THBFOODANDDRUGSACT Rao nods (under section 2/) Tire FOOD ñND Dnuos Rzo nose, 1975 (Made 6y file Minister on the 3rd d of March, I97fi) PART I. De)nitions 1. These Regulations may be cited as the Food and Drugs Regula- tions, 1975. L In these Regulations unless the context otherwise requires— can” means any hermetically sealed container; cubic centimetre" and its abbreviated form “cc” shall be inter- changeable with the term “millilitre” and its abbreviated form “declared" means written on the label attached to or accompany- ing the food, drug or substance in respect o1 which the declaration is required, in letters of the prescribed size: ^ice" means the product obtained by freezing potable water which hat been kept, stored and delivered under such hygienic conditions as to prevent contamination; “inner label” means the label on or afbxed to an immediate can or package of food, drug. cosmetic or device; “rein panel” means the principal label affixed to the package or container identifying its contents by sta’ting the name of the food. drug. cosmetic or device, the ingredients. weight. oianu- faaurer, place of manufacture and such other information aa may be required by these Regulations: "official methyl” means a method of analysis or examination designated as such by the Minister for use in the administra- tion of the Act: 4 “outer label” means the label on or affixed to the outside of a package of a food. drug. cosmetic or device; “parts per million" means part by weight per million parts by weight except where otherwise stated; “per cent” means per cent by weight (weight in weight) except where otherwise stated; “potable water" means water which is clear. colourless and free from any pathogenic micro-organism. PART II. £''Oods, Drugs, Cosmetics and Devices Division !. €7enerat 3. I) A person shall not advertise any food. drug. cosmetic or device unless such advertisement complies with the requirements of the Act and these Regulations. (2) Unless specifically required to do so by any enactment, no label or advertisement shall either directly or indirecUy make reference to the Ministry of Health and Environmental Conkol or these Regula- tions. 4.—(I) A person shall not advertise any drug unless he has first been granted approval in writing by the Minister to do so. and such approval has not been withdrawn at the time of publication of the advertisement. (2) The Minister may refuse to grant approval. or may withdraw the approval granted in respect of any advertisement by notifying in writing the applicant for the approval or the person to whom the approval was granted. as the case may be. in cases where (a) he has reasonable grounds to believe that the application on which approval in respect of any such advertisement war granted contained false or misleading statements: or (fi) the advertisement in respect of which approval was given does not comply with the requirements of these Regulations. 5.—(I) Any information required by these Regulations to be included on a label shall be clearly and prominently displayed thereon, so as to be readily discernible to the public under normal conditions of purchase and of use. (2) For the purposes of paragraph (I). the name by which any food, drug, cosmetic or device is generally lmown consisting of more than one word shall be deemed to be clearly and prominently dis- played on the main panel of the label if each word other than articles, THE FOOD AND DRUGS 2t GULATIONS, 1975 conjunctions and prepositions, is in identical type and identically dis- played. 6. All information required by these Regulations to be declared shall be in durable characters, and in boldfaced capital letters written in such colour or colours as to afford a distinct contrast with the back- ground. Division II. Food 7. In this Division— “artificial (non-nutritive) sweetening agent” means any cheatical compound which is sweet to the taste but does not include sugar or other carbohydrate or polyhydric alcohols; “bulk container” means a container in which more than one duly labelled package of a tood and its contents are placed for wholesale purposes, but in which the packages and their con- tents are not intended to be retailed; “close proximity” means with reference to a common name, written or graphic matter placed immediately adjacent to that com- mon name: “common name” means with reference to a food, the name by which the food is generally known: “food additive” means any substance, including any source of radiation. the use of which results. or may reasonably be expected to result, in it or its by-products becoming a part of or a8ecting the characteristics of a food excepting— (a) any nutritive material that is used, recognized, or commonly sold as an article or ingredient of food; (b) vitamins. minerals. and amino acids unless added for flavourings; (c) spices, seasoning, favouring preparations essential oils, oleoresins and natural extractives; (d) pesticides; (e) food packaging materials and components thereof; and (I) drugs recommended for administration to animals that may be a source of food for human beings; “unstandardized food” means any food for which a standard has not been prescribed. & A person shall not prepare, pack, store or transport any food intended for sale in any manner which renders it injurious to health, 1 2 be taclus oa of tlus Page u autborized by k.N 2g6/ 1976j or which injuriously afiects its nutritive properties, or which renders it unwholesome. nor shall a person sell any food which has become injurious to health. which has had its nutritive properties injuriously affected. or which has become unwholesome. 9. A person shall not sell any canned food the container of which is blown or punctured, or any frozen (ood which has been thawed in the package and subsequently refrozen. 10. A person shall not use water other than potable water as an ingredient in the manufacture or preparation of any food. Labelling 11.—(1) A person shall not sell a package of food which is not labelled or which bears a label that does not comply with the pro- visions of these Regulations. (2) The provisions of paragraph (1) shall not apply to food packaged from bulk on the premises where that food is retailed. so, however. that where any food so packaged bears any statement, mark or device regarding the ingredients or the substances contained therein other than the name of the food, the name and address of the retailer and the net contents, it shall be labelled as required by the Act. IN—(1) Unless otherwise specifically provided in these Regulations, every package of food o8ered for sale shall bear a label stating legibly and conspicuously in conformity with regulations 5 and (a) on the main panel— (i) the brand name or trade name, if any: and (ii) the common name of the food; and (iü) a statement of the weight, volume. number or measure of contents: and (b) on the remainder of the 1abel— (i) a declaration of added colour, if present; and (ii) the name and address of the manufacturer. packer. porter. vendor or of any person who assumes responsibilities of the manufacturer, packer, importer or vendor and indicates in conjunction with his name and address that he is not the manufacturer, packer. importer or vendor. [¥be IacJusioa of tbîs page is autborizcd by L.l'a 286/ 1976] (2) Notwithstanding paragraph (i) of sub-paragraph (b) of paragraph (1), a list of ingredients is not required to indicate the presence of caramel as a food colour ili— (a) non-excisable fermented beverages; (b) spirituous liquors other than gin; ( ) wine. 13. Except where the quantity of the contents marked on a package of food is stated in terms of minimum weight, volume, number or measure, there shall be permitted kom the stated qimntity, variations— (a) due exclusively to weighing. measuring or counting that occur in packaging conducted in compliance with good commercial racticc (b) due exclusively to difference in the capacities of containers resulting solely from unavoidable factors th manufacturing; (c) due exclUsively to the ordinary and customary expose of the package to evaporation under usual atmospheric ditions. 14. Unless otherwise specifically permitted by these Regulations, a person shall not sell a synthetic food as substitute for any food unless— (a) it is clearly indicated on the label or in any advertisement in respect thereof that it is a substitute. imitation, artificial or synthetic food: and (b) the label of every package of such food other than imitation favouring preparations, includes legibly and conipicuomly, the common names of all the ingredients of that food in descending order of their proportionate content 15. A person shall not sell any food bearing a label which suggests or implies the presence of one or more vitamins. that the food contains vitamins. or that it is rich in vitamins, imless there is written on the label in letters of not less than eight points. the actual vitamin content per 100 grammes of food. 16. Where any colouring or any favouring has been added to any food. every package to which that colouring or favouring has been added shall bear a label including the words “artificially coloured”. “artificially favoured" or “artificially coloured and favoured”. as the case may reqifire. lTbe iocJudoa of cbis page ie authorized by L.N 386/ tP76] 17. Any colouring substance or mixture of colouring substances which is sold or packaged for use in food shall bear a label on which shall be written legibly and prominently— (a) the name or names of the colouring substance or substances present; and (b) the words “food colour” in letters of not less than inch in height. Adulteration of Foods and Special Foods. 18. A person shall not add any colouring. favouring, preservative. or anti-oxidant to any food, extender. stabilizing or modifying agent “ other than to food in its natural form. or of a standard specified in these Regulations, or add any such substance to any food or sell any food containing any such substance unless the addition or presence of any such substance is specifically permitted by these Regulations. 19.—(1) A person shall not add any artificial sweetening agent, mineral oil, para8in. mineral salt (except sodium chloride), resin. glycol derivative, coumarin or any substance containing coumarin, to any food, or sell any food containing any such substance unless the addition or presence is permitted by these Regulations. (2) The provisions of this Regulation with respect to paraPin shall not apply to chewing gum. 20. A person shall not use or sell for use in or upon a food. any ingredient. unless it is of a purity that renders it safe and appropriate for we in foods. t1. A food shall be deemed to be adultcrated if any ot the following substances or classes of substances are present therein or have been added thereto (a) mineral oil, paraEin wax. or any preparation thereof; (b) coumarin, extracts of toaka beans, the seed of Dipteryx odorata Willd. or Diptcryx oppositi—folia Willd; (c) synthetic sweetening agents other than saccharin; (f) cottonsoed 8our that contains more than four hundred and fifty parts per million of free gossypol; -, (e) fatty-acids and their salts containing toxic factors: (J) dihydrosafarole; (g) isosafrole; (h) oil of American sassafras from sassafras alkidum (nut) Necs; (f*) Oil Of Brazilian sassafras from Ocotea cymbarum H.B.K.; tThe incl-"•ir'n ofi tnis psge ii authorized by L.N 286/ 1976] 9 (j3 oil of camphor sassafras from Cinnamon camphorum sieb; (k) oil of micranthum Hyata; or (f) safrole: Provided that— (i) a food shall not be adulterated if it contains not more than 0.3 per cent mineral oil, where the normal manufacturing practices require the we of mineral oil: (ii) chewùig gum shall not be adulterated if it contains a paraffin wax base; (iü) fresh fruits and vegetables (with the exception of turnips) shall not be adulterated if they are coated with not more than 0.3 per cent paraffin wax and petrolatum, where normal manufacturing practices require the use of such coating; and (iv) turnips and cheese shall not be adulterated if they are coated with parafbn wax in accordance with normal manufacturing practice. 