0A4F4F9BD490A749D5437F821CF06DF1
Food and Drugs Act (1975)
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Health / Drug Usage
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p.000004: THBFOODANDDRUGSACT
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p.000004: Rao nods
p.000004: (under section 2/)
p.000004:
p.000004: Tire FOOD ñND Dnuos Rzo nose, 1975
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p.000004: (Made 6y file Minister on the 3rd d of March, I97fi)
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p.000004: PART I. De)nitions
p.000004: 1. These Regulations may be cited as the Food and Drugs Regula- tions, 1975.
p.000004:
p.000004: L In these Regulations unless the context otherwise requires—
p.000004: can” means any hermetically sealed container;
p.000004: cubic centimetre" and its abbreviated form “cc” shall be inter- changeable with the term “millilitre” and
p.000004: its abbreviated form
p.000004:
p.000004: “declared" means written on the label attached to or accompany- ing the food, drug or substance in
p.000004: respect o1 which the declaration is required, in letters of the prescribed size:
p.000004: ^ice" means the product obtained by freezing potable water which hat been kept, stored and delivered
p.000004: under such hygienic conditions as to prevent contamination;
p.000004: “inner label” means the label on or afbxed to an immediate can or package of food, drug. cosmetic or device;
p.000004: “rein panel” means the principal label affixed to the package or container identifying its contents by
p.000004: sta’ting the name of the food. drug. cosmetic or device, the ingredients. weight. oianu-
p.000004: faaurer, place of manufacture and such other information aa
p.000004: may be required by these Regulations:
p.000004: "official methyl” means a method of analysis or examination designated as such by the Minister for
p.000004: use in the administra- tion of the Act:
p.000004:
p.000004: 4
p.000004:
p.000004: “outer label” means the label on or affixed to the outside of a
p.000004: package of a food. drug. cosmetic or device;
p.000004: “parts per million" means part by weight per million parts by weight except where otherwise
p.000004: stated;
p.000004: “per cent” means per cent by weight (weight in weight) except where otherwise stated;
p.000004: “potable water" means water which is clear. colourless and free from any pathogenic micro-organism.
p.000004:
p.000004: PART II. £''Oods, Drugs, Cosmetics and Devices
p.000004: Division !. €7enerat
p.000004: 3. I) A person shall not advertise any food. drug. cosmetic or device unless such advertisement
p.000004: complies with the requirements of the Act and these Regulations.
p.000004: (2) Unless specifically required to do so by any enactment, no label or advertisement shall either
p.000004: directly or indirecUy make reference to the Ministry of Health and Environmental Conkol or these Regula-
p.000004: tions.
p.000004: 4.—(I) A person shall not advertise any drug unless he has first been granted approval in writing by the Minister
p.000004: to do so. and such approval has not been withdrawn at the time of publication of the advertisement.
p.000004: (2) The Minister may refuse to grant approval. or may withdraw the approval granted in respect of any
p.000004: advertisement by notifying in writing the applicant for the approval or the person to whom the
p.000004: approval was granted. as the case may be. in cases where
p.000004: (a) he has reasonable grounds to believe that the application on which approval in respect of any
p.000004: such advertisement war granted contained false or misleading statements: or
p.000004: (fi) the advertisement in respect of which approval was given does not comply with the requirements
p.000004: of these Regulations.
p.000004: 5.—(I) Any information required by these Regulations to be included on a label shall be clearly and
p.000004: prominently displayed thereon, so as to be readily discernible to the public under normal conditions of
p.000004: purchase and of use.
p.000004: (2) For the purposes of paragraph (I). the name by which any food, drug, cosmetic or device is
p.000004: generally lmown consisting of more than one word shall be deemed to be clearly and prominently dis-
p.000004: played on the main panel of the label if each word other than articles,
p.000004:
p.000004: THE FOOD AND DRUGS 2t GULATIONS, 1975
p.000004:
p.000004: conjunctions and prepositions, is in identical type and identically dis- played.
p.000004: 6. All information required by these Regulations to be declared shall be in durable characters, and in
p.000004: boldfaced capital letters written in such colour or colours as to afford a distinct contrast with the
p.000004: back- ground.
p.000004:
p.000004: Division II. Food
p.000004: 7. In this Division—
p.000004: “artificial (non-nutritive) sweetening agent” means any cheatical compound which is sweet to the taste
p.000004: but does not include sugar or other carbohydrate or polyhydric alcohols;
p.000004: “bulk container” means a container in which more than one duly labelled package of a tood and its
p.000004: contents are placed for wholesale purposes, but in which the packages and their con- tents are not
p.000004: intended to be retailed;
p.000004: “close proximity” means with reference to a common name, written or graphic matter placed immediately adjacent
p.000004: to that com- mon name:
p.000004: “common name” means with reference to a food, the name by which the food is generally known:
p.000004: “food additive” means any substance, including any source of radiation. the use of which
p.000004: results. or may reasonably be expected to result, in it or its by-products becoming a part of or
...
p.000014: complete list of the food additives present in descending order of their pro- portions, as well as
p.000014: directions for their use, which if followed, shall produce a food containing such additives in
p.000014: accordance with the maximum levels of use permitted by these Regulations.
p.000014:
p.000014: Poisonous Substances in Food
p.000014: 37• A person shall not sell any food in a container that may transmit to its contents any substance that
p.000014: may be injurious to the health of a consumer of the food.
p.000014: 38. Notwithstanding paragraph (a) of Section 5 of the Act. the foods listed in the Second Schedule may
p.000014: contain in or upon them—
p.000014: (a) any or all of the poisonous or harmM substances listed in that Schedule opposite to that food in
p.000014: amounts not exceeding the quantities stated therein in parts per million (p.p.m.) for that food, as
p.000014: determined by the official method: and
p.000014: [b) other poisonous or harmful substances in amounts not con- sidered by the Minister likely to be
p.000014: injurious to health.
p.000014:
p.000014: Division III. Drugs
p.000014: 39. In this Division—
p.000014: “adequate directions for use” includes all information as may be necessary for proper use, including
p.000014: cautions as to the possible adverse reactions and contra-indications;
p.000014: “antibiotic” means any drug or combination of drugs prepared from certain micro-organisms. or which
p.000014: formerly was pre- pared from micro-organisms but is now made synthetically and which possesses inhibitory
p.000014: action on the growth of other micro-organisms:
p.000014: “common name” means, with reference to a drug, the name in the English language by which the drug is
p.000014: commonly known;
p.000014:
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p.000015:
p.000015: “expiration date” means any date prescribed in relation to a particular drug, as the date after
p.000015: which that drug is not recommended for use;
p.000015: “generic drug” means an unpatented drug product, including a
p.000015: ‹ltug whose patent has expired and one which has never been patented;
p.000015: “generic name” means the official name or international non- proprietory nomenclature;
p.000015: “internal use” means ingestion by mouth or application for systemic e8ect to any part of the body in which
p.000015: the drug comes into contact with mucous membrane;
p.000015: “parentcral use” means administration of a drug by means of a hypodeimic syringe. needle or other
p.000015: instrument through or into the skin or mucous membrane;
p.000015: “pharmacist” or “druggist” means any person registcmd as such under any enactment for the time being in
p.000015: force relating to the registration of druggists or pharniacistsi
p.000015: “medical practitioner" means any person registered as such under the Medical Act or any enactment for the
p.000015: time being in force relating to practise of medicine;
p.000015: “pr" means, when used in relation to a List 4 Drug. to be sold on prescription only;
p.000015: “practitioner” means any dentist. medical practitioner, veterinary surgeon or veterinary practitioner
p.000015: registered respectively as such under any relevant enactment for the time being in force;
p.000015: “prescription” means an order given by a practitioner directing that a stated amount of any drug or mixture
p.000015: of drug specified therein be dispensed for a person named in the order:
p.000015: “proper name” means, with reference to a drug. the name in the English language of that drug;
p.000015: “teaspoon” means for the purpose of calculation of dosage, a volume of five cubic centimetres.
p.000015:
p.000015: 40.—(1) A person shall not sell. manufacture, import or distribute a drpg ualess—
p.000015: (a) that drug has been registered with the Ministry or Health: and
p.000015: (b) a fee of $25.0Q has been paid in respect of such registmtion.
p.000015: (2} The Minister may. in his discretioii. exempt any person or any drug from thé requirements of
p.000015: paragraph (1).
p.000015: {The inclusion of this page is authorized by L.H. l,(•t/ j99l3
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p.000015: 41.—(l) A person shall not manufacture a drug unless he has applied for and been granted a permit to do so
p.000015: by the Minister.
p.000015: (2) A permit to manufacture a drug shall be in the form set
p.000015: ••"• ^- out as Form A in the Third Schedule.
p.000015: (3) A fee of one thousand dollars ($1,000) shall be paid in respect of each product for which a
p.000015: permit to manufacture is sought.
p.000015:
p.000015: person licensed to manufacture a drug pursuant to regulation 41 shall not sell a drug in dosage
p.000015: form unless the drug has been prepared, manufactured, preserved, packaged, stored, labelled and
p.000015: tested under suitable conditions.
p.000015: (2) For the purposes of paragraph (1) “suitable conditions”
p.000015: require
p.000015: (a) that the construction, fittings and furnishings in a building where a drug is processed and
p.000015: packaged shall be of such material and finish as to permit the ready and efficient clean- ing of all
p.000015: surfaces, to prevent the inkoduction of extraneous materials into drugs during their processing and
p.000015: testing, and to prevent the migmtion of dust, in accordance with good pharmaceutical practices;
p.000015: (h) that the premises used tor the processing. testing. finishing, distribution and storage of the drug,
p.000015: and all auxiliary facilities, shau be maintained in a clean. sanitary and orderly con- dition, free
p.000015: from vermin. infestation, accumulated waste or debris;
p.000015: (c) in cases where drugs for parentcral use am processed, that all fillings and aseptic processes
p.000015: shall be carried out in a separate and enclosed area designed for the processing and hlling of
p.000015: such drugs and operated in a manner that will pmvent contamination of the drug to be
p.000015: coDlpounded and
p.000015:
p.000015: (d) that the personnel used as supervisors in the formiilation. processing. testing. packaging and
p.000015: labelling of drugs, and the personnel responsible for the maintenance of machinery, equipment and
p.000015: sanitation shall have such technical training as is deemed necessary by the Minister. having regard to
p.000015: the duties and the responsibilities involved:
p.000015: (e) that each lot or batch of raw bulk material used in the processing of a drug in dosage
p.000015: form shall tc tested to ensure the identity and purity of such raw bulk materials:
p.000015:
p.000015: I7
p.000015:
p.000015: (J) that each lot or batch of a dnig in dosage form shall be tested to ensure its identity,
p.000015: potency and purity for its re- commended use;
p.000015: (g) that adequate quality controls shall used. having regard to the nature of each drug;
p.000015: (h) that a system of control shall be applied which will permit a complete and rapid recall of any
p.000015: lot or batch of the drug from the market. if necessary; and
p.000015: (i) thal records shall be maintained relating to each drug. in a form and manner satisfactory to the
p.000015: Minister showing—
p.000015: (i) the tests carried out on each lot or batch of raw bulk materials used in the proccssing
p.000015: of the drugs.
p.000015: (ü) the tests carricd out on each lot or batch of drugs in the dosage form;
p.000015: (iii) the quality controle applied;
p.000015: (iV) all information received pertaining to the quality or
p.000015: hazards of any drug;
p.000015: (V) th* adults Of tests to determine the stability of cach
p.000015: Aœ:eod
p.000015: I*') +* measures taken to ensure the re‹:all of unsatisfactory lots or batches of drugs from the market.
p.000015: (3) The records required to be maintained by sub-pamgraph (i) of paragraph (2) shall be kept until the
p.000015: expiration of three years from the date of the testing of each lot or batch of each drug. or until
p.000015: the expiration date of that drug, whichever first occurs. rind an adequate sample of each such batch or
p.000015: lot shall be submitted to the Minister. on his request. for analysis and examination.
p.000015: 43.—(1) A person shall not import a drug uaiess he has applied for and obtained permission to do so
p.000015: from the Minister and has paid a fee of two hundred doMars ($200) in respect of each permit bearing a
p.000015: maximum of ten products.
p.000015: (2) A person applyi9g for permission to import a drug pursuant to paragraph (1) may be required by the
p.000015: Minister—
p.000015: (a) to furnish information and evidence setisfactory to estnblish that the conditions of manufacture
p.000015: described in paragraph (2) of regulation 42 have been met in respect to such drug; and
p.000015: (6) before such drug is released for sale. to conduct tests in Jamaica by an acceptable method.
p.000015: on that drug in the form in which it is sought to be imported.
p.000015: prhe inclusion or this p48e is authorized bx L.l'l. l4Ji995]
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p.000018: 18
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p.000018: (3) Where. in the opinion of the Minister. a drug. or lot or batch of drugs, does not conform
p.000018: with the requirements of these Regulations. the drug, or the lot or batch thereof. as the case may
p.000018: be. shall not be admitted into the Island for use as a drug.
p.000018:
p.000018: 44•—(1) Except as otherwise provided in these Regulations. the label
p.000018: of a drug shall inch
p.000018: (o) on the main panel of both the inner and the outer labels—
p.000018: (i) the proper name: or
p.000018: (ii) where there is no proper name, the common name; (é) on both the inner and the outer
p.000018: labels—
p.000018: (i) the name of the manufacturer or distributor of the drugi
p.000018: (ii) the address of the manufacturer or distributor, except in cases where the immediate
p.000018: contains 5 millilitres or less. when this statement need not be made on the inner label:
p.000018: (iii) where a drug ii intended for parenteral use. the lot number thereof:
p.000018: (iv) a quantitative list of the medicinal ingredients contained therein by their proper names, or if
p.000018: they have no proper names, by their common names. except in the case of drugs sold on pmscription;
p.000018: and
p.000018: adequate directions for use:
p.000018: outer label—
p.000018: (i) a correct statement of net contents in terms of weight; and
p.000018:
p.000018: (ii)
p.000018: where the drug is intended for parenteral use, the oame and proportion of airy preservative pruient
p.000018: there-
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p.000018: (2) All the information required by this regulation to be included on a label shall be clearly and
p.000018: prominently displayed thereon. and shall be readily discernible tO the public under the customary
p.000018: con- ditions of pmhasc and use.
