeline - in preparations for external use, in preparations forinternal use with md 3mg and mdd 9mg (calculatedas base)
Loratadine - in tablets with ms 10 mg in syrup with ms 5 mg/5ml
Mafenide - in eye drops and ms 5%Magnesium citrateMalathion preparationsMebeverine - if in preparations for internal use with md 100mg
and mdd 300mgMeclozineMedicinal opium - in liquid preparations with ms 0.02% (calculated as
anhydrous morphine base) and md 3mg (calculatedas anhydrous morphine base)
- in solid preparations with ms 0.04% (calculated asanhydrous morphine base) and md 3mg (calculatedas anhydrous morphine base)
Menadiol - for internal use excluding parenteral routeMepenzolate bromide - in preparations for internal use with md 25mg and
mdd 75mgMepivacaine - in preparations for non-parenteral useMepyramine - if for non-parenteral use Mercuric oxide if for
human useMetabutethamineB - in preparations for non-parenteral useMethapyrileneMethoxamine - in nasal sprays or nasal drops not containing liquid
paraffin as a vehicle and ms 0.25%Methylephedrine - in preparations for internal use with md 30mg and
mdd 60mgMethylhydroxybenzoateMiristalkonium chlorideMonosulfiram - for external use Naphazoline - in nasal sprays or nasal drops not containing liquid
paraffin as a vehicle and ms 0.05%if in eye drops and ms 0.25%
Natuderm CreamNiclosamide
58
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
Nicotinic Acid - for internal useNicotinyl alcohol - for internal useNizatidine - in preparations for internal use with ms 75 mg Orthocaine - if in preparations for non-parenteral useOxolamineOxybuprocaine - if in preparations for non-parenteral useOxymetazolineOxyphenonium bromide - in preparations for internal use with md 5mg and
mdd 15mg PadimatePancreatinPapaverine - in preparations for internal use with md 50mg
(calculated as base) and mdd 150mg (calculated asbase)
Penthienate methobromide-
in preparations for internal use with md 5mg andmdd 15mg
Penthrane - if in preparations for non-parenteral usePhenacainePhenazone - in preparations for external usePhenindaminePheniraminePhenol - for all medicinal usePhenolphthaleinPhenylephrine - if for internal use (excluding parenteral route) with
md 20mg and mdd 40mgif for ophthalmic or nasal administration; with amaximum strength of 1%w/v
Phenylpropanolamine - in nasal sprays or nasal drops and ms 2% inpreparations for internal use (except controlledrelease capsules, nasal sprays or nasal drops) withmd 50mg and mdd 150mg
PhenyltoloxaminePholcodine - if for non-parenteral use and in undivided
preparations with ms 1.5% (calculated as base) andmd 20 mg (calculated as base)if for non-parenteral use and in single-dosepreparations with ms per dosage unit 1.5%(calculated as base) and md 20 mg (calculated asbase)
Phosphorylcolamine
59
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
Phytomenadione - if for non-parenteral use in preparations for internaluse with md 5mg and mdd 15mg
Pipenzolate bromide - in preparations for internal use with md 5mg andmdd 15mg Piperazine
PiperazinePiperidolate - if in preparations for internal use with md 50mg
and mdd 150mgPodophyllum resin - in preparations for external use and ms 20%Poldine methylsulphate - in preparations for internal use with md 2mg and
mdd 6mg Polvinyl alcohol if for ophthalmic usePolystyrene sulphonateresins - for use as an enema
PonoxylanPotassium arsenite - if in preparations for internal or external use and
ms 0.0127%Potassium citratepreparationsPotassiumguaicolsuphonatePovidone iodinepreparations - all
PramoxinePrilocaine - if in preparations for non-parenteral useProcaine - if in preparations for non-parenteral usePromethazinePropantheline bromide - if in preparations for internal use with md 15 mg
and mdd 45mgPropamidineProxamineProxymetacaine - if in preparations for non-parenteral usePseudoephedrine - if in preparations for internal use with md 60mg
and mdd 180mgPumilio pine oilPyrrobutamine phosphate Quinine - in preparations for internal use with md 100mg and
mdd 300mg (calculated as base) Racephedrine - in nasal sprays or nasal drops and ms 2% in
preparations for external useResonium A - in preparations for internal use (except nasal sprays
or nasal drops) with md 30mg and mdd 60mgResorcinal preparations - if for medicinal use
60
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
Retinol - in preparations containing 10,000 units or lessRose Bengal - if for ophthalmic use SalicylamideSalicylic Acid - if for medicinal useScarlet Red OintmentSelenium sulphideSennaSodium alkylsulphoacetate- if for rectal administration
Sodium apolate - if in preparations for external useSodium arsenite - if in preparations for internal or external use and
ms 0.013%Sodium Cellulosephosphate - if for internal use
Sodium cromoglycate - if in preparations for use by being administeredthrough the nose
Sodium fluoride - in preparations for use in the prevention of dentalcaries, other than dentifrices, in the form of: tabletsor drops and mdd 2.2mg; or mouth rinses otherthan those for daily use and ms 0.2%; or mouthrinses for daily use and ms 0.05%
Sodium ipodate capsulesSodium iron edetateSodium Perborate - in preparations for oral useSodium picosulphateSodium pidolateSqualaneSquill preparations - for human useSterculia preparationsStreptodornase - if in preparations for external useStreptokinase - if in preparations for external useSuccinamide - in products for decontaminating water Terpin hydrate - if for medicinal useTetracaineTetrahydrofurfurylsalicylateTetrahydrozolineThiabendazoleThiomersal - when used as a skin antisepticTolazoline - if in preparations for external use
61
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
Totaquine - if in preparations for internal use with md 100mgand mdd 300mg
TramazolineTripelennamineTriprolidineTripotassiumdicitratobismuthateTrypsin - if for external useTryptophan, L- - if used as an ingredient in dietary or nutritional
products as an essential amino-acid; or inpreparations for external use
Turpentine oil - if for internal useTyloxapol Tyrothricin - if in throat lozenges or throat pastilles Urea - if for application to the skinUrea hydrogen peroxide - if for aural use VanillylnonamideVipryniumVitamin D 1000-50,000 I.U.per dosage unit Xylometazoline Zinc Sulphate - if for oral useZinc Sulphate andAdrenaline Eye DropsZinc Sulphate Eye DropsBPC