2A Except in the case of special formulae. bakery products. and special dietary foods. a person shall not sell a food that is represented as being for babies if that food contains a food additive. 23. Where a statement or claim implying a special dietary use is made on the label of. or in any advertisement for a food, the type of diet for which that food is recommended shall be included in such label or advertisement. 24•—(1) Special dietary foods recommended for carbohydmte or sggar reduced diets shall be foods that contain not mon than 50° of the glycogenic carbohydrates normally present in foods of the same class. except that confectionery and pudding powders shall contain not more than 70% of the glycogenic carbohydrates normally pmsent in such foods. (2) For the purpose of these Regulations a food may be de- scribed as “sugarless”, “sugar-free” or by any other synonymous term It that food contains not more than 0.25 per cent glycogenic carbohy- drates. (3) Where a statement of claim relating to the carbohydrate, sugar or starch content of any food is made on the label of. or in any advertisement for that food. such label or advertisement shall in- clude a statement of the carbohydrate content in grammes per 100 grammes or on a pementage basis. tTa• in•iu•io• or ini* page is authorized by L.x 286/ ls7sj Jg I f:IE FOOD AND DR UGIS REG(/LA TIONS, 1975 25.—(1) Special dietary foods recommended for calorie reduced diets shall be foods that contain not more than 50 per cent of the total calories normally present in foods of that same type. (2) Where a statement or claim relating to the calorie content of any food is made on the label of, or in any advertisement for that food, such label or advertisement shall include a statement of the calorie content in calories per 100 grammes. (3) For the purpose of these Regulations. a food may be de- scribed as “low-caloried” or by any other synonymous term if it contains not more than 15k calories per average serving and 30k calories in a reasonable daily intake. 26.—(1) Where a statement or claim relating to the sodium content of any food is made on the label of, or in any advertisement for that food. such label or advertisement shall include a declaration of the sodium content in milligrammes per 100 grammes. (2) The number of milligrammes of sodium contributed by a reasonable daily intake of a special dietary food recommended loz a sodium reduced diet shall not exceed one-sixth the number of milli- grammes contained in a reasonable daily intake of the same food. (3) For the purposes of these Regulations, a food may be described as “low-sodium” or by any synonymous term if it contains not more than 10 milligrammes sodium in an average serving and 20 milligrammes in a reasonable daily intake. 27.—(1) A person shall not sell a food containing a non-nutritive sweetening agent unless— (a) the label bears a declaration that contains a non-nutritive artificial sweetener and the name of that sweetener; (b) the lsbel includes a statement specifying a special dietary use: (c) that food mets the requirements for special dietary foods prescribed in these Regulations; and (f) the lsbel includes a warning that the food should only be used on the advice of a registered medical practitioner. (2) The substances listed in the First Schedule may be used as artificial (non-nutritive) sweetening agents in foods. 2$.—(1) Where a standard for a ‘food is prescribed in these Regnla- tions— THE FOOD AND DR H GS REG ULA TIONS, 1975 a) that food shall conform to the requirements prescribed in that standard; b) each ingredient shall be incorporated in the food in a quantity within the limits prescribed for that ingredient: and (c) if the standard includes an ingredient to be used as a food additive for a specified purpose, that ingredient shall be a food additive approved by the Minister for use as an additive to that food for that purpose. (2) Where a standard for a food is not Regulations— in these a) the food shall not contain any food additives other than food additives approved by the Minister for use as additives to that food for that purpose; and (b) each food additive so approved shall be incorporated in the food in a quantity within the limits approved for that food and that food additive. (3) The provisions of sub-paragraph (c) of paragraph (1) and sub-paragraph (a) of paragraph (2) shall not apply— (a) the spices, seasonings, flavouring preparations essential oils, oleoresins and natural extractives; or (I›) in any case where a standard has been prescribed under any other enactment. 2f.—(1) A person shall not use as a preservative in or upon food, or sell as a preservative for food, any substance other than those specified in these Regulations as Gass I. Class II. Class HI or Cass IV preservatives, respectively. (2) Where any Cass H, Cass IH or Cass IV preservative, as the case may be, is sold for use on food. the label thereof shall include adequate directions for use in accordance with the limits prescribed for that preservative in these Regulations. 30.—tl) The following preservatives shall be Class I preservatives for the purposes of these Regulations— (a) alcohol; (b) ascorbic acid and its salts: (c) dextrose; (d) erythorbic acid and its salts; 12 TME. FOOD AND DR UGS REtS ULATIONS, 1975 (e) glucose; (J) potassium nitrate; (g) common salt; (h) sodium nitrate; (i) spices; (j) sugar: (k) vinegar; and (2) Notwithstanding paragraph (1). sodium nitrate or potassium nitrate shall be a Class I preservative in relation to preserved meats if used in quantities not exceeding 200 parts per million of the finished product. 31.—(1) The following preservatives shall be Class II preservatives for the purposes of these Regulations— (a) benzoic acid, including the salts thereof; (b) sulphurous acid, including the salts thereof: and (c) sorbic acid, including the salts thereof. (2) A person shall not use more than one Class M pmservative in or upon any food, except in the case of methyl-p-hydroxybenzoate and propyl-p-hydroxybenzoate, where a mixture of both may be used. (3) A person shall not in in or upon any food more than— (a) 1,0(D parts per million of benzoic acid or its salts calculated as benzoic acid: or (b) l,tXD parts per million of sorbic acid or its salts calculated as sorbic acid. (4) A person shall not use sulphurous acid or its salts calculated as sulphur dioxide. in amounts greater than— (a) IU parts per million in beverages prepared for consumption in accordance with label directions: (b) 2J00 parts per million in or upon dried fruits and vcgetables; (c) 500 parts per million in or upon other food. 3L—(1) The following preservatives shall be Gass IH pmservatives for the purposes of these Regulations— (a) propionic acid. inclialing the salts thereof; (b) sodium diacetate; and (c) sorbic acid, including the salts thereof. (Tbc iocîuiôo o1 tbü psgc s autboñsxd by L.N 28d]]97@ THE FOOD AND DRUGS REV ULA TIONS, 1975 13 (2) A person shall not use in or upon a food, more than 2,000 parts per million of propionic acid or its salts calculated as propionic acid. (3) No quantitative declaration is required on the label of any Gass III preservative used on bread, bakery products, cheese, or processed cheese. 33.—(1) The following preservatives shall be Class IV preservatives for the purposes of these Regulations— (i) gum quaiacpm; (ii) vegetable oils containing tocopherols; (iii) lecithin: (iv) citric. tartaric, or ascorbic acid; (v) monoisopropyl citrate; (vi) ascorbyl palmitate: (vii) n-propyl ballate, or n-octyl gallate, or n-dodecy1 ballate: (viii) butylated hydroxyanisole: and (ix) butylated hydroxytoluene. (2) A person shall not sell a food containing— (a) any combination of Class IV preservatives that includes both propyl gallate and nordihydroguaiaretic acid; (b) any combination of Class IV prnervatives, including the sub- stance in 0.2 per cent of are dissolved. in an amount greater than finished product; (c) a combination of Cass IV preservatives that includes more than three of the following preservatives— (i) butylated hydroxyanisole; (ii) butylated hydroxytoluene; (iii) propyl gallate: or (f) any combination of the Gass IV preservatives listed in para- graph (c) in an amount greater than 0.02 per cent of the finished product. 34. A person shall not sell or use as a preservative on food— (a) benzoic acid. including the salts thereof; (b) sulphurous acid. including the salts thereof; (c) propyl gallate; (d) butylated hydroxyanisole; (e) butylated hydroxytoluene, {The Inclusion of thii page fig authorizcdq by L.hI 286J lq76J 14 Secood THE FOOD AND DR UGS REG ULA TfONS, 1975 unless the la&I of each package includes a quantitative declaration of each of the preservatives present. Food Additives 35. A person shall not sell a food containing a food additive except as provided in these Regulations. 3d. A person shall not sell any substance or mixture of substances for use as a food additive unless the label includes a quantitative statement of the amount of each substance present, and a complete list of the food additives present in descending order of their pro- portions, as well as directions for their use, which if followed, shall produce a food containing such additives in accordance with the maximum levels of use permitted by these Regulations. Poisonous Substances in Food 37• A person shall not sell any food in a container that may transmit to its contents any substance that may be injurious to the health of a consumer of the food. 38. Notwithstanding paragraph (a) of Section 5 of the Act. the foods listed in the Second Schedule may contain in or upon them— (a) any or all of the poisonous or harmM substances listed in that Schedule opposite to that food in amounts not exceeding the quantities stated therein in parts per million (p.p.m.) for that food, as determined by the official method: and [b) other poisonous or harmful substances in amounts not con- sidered by the Minister likely to be injurious to health. Division III. Drugs 39. In this Division— “adequate directions for use” includes all information as may be necessary for proper use, including cautions as to the possible adverse reactions and contra-indications; “antibiotic” means any drug or combination of drugs prepared from certain micro-organisms. or which formerly was pre- pared from micro-organisms but is now made synthetically and which possesses inhibitory action on the growth of other micro-organisms: “common name” means, with reference to a drug, the name in the English language by which the drug is commonly known; 15 “expiration date” means any date prescribed in relation to a particular drug, as the date after which that drug is not recommended for use; “generic drug” means an unpatented drug product, including a ‹ltug whose patent has expired and one which has never been patented; “generic name” means the official name or international non- proprietory nomenclature; “internal use” means ingestion by mouth or application for systemic e8ect to any part of the body in which the drug comes into contact with mucous membrane; “parentcral use” means administration of a drug by means of a hypodeimic syringe. needle or other instrument through or into the skin or mucous membrane; “pharmacist” or “druggist” means any person registcmd as such under any enactment for the time being in force relating to the registration of druggists or pharniacistsi “medical practitioner" means any person registered as such under the Medical Act or any enactment for the time being in force relating to practise of medicine; “pr" means, when used in relation to a List 4 Drug. to be sold on prescription only; “practitioner” means any dentist. medical practitioner, veterinary surgeon or veterinary practitioner registered respectively as such under any relevant enactment for the time being in force; “prescription” means an order given by a practitioner directing that a stated amount of any drug or mixture of drug specified therein be dispensed for a person named in the order: “proper name” means, with reference to a drug. the name in the English language of that drug; “teaspoon” means for the purpose of calculation of dosage, a volume of five cubic centimetres. 