p.000018: (3) Where a package of a drug has only one label, that laR1 shall include the information required
p.000018: by these Regulations to be shown on both the inner and outer labels.
p.000018: (The inciu•io• or this p•ge is eutfiorimd by L.iq. i44¿ 1995j
p.000018:
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p.000018: (4) The provisions of paragraph (1) shall not apply to the label of a drug package from bulk on the
p.000018: premises where the drug is retailed, except that the name of the drug shall be included on the
p.000018: label and where the package of a drug bears a statement, mark or device regarding the ingredients
p.000018: declared therein, in addition to the name of the drug. including the name and address of the
p.000018: retailer. the net contents and adequate directions for use, the package shall be labelled as required
p.000018: by these Regulations.
p.000018: (5) Tàe provisions of this regulation shall not apply to drugs supplied on prescription.
p.000018: 45. Except as otherwise provided in these Regulations. a person shall not sell to the general public
p.000018: for human use. a drug. other than a preparation solely for external use. unless both the inner and
p.000018: outer labels on such drug include a statement of the quantitative content of each drug and the
p.000018: recommended single and daily adult dosage, and where the dru8 is recommended for children, the statement
p.000018: “dose for children, as directed by the physician“.
p.000018:
p.000018: 46.—{1) Both the inner and the outur labels of a drug for which a single or daily dosage or a statement of
p.000018: concentration in excess of the limits herein provided has been recommended ahall include a caution that
p.000018: the product is to fc used only on the advice of a physician.
p.000018: (2) The provisions of paragraph (1) shall not apply to a drug supplied on prescription. or to the inner
p.000018: label of a single dose container.
p.000018: 47. The label of every prepacked drug shall include the cautionary phr “keep out of the reach of
p.000018: children”.
p.000018: 48.—(1) A person shall not sell a drug containing—
p.000018: (a) saiicylic acid or its salts. acetylsalicylic acid or its salts or salicylamide. ualess, where the
p.000018: drug is recommended for children, both its inner and outer labels include cautionary statements to the
p.000018: effect thni the drug may be administered to children under two years of age only on the advice of a
p.000018: physiciani
p.000018: (6) hyoscinc (scopolamine) or its salts. unless both its inner and outer labels include a cautionary
p.000018: statement to the effect that the drug is not to be used by persma sn8eriog from glaucoma or where the drug
p.000018: causes blurring of the vision or pressure pain within the eye: and
p.000018: (o) phenacetin, either singly or in combination with other drugs,
p.000018: unlons its label bears the following statement—
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p.000020: “CAUTION : May be injurious if taken in large doses or for a long time. Do not exceed the
p.000020: recommended dose without consulting a physician.”
p.000020: (2) The provisions of paragraph (1) shall not apply to any pre- pamtion containing a drug that is
p.000020: required by anyone to be sold on prescription, or for parentcral or injectable use.
p.000020: 49.—(1) A person shall not sell a corticosteroid drug for ophthalmic use unless—
p.000020: (o) the outer label of the package insert includes as part of the directions for use, the following
p.000020: statements—
p.000020: “Contraindications—
p.000020: Viml disease of the cornea and conjuctiva:
p.000020: Tuberculosis of the eye; Fungal disease of the eye;
p.000020: Acute purulent retreated infection of the eye. which liLe other diseases caused by micro-organisms may
p.000020: be masked or eahanctd by the presence of the steroid.
p.000020: Side ellecc
p.000020: Extended ophthalmic use of corticosteroid drugs may cause increased intraocular pressure in certain
p.000020: individuals and in those diseases musing thinning of the cornea. per- foration has been known to occur”; and
p.000020: (b) the inner label includes the statement required by sub- paragraph (a) of paragraph (1) or
p.000020: instructions to refer to the outer label or package insert for information about con- traindications
p.000020: and side e8ects.
p.000020: (2) The provisions of paragraph (1) shall not apply to a corti- costeroid drug that is dispensed by a
p.000020: registered pharmacist pursuant to a prescription.
p.000020: (3) A person shall not disseminate to a practitioner promo- tional litemturc about corticosteroid drugs
p.000020: for ophthalmic use unless the statements required by sub-paragraph (a) of pangraph (1) are included in
p.000020: the literature.
p.000020: (4) The provisions of paragraphs (1) and (3) shall not apply to a drug sold solely for veterinary we.
p.000020: List 4 Drugc
p.000020: 50.—(1) The drugs listed in the Fourth Schedule (hereinafter referred to as List 4 Dmgs) are hereby prohibited
p.000020: from being retailed except on or in accordance with a prescription from a practitioner.
p.000020: (The inclusion of this paee is authorized by L.l4. t44/ 199f{
p.000020:
p.000020: THE FOOD AND DRtlGS A£G L’L. i FfONT, 1975 21
p.000020: (2) A person shall not advertise any List 4 Drugs to the general
p.000020: public.
p.000020: $1.—(1) Subject to regulations 52 and 58, a person shall not sell a List 4 Drug unless he has
p.000020: received a prescription therefor, either in writing or verbally.
p.000020: (2) A person selling a List 4 Drug pursuant to a written prescription shall retain such
p.000020: prescription for at least two years from the date of the filling thereof.
p.000020: (3) A person to whom a prescription for a List 4 Drug has been communicated verbally by a
p.000020: practitioner shall forthwith reduce the prescription to writing (which shall be validated by the
p.000020: practitioner within thirty-six hours) and shall upon the filling theretor. retain that written and
p.000020: validated prescription for a period of at least two years from the date of hlling thereof.
p.000020: (4) The person reducing a verbal prescription for a List 4 Drug to writing shall indicate
p.000020: on the written prescription—
p.000020: (o) the date and number of the prescription;
p.000020: b) the name and address of the person for whom the drug was prescribed;
p.000020: (c) the name and quantity of the drug prescribed;
p.000020: (d) the name and address of the practitioner prescribing the drug;
p.000020: (e) the directions for use given with the prescription, and if that prescription is to be repeated.
p.000020: the number of times and intervals of time at which it may be repeated;
p.000020: (h the name and address ot the person receiving the prescription. if given verbally: and
p.000020: (g) the name and address of the person dispensing the drug pursuant to a verbal prescription
p.000020: which has been reduced tO Whiting.
p.000020: (5) A person repeating a prescription for a List 4 Drug shall record on the original prescription
p.000020: therefor. in respect of each repeat, the date of the repeat, the quantity of the drug dispensed. and
p.000020: the name and address of the person who dispensed the drug.
p.000020: 51A.—(1) Where a prescription directs the dispensing of a named List 4 Drug and there is available a
p.000020: bioequivalent generic drug which is less costly than the named drug, the registered pharmacist shall,
p.000020: before supplying the drug, inform the person for whom the drug is supplied or the person presenting
p.000020: the prescription—
p.000020:
p.000020: {The inclusion ofi this page is authorined by L.N. 144/ 19951
p.000020:
p.000020: 22 THE POOD AND DR UGS REG UL ATIONS, 1975
p.000020: (o) that there is available a bioequivalent generic drug whch is interchangeable with the named drug;
p.000020: [b) that it is less costly than the named drug; and
p.000020: (c) that the generic drug will be dispensed for the one prescribed, except where the person objects
p.000020: or declines to accept the generic presentation.
p.000020:
p.000020: (2) This regulation shall not apply where there is a direction from the person who issued the
p.000020: prescripton that there shall not be any substitution.
p.000020:
p.000020: (3) Where a person is supplying a drug for which a prescrip- tion is not required and there is
p.000020: available a generic drug which is less costly than the one requested, the pharmacist shall, before
p.000020: supplying the drug, inform the person requesting the drug—
p.000020: a) that there is available a generic drug which is interchangeable with the drug requested;
p.000020: (b) that is less costly than the drug requested.
p.000020:
p.000020: 52.—(1) A person may sell a List 4 Drug on the strength of a written order duly signed, to—
p.000020: (o) a drug manufacturer;
p.000020: b) a practitioner;
p.000020: (c) a registered pharmacist:
p.000020: (d) a hospital or any nursing home duly registered under any law for the time being in force
p.000020: relating to the registration of nursing homes;
p.000020: (e) any person to whom a written order signed by the Minister has been issued.
p.000020: (2) A person selling a List 4 Drug in accordance with para- graph (1) shall, prior to electing the
p.000020: sale, verify the signature of the person signing the order if there are grounds for reasonable doubt
p.000020: as to the authenticity thereof.
p.000020: (3) A person selling a List 4 Drug in accordance with paragraph
p.000020: (l) shall retain the order on the strength of which the List 4 Drug was sold. for a period of at
p.000020: least two years from the date on whicJi the sale was elected.
p.000020: [The inclusion of this pa8e is authorized by L.N. 144/ 1995]
p.000020:
p.000020: THE FOOD AND DRUGS RECRULATIONS, 1975 23
p.000020:
p.000020: 53. A List 4 Drug shall not be imported other than by or for the
p.000020: use of—
p.000020: (a) a practitioner:
p.000020: [b) a drug manufacturer;
p.000020: (c) a registered pharmacist; or
p.000020: (d) a public hospital as defined under the Hospitals (Public) Act or any enactment for the time
p.000020: being in force relating to public hospitals.
p.000020: 54.—(l) Both the inner and outer labels of a package containing a drug represented for use
p.000020: primarily as a disinfectant. germicide, or antiseptic, shall include—
p.000020: (a) the chemical name and proportion or amount of each drug contained therein;
p.000020: {b) the batch number;
p.000020: (c) directions for use:
p.000020: (d) the words “For external use only” or “For internal use only”:
p.000020: (e) for preparations of phenolic type of natural oils other than soaps and ointments, as
p.000020: a declaration of the phenol co- efficient of the preparation as determined by the
p.000020: official method;
p.000020: IQ for preparations containing available chlorine. a declaration
p.000020: of the percentage of the available chlorine content.
p.000020: 55.—(1) A person shall not sell aminopyrine or dipyrone (a deriva-
p.000020: tive of aminopyrine) for oral or parenteral use. unless—
p.000020: (a) the inner label includes the follo 8 Statement— “WARNING : Fatal agranulocytosis may be
p.000020: associated
p.000020: with the use of aminopyrine and dipyrone. It is essential that adequate blood studies be made. (See
p.000020: enclosed warn- ings and precautions)”: and
p.000020: (I›) the outer label or the package insert includes the following
p.000020: statements—
p.000020: “WARl'tING: Fatal and even serious agranulocytosis is known to occur after the administration of
p.000020: aminopyrine or dipyrone. Fatal agranulocytosis has occurred after short term, intermittent and
p.000020: prolonged therapy with the drug: therefore, the use ot these drugs should be as brief as
p.000020: possible. Bearing in mind the possibility that such reactions may occur, aminopyrine or dipyrone should
p.000020: be used only when other less potentially dangerous agents are inefective”.
p.000020: lTbc inclusion of this page is authorized by L.N. l44J 1995)
p.000020:
p.000020: THE GOOD AND DR UGs REG ULA TIONS, 1975
p.000020:
p.000020: “PRECAUTIONS: It is essential that frequent white blood cell counts and differential counts be
p.000020: made during treatment with these drugs. However, it is emphasized that agranulocytosis may occur suddenly
p.000020: without prior warning. The drug should be discontinued at the first evidence of any alteration of the
p.000020: blood count or sign of agranulocytosis. and the patient should be instructed to discontinue use of
p.000020: the drug at the first indication of sore throat or sign of other infection in the mouth or
p.000020: throat (pain, swelling, tenderness, ulceration).”
p.000020: (2) A person shall not disseminate to a practitioner promotional literature about aminopyrine or dipyrone
p.000020: unless the statements specified in paragraph (1) are included in such literature.
p.000020: (3) The provisions of paragraphs (1) and (2) shall not apply to preparations containing aminopyrine or
p.000020: dipyrone that are dispensed by a pharmacist pursuant to a prescription, or sold for veterinary use
p.000020: only.
p.000020:
p.000020: 56.—(1) A person shall not sell coated tablets containing potassium salts. with or without thiazide
p.000020: diuretics. unless the inner label of the package or the package insert includes the following
p.000020: statement—
p.000020: “WARNING: A probable association exists between the use of coated tablets containing potassium salts.
p.000020: with or without thiazide diuretics. and the incidence of serious small bowel ulceration. Such
p.000020: preparations should be used only when adequate dietary supplementation is not practical, and should be
p.000020: discontinued if abnormal pain, distention. nausea. vomiting or gastrointestinal bleeding occur.”
p.000020: (2) A person shall not disseminate to a practitioner promotional literature about coated tablets
p.000020: containing potassium salts, with or without thiazide diuretics. unless the statement specified in
p.000020: paragraph
p.000020: (1) is included in such literature.
p.000020: (3) The provisions of paragraphs (1) and (2) shall apply to coated tablets containing potassium
p.000020: salts with or .pñthout thiazide diuretics that are sold for veterinary use only, or are dispensed by
p.000020: a pharmacist pursuant to a prescription.
p.000020: 57. A person shall not sell a drug for veterinary unless both
p.000020: the inner and the outer labels include, in addition to tire requirements
p.000020:
p.000020: of regulation 61, the quantitative content of the drug;
p.000020: [The inclusion of this page is authorized by L.N. 144/ l995J’
p.000020: except for
p.000020:
p.000025: 25
p.000025:
p.000025: drugs in a form not suitable for human use, the words “For Veterinaiy
p.000025: Use Only”.