2 Any ester or ether of a substance for the time being specified in paragraph 1.
3 Any salt of a substance for the time being specified in paragraph 1 or 2.
PART II
DRUGS OBTAINABLE ONLY FROM REGISTERED PHARMACISTS ATREGISTERED PHARMACIES
1
Acyclovir - in preparations for topical use and ms 5%
62
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
Bacitracin - in topical preparations for auricular or localopthalmic use
Chloroform - except for inhalational useClemestineClotrimazole - if in preparations for external or vaginal useCyproheptadine Diclofenac - in topical preparationsEconazole - in cream, powder or solution for external use if
in preparations for external vaginal useEnflurane - except for inhalational use
Ether - except for inhalational use Ethyl alcohol forexternal use
Ethyl alcohol - for external useEthylmorphine - in undivided preparations with ms 0.2%
(calculated as base) and with md 7.5mg(calculated as base); or in single dosepreparations with ms per dosage unit 0.2%(calculated as base) and 7.5mg (calculated asbase)
Folic acid - if in preparations for internal use and md 500micrograms and mdd 1000 micrograms
Gramicidin - in preparations for external use and ms 0.02%in topical preparations for auricular or localophthalmic use
Haloprogin - in preparations for external use Halothaneexcept for inhalational use
Homatropine - in preparations for external use, inpreparations for internal use with md 0.15mgand mdd 0.45mg
Homatropine methylbromide - in preparations for internal use with md 2mgand mdd 6mg
Hyaluronidase - if in preparations for external useHydrocortisone in preparations for topical usems 0.5% in preparations for external use andms 1%
Hydrocortisone - in preparations for topical use ms 0.5%in preparations for external use and ms 1%
63
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
Hydrogen cyanide - in preparations for internal or external use andms 0.1%
Ibuprofen - if for use in rheumatic and muscular pain,
backache, neuralgia, migraine, headache,dental pain, dysmenorrhoea, feverishness,symptoms of colds and influenza and with md400mg and mdd 1200mg
Injections - except insulin productsInsulin - allIodine, aqueous solution - for internal useIsoconazole - if in preparations for external or vaginal use
Isoconazole preparations - if for application to the skin (excluding mucousmembranes)
Isoflurane - except for inhalational useItraconazole - if in preparations for external or vaginal useKetoconazole - if in preparations for external or vaginal useKetoprofen - in preparations for internal use with ms 75 mg LevamizoleLoperamide if for the treatment of acute diarrhoea Mebendazole -
Miconazole - for external application to the skin, or for oraluse or vaginal use
Minoxidil - in topical preparations with ms 2%Morphine - in liquid preparations with ms 0.02%
(calculated as anhydrous morphine base) andmd 3 mg (calculated as anhydrous morphinebase) in solid preparations with ms 0.04% and300 micrograms per dosage unit (calculated asanhydrous morphine base) with md 3mg(calculated as anhydrous morphine base)
Neomycin - in preparations for external use with ms 3.5 mgper gram
Nicotine - if in oral preparations and md 2mg
- in liquid form for inhalation via any electronicdelivery system with ms 21mg
Nicotine - in patches with ms 21 mg/24 hoursNizatidine - in capsules with ms 75 mg Phenazopyridine
64
PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT)ORDER 2017
Phenylpropanolamine - in controlled release capsules with md 75 mgand mdd 150mg
Polymyxin B sulphateRanitidine - with ms 75 mgSilver Nitrate - in preparations for use on the skinSodium cromoglycate - Eye drops and ms 2% Eye ointment and ms 4%Syringes - InsulinTerfenadineTrichloroethylene - for other use
Any ester or ether of a substance for the time being specified in paragraph1.
Any salt of a substance for the time being specified in paragraph 1 or 2.”.
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