40.—(1) A person shall not sell. manufacture, import or distribute a drpg ualess— (a) that drug has been registered with the Ministry or Health: and (b) a fee of $25.0Q has been paid in respect of such registmtion. (2} The Minister may. in his discretioii. exempt any person or any drug from thé requirements of paragraph (1). {The inclusion of this page is authorized by L.H. l,(•t/ j99l3 la Tblrd 41.—(l) A person shall not manufacture a drug unless he has applied for and been granted a permit to do so by the Minister. (2) A permit to manufacture a drug shall be in the form set ••"• ^- out as Form A in the Third Schedule. (3) A fee of one thousand dollars ($1,000) shall be paid in respect of each product for which a permit to manufacture is sought. person licensed to manufacture a drug pursuant to regulation 41 shall not sell a drug in dosage form unless the drug has been prepared, manufactured, preserved, packaged, stored, labelled and tested under suitable conditions. (2) For the purposes of paragraph (1) “suitable conditions” require (a) that the construction, fittings and furnishings in a building where a drug is processed and packaged shall be of such material and finish as to permit the ready and efficient clean- ing of all surfaces, to prevent the inkoduction of extraneous materials into drugs during their processing and testing, and to prevent the migmtion of dust, in accordance with good pharmaceutical practices; (h) that the premises used tor the processing. testing. finishing, distribution and storage of the drug, and all auxiliary facilities, shau be maintained in a clean. sanitary and orderly con- dition, free from vermin. infestation, accumulated waste or debris; (c) in cases where drugs for parentcral use am processed, that all fillings and aseptic processes shall be carried out in a separate and enclosed area designed for the processing and hlling of such drugs and operated in a manner that will pmvent contamination of the drug to be coDlpounded and (d) that the personnel used as supervisors in the formiilation. processing. testing. packaging and labelling of drugs, and the personnel responsible for the maintenance of machinery, equipment and sanitation shall have such technical training as is deemed necessary by the Minister. having regard to the duties and the responsibilities involved: (e) that each lot or batch of raw bulk material used in the processing of a drug in dosage form shall tc tested to ensure the identity and purity of such raw bulk materials: I7 (J) that each lot or batch of a dnig in dosage form shall be tested to ensure its identity, potency and purity for its re- commended use; (g) that adequate quality controls shall used. having regard to the nature of each drug; (h) that a system of control shall be applied which will permit a complete and rapid recall of any lot or batch of the drug from the market. if necessary; and (i) thal records shall be maintained relating to each drug. in a form and manner satisfactory to the Minister showing— (i) the tests carried out on each lot or batch of raw bulk materials used in the proccssing of the drugs. (ü) the tests carricd out on each lot or batch of drugs in the dosage form; (iii) the quality controle applied; (iV) all information received pertaining to the quality or hazards of any drug; (V) th* adults Of tests to determine the stability of cach Aœ:eod I*') +* measures taken to ensure the re‹:all of unsatisfactory lots or batches of drugs from the market. (3) The records required to be maintained by sub-pamgraph (i) of paragraph (2) shall be kept until the expiration of three years from the date of the testing of each lot or batch of each drug. or until the expiration date of that drug, whichever first occurs. rind an adequate sample of each such batch or lot shall be submitted to the Minister. on his request. for analysis and examination. 43.—(1) A person shall not import a drug uaiess he has applied for and obtained permission to do so from the Minister and has paid a fee of two hundred doMars ($200) in respect of each permit bearing a maximum of ten products. (2) A person applyi9g for permission to import a drug pursuant to paragraph (1) may be required by the Minister— (a) to furnish information and evidence setisfactory to estnblish that the conditions of manufacture described in paragraph (2) of regulation 42 have been met in respect to such drug; and (6) before such drug is released for sale. to conduct tests in Jamaica by an acceptable method. on that drug in the form in which it is sought to be imported. prhe inclusion or this p48e is authorized bx L.l'l. l4Ji995] 18 (3) Where. in the opinion of the Minister. a drug. or lot or batch of drugs, does not conform with the requirements of these Regulations. the drug, or the lot or batch thereof. as the case may be. shall not be admitted into the Island for use as a drug. 44•—(1) Except as otherwise provided in these Regulations. the label of a drug shall inch (o) on the main panel of both the inner and the outer labels— (i) the proper name: or (ii) where there is no proper name, the common name; (é) on both the inner and the outer labels— (i) the name of the manufacturer or distributor of the drugi (ii) the address of the manufacturer or distributor, except in cases where the immediate contains 5 millilitres or less. when this statement need not be made on the inner label: (iii) where a drug ii intended for parenteral use. the lot number thereof: (iv) a quantitative list of the medicinal ingredients contained therein by their proper names, or if they have no proper names, by their common names. except in the case of drugs sold on pmscription; and adequate directions for use: outer label— (i) a correct statement of net contents in terms of weight; and (ii) where the drug is intended for parenteral use, the oame and proportion of airy preservative pruient there- (2) All the information required by this regulation to be included on a label shall be clearly and prominently displayed thereon. and shall be readily discernible tO the public under the customary con- ditions of pmhasc and use. (3) Where a package of a drug has only one label, that laR1 shall include the information required by these Regulations to be shown on both the inner and outer labels. (The inciu•io• or this p•ge is eutfiorimd by L.iq. i44¿ 1995j lf (4) The provisions of paragraph (1) shall not apply to the label of a drug package from bulk on the premises where the drug is retailed, except that the name of the drug shall be included on the label and where the package of a drug bears a statement, mark or device regarding the ingredients declared therein, in addition to the name of the drug. including the name and address of the retailer. the net contents and adequate directions for use, the package shall be labelled as required by these Regulations. (5) Tàe provisions of this regulation shall not apply to drugs supplied on prescription. 45. Except as otherwise provided in these Regulations. a person shall not sell to the general public for human use. a drug. other than a preparation solely for external use. unless both the inner and outer labels on such drug include a statement of the quantitative content of each drug and the recommended single and daily adult dosage, and where the dru8 is recommended for children, the statement “dose for children, as directed by the physician“. 46.—{1) Both the inner and the outur labels of a drug for which a single or daily dosage or a statement of concentration in excess of the limits herein provided has been recommended ahall include a caution that the product is to fc used only on the advice of a physician. (2) The provisions of paragraph (1) shall not apply to a drug supplied on prescription. or to the inner label of a single dose container. 47. The label of every prepacked drug shall include the cautionary phr “keep out of the reach of children”. 48.—(1) A person shall not sell a drug containing— (a) saiicylic acid or its salts. acetylsalicylic acid or its salts or salicylamide. ualess, where the drug is recommended for children, both its inner and outer labels include cautionary statements to the effect thni the drug may be administered to children under two years of age only on the advice of a physiciani (6) hyoscinc (scopolamine) or its salts. unless both its inner and outer labels include a cautionary statement to the effect that the drug is not to be used by persma sn8eriog from glaucoma or where the drug causes blurring of the vision or pressure pain within the eye: and (o) phenacetin, either singly or in combination with other drugs, unlons its label bears the following statement— 20 Pounb “CAUTION : May be injurious if taken in large doses or for a long time. Do not exceed the recommended dose without consulting a physician.” (2) The provisions of paragraph (1) shall not apply to any pre- pamtion containing a drug that is required by anyone to be sold on prescription, or for parentcral or injectable use. 49.—(1) A person shall not sell a corticosteroid drug for ophthalmic use unless— (o) the outer label of the package insert includes as part of the directions for use, the following statements— “Contraindications— Viml disease of the cornea and conjuctiva: Tuberculosis of the eye; Fungal disease of the eye; Acute purulent retreated infection of the eye. which liLe other diseases caused by micro-organisms may be masked or eahanctd by the presence of the steroid. Side ellecc Extended ophthalmic use of corticosteroid drugs may cause increased intraocular pressure in certain individuals and in those diseases musing thinning of the cornea. per- foration has been known to occur”; and (b) the inner label includes the statement required by sub- paragraph (a) of paragraph (1) or instructions to refer to the outer label or package insert for information about con- traindications and side e8ects. (2) The provisions of paragraph (1) shall not apply to a corti- costeroid drug that is dispensed by a registered pharmacist pursuant to a prescription. (3) A person shall not disseminate to a practitioner promo- tional litemturc about corticosteroid drugs for ophthalmic use unless the statements required by sub-paragraph (a) of pangraph (1) are included in the literature. (4) The provisions of paragraphs (1) and (3) shall not apply to a drug sold solely for veterinary we. List 4 Drugc 50.—(1) The drugs listed in the Fourth Schedule (hereinafter referred to as List 4 Dmgs) are hereby prohibited from being retailed except on or in accordance with a prescription from a practitioner. (The inclusion of this paee is authorized by L.l4. t44/ 199f{ THE FOOD AND DRtlGS A£G L’L. i FfONT, 1975 21 (2) A person shall not advertise any List 4 Drugs to the general public. $1.