p.000025: 58. A person may sell a List 4 Drug on the strength of a prescription from a veterinary surgeon provided
p.000025: that—
p.000025: (a) the drug is in a form not suitable for human use; or
p.000025: (I›) the main panel of both the inner and outer labels carries the words “For Veterinary Use
p.000025: Only”. immediately following or preceding the proprietary or brand name, proper name or common name, in
p.000025: type not less than one-half as large as the largest type on the label.
p.000025: 59. Both the inner and the outer labels of a veterinary drug repre- sented as containing one or snort
p.000025: vitamins shall include in addition to the requirements of regulation 61—
p.000025: (a) a statement of the amount of each vitamin present in the drug, expressed in terms of the
p.000025: proper name of the vitamin in—
p.000025: (i) international units per gramme or per millilitre in the case of vitamin A, provitamin A.
p.000025: vitamin D and vitamin E:
p.000025:
p.000025: (!!)
p.000025:
p.000025:
p.000025:
p.000025: (iü)
p.000025:
p.000025:
p.000025: (iv)
p.000025:
p.000025: ()
p.000025: milligrammes per gramme in the case of solid or viscous liquids, or per millilitre in the case
p.000025: of other liquids, thiamine, riboflavin, niacin. niacinamide, pyri- doxine, d-pantothenic acid,
p.000025: d-panthenol. folic acid, ascorbic acid and vitamin K;
p.000025: microgrammes per gramme in the case of solid or viscous liquids. per millilitre in the case
p.000025: of other liquids. biotin and Vitamin B12;
p.000025: oral units for vitamin B12 with intrinsic factor con- centrate; and
p.000025: the specified units per individual dose or dispensing form in the case of vitamin products put up
p.000025: in in- dividual doses or dispensing forms;
p.000025: (b) except for drugs in a form not suitable for himan use, the words “For Veterinary Use Only”.
p.000025: 60. A person may sell an antibiotic preparation for the treatment
p.000025: of cattle if—
p.000025: (a) the preparation is not to be used for lactating cattle and the inner and outer labels of
p.000025: the preparation include a statement to that e8ect: or
p.000025: JThe inclusion of this page is authorized by L.H. i4a/ i995j
p.000025:
p.000025: 26 THE FOOD A ND DR UGS REG ULA TIONS, 1975
p.000025:
p.000025:
p.000025: (b) where
p.000025: (i)
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: (ii)
p.000025: the preparation may be used for lactating cattle— there has been submitted to the Minister on
p.000025: request, evidence acceptable to him, to show the period of
p.000025: time required to elapse after the last treatment with
p.000025: the preparation, in order that the milk from lactating animals so treated shall not contain
p.000025: residues of anti- biotics, and that period does not exceed ninety-six hours;
p.000025: the main panel of the outer label of the preparation and either the inner label or a packaging
p.000025: insert describ- ing the antibiotic preparation includes the words :
p.000025: “WARNING : MiLK TAKEH FROM TREATED ANIMALS wioiiN...... 72.........HOURS APTER THB LATEST TREAT-
p.000025: MENT WITH AH INTR tMAMMARv M £DICAT1ON SHALL NOT BE USED IN FooD”; and
p.000025: the relevant space on the label is filled in witb the appropriate figure.
p.000025: 61. A person shall not sell any substance having oestrogenic activity for administration to poultry which
p.000025: may be used as food for human consumption.
p.000025: 62.—(1) The Minister may from time to time require the manu- facturer of a drug recommended
p.000025: for administration to animals which may be used as food for human consumption—
p.000025: (a) to file with him in respect of that drug, a submission in writing, in form and
p.000025: content satisfactory to the Minister, describing in detail, tests carried out to determine that
p.000025: no residues of the drug, other than residues within the limits prescribed by these
p.000025: Regulations remain in meat, neat by- products, eggs or milk obtained from animals treated
p.000025: with that drug; and
p.000025: b) to print on the main panel of the outer label of any drug recommended for administration to
p.000025: animals which may be used for human consumption and on either the inner label or on a
p.000025: package insert describing the druy, a warning that meat. meat-products, eggs or milk obtained
p.000025: from animals to which the drug has been administered cannot be sold as food for human consumption
p.000025: if they are obtained within ssh time after administration as may be specified by the Minister.
p.000025: (2) A manufacturer shall not sell a drug in respect of which the Minister has required a warning
p.000025: to be printed pursuant to paragraph
p.000025: (b) of subsection (1). unless that requirement has been complied with.
p.000025: (The inclusion of this page is authorized by L.N. 144/ 1995j
p.000025:
p.000025: THE 'OOD AND DR OGS REGULA TIOWS, 1975 27
p.000025:
p.000025: ä3.—(l) A person shall not sell a drug in tablet form, the label of which indicates that it
p.000025: carries an enteric coating or a coating designed to have a similar purpose, unless the tablet—
p.000025: (a) does not disintegrate when exposed to simulated gastric juice for sixty minutes; and
p.000025: (b) disintegrates in not more than an additional sixty minutes in simulated intestinal juice when
p.000025: tested by the official method.
p.000025: (2) Where a standard of disintegration has not been prescribed for a drug in any of the
p.000025: publications listed in the Second Schedule to the Act or in paragraph (1) of this regulation, a
p.000025: person shall not sell a drug in the form of a tablet that is intended to be swallowed whole,
p.000025: unless the tablet disintegrates in not more than sixty minutes when tested by the official method.
p.000025: (3) The provisions of paragraphs (l) and (2) shall not apply to tablets containing a drug which has
p.000025: been demonstrated by the oföcial method to the satisfaction of the Minister to be assimilable by
p.000025: the body.
p.000025: (4) Paragraph (2) shall not apply to tablets that are described on their label as releasing the dnig
p.000025: at timed intervals or in sustained quantities over a period of time.
p.000025: New Drugs
p.000025:
p.000025: 64. In
p.000025: (o)
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: Nb)
p.000025:
p.000025:
p.000025:
p.000025: (c)
p.000025: this Division “new drug” means—
p.000025: a drug that contains or consists of a substance. whether as an active or inactive ingredient,
p.000025: carrier, coating. excipient, menstrum or other component, that has not been imported into the Island
p.000025: for use as a drug for a sufficient time and in sufficient quantities prior to the 4th of August,
p.000025: 1975 to establish its efficacy and safety. or is a new drug in the country in which it was
p.000025: manufactured:
p.000025: a combination of twO OT more drugs, with or without other ingredients which have not been imported
p.000025: into the island prior to the 4th of August, 1975, in that combination or in the proportion in which
p.000025: those drugs are combined;
p.000025: a drug in relation to which the manufacturer prescribes, recommends. proposes or claims a
p.000025: use as a drug. or a condition o1 use as a drug, including dosage, demonstration or duration of
p.000025: action, and which has not been imported into the Island prior to the 4th of August, 1975, for
p.000025: that use or condition of use: or
p.000025: lTbe inclusion of this page is a uthorized br L.N. i 44 / 1995]
p.000025:
p.000025: 28 TPE FOOD AND DRUGS 2t EG ULA TIONS, ’1975
p.000025:
p.000025: (d) any other drug which the Minister may prescribe.
p.000025: ä5.—(1) A person shall not import; sell. advertise for sale, or manu- facture. a new drug unless—
p.000025: (a) he has been issued a licence by the Minister in respect of the importing, sale, or manufacture, as
p.000025: the case may requise. of that new drug, and which licence has not been withdrawn in accordance with
p.000025: regulation 69; and
p.000025: (b) tte has paid an initial fee of five thousand dollars in respect of that licence instead of the
p.000025: registration lee imposed pursuant to regulation 40.
p.000025: (2) Any person desirous of obtaining a licence in accordance with paragraph (1) shall make an
p.000025: application to the Minister contain-
p.000025: g—
p.000025: (o) a description of the new drug, ineluding the name and address of the manufacturer thereof, and a
p.000025: declaration of the proper name, il any, and the name under which it is proposed to be sold;
p.000025: (b) a statement of all the ingredients. the route of administration, the proposed dosage. the
p.000025: therapeutie or diagnostic claims for the new drug. if known, a description of the pharmaceutical dosage
p.000025: form in which the new drug is to be sold, and any known contra-indications and side affects thereofi
p.000025: (c) details of the tests condueted to control the potency, purity and safety of the new dmg;
p.000025: (d) a dratt of every label proposed to be uscd in connection with the new drug;
p.000025: (e) samples of the new drug in the finished and pharmaceutical form in which it is to be sold;
p.000025: IJ) such samples of the eomponents of the new drug as the Minister may require;
p.000025: (g) a certificats from the competent authority in the country of manufacture or export certifying that
p.000025: the new drug is approved for use in that country and the conditions under which it may be used or sold in
p.000025: that country; and
p.000025: (A) a certifieate in the English language in addition to any other latiguage. from the manufacturer,
p.000025: respecting the safety of the new drug conditions of use recommended, and giving the conditions
p.000025: under which it may be sold. issued by an official
p.000025: ' body or goV'ernfrient department having authority to issue such certificate, such official body
p.000025: or government department
p.000025:
p.000029: 29
p.000029:
p.000029: having the experience and facilities for testing the safety of a new drug that are considered by the
p.000029: Minister as adequate to ensure the safety of the new drug under the conditions of use
p.000029: recommended.
p.000029: (3) The Minister may in his discretion, refuse any application for a licence made pursuant to
p.000029: this regulation. or grant any such application which does not comply with the requirements
p.000029: of sub- paragraph (g) of paragraph f2) but is accompanied by—
p.000029: (a) detailed reports of the tests made to establish the safety of the new drug for
p.000029: the purpose and under the conditions of use for which it is recommended; and
p.000029: (b) such other information and material as the Minister may in
p.000029: any particular case require.
p.000029: 66. A person shall not import, sell, advertise for sale or manufacture a new drug in respect of which
p.000029: he has been granted a licence. if any material change has been made in respect of that new
p.000029: drug. in—
p.000029: (a) the strength, purity or quality:
p.000029: b) the pharmaceutical dosage form in which it is sold;
p.000029: (c) the conditions of use, including indications for use and the route of administration:
p.000029: (f) the dosage; or
p.000029: (e) the label,
p.000029: unless he makes application for a new licence in respect thereof, giving full details of the
p.000029: changes and the manner in which the new drug in respect of which the original licence was
p.000029: granted. is affected by the change.
p.000029: 67. Where a person wishes to import, sell, advertise for sale or manufacture, a new drug in
p.000029: respect of which a licence has been previously granted to another applicant. that person
p.000029: shall make a separate application in accordance with regulation 65.
p.000029: 68. The Minister shall, within one hundred and twenty days after the filing of an application for
p.000029: a licence to import, sell. advertise for sale, or manufacture a new drug—
p.000029: (a) notify the applicant whether or not his application is satis- factory: and
p.000029: (b1 ‘ñ so, may gmnt a licence to the applicant in accordance therewith.
p.000029: 69.—{I) The Minister may withdraw a licence in respect of any new drug by sending a notice in
p.000029: writing to that e8ect to the person to
p.000029: (The inclusion of this page is authorized by L.N. 144 J 1995]
p.000029:
p.000029:
p.000029: whom a licence bas been granted in respect of that new drug, and such a withdrawal may be made
p.000029: where—
p.000029: in) evidence obtained from clinical or other experience, or from tests by new methods or by
p.000029: methods not used before the approval was given, reveal that the new drug is not shown to be safe for
p.000029: the use represented in the application made to the Minister in respect of that new drug and on
p.000029: which the approval by the Minister was based; or
p.000029: b) the submission filed with the Minis'••-r in relation to that new drug and on which approval
p.000029: by the Minister was based, contained any untrue Statement of material fact; or
p.000029: (c) the withdrawal is necessary in the public interest.
p.000029: (2) Notice of withdrawal of approval in respect of any new drug shall be published for three
p.000029: consecutive weeks in the Gazette and in at least one issue of a daily newspaper printed and
p.000029: circulating in Jamaica. for three consecutive weeks.
p.000029: 7ti. Where any person receives any report of any unexpected side effects, injury. toxicity or
p.000029: sensitivity reaction associated with clinical uses, studies. investigation and tests respecting
p.000029: any new drug, he shall immediately inform the Minister thereof, furnishing him with the full
p.000029: information available.
p.000029: 71.—(1) Notwithstanding anything to the contrary in these Regula- tions, a new drug may be imported for
p.000029: the use of investigators having such technical qualifications as is deemed necessary by the Minister in
p.000029: the circumstances for the sole purpose of obtaining clinical and scientific data with respect to
p.000029: its safety. stability, dosage or efficiency, if—-
p.000029: a) the investigators have written authority from the Minister to carry out investigations on the new
p.000029: drug and the facilities for so doing;
p.000029: (b) before the importation. the Minister is informed of the identify- ing name or mark by which the new drug
p.000029: may be recognized;
p.000029: (c) both the inner and outer labels on any package of such new drug bear the statement “To be used
p.000029: for investigational pur- poses only”;
p.000029: (d) before the sale, the importer ensures that any person to whom the new drug is to be sold has
p.000029: written authority from the Minister to conduct investigations relating to that new drug, and obtains in
p.000029: writing from that person an undertaking that the new drug will be used solely by him or under
p.000029: his direction for investigational purposes.
p.000029: {The incluéon of this page is authorized by L.H. 144/ 1995)
p.000029:
p.000029:
p.000029:
p.000029: (2) A person who imports a new drug for the purpose of sale to any other person authorized by the
p.000029: Minister to carry out investiga- tions in relation to that new drug, shall keep accurate records
p.000029: of such sales, and shall make these records available for inspection by inspectors duly designated
p.000029: under the Act.
p.000029: 72. Notwithstanding anything to the contrary in these Regulations, the Minister may grant permission
p.000029: in writing to any person to import any specified quantity of a new drug, for submission as
p.000029: a sample with an application for a licence in relation to that new drug.
p.000029: 73. NOtWithst2nding any other provision in these Regulations. the Minister may grant any
p.000029: emergency licence to a practitioner for the importation of a new drug, the application for which
p.000029: does not comply with the requirements of these Regulations, if that drug is required for the
p.000029: treatment of an urgent case, and the Minister is satisfied that it is in the best interest of the
p.000029: patient for whom the drug is intended, that the importation be elected without delay.
p.000029:
p.000029:
p.000029: 74. In this Division—
p.000029: “controlled drug” means any drug listed in the Fifth Schedule and includes a mixture
p.000029: containing any such drug;
p.000029: “licensed dealer" means any person licensed to manufacture or sell a controlled drug, authorized
p.000029: by the Minister to have a controlled drwg in his possession, or granted a permit to import
p.000029: or export a controlled drug pursuant to regulations 75 and 76 respectively.
p.000029: 75.—(1) A person shall not manufacture or sell a controlled drug unless he has been granted a
p.000029: licence to do so by the Minister nor shall a person have a controlled drug in his possession unless
p.000029: he has authorization from the Minister to do so.
p.000029: (2) A person shall not import or export a controlled drug unless he has first obtained a permit
p.000029: to do so from the Minister.
p.000029: 76.—(1) The Minister may. on application therefor—
p.000029: (a) issoe a lioence in the form set out as Form B in the Third Schedule to any person to
p.000029: manufacture or sell a controlled
p.000029:
p.000029: (h) issue a permit to any person to import or export a controlled drug subject to such terms and
p.000029: conditions as he may think fit.
p.000029: {The inclusion of this page is authorized by L.N. l44J 1995]
p.000031: 31
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Schedule.
p.000031:
p.000031: 32 THE FOOD AND DR t/ GS REG ULA TIONS, IW5
p.000031:
p.000031: (2) A fee of $10.00 is payable by the applicant in respect of each licence or permit, as the
p.000031: case may be, issued pursuant to para- graph (l), in addition to any registration fee payable
p.000031: in respect of that drug pursuant to regulation 40.
p.000031: (3) The Minister may revoke or suspend a licence or a permit issued pursuant to paragraph (l) if, in
p.000031: his opinion, the person to whom it is issued, or any person in his employ, has violated or
p.000031: failed to comply with any term or condition of such licence or permit or any provision of these
p.000031: Regulations.
p.000031: (4) A licence issued pursuant to paragraph (1), unless it is sooner revoked. shall expire on the 3lst
p.000031: day of March next following the date on which it is issued and may be renewed by the
p.000031: Minister on the appropriate application being made to the Minister in respect thereof. Where a
p.000031: licence has been suspended it has no validity during the period of suspension.
p.000031:
p.000031: 77. Subject to the terms and conditions of his licence, and to the requirements of these
p.000031: Regulations a licensed dealer may supply a controlled drug—
p.000031: (a) to another licensed dealer or to a practitioner, if he receives a written order therefor from such
p.000031: dealer or pmctitioner, and he verifies the signature affixed to the order prior to supplying same; and
p.000031: (b) to a hospital. if he receives a written order signed by a pharmacist, practitioner or
p.000031: other official duly authorized by the hospital to place such an order, and he verifies the signa- ture
p.000031: affixed to the order prior to supplying same.
p.000031:
p.000031: 78.—(1) A licensed dealer who is a pharmacist carrying on the business of a pharmacy. or a
p.000031: pharmacist employed by him for the purposes of conducting that business, may supply a
p.000031: controlled drug to any person if—
p.000031: (a) the drug forms part of the stock in trade of the pharmacy: (I›) be has first received a
p.000031: prescription in writing authorizing the
p.000031: dispensing of that drug;
p.000031: (c) the prescription has been dated and signed by the pmctitioner
p.000031: who issued it;
p.000031: (d) the prescription includes the full name and address of the prescribing practitioner; and
p.000031: (e) the signature of the practitioner is verified prior to electing the sale.
p.000031: [The inclusion of this page is authorized by L.N. l4d f l99s)
p.000031:
p.000033: 33
p.000033:
p.000033: (2) A pharmacist shall not repeat a prescription for a con- trolled drug unless the practitioner
p.000033: issuing the original prescription specifies therein the number of times it may be repeated, and
p.000033: the intervals at which it may be repeated.
p.000033: 79.—(l) Every licensed dealer and every pharmacist in control of a place of business carrying on the
p.000033: business of a pharmacy shall keep a separate register in relation to controlled drugs in which he
p.000033: shall enter or cause to be entered within 48 hours of every receipt or dispensation of any
p.000033: controlled drug, the following—
p.000033: (o) the name. quantity and form of any controlled drug received by him. the name and address of the
p.000033: person from whom he received it, and the date on which it was received;
p.000033: (b) the name, quantity and form of any controlled drug supplied, the name and address of the person to
p.000033: whom it was supplied. the date on which it was supplied, and if supplied pursuant to a prescription,
p.000033: the name and address of the person for whom it was prescribed and the name and address of the
p.000033: practitioner who issued the prescription;
p.000033: (r) the name and quantity of any controlled drug used in manu- facturing. the name and quantity
p.000033: of any controlled drug manufactured, and the date any manufactured controlled drug was placed in stock; and
p.000033: (d) the name, quantity and form of all controlled drugs in his stock at the end of each month.
p.000033: (2) A licensed dealer in both the business of a wholesaler dealing in drugs and the business of
p.000033: a pharmacy, shall keep separate registers as required by paragraph (1), in relation to each business.
p.000033: (3) Every licensed dealer and every phamiacist shall maintain all vouchers relative to receipts and
p.000033: disposals of controlled drugs in separate hles, in sequence of number and date, for a period of at least
p.000033: two years from the date on which each transaction took place and such vouchers shall be kept in a
p.000033: manner that will enable an audit thereof to be made at any time.
p.000033: 8ti. Eyery licensed dealer shall take all necessary steps to protect controlléd, drugs in his possession
p.000033: or under his control against loss Or theft and shall report to the Minister any 6uch loss or theft
p.000033: of a controlled drug within ten days of the discovery of such loss or theft.
p.000033:
p.000033: 81. 1) A° rson shall not sell a cosmetic which is not labelled in accordance with these Regulations.
p.000033: “ tT jfiElusion of this page is authorized by L.N. 144/ 1995]
p.000033:
p.000033: 34 TPE FOOD AND DRUGS REG C/ LATIONS, 1vz5
p.000033: (2) Except as otherwise provided in thèse Regulations there shall be included—
p.000033: a) on both the inner and outer labels of a cosmetic—
p.000033: (i) the name, if any. of the cosmetic, and the identification
p.000033: thereof: and
p.000033: (ii) the name and address of the place of business of the manufacturer or distributor and if he bas
p.000033: more than one place of business. the address of his principal place of business:
p.000033: (b) on the label of a cosmetic a declaration of the net contents expressed in terms of—
p.000033: (i) weight for solids;
p.000033: (ü) 8uid measure for liquids; and (üi) weight for semi-solids,
p.000033: so, however, that in all cases 8uid measurement may be used if it conveys accurate information in respect
p.000033: of the net content, and is in accordance with established commercial practice, and where a hazard
p.000033: exists, adequate directions for safe use shall be included as well as any warning, cauticn or special
p.000033: direction required by thèse Regulations.
p.000033: 82. A person shall not sell a cosmetic on the label or in any advertisement for whicb is
p.000033: included any symbol or device suggesting that the cosmetic has been prepared or coinpounded in
...
p.000033: where only one part bears the label, that part shall be identified as the sample;
p.000033: (The inclusion of this page is authorizcd by L.H. 344/ 1995}
p.000033:
p.000033:
p.000033: (iii) seal each part in such a manner that it cannot be opened without breaking the seal;
p.000033: (iv) deliver the part identified as the owner’s portion to the owner or to the person from whom
p.000033: the sample was obtained, and have the sample and the duplicate analysed or examined; or
p.000033: (b) where, in his opinion division of the procured quantity would interferc with analysis or
p.000033: examination, the inspector shall—
p.000033: (i) identify the entire quantity as the sample;
p.000033: (ii) seal the sample in such a manner that it cannot be opened without breaking the seal; and
p.000033: (iii) have the sample analysed or examined:
p.000033: (c) where the owner or the person from whom the sample was obtained objects to the procedure followed
p.000033: by an inspector at the time the sample was obtained, the inspector shall follow both procedures specified
p.000033: in this regulation, if the owner or the person from whom the sample was obtained supplies him
p.000033: with a sufficient quantity of the article to do so.
p.000033:
p.000033:
p.000033: 85.—(l) A certificate of examination or analysis of an article or sample detained by an inspector
p.000033: shall be in the form set out as Form D in the Third Schedule.
p.000033: (2) Where as a result of an examination or analysis it is reported that a food, drug. cosmetic or
p.000033: device, would, if sold in the Island. constitute a violation of the Act or these Regulations, that
p.000033: food, drug, cosmetic or device, shall not be admitted into the Island, for use as a food, drug,
p.000033: cosmetic or device, and the inspector shall send a written report of the analysis or examination to
p.000033: the Collector-General and a copy of such report to the importers.
p.000033:
p.000033: 86. Where a food, drug, cosmetic or device sought to be admitted into the Island, would, if
p.000033: sold in the Island, be contrary to the provisions of the Act or these Regulations, the
p.000033: food, drug, cosmetic or device may be admitted into the Island for the purpose of being
p.000033: relabelled or reconditioned under the supervision of an inspector in compliance with such
p.000033: conditions as may be specified in the report, and where such relabelling or reconditioning is not
p.000033: satisfactorily carried out within three months after the report is made or such lesser period as may
p.000033: be specified in the report, such food, drug, cosmetic or device
p.000033: (The Inclusion of this page is authorized by L.H. l44J 1995)
p.000033:
p.000033:
p.000033: Ttdrd
p.000033: Pozm D•
p.000033:
p.000036: 36
p.000036: shall be re-exported and, if not re-exported within a further period of three months shall be disposed
p.000036: of as the Minister may direct, so. however, that the Minister may, in his discretion, extend
p.000036: the time for complying with the conditions for re-exporting the said goods.
p.000036:
p.000036: PnnT IV. O$ences and Penalties
p.000036: 87. Any person who fails to comply with any of these Regulations shall be guilty of an offence, and
p.000036: upon summary conviction before a Resident Magistrate shall be liable to a fine not exceeding two thousand
p.000036: dollars or to a term of imprisonment not exceeding twelve months.
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036: [The inclusion of this page is authorized by L.N. 146/ 19951
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036: Item Additive
p.000036:
p.000036:
p.000036: MR8TSCHEDULR
p.000036: ’metal con-niiwirirc r»eeiening agents
p.000036:
p.000036: Preparation usually added to
p.000037: 37
p.000037: Ie z•iatioa z7 ‹z›j
p.000037:
p.000037:
p.000037: 1. Ammonium Special dietary foo6s recommended Saccharin for carbohydrate or
...
p.000001: 1
p.000002: 2
p.000002: 10 50 SO 2
p.000002: 20 50 30 2
p.000002: 10 SO 50 2
p.000010: 10
p.000010: 2 152 2
p.000010: 7 SO 2
p.000010:
p.000010: Frmb Vegetable ..
p.000010: ..
p.000010: ..
p.000010: Dried Herb and SQ . . ..
p.000010: Apple Juice, Cider, Wine and liner .. Fruit Juice ezcept Apple JR .. 8svaza es aa Cossutaed
p.000010: aod Bottled
p.000001: 1
p.000002: 2
p.000002: 2
p.000002: s
p.000002: 0.2
p.000002: 0.1
p.000002: 2 30 2
p.000002: 7 30
p.000002: 20 50
p.000002: to 50 50
p.000002: 0.5 2
p.000002: 0.2 2
p.000002:
p.000002: Water . . .
p.000002: Tm .. .. . .
p.000002: Rdible Bone Mol . . ..
p.000002: 0.1
p.000002: 0.2
p.000010: 10
p.000010: 10
p.000002: 2
p.000150: 150
p.000020: 20
p.000020:
p.000020:
p.000020: 150 6X
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020: {The incluaim of thls pcge ii authorized by L.l4. 144/ l993j
p.000020:
p.000039: 39
p.000039:
p.000039:
p.000039:
p.000039: Pot A
p.000039: the f'ook and Drugc Act
p.000039: Permit to Manufacture a Drug
p.000039: (Regulation 41 (2) )
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039: Is Harrow Li sun, subject to the provisions of the Pood and Drugs Act, and the Regulations
p.000039: made thereunder, and to the subjoined conditions, to manufacture at premises situated at—
p.000039:
p.000039: .......... ........... ................................... ............ .. . ...... .......... . ......
p.000039:
p.000039: . .... .. . . .... . . .... . .... . ...... ... .... . ... . . .. . . ...
p.000039: ..
p.000039: foVowing—
p.000039: ...... ........ .... ............. . . . . ... . ................ ... ............. ..... .........
p.000039:
p.000039: Conditions
p.000039: 1. This Licence shall expire on the...............day of.................................
p.000039: Name and address of Licensee.
p.000039:
p.000039:
p.000039:
p.000039: 2. This licence ie not tmnsferable.
p.000039:
p.000039: 3. The Minister of Health may at any time revoke this licence failure of the licensee to comply
p.000039: with all or any of the conditions therein, or in the Regulations.
p.000039:
p.000039:
p.000039:
p.000039: coataTacd
p.000039:
p.000039: 4. Nothing in this licence shall be deemed to anthorim the licensee to keep any drugs or poisons for
p.000039: the purpose of sale.
p.000039:
p.000039: Datad at........................tbis............day of.................................I9..........
p.000039:
p.000039:
p.000039:
p.000039:
p.000039: (Regulation 76 (1) )
p.000039:
p.000039: Licence to Manufacture or Sell a Controlled Drug
p.000039: ’ ””””“ ”"”"“””“””””“"“"””““’”””"”””“"““”"”"““““““”“””””“’ address of
p.000039: Licensee.
p.000039:
p.000039: Is Haneav Licausao, subject to the provisions of the Food and Drugs Act and the Regulations made
p.000039: thereunder, and to the aubjoined conditions, to manufactureJ sell the controlled druge eet out
p.000039: hereund
p.000039:
p.000039:
p.000039:
p.000039: Exact description of drugs to be manufac-
p.000039: tured /sold.
p.000039:
p.000039:
p.000039:
p.000039: Quantity of drugs to be
p.000039: fared /soId.
p.000039:
p.000039: .. . ......... . . .. ............... .................. .......... .... . . ... . ...
p.000039: .....................................
p.000039:
p.000039: ... ..... ......... . .. .................... ............ .... ......... ....................
p.000039: .........................•.......
p.000039: Conditions
p.000039: 1. This Licence shall expire on the 31et day of March, 19........................
p.000039: 2. The Minister may mvoke at any time this Licence upon failure
p.000039: with all or anr of tin conditions contained themin, or in Regulation
p.000039: 3. This Licence is not transferable.
p.000039: Dated at........................this............day of.................................19..........
p.000039: .....................................................................
p.000039: Minister of Health end Environmental Control.
p.000039:
p.000039: Foes C (Regulation &t)
p.000039: The f•ood and Drugc Act
p.000039: Certificate of Doignation of Inspector This is to certify that
p.000039: jar.J Mrs.JMiss..........................................................................................