—(1) Subject to regulations 52 and 58, a person shall not sell a List 4 Drug unless he has received a prescription therefor, either in writing or verbally. (2) A person selling a List 4 Drug pursuant to a written prescription shall retain such prescription for at least two years from the date of the filling thereof. (3) A person to whom a prescription for a List 4 Drug has been communicated verbally by a practitioner shall forthwith reduce the prescription to writing (which shall be validated by the practitioner within thirty-six hours) and shall upon the filling theretor. retain that written and validated prescription for a period of at least two years from the date of hlling thereof. (4) The person reducing a verbal prescription for a List 4 Drug to writing shall indicate on the written prescription— (o) the date and number of the prescription; b) the name and address of the person for whom the drug was prescribed; (c) the name and quantity of the drug prescribed; (d) the name and address of the practitioner prescribing the drug; (e) the directions for use given with the prescription, and if that prescription is to be repeated. the number of times and intervals of time at which it may be repeated; (h the name and address ot the person receiving the prescription. if given verbally: and (g) the name and address of the person dispensing the drug pursuant to a verbal prescription which has been reduced tO Whiting. (5) A person repeating a prescription for a List 4 Drug shall record on the original prescription therefor. in respect of each repeat, the date of the repeat, the quantity of the drug dispensed. and the name and address of the person who dispensed the drug. 51A.—(1) Where a prescription directs the dispensing of a named List 4 Drug and there is available a bioequivalent generic drug which is less costly than the named drug, the registered pharmacist shall, before supplying the drug, inform the person for whom the drug is supplied or the person presenting the prescription— {The inclusion ofi this page is authorined by L.N. 144/ 19951 22 THE POOD AND DR UGS REG UL ATIONS, 1975 (o) that there is available a bioequivalent generic drug whch is interchangeable with the named drug; [b) that it is less costly than the named drug; and (c) that the generic drug will be dispensed for the one prescribed, except where the person objects or declines to accept the generic presentation. (2) This regulation shall not apply where there is a direction from the person who issued the prescripton that there shall not be any substitution. (3) Where a person is supplying a drug for which a prescrip- tion is not required and there is available a generic drug which is less costly than the one requested, the pharmacist shall, before supplying the drug, inform the person requesting the drug— a) that there is available a generic drug which is interchangeable with the drug requested; (b) that is less costly than the drug requested. 52.—(1) A person may sell a List 4 Drug on the strength of a written order duly signed, to— (o) a drug manufacturer; b) a practitioner; (c) a registered pharmacist: (d) a hospital or any nursing home duly registered under any law for the time being in force relating to the registration of nursing homes; (e) any person to whom a written order signed by the Minister has been issued. (2) A person selling a List 4 Drug in accordance with para- graph (1) shall, prior to electing the sale, verify the signature of the person signing the order if there are grounds for reasonable doubt as to the authenticity thereof. (3) A person selling a List 4 Drug in accordance with paragraph (l) shall retain the order on the strength of which the List 4 Drug was sold. for a period of at least two years from the date on whicJi the sale was elected. [The inclusion of this pa8e is authorized by L.N. 144/ 1995] THE FOOD AND DRUGS RECRULATIONS, 1975 23 53. A List 4 Drug shall not be imported other than by or for the use of— (a) a practitioner: [b) a drug manufacturer; (c) a registered pharmacist; or (d) a public hospital as defined under the Hospitals (Public) Act or any enactment for the time being in force relating to public hospitals. 54.—(l) Both the inner and outer labels of a package containing a drug represented for use primarily as a disinfectant. germicide, or antiseptic, shall include— (a) the chemical name and proportion or amount of each drug contained therein; {b) the batch number; (c) directions for use: (d) the words “For external use only” or “For internal use only”: (e) for preparations of phenolic type of natural oils other than soaps and ointments, as a declaration of the phenol co- efficient of the preparation as determined by the official method; IQ for preparations containing available chlorine. a declaration of the percentage of the available chlorine content. 55.—(1) A person shall not sell aminopyrine or dipyrone (a deriva- tive of aminopyrine) for oral or parenteral use. unless— (a) the inner label includes the follo 8 Statement— “WARNING : Fatal agranulocytosis may be associated with the use of aminopyrine and dipyrone. It is essential that adequate blood studies be made. (See enclosed warn- ings and precautions)”: and (I›) the outer label or the package insert includes the following statements— “WARl'tING: Fatal and even serious agranulocytosis is known to occur after the administration of aminopyrine or dipyrone. Fatal agranulocytosis has occurred after short term, intermittent and prolonged therapy with the drug: therefore, the use ot these drugs should be as brief as possible. Bearing in mind the possibility that such reactions may occur, aminopyrine or dipyrone should be used only when other less potentially dangerous agents are inefective”. lTbc inclusion of this page is authorized by L.N. l44J 1995) THE GOOD AND DR UGs REG ULA TIONS, 1975 “PRECAUTIONS: It is essential that frequent white blood cell counts and differential counts be made during treatment with these drugs. However, it is emphasized that agranulocytosis may occur suddenly without prior warning. The drug should be discontinued at the first evidence of any alteration of the blood count or sign of agranulocytosis. and the patient should be instructed to discontinue use of the drug at the first indication of sore throat or sign of other infection in the mouth or throat (pain, swelling, tenderness, ulceration).” (2) A person shall not disseminate to a practitioner promotional literature about aminopyrine or dipyrone unless the statements specified in paragraph (1) are included in such literature. (3) The provisions of paragraphs (1) and (2) shall not apply to preparations containing aminopyrine or dipyrone that are dispensed by a pharmacist pursuant to a prescription, or sold for veterinary use only. 56.—(1) A person shall not sell coated tablets containing potassium salts. with or without thiazide diuretics. unless the inner label of the package or the package insert includes the following statement— “WARNING: A probable association exists between the use of coated tablets containing potassium salts. with or without thiazide diuretics. and the incidence of serious small bowel ulceration. Such preparations should be used only when adequate dietary supplementation is not practical, and should be discontinued if abnormal pain, distention. nausea. vomiting or gastrointestinal bleeding occur.” (2) A person shall not disseminate to a practitioner promotional literature about coated tablets containing potassium salts, with or without thiazide diuretics. unless the statement specified in paragraph (1) is included in such literature. (3) The provisions of paragraphs (1) and (2) shall apply to coated tablets containing potassium salts with or .pñthout thiazide diuretics that are sold for veterinary use only, or are dispensed by a pharmacist pursuant to a prescription. 57. A person shall not sell a drug for veterinary unless both the inner and the outer labels include, in addition to tire requirements of regulation 61, the quantitative content of the drug; [The inclusion of this page is authorized by L.N. 144/ l995J’ except for 25 drugs in a form not suitable for human use, the words “For Veterinaiy Use Only”. 58. A person may sell a List 4 Drug on the strength of a prescription from a veterinary surgeon provided that— (a) the drug is in a form not suitable for human use; or (I›) the main panel of both the inner and outer labels carries the words “For Veterinary Use Only”. immediately following or preceding the proprietary or brand name, proper name or common name, in type not less than one-half as large as the largest type on the label. 59. Both the inner and the outer labels of a veterinary drug repre- sented as containing one or snort vitamins shall include in addition to the requirements of regulation 61— (a) a statement of the amount of each vitamin present in the drug, expressed in terms of the proper name of the vitamin in— (i) international units per gramme or per millilitre in the case of vitamin A, provitamin A. vitamin D and vitamin E: (!!) (iü) (iv) () milligrammes per gramme in the case of solid or viscous liquids, or per millilitre in the case of other liquids, thiamine, riboflavin, niacin. niacinamide, pyri- doxine, d-pantothenic acid, d-panthenol. folic acid, ascorbic acid and vitamin K; microgrammes per gramme in the case of solid or viscous liquids. per millilitre in the case of other liquids. biotin and Vitamin B12; oral units for vitamin B12 with intrinsic factor con- centrate; and the specified units per individual dose or dispensing form in the case of vitamin products put up in in- dividual doses or dispensing forms; (b) except for drugs in a form not suitable for himan use, the words “For Veterinary Use Only”. 60. A person may sell an antibiotic preparation for the treatment of cattle if— (a) the preparation is not to be used for lactating cattle and the inner and outer labels of the preparation include a statement to that e8ect: or JThe inclusion of this page is authorized by L.H. i4a/ i995j 26 THE FOOD A ND DR UGS REG ULA TIONS, 1975 (b) where (i) (ii) the preparation may be used for lactating cattle— there has been submitted to the Minister on request, evidence acceptable to him, to show the period of time required to elapse after the last treatment with the preparation, in order that the milk from lactating animals so treated shall not contain residues of anti- biotics, and that period does not exceed ninety-six hours; the main panel of the outer label of the preparation and either the inner label or a packaging insert describ- ing the antibiotic preparation includes the words : “WARNING : MiLK TAKEH FROM TREATED ANIMALS wioiiN...... 72.........HOURS APTER THB LATEST TREAT- MENT WITH AH INTR tMAMMARv M £DICAT1ON SHALL NOT BE USED IN FooD”; and the relevant space on the label is filled in witb the appropriate figure. 61. A person shall not sell any substance having oestrogenic activity for administration to poultry which may be used as food for human consumption. 62.—(1) The Minister may from time to time require the manu- facturer of a drug recommended for administration to animals which may be used as food for human consumption— (a) to file with him in respect of that drug, a submission in writing, in form and content satisfactory to the Minister, describing in detail, tests carried out to determine that no residues of the drug, other than residues within the limits prescribed by these Regulations remain in meat, neat by- products, eggs or milk obtained from animals treated with that drug; and b) to print on the main panel of the outer label of any drug recommended for administration to animals which may be used for human consumption and on either the inner label or on a package insert describing the druy, a warning that meat. meat-products, eggs or milk obtained from animals to which the drug has been administered cannot be sold as food for human consumption if they are obtained within ssh time after administration as may be specified by the Minister. (2) A manufacturer shall not sell a drug in respect of which the Minister has required a warning to be printed pursuant to paragraph (b) of subsection (1). unless that requirement has been complied with. (The inclusion of this page is authorized by L.N. 144/ 1995j THE 'OOD AND DR OGS REGULA TIOWS, 1975 27 ä3.