...
Searching for indicator substance:
(return to top)
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: THBFOODANDDRUGSACT
p.000004:
p.000004: Rao nods
p.000004: (under section 2/)
p.000004:
p.000004: Tire FOOD ñND Dnuos Rzo nose, 1975
p.000004:
p.000004: (Made 6y file Minister on the 3rd d of March, I97fi)
p.000004:
p.000004:
p.000004:
p.000004: PART I. De)nitions
p.000004: 1. These Regulations may be cited as the Food and Drugs Regula- tions, 1975.
p.000004:
p.000004: L In these Regulations unless the context otherwise requires—
p.000004: can” means any hermetically sealed container;
p.000004: cubic centimetre" and its abbreviated form “cc” shall be inter- changeable with the term “millilitre” and
p.000004: its abbreviated form
p.000004:
p.000004: “declared" means written on the label attached to or accompany- ing the food, drug or substance in
p.000004: respect o1 which the declaration is required, in letters of the prescribed size:
p.000004: ^ice" means the product obtained by freezing potable water which hat been kept, stored and delivered
p.000004: under such hygienic conditions as to prevent contamination;
p.000004: “inner label” means the label on or afbxed to an immediate can or package of food, drug. cosmetic or device;
p.000004: “rein panel” means the principal label affixed to the package or container identifying its contents by
p.000004: sta’ting the name of the food. drug. cosmetic or device, the ingredients. weight. oianu-
p.000004: faaurer, place of manufacture and such other information aa
p.000004: may be required by these Regulations:
p.000004: "official methyl” means a method of analysis or examination designated as such by the Minister for
p.000004: use in the administra- tion of the Act:
p.000004:
p.000004: 4
p.000004:
p.000004: “outer label” means the label on or affixed to the outside of a
p.000004: package of a food. drug. cosmetic or device;
p.000004: “parts per million" means part by weight per million parts by weight except where otherwise
p.000004: stated;
p.000004: “per cent” means per cent by weight (weight in weight) except where otherwise stated;
p.000004: “potable water" means water which is clear. colourless and free from any pathogenic micro-organism.
p.000004:
p.000004: PART II. £''Oods, Drugs, Cosmetics and Devices
...
p.000004: purchase and of use.
p.000004: (2) For the purposes of paragraph (I). the name by which any food, drug, cosmetic or device is
p.000004: generally lmown consisting of more than one word shall be deemed to be clearly and prominently dis-
p.000004: played on the main panel of the label if each word other than articles,
p.000004:
p.000004: THE FOOD AND DRUGS 2t GULATIONS, 1975
p.000004:
p.000004: conjunctions and prepositions, is in identical type and identically dis- played.
p.000004: 6. All information required by these Regulations to be declared shall be in durable characters, and in
p.000004: boldfaced capital letters written in such colour or colours as to afford a distinct contrast with the
p.000004: back- ground.
p.000004:
p.000004: Division II. Food
p.000004: 7. In this Division—
p.000004: “artificial (non-nutritive) sweetening agent” means any cheatical compound which is sweet to the taste
p.000004: but does not include sugar or other carbohydrate or polyhydric alcohols;
p.000004: “bulk container” means a container in which more than one duly labelled package of a tood and its
p.000004: contents are placed for wholesale purposes, but in which the packages and their con- tents are not
p.000004: intended to be retailed;
p.000004: “close proximity” means with reference to a common name, written or graphic matter placed immediately adjacent
p.000004: to that com- mon name:
p.000004: “common name” means with reference to a food, the name by which the food is generally known:
p.000004: “food additive” means any substance, including any source of radiation. the use of which
p.000004: results. or may reasonably be expected to result, in it or its by-products becoming a part of or
p.000004: a8ecting the characteristics of a food excepting—
p.000004: (a) any nutritive material that is used, recognized, or commonly sold as an article or ingredient
p.000004: of food;
p.000004: (b) vitamins. minerals. and amino acids unless added for flavourings;
p.000004: (c) spices, seasoning, favouring preparations essential oils, oleoresins and natural extractives;
p.000004: (d) pesticides;
p.000004: (e) food packaging materials and components thereof; and
p.000004: (I) drugs recommended for administration to animals that may be a source of food for human beings;
p.000004: “unstandardized food” means any food for which a standard has not been prescribed.
p.000004: & A person shall not prepare, pack, store or transport any food intended for sale in any manner which
p.000004: renders it injurious to health,
p.000004: 1 2 be taclus oa of tlus Page u autborized by k.N 2g6/ 1976j
p.000004:
p.000004:
p.000004: or which injuriously afiects its nutritive properties, or which renders it unwholesome. nor shall a
p.000004: person sell any food which has become injurious to health. which has had its nutritive properties
p.000004: injuriously affected. or which has become unwholesome.
p.000004:
p.000004: 9. A person shall not sell any canned food the container of which is blown or punctured, or any
p.000004: frozen (ood which has been thawed in the package and subsequently refrozen.
p.000004:
p.000004: 10. A person shall not use water other than potable water as an ingredient in the manufacture or
...
p.000004: (b) due exclusively to difference in the capacities of containers resulting solely from unavoidable
p.000004: factors th manufacturing;
p.000004: (c) due exclUsively to the ordinary and customary expose of the package to evaporation under usual
p.000004: atmospheric ditions.
p.000004:
p.000004: 14. Unless otherwise specifically permitted by these Regulations, a person shall not sell a synthetic food as
p.000004: substitute for any food unless—
p.000004: (a) it is clearly indicated on the label or in any advertisement in respect thereof that it is a
p.000004: substitute. imitation, artificial or synthetic food: and
p.000004: (b) the label of every package of such food other than imitation favouring preparations, includes
p.000004: legibly and conipicuomly, the common names of all the ingredients of that food in descending order of
p.000004: their proportionate content
p.000004:
p.000004: 15. A person shall not sell any food bearing a label which suggests or implies the presence of one or
p.000004: more vitamins. that the food contains vitamins. or that it is rich in vitamins, imless there is written on
p.000004: the label in letters of not less than eight points. the actual vitamin content per 100 grammes of food.
p.000004:
p.000004: 16. Where any colouring or any favouring has been added to any food. every package to which that
p.000004: colouring or favouring has been added shall bear a label including the words “artificially coloured”.
p.000004: “artificially favoured" or “artificially coloured and favoured”. as the case may reqifire.
p.000004: lTbe iocJudoa of cbis page ie authorized by L.N 386/ tP76]
p.000004:
p.000004:
p.000004: 17. Any colouring substance or mixture of colouring substances which is sold or packaged for
p.000004: use in food shall bear a label on which shall be written legibly and prominently—
p.000004: (a) the name or names of the colouring substance or substances present; and
p.000004: (b) the words “food colour” in letters of not less than inch in
p.000004: height.
p.000004: Adulteration of Foods and Special Foods.
p.000004: 18. A person shall not add any colouring. favouring, preservative.
p.000004: or anti-oxidant to any food, extender. stabilizing or modifying agent “ other than
p.000004: to food in its natural form. or of a standard specified in
p.000004: these Regulations, or add any such substance to any food or sell any food containing any such substance
p.000004: unless the addition or presence of any such substance is specifically permitted by these Regulations.
p.000004: 19.—(1) A person shall not add any artificial sweetening agent, mineral oil, para8in. mineral salt
p.000004: (except sodium chloride), resin. glycol derivative, coumarin or any substance containing coumarin, to any
p.000004: food, or sell any food containing any such substance unless the addition or presence is permitted by these
p.000004: Regulations.
p.000004: (2) The provisions of this Regulation with respect to paraPin shall not apply to chewing gum.
p.000004: 20. A person shall not use or sell for use in or upon a food. any ingredient. unless it is of a
p.000004: purity that renders it safe and appropriate for we in foods.
p.000004: t1. A food shall be deemed to be adultcrated if any ot the following substances or classes of substances are
p.000004: present therein or have been added thereto
p.000004: (a) mineral oil, paraEin wax. or any preparation thereof;
p.000004: (b) coumarin, extracts of toaka beans, the seed of Dipteryx odorata Willd. or Diptcryx oppositi—folia Willd;
p.000004: (c) synthetic sweetening agents other than saccharin;
p.000004: (f) cottonsoed 8our that contains more than four hundred and
p.000004: fifty parts per million of free gossypol; -,
p.000004: (e) fatty-acids and their salts containing toxic factors:
p.000004: (J) dihydrosafarole;
p.000004: (g) isosafrole;
p.000004: (h) oil of American sassafras from sassafras alkidum (nut) Necs; (f*) Oil Of Brazilian sassafras from
p.000004: Ocotea cymbarum H.B.K.;
p.000004: tThe incl-"•ir'n ofi tnis psge ii authorized by L.N 286/ 1976]
p.000004:
p.000009: 9
p.000009:
p.000009: (j3 oil of camphor sassafras from Cinnamon camphorum sieb;
p.000009: (k) oil of micranthum Hyata; or
p.000009: (f) safrole:
p.000009: Provided that—
p.000009: (i) a food shall not be adulterated if it contains not more than
p.000009: 0.3 per cent mineral oil, where the normal manufacturing practices require the we of mineral oil:
...
p.000009: in foods.
p.000009: 2$.—(1) Where a standard for a ‘food is prescribed in these Regnla-
p.000009: tions—
p.000009:
p.000009: THE FOOD AND DR H GS REG ULA TIONS, 1975
p.000009:
p.000009: a) that food shall conform to the requirements prescribed in that standard;
p.000009: b) each ingredient shall be incorporated in the food in a quantity within the limits prescribed for that
p.000009: ingredient: and
p.000009: (c) if the standard includes an ingredient to be used as a food additive for a specified purpose,
p.000009: that ingredient shall be a food additive approved by the Minister for use as an additive to that food
p.000009: for that purpose.
p.000009:
p.000009: (2) Where a standard for a food is not Regulations—
p.000009: in these
p.000009: a) the food shall not contain any food additives other than food additives approved by the
p.000009: Minister for use as additives to that food for that purpose; and
p.000009: (b) each food additive so approved shall be incorporated in the food in a quantity within the limits
p.000009: approved for that food and that food additive.
p.000009: (3) The provisions of sub-paragraph (c) of paragraph (1) and sub-paragraph (a) of paragraph (2) shall not
p.000009: apply—
p.000009: (a) the spices, seasonings, flavouring preparations essential oils, oleoresins and natural extractives; or
p.000009: (I›) in any case where a standard has been prescribed under any other enactment.
p.000009:
p.000009:
p.000009: 2f.—(1) A person shall not use as a preservative in or upon food, or sell as a preservative for food, any
p.000009: substance other than those specified in these Regulations as Gass I. Class II. Class HI or Cass IV
p.000009: preservatives, respectively.
p.000009: (2) Where any Cass H, Cass IH or Cass IV preservative, as the case may be, is sold for use on food.
p.000009: the label thereof shall include adequate directions for use in accordance with the limits
p.000009: prescribed for that preservative in these Regulations.
p.000009: 30.—tl) The following preservatives shall be Class I preservatives for the purposes of these Regulations—
p.000009: (a) alcohol;
p.000009: (b) ascorbic acid and its salts:
p.000009: (c) dextrose;
p.000009: (d) erythorbic acid and its salts;
p.000009:
p.000009: 12 TME. FOOD AND DR UGS REtS ULATIONS, 1975
p.000009:
p.000009: (e) glucose;
p.000009: (J) potassium nitrate;
p.000009: (g) common salt;
p.000009: (h) sodium nitrate;
p.000009: (i) spices;
p.000009: (j) sugar:
p.000009: (k) vinegar; and
p.000009:
p.000009: (2) Notwithstanding paragraph (1). sodium nitrate or potassium nitrate shall be a Class I preservative in
p.000009: relation to preserved meats if used in quantities not exceeding 200 parts per million of the finished
p.000009: product.
p.000009: 31.—(1) The following preservatives shall be Class II preservatives for the purposes of these Regulations—
p.000009: (a) benzoic acid, including the salts thereof;
p.000009: (b) sulphurous acid, including the salts thereof: and
p.000009: (c) sorbic acid, including the salts thereof.
p.000009: (2) A person shall not use more than one Class M pmservative in or upon any food, except in the case
p.000009: of methyl-p-hydroxybenzoate and propyl-p-hydroxybenzoate, where a mixture of both may be used.
...
p.000009: acid;
p.000009: (b) any combination of Class IV prnervatives, including the sub-
p.000009:
p.000009: stance in
p.000009: 0.2 per cent of
p.000009: are dissolved. in an amount greater than
p.000009: finished product;
p.000009: (c) a combination of Cass IV preservatives that includes more than three of the following preservatives—
p.000009: (i) butylated hydroxyanisole;
p.000009: (ii) butylated hydroxytoluene;
p.000009: (iii) propyl gallate: or
p.000009: (f) any combination of the Gass IV preservatives listed in para- graph (c) in an amount greater than
p.000009: 0.02 per cent of the finished product.
p.000009: 34. A person shall not sell or use as a preservative on food—
p.000009: (a) benzoic acid. including the salts thereof;
p.000009: (b) sulphurous acid. including the salts thereof;
p.000009: (c) propyl gallate;
p.000009: (d) butylated hydroxyanisole;
p.000009: (e) butylated hydroxytoluene,
p.000009: {The Inclusion of thii page fig authorizcdq by L.hI 286J lq76J
p.000009:
p.000014: 14
p.000014:
p.000014:
p.000014:
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p.000014:
p.000014: Secood
p.000014: THE FOOD AND DR UGS REG ULA TfONS, 1975
p.000014:
p.000014: unless the la&I of each package includes a quantitative declaration of each of the preservatives
p.000014: present.
p.000014:
p.000014: Food Additives
p.000014: 35. A person shall not sell a food containing a food additive except as provided in these Regulations.
p.000014: 3d. A person shall not sell any substance or mixture of substances for use as a food additive
p.000014: unless the label includes a quantitative statement of the amount of each substance present, and a
p.000014: complete list of the food additives present in descending order of their pro- portions, as well as
p.000014: directions for their use, which if followed, shall produce a food containing such additives in
p.000014: accordance with the maximum levels of use permitted by these Regulations.
p.000014:
p.000014: Poisonous Substances in Food
p.000014: 37• A person shall not sell any food in a container that may transmit to its contents any substance that
p.000014: may be injurious to the health of a consumer of the food.
p.000014: 38. Notwithstanding paragraph (a) of Section 5 of the Act. the foods listed in the Second Schedule may
p.000014: contain in or upon them—
p.000014: (a) any or all of the poisonous or harmM substances listed in that Schedule opposite to that food in
p.000014: amounts not exceeding the quantities stated therein in parts per million (p.p.m.) for that food, as
p.000014: determined by the official method: and
p.000014: [b) other poisonous or harmful substances in amounts not con- sidered by the Minister likely to be
p.000014: injurious to health.
p.000014:
p.000014: Division III. Drugs
p.000014: 39. In this Division—
p.000014: “adequate directions for use” includes all information as may be necessary for proper use, including
p.000014: cautions as to the possible adverse reactions and contra-indications;
p.000014: “antibiotic” means any drug or combination of drugs prepared from certain micro-organisms. or which
p.000014: formerly was pre- pared from micro-organisms but is now made synthetically and which possesses inhibitory
p.000014: action on the growth of other micro-organisms:
p.000014: “common name” means, with reference to a drug, the name in the English language by which the drug is
p.000014: commonly known;
p.000014:
p.000015: 15
p.000015:
...
p.000025: 60. A person may sell an antibiotic preparation for the treatment
p.000025: of cattle if—
p.000025: (a) the preparation is not to be used for lactating cattle and the inner and outer labels of
p.000025: the preparation include a statement to that e8ect: or
p.000025: JThe inclusion of this page is authorized by L.H. i4a/ i995j
p.000025:
p.000025: 26 THE FOOD A ND DR UGS REG ULA TIONS, 1975
p.000025:
p.000025:
p.000025: (b) where
p.000025: (i)
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: (ii)
p.000025: the preparation may be used for lactating cattle— there has been submitted to the Minister on
p.000025: request, evidence acceptable to him, to show the period of
p.000025: time required to elapse after the last treatment with
p.000025: the preparation, in order that the milk from lactating animals so treated shall not contain
p.000025: residues of anti- biotics, and that period does not exceed ninety-six hours;
p.000025: the main panel of the outer label of the preparation and either the inner label or a packaging
p.000025: insert describ- ing the antibiotic preparation includes the words :
p.000025: “WARNING : MiLK TAKEH FROM TREATED ANIMALS wioiiN...... 72.........HOURS APTER THB LATEST TREAT-
p.000025: MENT WITH AH INTR tMAMMARv M £DICAT1ON SHALL NOT BE USED IN FooD”; and
p.000025: the relevant space on the label is filled in witb the appropriate figure.
p.000025: 61. A person shall not sell any substance having oestrogenic activity for administration to poultry which
p.000025: may be used as food for human consumption.
p.000025: 62.—(1) The Minister may from time to time require the manu- facturer of a drug recommended
p.000025: for administration to animals which may be used as food for human consumption—
p.000025: (a) to file with him in respect of that drug, a submission in writing, in form and
p.000025: content satisfactory to the Minister, describing in detail, tests carried out to determine that
p.000025: no residues of the drug, other than residues within the limits prescribed by these
p.000025: Regulations remain in meat, neat by- products, eggs or milk obtained from animals treated
p.000025: with that drug; and
p.000025: b) to print on the main panel of the outer label of any drug recommended for administration to
p.000025: animals which may be used for human consumption and on either the inner label or on a
p.000025: package insert describing the druy, a warning that meat. meat-products, eggs or milk obtained
...
p.000025: tested by the official method.
p.000025: (2) Where a standard of disintegration has not been prescribed for a drug in any of the
p.000025: publications listed in the Second Schedule to the Act or in paragraph (1) of this regulation, a
p.000025: person shall not sell a drug in the form of a tablet that is intended to be swallowed whole,
p.000025: unless the tablet disintegrates in not more than sixty minutes when tested by the official method.
p.000025: (3) The provisions of paragraphs (l) and (2) shall not apply to tablets containing a drug which has
p.000025: been demonstrated by the oföcial method to the satisfaction of the Minister to be assimilable by
p.000025: the body.
p.000025: (4) Paragraph (2) shall not apply to tablets that are described on their label as releasing the dnig
p.000025: at timed intervals or in sustained quantities over a period of time.
p.000025: New Drugs
p.000025:
p.000025: 64. In
p.000025: (o)
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: Nb)
p.000025:
p.000025:
p.000025:
p.000025: (c)
p.000025: this Division “new drug” means—
p.000025: a drug that contains or consists of a substance. whether as an active or inactive ingredient,
p.000025: carrier, coating. excipient, menstrum or other component, that has not been imported into the Island
p.000025: for use as a drug for a sufficient time and in sufficient quantities prior to the 4th of August,
p.000025: 1975 to establish its efficacy and safety. or is a new drug in the country in which it was
p.000025: manufactured:
p.000025: a combination of twO OT more drugs, with or without other ingredients which have not been imported
p.000025: into the island prior to the 4th of August, 1975, in that combination or in the proportion in which
p.000025: those drugs are combined;
p.000025: a drug in relation to which the manufacturer prescribes, recommends. proposes or claims a
p.000025: use as a drug. or a condition o1 use as a drug, including dosage, demonstration or duration of
p.000025: action, and which has not been imported into the Island prior to the 4th of August, 1975, for
p.000025: that use or condition of use: or
p.000025: lTbe inclusion of this page is a uthorized br L.N. i 44 / 1995]
p.000025:
p.000025: 28 TPE FOOD AND DRUGS 2t EG ULA TIONS, ’1975
p.000025:
...
p.000058: Afnphotef iciD
p.000058: pieillin raaiycin
p.000058: BacampicilliD Bacitracin B»oethamine Penioillin
p.000058: Benzatbnc Penicillin Bcnzyl Peni
p.000058:
p.000058: CAròenicilIin
p.000058: Cephazolin
p.000058: ChlOPàTDQÒCttÍHl
p.000058: Chlorietracycline Cinoxacin Clindamycin Clomocycline Cloxacillin CoEetin
p.000058:
p.000058: Demeclocyeline Oihydroetreptoatycin Doxorubicin
p.000058:
p.000058: Erthromycin Floxaoülin Framyce’tin
p.000058:
p.000058: Cofamandole Gephalosporine Fusidic Acid gt(g
p.000058: Gentamiciii
p.000058: Jytp p Gmmicidin
p.000058: Cephalexin GiSBOfttlVifl
p.000058: C»pha1oridine Kanamyoin
p.000058: Cephalothin Lincomycin
p.000058: Gephapirin Meclocyclinc
p.000058: lThe inclusloo of tbis past ia authorined by L.N. 54]2tD0J
p.000058:
p.000062: 62
p.000062:
p.000062:
p.000062:
p.000062: Methacycline Methicillin Minocycline Neomycin Novobiocin
p.000062: Nystatin except Topical Preparation Oleandomycin
p.000062: Oxytctracycline Paromomycin
p.000062: Penicillin G & V Phenoxyuiethyl Penicillin
p.000062:
p.000062: Pivmecillinam Polymyxin B Potassium Clavulanate Potassium Penicillin
p.000062:
p.000062: Rifampicin
p.000062:
p.000062: Rolitetracycline Roxithromycin Salinomycin Spectinomyoin Spiramycin Streptomycin
p.000062: Tetracycline (other than 3%
p.000062:
p.000062: Tobraaiycin Ty1‹min Tyrothricin Vancomycin
p.000062:
p.000062:
p.000062: Morphine and iti salu, and any solution or dilution of morphine or its salts in an inert
p.000062: substance whether liquid or solid containing any proportion of morphine, and any preparation,
p.000062: admixture, extract or other substance (not being such solution or dilution as aforesaid) containing not
p.000062: less than one-fifth of one per cent morphine (calculated in respect of anhydrous morphine);
p.000062: Cocaine (including synthetic cocaine) and ecgonine and their respective salti, and any solution or
p.000062: dilution of cocaine or iti salti in an inert substance, whether liquid or aolid, containing
p.000062: any proportion of cocaine, and any pm- pamtion, admixture, extract or otlher sñbotance (not being
p.000062: auoh a solution or dilution as nffiresaid) containing not less than one-teirth of one per cent
p.000062: of
p.000062: ‹x›caine or any proportion of mgonine;
p.000062: Acetyldtitydrocodeinone Atphaprodine
p.000062:
p.000062:
p.000062: Botaprodine Dietliylthianibutene
p.000062: Dihydrodesoxymorphine (also known as desomorphine) Dihydromorphine
p.000062: 1 : 3—Dimet1iy1—4-pheny1-4-propionyloxyhexamet1iyleneimine
p.000062: Dimethylthiambutene
p.000062: Dioxaphetyl butyrate (4-morpholino—2: 2—diphenyl ethyl butyrate) Didipanone
p.000062: Ethylmetliylthiambutene
p.000062: Hydrocodone (also known as dihydrocodeinone or dicodide) Hydromorphone (also known as dihydromorphinone or
p.000062: dilaudide) Hydroxypethidine
p.000062: Isomethadone (aleo known as isoamidone) Ketobemidone
p.000062: lTbe inclusion of this page is authorized by L.l'4. S4/20(Dl
p.000062:
p.000062: ,63
p.000062:
p.000062:
p.000062: Lcvomethorphan Lnvorpbanol Methadol
p.000062: Methadone (also known as amidone) Mcthadyl acetate
p.000062: Methyldesomorphine (6- methyl —6-desoxymorphine) I—Methyl—4-phenylpiperidine-4-carboxy1ic acid isopropyl ester
p.000062: Metopon (also known as methyldihydromorphinone)
p.000062: Morphine-N—oxide (also known as genomorphine) Normethadone
p.000062: Oxycodone (also known as dihydrohydroxycodeinone or eucodal)
p.000062: Pethidine
p.000062: Phenadoxone
p.000062: “ Phenomorphan (3-hydroxy—N-phenethy1morphioan) Racemethorphan
p.000062: Raccmorphan Thebaine
p.000062: The esters of morphine (other than diac•ty1morphine), ecogonine, Oxxcodone. hydrocodone, hydromorphone,
...
Social / Age
Searching for indicator age:
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p.000018: “dose for children, as directed by the physician“.
p.000018:
p.000018: 46.—{1) Both the inner and the outur labels of a drug for which a single or daily dosage or a statement of
p.000018: concentration in excess of the limits herein provided has been recommended ahall include a caution that
p.000018: the product is to fc used only on the advice of a physician.
p.000018: (2) The provisions of paragraph (1) shall not apply to a drug supplied on prescription. or to the inner
p.000018: label of a single dose container.
p.000018: 47. The label of every prepacked drug shall include the cautionary phr “keep out of the reach of
p.000018: children”.
p.000018: 48.—(1) A person shall not sell a drug containing—
p.000018: (a) saiicylic acid or its salts. acetylsalicylic acid or its salts or salicylamide. ualess, where the
p.000018: drug is recommended for children, both its inner and outer labels include cautionary statements to the
p.000018: effect thni the drug may be administered to children under two years of age only on the advice of a
p.000018: physiciani
p.000018: (6) hyoscinc (scopolamine) or its salts. unless both its inner and outer labels include a cautionary
p.000018: statement to the effect that the drug is not to be used by persma sn8eriog from glaucoma or where the drug
p.000018: causes blurring of the vision or pressure pain within the eye: and
p.000018: (o) phenacetin, either singly or in combination with other drugs,
p.000018: unlons its label bears the following statement—
p.000018:
p.000020: 20
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p.000020:
p.000020:
p.000020:
p.000020: Pounb
p.000020:
p.000020:
p.000020: “CAUTION : May be injurious if taken in large doses or for a long time. Do not exceed the
p.000020: recommended dose without consulting a physician.”
p.000020: (2) The provisions of paragraph (1) shall not apply to any pre- pamtion containing a drug that is
p.000020: required by anyone to be sold on prescription, or for parentcral or injectable use.
p.000020: 49.—(1) A person shall not sell a corticosteroid drug for ophthalmic use unless—
p.000020: (o) the outer label of the package insert includes as part of the directions for use, the following
p.000020: statements—
...