—(l) A person shall not sell a drug in tablet form, the label of which indicates that it carries an enteric coating or a coating designed to have a similar purpose, unless the tablet— (a) does not disintegrate when exposed to simulated gastric juice for sixty minutes; and (b) disintegrates in not more than an additional sixty minutes in simulated intestinal juice when tested by the official method. (2) Where a standard of disintegration has not been prescribed for a drug in any of the publications listed in the Second Schedule to the Act or in paragraph (1) of this regulation, a person shall not sell a drug in the form of a tablet that is intended to be swallowed whole, unless the tablet disintegrates in not more than sixty minutes when tested by the official method. (3) The provisions of paragraphs (l) and (2) shall not apply to tablets containing a drug which has been demonstrated by the oföcial method to the satisfaction of the Minister to be assimilable by the body. (4) Paragraph (2) shall not apply to tablets that are described on their label as releasing the dnig at timed intervals or in sustained quantities over a period of time. New Drugs 64. In (o) Nb) (c) this Division “new drug” means— a drug that contains or consists of a substance. whether as an active or inactive ingredient, carrier, coating. excipient, menstrum or other component, that has not been imported into the Island for use as a drug for a sufficient time and in sufficient quantities prior to the 4th of August, 1975 to establish its efficacy and safety. or is a new drug in the country in which it was manufactured: a combination of twO OT more drugs, with or without other ingredients which have not been imported into the island prior to the 4th of August, 1975, in that combination or in the proportion in which those drugs are combined; a drug in relation to which the manufacturer prescribes, recommends. proposes or claims a use as a drug. or a condition o1 use as a drug, including dosage, demonstration or duration of action, and which has not been imported into the Island prior to the 4th of August, 1975, for that use or condition of use: or lTbe inclusion of this page is a uthorized br L.N. i 44 / 1995] 28 TPE FOOD AND DRUGS 2t EG ULA TIONS, ’1975 (d) any other drug which the Minister may prescribe. ä5.—(1) A person shall not import; sell. advertise for sale, or manu- facture. a new drug unless— (a) he has been issued a licence by the Minister in respect of the importing, sale, or manufacture, as the case may requise. of that new drug, and which licence has not been withdrawn in accordance with regulation 69; and (b) tte has paid an initial fee of five thousand dollars in respect of that licence instead of the registration lee imposed pursuant to regulation 40. (2) Any person desirous of obtaining a licence in accordance with paragraph (1) shall make an application to the Minister contain- g— (o) a description of the new drug, ineluding the name and address of the manufacturer thereof, and a declaration of the proper name, il any, and the name under which it is proposed to be sold; (b) a statement of all the ingredients. the route of administration, the proposed dosage. the therapeutie or diagnostic claims for the new drug. if known, a description of the pharmaceutical dosage form in which the new drug is to be sold, and any known contra-indications and side affects thereofi (c) details of the tests condueted to control the potency, purity and safety of the new dmg; (d) a dratt of every label proposed to be uscd in connection with the new drug; (e) samples of the new drug in the finished and pharmaceutical form in which it is to be sold; IJ) such samples of the eomponents of the new drug as the Minister may require; (g) a certificats from the competent authority in the country of manufacture or export certifying that the new drug is approved for use in that country and the conditions under which it may be used or sold in that country; and (A) a certifieate in the English language in addition to any other latiguage. from the manufacturer, respecting the safety of the new drug conditions of use recommended, and giving the conditions under which it may be sold. issued by an official ' body or goV'ernfrient department having authority to issue such certificate, such official body or government department 29 having the experience and facilities for testing the safety of a new drug that are considered by the Minister as adequate to ensure the safety of the new drug under the conditions of use recommended. (3) The Minister may in his discretion, refuse any application for a licence made pursuant to this regulation. or grant any such application which does not comply with the requirements of sub- paragraph (g) of paragraph f2) but is accompanied by— (a) detailed reports of the tests made to establish the safety of the new drug for the purpose and under the conditions of use for which it is recommended; and (b) such other information and material as the Minister may in any particular case require. 66. A person shall not import, sell, advertise for sale or manufacture a new drug in respect of which he has been granted a licence. if any material change has been made in respect of that new drug. in— (a) the strength, purity or quality: b) the pharmaceutical dosage form in which it is sold; (c) the conditions of use, including indications for use and the route of administration: (f) the dosage; or (e) the label, unless he makes application for a new licence in respect thereof, giving full details of the changes and the manner in which the new drug in respect of which the original licence was granted. is affected by the change. 67. Where a person wishes to import, sell, advertise for sale or manufacture, a new drug in respect of which a licence has been previously granted to another applicant. that person shall make a separate application in accordance with regulation 65. 68. The Minister shall, within one hundred and twenty days after the filing of an application for a licence to import, sell. advertise for sale, or manufacture a new drug— (a) notify the applicant whether or not his application is satis- factory: and (b1 ‘ñ so, may gmnt a licence to the applicant in accordance therewith. 69.—{I) The Minister may withdraw a licence in respect of any new drug by sending a notice in writing to that e8ect to the person to (The inclusion of this page is authorized by L.N. 144 J 1995] whom a licence bas been granted in respect of that new drug, and such a withdrawal may be made where— in) evidence obtained from clinical or other experience, or from tests by new methods or by methods not used before the approval was given, reveal that the new drug is not shown to be safe for the use represented in the application made to the Minister in respect of that new drug and on which the approval by the Minister was based; or b) the submission filed with the Minis'••-r in relation to that new drug and on which approval by the Minister was based, contained any untrue Statement of material fact; or (c) the withdrawal is necessary in the public interest. (2) Notice of withdrawal of approval in respect of any new drug shall be published for three consecutive weeks in the Gazette and in at least one issue of a daily newspaper printed and circulating in Jamaica. for three consecutive weeks. 7ti. Where any person receives any report of any unexpected side effects, injury. toxicity or sensitivity reaction associated with clinical uses, studies. investigation and tests respecting any new drug, he shall immediately inform the Minister thereof, furnishing him with the full information available. 71.—(1) Notwithstanding anything to the contrary in these Regula- tions, a new drug may be imported for the use of investigators having such technical qualifications as is deemed necessary by the Minister in the circumstances for the sole purpose of obtaining clinical and scientific data with respect to its safety. stability, dosage or efficiency, if—- a) the investigators have written authority from the Minister to carry out investigations on the new drug and the facilities for so doing; (b) before the importation. the Minister is informed of the identify- ing name or mark by which the new drug may be recognized; (c) both the inner and outer labels on any package of such new drug bear the statement “To be used for investigational pur- poses only”; (d) before the sale, the importer ensures that any person to whom the new drug is to be sold has written authority from the Minister to conduct investigations relating to that new drug, and obtains in writing from that person an undertaking that the new drug will be used solely by him or under his direction for investigational purposes. {The incluéon of this page is authorized by L.H. 144/ 1995) (2) A person who imports a new drug for the purpose of sale to any other person authorized by the Minister to carry out investiga- tions in relation to that new drug, shall keep accurate records of such sales, and shall make these records available for inspection by inspectors duly designated under the Act. 72. Notwithstanding anything to the contrary in these Regulations, the Minister may grant permission in writing to any person to import any specified quantity of a new drug, for submission as a sample with an application for a licence in relation to that new drug. 73. NOtWithst2nding any other provision in these Regulations. the Minister may grant any emergency licence to a practitioner for the importation of a new drug, the application for which does not comply with the requirements of these Regulations, if that drug is required for the treatment of an urgent case, and the Minister is satisfied that it is in the best interest of the patient for whom the drug is intended, that the importation be elected without delay. 74. In this Division— “controlled drug” means any drug listed in the Fifth Schedule and includes a mixture containing any such drug; “licensed dealer" means any person licensed to manufacture or sell a controlled drug, authorized by the Minister to have a controlled drwg in his possession, or granted a permit to import or export a controlled drug pursuant to regulations 75 and 76 respectively. 75.—(1) A person shall not manufacture or sell a controlled drug unless he has been granted a licence to do so by the Minister nor shall a person have a controlled drug in his possession unless he has authorization from the Minister to do so. (2) A person shall not import or export a controlled drug unless he has first obtained a permit to do so from the Minister. 76.—(1) The Minister may. on application therefor— (a) issoe a lioence in the form set out as Form B in the Third Schedule to any person to manufacture or sell a controlled (h) issue a permit to any person to import or export a controlled drug subject to such terms and conditions as he may think fit. {The inclusion of this page is authorized by L.N. l44J 1995] 31 Schedule. 32 THE FOOD AND DR t/ GS REG ULA TIONS, IW5 (2) A fee of $10.00 is payable by the applicant in respect of each licence or permit, as the case may be, issued pursuant to para- graph (l), in addition to any registration fee payable in respect of that drug pursuant to regulation 40. (3) The Minister may revoke or suspend a licence or a permit issued pursuant to paragraph (l) if, in his opinion, the person to whom it is issued, or any person in his employ, has violated or failed to comply with any term or condition of such licence or permit or any provision of these Regulations. (4) A licence issued pursuant to paragraph (1), unless it is sooner revoked. shall expire on the 3lst day of March next following the date on which it is issued and may be renewed by the Minister on the appropriate application being made to the Minister in respect thereof. Where a licence has been suspended it has no validity during the period of suspension. 