Social / Child
Searching for indicator children:
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p.000018: (The inciu•io• or this p•ge is eutfiorimd by L.iq. i44¿ 1995j
p.000018:
p.000018: lf
p.000018:
p.000018: (4) The provisions of paragraph (1) shall not apply to the label of a drug package from bulk on the
p.000018: premises where the drug is retailed, except that the name of the drug shall be included on the
p.000018: label and where the package of a drug bears a statement, mark or device regarding the ingredients
p.000018: declared therein, in addition to the name of the drug. including the name and address of the
p.000018: retailer. the net contents and adequate directions for use, the package shall be labelled as required
p.000018: by these Regulations.
p.000018: (5) Tàe provisions of this regulation shall not apply to drugs supplied on prescription.
p.000018: 45. Except as otherwise provided in these Regulations. a person shall not sell to the general public
p.000018: for human use. a drug. other than a preparation solely for external use. unless both the inner and
p.000018: outer labels on such drug include a statement of the quantitative content of each drug and the
p.000018: recommended single and daily adult dosage, and where the dru8 is recommended for children, the statement
p.000018: “dose for children, as directed by the physician“.
p.000018:
p.000018: 46.—{1) Both the inner and the outur labels of a drug for which a single or daily dosage or a statement of
p.000018: concentration in excess of the limits herein provided has been recommended ahall include a caution that
p.000018: the product is to fc used only on the advice of a physician.
p.000018: (2) The provisions of paragraph (1) shall not apply to a drug supplied on prescription. or to the inner
p.000018: label of a single dose container.
p.000018: 47. The label of every prepacked drug shall include the cautionary phr “keep out of the reach of
p.000018: children”.
p.000018: 48.—(1) A person shall not sell a drug containing—
p.000018: (a) saiicylic acid or its salts. acetylsalicylic acid or its salts or salicylamide. ualess, where the
p.000018: drug is recommended for children, both its inner and outer labels include cautionary statements to the
p.000018: effect thni the drug may be administered to children under two years of age only on the advice of a
p.000018: physiciani
p.000018: (6) hyoscinc (scopolamine) or its salts. unless both its inner and outer labels include a cautionary
p.000018: statement to the effect that the drug is not to be used by persma sn8eriog from glaucoma or where the drug
p.000018: causes blurring of the vision or pressure pain within the eye: and
p.000018: (o) phenacetin, either singly or in combination with other drugs,
p.000018: unlons its label bears the following statement—
p.000018:
p.000020: 20
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
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p.000020:
p.000020:
p.000020:
p.000020:
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p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020: Pounb
p.000020:
p.000020:
p.000020: “CAUTION : May be injurious if taken in large doses or for a long time. Do not exceed the
p.000020: recommended dose without consulting a physician.”
p.000020: (2) The provisions of paragraph (1) shall not apply to any pre- pamtion containing a drug that is
p.000020: required by anyone to be sold on prescription, or for parentcral or injectable use.
p.000020: 49.—(1) A person shall not sell a corticosteroid drug for ophthalmic use unless—
...
Social / Linguistic Proficiency
Searching for indicator language:
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p.000014: accordance with the maximum levels of use permitted by these Regulations.
p.000014:
p.000014: Poisonous Substances in Food
p.000014: 37• A person shall not sell any food in a container that may transmit to its contents any substance that
p.000014: may be injurious to the health of a consumer of the food.
p.000014: 38. Notwithstanding paragraph (a) of Section 5 of the Act. the foods listed in the Second Schedule may
p.000014: contain in or upon them—
p.000014: (a) any or all of the poisonous or harmM substances listed in that Schedule opposite to that food in
p.000014: amounts not exceeding the quantities stated therein in parts per million (p.p.m.) for that food, as
p.000014: determined by the official method: and
p.000014: [b) other poisonous or harmful substances in amounts not con- sidered by the Minister likely to be
p.000014: injurious to health.
p.000014:
p.000014: Division III. Drugs
p.000014: 39. In this Division—
p.000014: “adequate directions for use” includes all information as may be necessary for proper use, including
p.000014: cautions as to the possible adverse reactions and contra-indications;
p.000014: “antibiotic” means any drug or combination of drugs prepared from certain micro-organisms. or which
p.000014: formerly was pre- pared from micro-organisms but is now made synthetically and which possesses inhibitory
p.000014: action on the growth of other micro-organisms:
p.000014: “common name” means, with reference to a drug, the name in the English language by which the drug is
p.000014: commonly known;
p.000014:
p.000015: 15
p.000015:
p.000015: “expiration date” means any date prescribed in relation to a particular drug, as the date after
p.000015: which that drug is not recommended for use;
p.000015: “generic drug” means an unpatented drug product, including a
p.000015: ‹ltug whose patent has expired and one which has never been patented;
p.000015: “generic name” means the official name or international non- proprietory nomenclature;
p.000015: “internal use” means ingestion by mouth or application for systemic e8ect to any part of the body in which
p.000015: the drug comes into contact with mucous membrane;
p.000015: “parentcral use” means administration of a drug by means of a hypodeimic syringe. needle or other
p.000015: instrument through or into the skin or mucous membrane;
p.000015: “pharmacist” or “druggist” means any person registcmd as such under any enactment for the time being in
p.000015: force relating to the registration of druggists or pharniacistsi
p.000015: “medical practitioner" means any person registered as such under the Medical Act or any enactment for the
p.000015: time being in force relating to practise of medicine;
p.000015: “pr" means, when used in relation to a List 4 Drug. to be sold on prescription only;
p.000015: “practitioner” means any dentist. medical practitioner, veterinary surgeon or veterinary practitioner
p.000015: registered respectively as such under any relevant enactment for the time being in force;
p.000015: “prescription” means an order given by a practitioner directing that a stated amount of any drug or mixture
p.000015: of drug specified therein be dispensed for a person named in the order:
p.000015: “proper name” means, with reference to a drug. the name in the English language of that drug;
p.000015: “teaspoon” means for the purpose of calculation of dosage, a volume of five cubic centimetres.
p.000015:
p.000015: 40.—(1) A person shall not sell. manufacture, import or distribute a drpg ualess—
p.000015: (a) that drug has been registered with the Ministry or Health: and
p.000015: (b) a fee of $25.0Q has been paid in respect of such registmtion.
p.000015: (2} The Minister may. in his discretioii. exempt any person or any drug from thé requirements of
p.000015: paragraph (1).
p.000015: {The inclusion of this page is authorized by L.H. l,(•t/ j99l3
p.000015:
p.000015: la
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015: Tblrd
p.000015: 41.—(l) A person shall not manufacture a drug unless he has applied for and been granted a permit to do so
p.000015: by the Minister.
p.000015: (2) A permit to manufacture a drug shall be in the form set
p.000015: ••"• ^- out as Form A in the Third Schedule.
p.000015: (3) A fee of one thousand dollars ($1,000) shall be paid in respect of each product for which a
p.000015: permit to manufacture is sought.
p.000015:
p.000015: person licensed to manufacture a drug pursuant to regulation 41 shall not sell a drug in dosage
...
p.000025: g—
p.000025: (o) a description of the new drug, ineluding the name and address of the manufacturer thereof, and a
p.000025: declaration of the proper name, il any, and the name under which it is proposed to be sold;
p.000025: (b) a statement of all the ingredients. the route of administration, the proposed dosage. the
p.000025: therapeutie or diagnostic claims for the new drug. if known, a description of the pharmaceutical dosage
p.000025: form in which the new drug is to be sold, and any known contra-indications and side affects thereofi
p.000025: (c) details of the tests condueted to control the potency, purity and safety of the new dmg;
p.000025: (d) a dratt of every label proposed to be uscd in connection with the new drug;
p.000025: (e) samples of the new drug in the finished and pharmaceutical form in which it is to be sold;
p.000025: IJ) such samples of the eomponents of the new drug as the Minister may require;
p.000025: (g) a certificats from the competent authority in the country of manufacture or export certifying that
p.000025: the new drug is approved for use in that country and the conditions under which it may be used or sold in
p.000025: that country; and
p.000025: (A) a certifieate in the English language in addition to any other latiguage. from the manufacturer,
p.000025: respecting the safety of the new drug conditions of use recommended, and giving the conditions
p.000025: under which it may be sold. issued by an official
p.000025: ' body or goV'ernfrient department having authority to issue such certificate, such official body
p.000025: or government department
p.000025:
p.000029: 29
p.000029:
p.000029: having the experience and facilities for testing the safety of a new drug that are considered by the
p.000029: Minister as adequate to ensure the safety of the new drug under the conditions of use
p.000029: recommended.
p.000029: (3) The Minister may in his discretion, refuse any application for a licence made pursuant to
p.000029: this regulation. or grant any such application which does not comply with the requirements
p.000029: of sub- paragraph (g) of paragraph f2) but is accompanied by—
p.000029: (a) detailed reports of the tests made to establish the safety of the new drug for
p.000029: the purpose and under the conditions of use for which it is recommended; and
p.000029: (b) such other information and material as the Minister may in
p.000029: any particular case require.
p.000029: 66. A person shall not import, sell, advertise for sale or manufacture a new drug in respect of which
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.000018: by these Regulations to be shown on both the inner and outer labels.
p.000018: (The inciu•io• or this p•ge is eutfiorimd by L.iq. i44¿ 1995j
p.000018:
p.000018: lf
p.000018:
p.000018: (4) The provisions of paragraph (1) shall not apply to the label of a drug package from bulk on the
p.000018: premises where the drug is retailed, except that the name of the drug shall be included on the
p.000018: label and where the package of a drug bears a statement, mark or device regarding the ingredients
p.000018: declared therein, in addition to the name of the drug. including the name and address of the
p.000018: retailer. the net contents and adequate directions for use, the package shall be labelled as required
p.000018: by these Regulations.
p.000018: (5) Tàe provisions of this regulation shall not apply to drugs supplied on prescription.
p.000018: 45. Except as otherwise provided in these Regulations. a person shall not sell to the general public
p.000018: for human use. a drug. other than a preparation solely for external use. unless both the inner and
p.000018: outer labels on such drug include a statement of the quantitative content of each drug and the
p.000018: recommended single and daily adult dosage, and where the dru8 is recommended for children, the statement
p.000018: “dose for children, as directed by the physician“.
p.000018:
p.000018: 46.—{1) Both the inner and the outur labels of a drug for which a single or daily dosage or a statement of
p.000018: concentration in excess of the limits herein provided has been recommended ahall include a caution that
p.000018: the product is to fc used only on the advice of a physician.
p.000018: (2) The provisions of paragraph (1) shall not apply to a drug supplied on prescription. or to the inner
p.000018: label of a single dose container.
p.000018: 47. The label of every prepacked drug shall include the cautionary phr “keep out of the reach of
p.000018: children”.
p.000018: 48.—(1) A person shall not sell a drug containing—
p.000018: (a) saiicylic acid or its salts. acetylsalicylic acid or its salts or salicylamide. ualess, where the
p.000018: drug is recommended for children, both its inner and outer labels include cautionary statements to the
p.000018: effect thni the drug may be administered to children under two years of age only on the advice of a
p.000018: physiciani
p.000018: (6) hyoscinc (scopolamine) or its salts. unless both its inner and outer labels include a cautionary
p.000018: statement to the effect that the drug is not to be used by persma sn8eriog from glaucoma or where the drug
p.000018: causes blurring of the vision or pressure pain within the eye: and
p.000018: (o) phenacetin, either singly or in combination with other drugs,
p.000018: unlons its label bears the following statement—
p.000018:
p.000020: 20
p.000020:
p.000020:
p.000020:
p.000020:
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p.000020:
p.000020:
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p.000020:
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Social / Property Ownership
Searching for indicator home:
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p.000020: (c) that the generic drug will be dispensed for the one prescribed, except where the person objects
p.000020: or declines to accept the generic presentation.
p.000020:
p.000020: (2) This regulation shall not apply where there is a direction from the person who issued the
p.000020: prescripton that there shall not be any substitution.
p.000020:
p.000020: (3) Where a person is supplying a drug for which a prescrip- tion is not required and there is
p.000020: available a generic drug which is less costly than the one requested, the pharmacist shall, before
p.000020: supplying the drug, inform the person requesting the drug—
p.000020: a) that there is available a generic drug which is interchangeable with the drug requested;
p.000020: (b) that is less costly than the drug requested.
p.000020:
p.000020: 52.—(1) A person may sell a List 4 Drug on the strength of a written order duly signed, to—
p.000020: (o) a drug manufacturer;
p.000020: b) a practitioner;
p.000020: (c) a registered pharmacist:
p.000020: (d) a hospital or any nursing home duly registered under any law for the time being in force
p.000020: relating to the registration of nursing homes;
p.000020: (e) any person to whom a written order signed by the Minister has been issued.
p.000020: (2) A person selling a List 4 Drug in accordance with para- graph (1) shall, prior to electing the
p.000020: sale, verify the signature of the person signing the order if there are grounds for reasonable doubt
p.000020: as to the authenticity thereof.
p.000020: (3) A person selling a List 4 Drug in accordance with paragraph
p.000020: (l) shall retain the order on the strength of which the List 4 Drug was sold. for a period of at
p.000020: least two years from the date on whicJi the sale was elected.
p.000020: [The inclusion of this pa8e is authorized by L.N. 144/ 1995]
p.000020:
p.000020: THE FOOD AND DRUGS RECRULATIONS, 1975 23
p.000020:
p.000020: 53. A List 4 Drug shall not be imported other than by or for the
p.000020: use of—
p.000020: (a) a practitioner:
p.000020: [b) a drug manufacturer;
p.000020: (c) a registered pharmacist; or
p.000020: (d) a public hospital as defined under the Hospitals (Public) Act or any enactment for the time
p.000020: being in force relating to public hospitals.
p.000020: 54.—(l) Both the inner and outer labels of a package containing a drug represented for use
...