77. Subject to the terms and conditions of his licence, and to the requirements of these Regulations a licensed dealer may supply a controlled drug— (a) to another licensed dealer or to a practitioner, if he receives a written order therefor from such dealer or pmctitioner, and he verifies the signature affixed to the order prior to supplying same; and (b) to a hospital. if he receives a written order signed by a pharmacist, practitioner or other official duly authorized by the hospital to place such an order, and he verifies the signa- ture affixed to the order prior to supplying same. 78.—(1) A licensed dealer who is a pharmacist carrying on the business of a pharmacy. or a pharmacist employed by him for the purposes of conducting that business, may supply a controlled drug to any person if— (a) the drug forms part of the stock in trade of the pharmacy: (I›) be has first received a prescription in writing authorizing the dispensing of that drug; (c) the prescription has been dated and signed by the pmctitioner who issued it; (d) the prescription includes the full name and address of the prescribing practitioner; and (e) the signature of the practitioner is verified prior to electing the sale. [The inclusion of this page is authorized by L.N. l4d f l99s) 33 (2) A pharmacist shall not repeat a prescription for a con- trolled drug unless the practitioner issuing the original prescription specifies therein the number of times it may be repeated, and the intervals at which it may be repeated. 79.—(l) Every licensed dealer and every pharmacist in control of a place of business carrying on the business of a pharmacy shall keep a separate register in relation to controlled drugs in which he shall enter or cause to be entered within 48 hours of every receipt or dispensation of any controlled drug, the following— (o) the name. quantity and form of any controlled drug received by him. the name and address of the person from whom he received it, and the date on which it was received; (b) the name, quantity and form of any controlled drug supplied, the name and address of the person to whom it was supplied. the date on which it was supplied, and if supplied pursuant to a prescription, the name and address of the person for whom it was prescribed and the name and address of the practitioner who issued the prescription; (r) the name and quantity of any controlled drug used in manu- facturing. the name and quantity of any controlled drug manufactured, and the date any manufactured controlled drug was placed in stock; and (d) the name, quantity and form of all controlled drugs in his stock at the end of each month. (2) A licensed dealer in both the business of a wholesaler dealing in drugs and the business of a pharmacy, shall keep separate registers as required by paragraph (1), in relation to each business. (3) Every licensed dealer and every phamiacist shall maintain all vouchers relative to receipts and disposals of controlled drugs in separate hles, in sequence of number and date, for a period of at least two years from the date on which each transaction took place and such vouchers shall be kept in a manner that will enable an audit thereof to be made at any time. 8ti. Eyery licensed dealer shall take all necessary steps to protect controlléd, drugs in his possession or under his control against loss Or theft and shall report to the Minister any 6uch loss or theft of a controlled drug within ten days of the discovery of such loss or theft. 81. 1) A° rson shall not sell a cosmetic which is not labelled in accordance with these Regulations. “ tT jfiElusion of this page is authorized by L.N. 144/ 1995] 34 TPE FOOD AND DRUGS REG C/ LATIONS, 1vz5 (2) Except as otherwise provided in thèse Regulations there shall be included— a) on both the inner and outer labels of a cosmetic— (i) the name, if any. of the cosmetic, and the identification thereof: and (ii) the name and address of the place of business of the manufacturer or distributor and if he bas more than one place of business. the address of his principal place of business: (b) on the label of a cosmetic a declaration of the net contents expressed in terms of— (i) weight for solids; (ü) 8uid measure for liquids; and (üi) weight for semi-solids, so, however, that in all cases 8uid measurement may be used if it conveys accurate information in respect of the net content, and is in accordance with established commercial practice, and where a hazard exists, adequate directions for safe use shall be included as well as any warning, cauticn or special direction required by thèse Regulations. 82. A person shall not sell a cosmetic on the label or in any advertisement for whicb is included any symbol or device suggesting that the cosmetic has been prepared or coinpounded in accordance with a prescription. Tbird WorœC. PART HL Administration 83. A certificate of designation to be furnished to an inspector pursuant to subsection (4) of section 19 of the Act, shall be in the form set out as Form C in the Third Schedule. 84. When tasting a sample in accordance with the provisions of section 19 of the Act, an inspector shall, after procuring a suitable quantity of the article in question, forthwith notify the owner thereof or the person from whom the sample was obtained. of his intention to have that sample examined or analysed and— [a) where in his opinion, division of the procured quantity would not interfere with analysis or examination, the inspector shell— (i) divide the quantity into three parts; (ii) identify the three parts as the owner’s portion, the sample, and the duplicate sample, and where only one part bears the label, that part shall be identified as the sample; (The inclusion of this page is authorizcd by L.H. 344/ 1995} (iii) seal each part in such a manner that it cannot be opened without breaking the seal; (iv) deliver the part identified as the owner’s portion to the owner or to the person from whom the sample was obtained, and have the sample and the duplicate analysed or examined; or (b) where, in his opinion division of the procured quantity would interferc with analysis or examination, the inspector shall— (i) identify the entire quantity as the sample; (ii) seal the sample in such a manner that it cannot be opened without breaking the seal; and (iii) have the sample analysed or examined: (c) where the owner or the person from whom the sample was obtained objects to the procedure followed by an inspector at the time the sample was obtained, the inspector shall follow both procedures specified in this regulation, if the owner or the person from whom the sample was obtained supplies him with a sufficient quantity of the article to do so. 85.—(l) A certificate of examination or analysis of an article or sample detained by an inspector shall be in the form set out as Form D in the Third Schedule. (2) Where as a result of an examination or analysis it is reported that a food, drug. cosmetic or device, would, if sold in the Island. constitute a violation of the Act or these Regulations, that food, drug, cosmetic or device, shall not be admitted into the Island, for use as a food, drug, cosmetic or device, and the inspector shall send a written report of the analysis or examination to the Collector-General and a copy of such report to the importers. 86. Where a food, drug, cosmetic or device sought to be admitted into the Island, would, if sold in the Island, be contrary to the provisions of the Act or these Regulations, the food, drug, cosmetic or device may be admitted into the Island for the purpose of being relabelled or reconditioned under the supervision of an inspector in compliance with such conditions as may be specified in the report, and where such relabelling or reconditioning is not satisfactorily carried out within three months after the report is made or such lesser period as may be specified in the report, such food, drug, cosmetic or device (The Inclusion of this page is authorized by L.H. l44J 1995) Ttdrd Pozm D• 36 shall be re-exported and, if not re-exported within a further period of three months shall be disposed of as the Minister may direct, so. however, that the Minister may, in his discretion, extend the time for complying with the conditions for re-exporting the said goods. PnnT IV. O$ences and Penalties 87. Any person who fails to comply with any of these Regulations shall be guilty of an offence, and upon summary conviction before a Resident Magistrate shall be liable to a fine not exceeding two thousand dollars or to a term of imprisonment not exceeding twelve months. [The inclusion of this page is authorized by L.N. 146/ 19951 Item Additive MR8TSCHEDULR ’metal con-niiwirirc r»eeiening agents Preparation usually added to 37 Ie z•iatioa z7 ‹z›j 1. Ammonium Special dietary foo6s recommended Saccharin for carbohydrate or su8ar reduced diets, and special dietary food recommended #0£ £€€(\I€@tt StCt Good manu- facturing practice. 2. Saccharin 5. Sodiu zs Sacckarta Special dietary foods recommended for carbohydrate or sugar reduced diets, aod special dietary food zecommcaded foF calorie reduced diets. SBCONDSCMEDULB Poisonous Suasrnncns Pee arreo Arsenic parts per million Citric Acid .. .. Tartaric Acid Cram of Tartar . . . . 1 . . 1 . 2 . . 2 2 10 50 10 50 20 50 5 ' 50 10 50 50 2 50 2 J0 2 50 2 50 10 Phosphoric Acid .. . . 4 .. 4 5 30 5 30 30 30 20 30 30 30 S/ 23 SBCOHD SCHRDULB, contd. Poisonous Sunsznnc:as Pmsurreo, contd. Sunsrwcz Arsenic m million Lead m million Copper partsm million Zinc parted million Fluorine r• million 5OdiuoD&odflOMMstmoNitM*ts . 1 1 AJuafioiuta Cozopouads 3 htarioa aod F'resb Watsc Aoiaml Products 5 1 2 10 50 SO 2 20 50 30 2 10 SO 50 2 10 2 152 2 7 SO 2 Frmb Vegetable .. .. .. Dried Herb and SQ . . .. Apple Juice, Cider, Wine and liner .. Fruit Juice ezcept Apple JR .. 8svaza es aa Cossutaed aod Bottled 1 2 2 s 0.2 0.1 2 30 2 7 30 20 50 to 50 50 0.5 2 0.2 2 Water . . . Tm .. .. . . Rdible Bone Mol . . .. 0.1 0.2 10 10 2 150 20 150 6X {The incluaim of thls pcge ii authorized by L.l4. 144/ l993j 39 Pot A the f'ook and Drugc Act Permit to Manufacture a Drug (Regulation 41 (2) ) Is Harrow Li sun, subject to the provisions of the Pood and Drugs Act, and the Regulations made thereunder, and to the subjoined conditions, to manufacture at premises situated at— .......... ........... ................................... ............ .. . ...... .......... . ...... . .... .. . . .... . . .... . .... . ...... ... .... . ... . . .. . . ... .. foVowing— ...... ........ .... ............. . . . . ... . ................ ... ............. ..... ......... Conditions 1. This Licence shall expire on the...............day of................................. Name and address of Licensee. 2. This licence ie not tmnsferable. 3. The Minister of Health may at any time revoke this licence failure of the licensee to comply with all or any of the conditions therein, or in the Regulations. coataTacd 4. Nothing in this licence shall be deemed to anthorim the licensee to keep any drugs or poisons for the purpose of sale. Datad at........................tbis............day of.................................I9.......... (Regulation 76 (1) ) Licence to Manufacture or Sell a Controlled Drug ’ ””””“ ”"”"“””“””””“"“"””““’”””"”””“"““”"”"““““““”“””””“’ address of Licensee. Is Haneav Licausao, subject to the provisions of the Food and Drugs Act and the Regulations made thereunder, and to the aubjoined conditions, to manufactureJ sell the controlled druge eet out hereund Exact description of drugs to be manufac- tured /sold. Quantity of drugs to be fared /soId. .. . ......... . . .. ............... .................. .......... .... . . ... . ... ..................................... ... ..... ......... . .. .................... ............ .... ......... .................... .........................•....... Conditions 1. This Licence shall expire on the 31et day of March, 19........................ 2. The Minister may mvoke at any time this Licence upon failure with all or anr of tin conditions contained themin, or in Regulation 3. This Licence is not transferable. Dated at........................this............day of.................................19.......... ..................................................................... Minister of Health end Environmental Control. Foes C (Regulation &t) The f•ood and Drugc Act Certificate of Doignation of Inspector This is to certify that jar.J Mrs.JMiss.......................................................................................... ba6 bem dcsigaatcd aa Zospector for tbc purposaa of section J7 of tbc Pood aad Drugs Act Minister of Health and Environmental Control. persoa duly dmigaatad aa inspector/analyst uadcr tbc Pood aod Drugs Act o bcrcb csrtit THE FOOD AND DRUGS REGULATIONS, 1975 41 THIRD SCHEDULE, contd. (1) that on the...........................day of....... ,. ,................................l9. ,. I received from........................................... ..............,......a sealed package, which said package was unopened and the seals thereon unbroken; (2) that I broke the seals and opened the said package and removed therefrom a sample, submitted as a sample of............................. , ................................... taken from...... .............................................of............., ........ ......................, ....... (3) that 1 duly analysed or examined the said samplt for the purpose of determining if same conformed to the requirements of the Food and Drugs Act, and the Regulations made thereunder, and 1 obtained the following results— Dated this....................... ....doy of... ... .......... ...................................19............ Acebutolol Hydrochloride Acetocoumarol Acepromazine Acetanilide: Alkyl Acetanilides Acetazolamide Sodium Acetohexamide Aeetomtnaphthone Acetrizoic Acid and its salts Acetyl Choline Acyclovir Adenosine and its salts Adipiodone and its salts FOURTH SCHEDULE LIsT 4 DeUcs Part I A (Regulation 50) Adrenaline Tartrate (1-1000 Injection) Adrenocorticotrophic Hormone and its derivatives Alclofenac Allopurinol Allylisopropylaoetylurea Almitrine Dimesylale Alphadolone Acetate Alphaxalone and its salts Alprazolam Alprenolol Hydrochloride Amantadine Hydrochloride and Sulphate 42 THE FOOD AND DRUGS R2fGUE TIONS, 1975 FOURTH SCHEDULE, contd. A, contd. Amidopyrine; ite Salts and Derivatives; except when contained in ointmmts or in preparations for the prevmtion and treatment of disease in poultry. Amiloride Hydrochloride Amino-Acids; preparations for Intravmous Administration Aminocaproic Acid Aminoglutethimide Aminopentamide and its salts Aminophylline Aminopromazine Fumarate Aminopterin and its salts Aminosalicyclic Acid and its salts Amitriptyline Hydrochloride Amoxapine Amphetamine and its salts Amrinone Anaesthetics; for ophthalmic or parenteral use, including— Amethocaine and its salts Benzocaine and its salts Butacaine and its salts Cinchocaine and its salts Cyclomethycaine and its salts Dimethisoquin and its salts Diperodon and its salts Lidocaine and its salts Piperocaine and its salts Pramoxine and its salts Proxymetacaine and its salts Androgenic, Oestrogenic and Progestational Substances; their Esters (except when combined as an Oral Contraceptive) including— Allyloestrenol Benzoestrol Boldenone Chlormadinone Clomiphene Conjugated Estrogens Dienoestrol Diethylstilboestrol Dimethisterone Dydrogesterone Epioestriol Ethinyloestmdiol Ethisterone Elhyloestrenol Ethynodiol Fluoxymesterone Gestronol Hexoestrol Gcstodene Medrogestrone Hydroxyprogesterone MCgCStfOl Lyngestrenol Mestranol Medroxyprogesterone Methandriol Mesterolone Methyloestradiol Methandienone Nandrolone Methenolone Norethynodrel Methyltestosterone [Ne Inclusion of this page is authorized by L.N, 33A/2005) Notethaadrolone Noretbisterone Stilboeatrol Antazoline and its ealts Antihaemophilic Pactm Apramyoia Atrocrium Bmylato Atropine and its salts a »a« Amcyclonol Hydrochloride Aza one B—Aminopropyl' and analogues except Bpbedrine• g'forepbcdriac Bad PrmalyzlñAe. Allobarbitone Bartiitone Butobarbitone Heptabarb’itone Metbarbitono tt'ieaibarbitonc Sect›utobar6itono Via0arbitono Ontradiol Occtroac Oxyrrietholone Staoozelol Teotoetcrone FOURTH RXi RD UIm, contd. B, contd. Barium Sulphate Beclamide Belladonna and its alkoloids Benactyz jne Hydrochloride BeDcyclaoe and its salts Bendazac and its salts Bendrofluazide Benfluorex Hydrochloride Benserazide HydroChlo ride Benzetimide Hydrochloride Benzhexol Hydrochloride Benzocaine Benzoyl Peroxide (l0>) Benzphetami ne Hydrochloride Benztropine and ite Homologuee, their aalts Benzydamie Hydrochloride Bemegride Betahistine and its salts Betaxolol and its salta Bethanidine and its salta BiporJdeo and its salts Bitolterol and its salts Bromazepam Bromhcxine and its sale Bromocryptine end its salts Bronvaletone Broxaldine Broxyquinoline Buclosamide Bufiomedil Hydrochloride Bumetanide Buphenine Hydrochloride Buspirone Hydrochloride Busulphan Hydrochloride Butaperazine Hydrochloride Butorphanol Tartrate Butryptiline Hydrochloride {Tbe iaclusioa of tbis page Is autborizeü by L.N. t44/ t995] Calciferol #5 FOURTMSCHEDUL ooud. c Calcium Disodium Versenate Injection Calcium Gluconate Injection Calcium Iodide Injection Calcium Sodium Edetate Cannabinoids (of Cannabis Sativa) Gaptodiamine and its salts CaptoPril Carbamazepine Carbachol Carbamide Oarbeaoxolone and its aalts Carbimazole Carbidopa AcetyloarbyooiaJ Allylisopropylacctylurea Oictby1broœacetao›idc Carisoproüol Carphenazine and its salle Cefroxadine Ccftazidime Ceturoxinin Cephapirin Sodium Cetylpyridinium Càenodeoxycholic Acid Choral and its derivativœ Chloralose Cbloral Hydrate Chloralodol Chlorambucil and iti salta and derivatives Chloracyzine (exoept preparations for external u8e only) Chloradiazepoxide and its mite Chlorhexidioc end ite mlte Chlorisondamine and its calts Chlormethiazole and its mlts Ohloroquin and its nelts Cblorotbiazide and iii Jts and derivatives 46 C, contd. lorphentermine Ttydrochloridc Chlorphenozamine C1(lorpro£r1 eine and it• saltg C1i1orpropamid• ana its saits C lorprotbixene and ig aalp Chlorquinaldol C'b1Or O afo ny °le*tYraOtine and its aalis Clebopride Acid halo te Clemstine and its rafts Clidinium Bromide Clioquinol Clobamm Cl6benzorex Clobetasono Butyrate Clofibrato Clooñpbene Cl‹xnipraminc Hydcocl£toride Clonazejum Clonidino Hydrochloride Clopenthixol Hydrochloñde Goprostcnol Sodium Clorazopate Sodium Clotrimazolo Clocortolone c inclusion ct this is autb‹u•lzcd 47 Cortisonc FOURTH SCHEDULB, could. C, could. Hydrocortisong (Ot'her than /. § % BRd l lo H ydrocofi- tisonr Cr€am aad 0•5% and 1 $ Hydrocoitisone Desoxymethasone Dexamethasone Diflucortolone Fluclorolone Flumethasone Cotrimozazole Cromoglycato Sodium Cromoglycic Acid aOd ik 8Rlts Crotamiton Cyclandelate Cyclobenzaprine Cyclopentamine Hydrochloride Cyclopenthiazide Cyclophosphamide Cycrimine and iti salts Cymevene Cyproterone and ik salts Cytarabine and its salts Oantrolene Sodium Oapsonc Debrisoquine Sulphate Dcmccarium Bromide Deproteinised Extract of Blood Dequalinium dethylprednisolone Mometasone PredinisOlOnO Prcdnisono Triamoinolooe Deslanoside Desmopressin Acetate Desonidn Dexfenfluramine and its mite @pgtrppropoxyphcne Hydrochloride Diaphenylsulfone Diatrizoale and its salta Oiazepam Oiazoxide and its salts Dibasic Calcium Phosphate Dicblorpbtnamide and its nalti Dichlorvos Diclofenac and ita salts (other than Diclofcnac topical preparation) inriusion of tliii o ii authorized b L. 'i. S4 2igD 48 FOURTH SCHEDULE, coned. Diethylcarbamazine Citrate Diethylpropion Hydrochloride Diflorasone Diacetate Digitalis, its glycoside or derivatives, or preparations including Acet¥ldigitoxin Digitoxin Acetyldigoxin Digoxia Deslanoslde Lanatosidc Digitalis Leaves Dihydroergocristine M aleate /Clopamide / Reserpine Dihexyverine Hydrochloride Dihydralazine and iti saltn Diltiazem and its salts Dimenhydrinate Inspection Dimethyl Sulfoxide Diminazcne Aceturaie Dinoprost and iti nalts Diosmin Diphenidol Hydrochloride Diphenoxylate ’I-lydrochlorido Dipyridamole Dipyrone and its salti Disopyramide and in ulk Disulñram Dobutamine Dopamine Hydrochloride Dothicpin Hydrochloride Doxepin and its calta Droperidol and iti salti Drotaveriae and its salti Diflucortolone Echothiophate Iodine Econazole Nitrate Ectylurea Edrophonium Chloride Electrolyte Mixtures Emylcamate Enalapril Maleate Endralazine Enzymes, including A mylolytic Lipolytic Cellulolytic Mucolytic Febrinolytic Proteolytic (The inclusion of this pegs is authorized by L.II. 54/ ) 49 g, con/d.” Epbcdrtae Hydrochloride doses of 30mg or aore Ephedrine Sulphate Injection Epinephrine and its saIt8 Rthacrynic Acid Ethambutol Hydrochloride Ethchlorvynol Etbinamate Rthionamide flthoheptañne bitrate Ethosuximidc Ethylchloride Etkyleaediatafise Ethylefrine and iti aalts Etodolac Etrotinate Ergot, its alkaloids and their ealts including— Dihydroergotamine Ergometrine Ergotamine Ergotoxine Famotidine Felyprensin Fcnfluramine Hydrochloride Feniproetalme Fcn'metozole Fenoprofen and its salta Penotcrol and ita aalts Fentanyl and its ealts Fentiamc and ito aalta Folic Acid Flavonoids (Extracts from Rutaceae) Flavoxate and its 8<$ Flecainide and its salts Flucytosine Flunarizine and its ealta Fluocinlone Fluorouracil and its derivative Fluoxetine and its aalla Flupentixol and its salts Fluphenazine and its salts tTae inclusion of tors p•ee is authorized br L.H. 144/1995) 50 Fliapirilene Plutauiide Puraltadone Hydroobloride Furazolidone urosemide Prusemide Gom6tirozil Gcstodeoe Glibenclamido Glucegon and ita ealtn Glutamic Acid and ita aalts Glutethimide and ira aalts Glycopyrronium and ito alte Gosadotropkta Guaoabaox testate Halomnetason Haloperidol Halothane Ttetmrin and its derivatives Hexamethonium and its naita Hexapropymate ilistapyrodine and its salto Homatropioe and its aalts HyaluronÌdaso Mydaotoia Dezivativaa HydraJaaioe aad its mlts THE FOOD AND DRUGS REGULATIONS, 1975 51 Hydrochlorothiazide Hydroflumethiazide Hydroxypropyl Cellulose Hydroxyzine and its salts Hyoscine and its salts Hyoscyamine and its salts Hypromellose FOURTH SCHEDULE, contd. H, contd. Ibuprofen and its salts except strength 200mg Idoxuridine lfosfamide lmipenem Imipramine and its salts Immunoglobulin Antihepatitis B Anti-D RHo Tetanus Immune Globulin lndapamide Indomethacin lndoramin and its salts lnosine Pranobex lnositol Inosine Insulin Interferon (alpha 2a rbe) lohexol lopidine lopromide lotrolan Ipratropium Bromide Iproniazid and its salts Iron Dextran Iron Sorbitol Isocarboxazide Isoconazole Nitrate Isoetharine HydrocHoride Isometheptene and its salts Isoniazid and its ealts lroprenaline Hydrochloride Isosorbide and its salts Isoxsuprine Hydrochloride Isradipine Itraconazole Ketamine HydrocHoride Ketazolam K (Tha In*luaion of itis puge is authorized by L.H. 33A/2003 THE POOD AHD DRUGS REGULA TIONS, 197J Ketoconazole Cream 2% Ovules 400mgn Shampoo 2% Suspension 200mg/m1 Tablets 200mgn Ketoprofen Ketotifen and its salts Labetalol HydrocHoride Lanatoside Latamoxef FOURTH SCHEDULE, contd. K. contd. L Levamphetamine and its salts Levodopa and its salts Levonordefrin and its salts Lidoflazine Liothyronine and its salts Lisinopril and its salts Lithium and its salts Lomustine Loperamide and its salts Lorazepam Lormetazepatn Lovastatin Loxapine and its salts L-Thyroxine Sodium Lypressin M Mafenide and its salts Mannitol Maprotiline and its sahs Mazindol Mebanazine Mecamylamine and its salts Meclozine (Meclizine) and its salts Meclofenamate Meclofenoxate Medazepain Menadiol Menaphthone (Menadione) Mepazine Mephenesin and its salts Mephentermine and its salts [The Inclusion of this page is authorind by L.N. 33A/2005] round sGœDULB, contd. M, Contd. Mcpindolol and its salts Mepivacaine Meprobamate Meptaainol and its saltß Mequitøzine Mercaptopropionic Acid Mercaptopurine Murcuric Oxide Merealyl blesalazine Mesoaline and its ealts Meioridazine and its salts Metamizol and its salti Metaraminol Tartrate Metaxalone Metfornón and its ealtø Metbamphetamine aad ita salts ' Methøpyrilene and itø øalts Methaqualone and its aalts Methenamine and its eahs Methixene and its øa1ts Methohexitone Methotrexate and its salts Metbotrimenprazine ønd ita salts ' ’ Mcthoxyfliirane Methoxaalen Methpclothiazíde Methyldopa and its salts Methylene Blue (Injection) Methylergometine and itø øa1ts Methrclothiazide Methylpentynol grid its salts Methyłlphenidate and İtS Salt4 Mcthylsergide and its salts and derivativeß Methypryon Mctoclopramide aDd its øalts Metolazonc ’ Metomidatc Hydrochloride Metoprolol Tartrate Metrizamide Metronidazole Meconazole and its salti Midazolazn Milrinone and ita øalts Minoxidil (Th*. inclusion of this pase is authorized by L.D. 144/ I99SJ Mitoxantrone and its salta Monoethanolamine Hemisuccinate labtnnetone Nadolol Nalidixic Acid and its salti Naloxone and its melts H6phazoline and ik salte Nialamide Nikethamide and ia salts Nitnzopam Nitrofuiantoin and rig mlts Nitrofurazone Nortriptyline and iti salti O—(B-tlydroxyethyl) — Rutoxde Orciprenaline and in nalti Ornidazole Orphenadrine Acetate Oxitriptylinc Oxpronolel end iti plti Ozymctbolone [¥'bc iaclustoa of tbis page k authorized by L.J"?. 24d/ 299S] THE FOOD AND DRUGS REGULATIONS, 1975 55 Oxypertine and its salts Oxyphenonium and its salte Oxytocfll FOURTH SCHEDULE, contd. O, contd. Pancreatic Pancuronium &omide Papaverine and its salts Paramethazone and its sahs Pargyline and its salts Pecazine Pemoline and its salts Penicillamine Pentaerythrtol and its salts Pentazocine and its salts Pentetrazol Pentifylline Peritolinium Peritoxifylline Pericyazine and its salts Perindopril Perphenazine Petazocine Pethidine and its salts Phenaglycodol Phenazopyridine and its salts Phendimeoazine and its salts Phenelzine and its salts Phenforinin and its salts Phenmetrazine and its salts Phenothiazine derivatives and theé salts Phenterinine and its salts Phentolamine and its salts Phenylbutazone and its salts Phcnylephrine and its selts Phenylliydantoin ita derivatives and theé salts P}teny1propano1amine and ita salts Physostigmine and its eahs Pilocaipine aad its salts P-lnactivated Luetobacilli Pindolol 56 THE '•OOD AHD DRUGS REGULATIONS, 1975 FOURTH SCHEDULE, contd. P, contd. Pipercuronium and its ealts Pituitary Gland and its principles Plasmin Potassium Iodide (Oral Doange Forms) Prasterone Prazinamide Pruzosin and its salts Prednisolone, Prednisone Prenylainine and its salts Primidone Probenecid Procainamide and its salts ProcHoiperazine and its salts Procyclidine and its salts Promazine and its sahs Promethazine and its sahs Propanthelino and its salts Propoxyphene and its salts Propofol Propranolol and its salts Propylthiouracil and its salts Prostaglandin Protriptyline and its salts Pyrazinamide Pyridostigmine and its salts Pyrrobutamine and its salts Quinapril and its salts Quinethazone Quinfamide Quinidine and its salts R Ranitidine Injection 50 mg/5m1 Syrup 150mg/10m1 Tablets 150mg and 300 mgn Rauwofiia alkaloid of, and theé sahs, including— (The Inclusion of ihis pege is euthorired by L.i'4. 33A/2005) 5T FDURTH SOHEDULI8, contd. R› contd. Raubasine Rescinnamine Reaerpine Rimetcrol Hydrochloride Roxaudine and its salts Rutoside Roxatidine Acetate Hydrochloride Salbuinmol and its salt• Selegiline end ite aalt8 Immune Soruei Globulin Jpmial 5ertgn Gl66u£in Sodium Aurotbiottlalato Sodium Caloiwodetate Sodium Hyelurooate Sodium lodids Sodium Nitropruseide Sodium Polyatyrene Sulfonate Sodium Tyropan‹mto Sodiinn Valprnete Parcntwal Solutions of— Mannitol Sortiitol Potaaaiuaz Chloride b&um CMondc 6orbide Nitrate S.ota1ol and its cait6 Sparteine and its selto Spironolactone Stanozolol Sucralfatc Su1'butiamine {The incitision 9f this papo is authorlmd by L.1'4. 144/ 1993) 58 F URTH SOHED'ULR. contd. S, cenfd. Sulphonamides and their aalts and derivative» including— Mafc0idc Sulpbabczamidc Sulphadiazine Sulphadimethoxine Sulphadimeratijje Sulphadoxine Sulphafurazole Sulphaguanidine SNpbamehaioe Sulphaoiethizole Sulphamethoxazole Sulphamethnxyp.yrid; fine Sulphamethoxydiazine Sulphametrole Sulphaoilamide Sulpttanitran Sulphaphmazole Sul a idine Sulptiaquinoxaline Sulphasalazine Sulphathiamle Sulp1ti* P ** Suiphonal and al¥yl suiphonale SuprareDal Glands Medulla its active prineiply and their palto Suxamethonium and ita sala Tamoxinfen and its salts Tenoxicam Terconazole Tertatolol and its aaltg Tetanus Antitoxine Tetrabenazine and its ealta Theophylline and iti calts Tbiacetarsainide Sodium Thjocarlide Thìooolchicooide (Tht inclusion o( his page is authocixed by L.l'4. 14A/ 199$] $9 FOURTH m£teDULS, confd. Tbiopentone Sodium Thiothixene and its aalts Thiouracil and its derivativn Thyroid Glands, its active ptinciplo, tlieir gulta Thyroxine end its calts Tiamulin and itfi salts Tiaprotenic Acid and 'its salte Ticarcillin toisodium TicRtone Timolol and lto salto Tinidazole Tofizopani Tolazamide Tolazoline and its Calt6 Tolbutno ide and it• •alt• Tamoxifen Acotate Zi&ZOnitirn Toxoiara Antigen TranylcypromÎne and itG salts Tr etjDo in Triacetarsamide Sodium TriamRrene and its alte Triazotam Tribromoothanol Triohlorniethiazidc Trich1orocthyle•e Triflucidine Trifiuperidol aud ite salts Tri8upmmazioo and its salt« Triibexyphenipyl and iti mlts Trilostane Trimetaphan Cdmuylate T rimotBudione Ț nmetbazi dinp and jt4 mlts Trimethoprăn Trim»prazine and its salia Triinpraeiine end ito sub Tromethamine Tropicamidc (The inc ron gf tbi• pagc is autherized by L.N. 144/ l99J) FOURTH HB- EOULE, con/‹f. Tubocurarine Chlorido Tybamate Tylosin Intermediate Tyrothficin VAOCINRS Bursal Discasc Vacctae Killod Canine Distemper — Adenovirua The 1 Oanine Distemper — Hepatitis Vaccine Canine Distemper — Hepatitis with Leptoepira Clostridiurq — Chauvoei — Septicum — Novyi — Sordelli — “ i•erfringens Types C + D Baoterin Toxoid C1ostr¡dium Chauv‹iei — Sopticum Pasturella Hnemolytic Mnltocida Coryza Vaccine Diptheria and Tetanus £' etc ipnr] Hepatitis /iParainfluenza and ptoepira Fow1 Pox Vaccino Gas Gangrene Antitoxin Killed E. Coli Culture Killed Virui flsquine Rhinopneumonitis Marok’s Diseaec Live Turkcy› Herp Virua ›Meas1es, Mumps, Rui›ella Live Vaccino Newcastle Bronchitis Dismse Newcastle Disease Vaccino iNewcastle Disease Water Vaccino Parvovirua Vaccine i•igeon i•ox Vaccine Pneumococal Vaccine Tetanus Antitoxin Tetanus Toxoid Tetanus Vaccine Tu'borculin HPD Valmitrine Vecuronium Bromide Verapamil and its salte Vinblastine and its salts Vinoamine and its Mlts Vincristine and its salts Vinpocetine Vitamin A for internal or iparenteml use in human, with a daily dodge of more than l0,tXD International unite. Vitamin B-12, with Intrinsic Faotor Oonceuitrate (for parenteral used Vi'tamin D, for internal or parenteml use in human, with a daily dosage of moore than l,ffD intcmational unia. {Thé incltision of this Page is 'eGthorized by L.N. 144/1991] THE FOOD A?"fD DRUGS REGUSATION 3, 1W5 61 FOURTH SCI-tRDULE, corifd. V, conld. vitamin E, (dl-Alpha Tocopherol) Vitamin K Warfarin and its salts Xantinol and its salt6 Zeranol Zidovudi•e zi•• Sulphate Zopiclone zoxazolaniine and its balta Zuclopentóixol Ac&ate Anti'bioti.$ i4• •*=*g tbq tollowing and &eir eal*s and derivaiives— y ¡ppmycIn-D nmikucin oxycillin phomycin Afnphotef iciD pieillin raaiycin BacampicilliD Bacitracin B»oethamine Penioillin Benzatbnc Penicillin Bcnzyl Peni CAròenicilIin Cephazolin ChlOPàTDQÒCttÍHl Chlorietracycline Cinoxacin Clindamycin Clomocycline Cloxacillin CoEetin Demeclocyeline Oihydroetreptoatycin Doxorubicin Erthromycin Floxaoülin Framyce’tin Cofamandole Gephalosporine Fusidic Acid gt(g Gentamiciii Jytp p Gmmicidin Cephalexin GiSBOfttlVifl C»pha1oridine Kanamyoin Cephalothin Lincomycin Gephapirin Meclocyclinc lThe inclusloo of tbis past ia authorined by L.N. 54]2tD0J 62 Methacycline Methicillin Minocycline Neomycin Novobiocin Nystatin except Topical Preparation Oleandomycin Oxytctracycline Paromomycin Penicillin G & V Phenoxyuiethyl Penicillin Pivmecillinam Polymyxin B Potassium Clavulanate Potassium Penicillin Rifampicin Rolitetracycline Roxithromycin Salinomycin Spectinomyoin Spiramycin Streptomycin Tetracycline (other than 3% Tobraaiycin Ty1‹min Tyrothricin Vancomycin Morphine and iti salu, 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); Cocaine (including synthetic cocaine) and ecgonine and their respective salti, and any solution or dilution of cocaine or iti salti in an inert substance, whether liquid or aolid, containing any proportion of cocaine, and any pm- pamtion, admixture, extract or otlher sñbotance (not being auoh a solution or dilution as nffiresaid) containing not less than one-teirth of one per cent of ‹x›caine or any proportion of mgonine; Acetyldtitydrocodeinone Atphaprodine Botaprodine Dietliylthianibutene Dihydrodesoxymorphine (also known as desomorphine) Dihydromorphine 1 : 3—Dimet1iy1—4-pheny1-4-propionyloxyhexamet1iyleneimine Dimethylthiambutene Dioxaphetyl butyrate (4-morpholino—2: 2—diphenyl ethyl butyrate) Didipanone Ethylmetliylthiambutene Hydrocodone (also known as dihydrocodeinone or dicodide) Hydromorphone (also known as dihydromorphinone or dilaudide) Hydroxypethidine Isomethadone (aleo known as isoamidone) Ketobemidone lTbe inclusion of this page is authorized by L.l'4. S4/20(Dl ,63 Lcvomethorphan Lnvorpbanol Methadol Methadone (also known as amidone) Mcthadyl acetate Methyldesomorphine (6- methyl —6-desoxymorphine) I—Methyl—4-phenylpiperidine-4-carboxy1ic acid isopropyl ester Metopon (also known as methyldihydromorphinone) Morphine-N—oxide (also known as genomorphine) Normethadone Oxycodone (also known as dihydrohydroxycodeinone or eucodal) Pethidine Phenadoxone “ Phenomorphan (3-hydroxy—N-phenethy1morphioan) Racemethorphan Raccmorphan Thebaine The esters of morphine (other than diac•ty1morphine), ecogonine, Oxxcodone. hydrocodone, hydromorphone, acetyldihydrocodeinone and dihydromorphine; the ethers of morphine (other than bonzrlmorphine, codeine, ethylmorphine, and pholcodine); the morphine-N—oxide derivatives, and any other pentavalent nitrogen morphine derivatives Amphotericin B Bacitracin Cephaloridine Chloramphenicol Chloramphenicol and its salts Colistin Sulphate Cycloserine flrythromycin Framycetin Griseofulvin Kanamycin sulphate Lincomycin hydrochloride Wo omycin Novobiocin Nystatin Paromomycin sulphate PenicGillin Lisr 4 DRUGS P rf Jff Benzyl penicillin sodium or potassium salt Procaine penicillin Fortified procaine, penicillin and other long-acting preparations Benzathine penicillin Phenoxy-methyl ;mnicillin Penicillin V, free base or potassium salt or calcium salt Phenbenicillin Phenoxybenzyl penicillin Propicillin potassium Cloxacillin sodium Methicillin sodium Ampicillin Polymyxin-B sulphato Ristocetin Spiramycia Stroptomycin sulphate Streptomycin penicillin mixtures Dibydro-stinptornycin Sulphomyxin sodium Tetraeyclines Chlortetra-cycline Tetracyclino Demethylchlor-tetraeycline Lymeoycline Methacycline Triacetyloleando-iapcin Tyrothricin Vancomycin Viomycin sulphnto Vioinycin p ntotheoate and sulphate FIFZTE SCHSDULS Controlled Date Couiziarin Dinitrobeng e Lysorgic Acid Dietbyla ide Tetrahydrocannabinoe TTDo Duomo ef Un pm• B eutb‹sùmé by t.N. l4NJ]99X