Social / Religion
Searching for indicator conviction:
(return to top)
p.000033: the Collector-General and a copy of such report to the importers.
p.000033:
p.000033: 86. Where a food, drug, cosmetic or device sought to be admitted into the Island, would, if
p.000033: sold in the Island, be contrary to the provisions of the Act or these Regulations, the
p.000033: food, drug, cosmetic or device may be admitted into the Island for the purpose of being
p.000033: relabelled or reconditioned under the supervision of an inspector in compliance with such
p.000033: conditions as may be specified in the report, and where such relabelling or reconditioning is not
p.000033: satisfactorily carried out within three months after the report is made or such lesser period as may
p.000033: be specified in the report, such food, drug, cosmetic or device
p.000033: (The Inclusion of this page is authorized by L.H. l44J 1995)
p.000033:
p.000033:
p.000033: Ttdrd
p.000033: Pozm D•
p.000033:
p.000036: 36
p.000036: shall be re-exported and, if not re-exported within a further period of three months shall be disposed
p.000036: of as the Minister may direct, so. however, that the Minister may, in his discretion, extend
p.000036: the time for complying with the conditions for re-exporting the said goods.
p.000036:
p.000036: PnnT IV. O$ences and Penalties
p.000036: 87. Any person who fails to comply with any of these Regulations shall be guilty of an offence, and
p.000036: upon summary conviction before a Resident Magistrate shall be liable to a fine not exceeding two thousand
p.000036: dollars or to a term of imprisonment not exceeding twelve months.
p.000036:
p.000036:
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p.000036:
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p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036: [The inclusion of this page is authorized by L.N. 146/ 19951
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036: Item Additive
p.000036:
p.000036:
p.000036: MR8TSCHEDULR
p.000036: ’metal con-niiwirirc r»eeiening agents
p.000036:
p.000036: Preparation usually added to
p.000037: 37
p.000037: Ie z•iatioa z7 ‹z›j
p.000037:
p.000037:
p.000037: 1. Ammonium Special dietary foo6s recommended Saccharin for carbohydrate or
p.000037: su8ar reduced diets, and special dietary food recommended
p.000037: #0£ £€€(\I€@tt StCt
p.000037:
p.000037:
p.000037: Good manu- facturing practice.
p.000037:
p.000037: 2. Saccharin
p.000037:
p.000037:
p.000037: 5. Sodiu zs Sacckarta
p.000037: Special dietary foods recommended for carbohydrate or sugar reduced diets, aod special dietary food
p.000037: zecommcaded foF calorie reduced diets.
p.000037:
p.000037: SBCONDSCMEDULB
p.000037: Poisonous Suasrnncns Pee arreo
p.000037:
p.000037:
p.000037:
p.000037: Arsenic parts per million
p.000037:
p.000037:
p.000037: Citric Acid .. ..
p.000037: Tartaric Acid Cram of Tartar . .
p.000037: . . 1
p.000037: . . 1
p.000037: . 2
p.000037: . . 2
p.000002: 2
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.000015: expiration of three years from the date of the testing of each lot or batch of each drug. or until
p.000015: the expiration date of that drug, whichever first occurs. rind an adequate sample of each such batch or
p.000015: lot shall be submitted to the Minister. on his request. for analysis and examination.
p.000015: 43.—(1) A person shall not import a drug uaiess he has applied for and obtained permission to do so
p.000015: from the Minister and has paid a fee of two hundred doMars ($200) in respect of each permit bearing a
p.000015: maximum of ten products.
p.000015: (2) A person applyi9g for permission to import a drug pursuant to paragraph (1) may be required by the
p.000015: Minister—
p.000015: (a) to furnish information and evidence setisfactory to estnblish that the conditions of manufacture
p.000015: described in paragraph (2) of regulation 42 have been met in respect to such drug; and
p.000015: (6) before such drug is released for sale. to conduct tests in Jamaica by an acceptable method.
p.000015: on that drug in the form in which it is sought to be imported.
p.000015: prhe inclusion or this p48e is authorized bx L.l'l. l4Ji995]
p.000015:
p.000018: 18
p.000018:
p.000018: (3) Where. in the opinion of the Minister. a drug. or lot or batch of drugs, does not conform
p.000018: with the requirements of these Regulations. the drug, or the lot or batch thereof. as the case may
p.000018: be. shall not be admitted into the Island for use as a drug.
p.000018:
p.000018: 44•—(1) Except as otherwise provided in these Regulations. the label
p.000018: of a drug shall inch
p.000018: (o) on the main panel of both the inner and the outer labels—
p.000018: (i) the proper name: or
p.000018: (ii) where there is no proper name, the common name; (é) on both the inner and the outer
p.000018: labels—
p.000018: (i) the name of the manufacturer or distributor of the drugi
p.000018: (ii) the address of the manufacturer or distributor, except in cases where the immediate
p.000018: contains 5 millilitres or less. when this statement need not be made on the inner label:
p.000018: (iii) where a drug ii intended for parenteral use. the lot number thereof:
p.000018: (iv) a quantitative list of the medicinal ingredients contained therein by their proper names, or if
p.000018: they have no proper names, by their common names. except in the case of drugs sold on pmscription;
p.000018: and
p.000018: adequate directions for use:
p.000018: outer label—
p.000018: (i) a correct statement of net contents in terms of weight; and
p.000018:
p.000018: (ii)
...
p.000029: he has authorization from the Minister to do so.
p.000029: (2) A person shall not import or export a controlled drug unless he has first obtained a permit
p.000029: to do so from the Minister.
p.000029: 76.—(1) The Minister may. on application therefor—
p.000029: (a) issoe a lioence in the form set out as Form B in the Third Schedule to any person to
p.000029: manufacture or sell a controlled
p.000029:
p.000029: (h) issue a permit to any person to import or export a controlled drug subject to such terms and
p.000029: conditions as he may think fit.
p.000029: {The inclusion of this page is authorized by L.N. l44J 1995]
p.000031: 31
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
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p.000031:
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p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Schedule.
p.000031:
p.000031: 32 THE FOOD AND DR t/ GS REG ULA TIONS, IW5
p.000031:
p.000031: (2) A fee of $10.00 is payable by the applicant in respect of each licence or permit, as the
p.000031: case may be, issued pursuant to para- graph (l), in addition to any registration fee payable
p.000031: in respect of that drug pursuant to regulation 40.
p.000031: (3) The Minister may revoke or suspend a licence or a permit issued pursuant to paragraph (l) if, in
p.000031: his opinion, the person to whom it is issued, or any person in his employ, has violated or
p.000031: failed to comply with any term or condition of such licence or permit or any provision of these
p.000031: Regulations.
p.000031: (4) A licence issued pursuant to paragraph (1), unless it is sooner revoked. shall expire on the 3lst
p.000031: day of March next following the date on which it is issued and may be renewed by the
p.000031: Minister on the appropriate application being made to the Minister in respect thereof. Where a
p.000031: licence has been suspended it has no validity during the period of suspension.
p.000031:
p.000031: 77. Subject to the terms and conditions of his licence, and to the requirements of these
p.000031: Regulations a licensed dealer may supply a controlled drug—
p.000031: (a) to another licensed dealer or to a practitioner, if he receives a written order therefor from such
p.000031: dealer or pmctitioner, and he verifies the signature affixed to the order prior to supplying same; and
p.000031: (b) to a hospital. if he receives a written order signed by a pharmacist, practitioner or
p.000031: other official duly authorized by the hospital to place such an order, and he verifies the signa- ture
p.000031: affixed to the order prior to supplying same.
p.000031:
p.000031: 78.—(1) A licensed dealer who is a pharmacist carrying on the business of a pharmacy. or a
p.000031: pharmacist employed by him for the purposes of conducting that business, may supply a
p.000031: controlled drug to any person if—
...
p.000033: (b) on the label of a cosmetic a declaration of the net contents expressed in terms of—
p.000033: (i) weight for solids;
p.000033: (ü) 8uid measure for liquids; and (üi) weight for semi-solids,
p.000033: so, however, that in all cases 8uid measurement may be used if it conveys accurate information in respect
p.000033: of the net content, and is in accordance with established commercial practice, and where a hazard
p.000033: exists, adequate directions for safe use shall be included as well as any warning, cauticn or special
p.000033: direction required by thèse Regulations.
p.000033: 82. A person shall not sell a cosmetic on the label or in any advertisement for whicb is
p.000033: included any symbol or device suggesting that the cosmetic has been prepared or coinpounded in
p.000033: accordance with a prescription.
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033: Tbird
p.000033: WorœC.
p.000033: PART HL Administration
p.000033: 83. A certificate of designation to be furnished to an inspector pursuant to subsection (4) of
p.000033: section 19 of the Act, shall be in the form set out as Form C in the Third Schedule.
p.000033: 84. When tasting a sample in accordance with the provisions of section 19 of the Act, an
p.000033: inspector shall, after procuring a suitable quantity of the article in question, forthwith notify the
p.000033: owner thereof or the person from whom the sample was obtained. of his intention to have that sample
p.000033: examined or analysed and—
p.000033: [a) where in his opinion, division of the procured quantity would not interfere with analysis or
p.000033: examination, the inspector shell—
p.000033: (i) divide the quantity into three parts;
p.000033: (ii) identify the three parts as the owner’s portion, the sample, and the duplicate sample, and
p.000033: where only one part bears the label, that part shall be identified as the sample;
p.000033: (The inclusion of this page is authorizcd by L.H. 344/ 1995}
p.000033:
p.000033:
p.000033: (iii) seal each part in such a manner that it cannot be opened without breaking the seal;
p.000033: (iv) deliver the part identified as the owner’s portion to the owner or to the person from whom
p.000033: the sample was obtained, and have the sample and the duplicate analysed or examined; or
p.000033: (b) where, in his opinion division of the procured quantity would interferc with analysis or
p.000033: examination, the inspector shall—
p.000033: (i) identify the entire quantity as the sample;
p.000033: (ii) seal the sample in such a manner that it cannot be opened without breaking the seal; and
p.000033: (iii) have the sample analysed or examined:
p.000033: (c) where the owner or the person from whom the sample was obtained objects to the procedure followed
p.000033: by an inspector at the time the sample was obtained, the inspector shall follow both procedures specified
p.000033: in this regulation, if the owner or the person from whom the sample was obtained supplies him
p.000033: with a sufficient quantity of the article to do so.
p.000033:
p.000033:
p.000033: 85.—(l) A certificate of examination or analysis of an article or sample detained by an inspector
p.000033: shall be in the form set out as Form D in the Third Schedule.
p.000033: (2) Where as a result of an examination or analysis it is reported that a food, drug. cosmetic or
p.000033: device, would, if sold in the Island. constitute a violation of the Act or these Regulations, that
p.000033: food, drug, cosmetic or device, shall not be admitted into the Island, for use as a food, drug,
p.000033: cosmetic or device, and the inspector shall send a written report of the analysis or examination to
p.000033: the Collector-General and a copy of such report to the importers.
p.000033:
...
General/Other / Natural Hazards
Searching for indicator hazard:
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p.000033: 8ti. Eyery licensed dealer shall take all necessary steps to protect controlléd, drugs in his possession
p.000033: or under his control against loss Or theft and shall report to the Minister any 6uch loss or theft
p.000033: of a controlled drug within ten days of the discovery of such loss or theft.
p.000033:
p.000033: 81. 1) A° rson shall not sell a cosmetic which is not labelled in accordance with these Regulations.
p.000033: “ tT jfiElusion of this page is authorized by L.N. 144/ 1995]
p.000033:
p.000033: 34 TPE FOOD AND DRUGS REG C/ LATIONS, 1vz5
p.000033: (2) Except as otherwise provided in thèse Regulations there shall be included—
p.000033: a) on both the inner and outer labels of a cosmetic—
p.000033: (i) the name, if any. of the cosmetic, and the identification
p.000033: thereof: and
p.000033: (ii) the name and address of the place of business of the manufacturer or distributor and if he bas
p.000033: more than one place of business. the address of his principal place of business:
p.000033: (b) on the label of a cosmetic a declaration of the net contents expressed in terms of—
p.000033: (i) weight for solids;
p.000033: (ü) 8uid measure for liquids; and (üi) weight for semi-solids,
p.000033: so, however, that in all cases 8uid measurement may be used if it conveys accurate information in respect
p.000033: of the net content, and is in accordance with established commercial practice, and where a hazard
p.000033: exists, adequate directions for safe use shall be included as well as any warning, cauticn or special
p.000033: direction required by thèse Regulations.
p.000033: 82. A person shall not sell a cosmetic on the label or in any advertisement for whicb is
p.000033: included any symbol or device suggesting that the cosmetic has been prepared or coinpounded in
p.000033: accordance with a prescription.
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033: Tbird
p.000033: WorœC.
p.000033: PART HL Administration
p.000033: 83. A certificate of designation to be furnished to an inspector pursuant to subsection (4) of
p.000033: section 19 of the Act, shall be in the form set out as Form C in the Third Schedule.
p.000033: 84. When tasting a sample in accordance with the provisions of section 19 of the Act, an
p.000033: inspector shall, after procuring a suitable quantity of the article in question, forthwith notify the
p.000033: owner thereof or the person from whom the sample was obtained. of his intention to have that sample
p.000033: examined or analysed and—
p.000033: [a) where in his opinion, division of the procured quantity would not interfere with analysis or
p.000033: examination, the inspector shell—
p.000033: (i) divide the quantity into three parts;
p.000033: (ii) identify the three parts as the owner’s portion, the sample, and the duplicate sample, and
p.000033: where only one part bears the label, that part shall be identified as the sample;
p.000033: (The inclusion of this page is authorizcd by L.H. 344/ 1995}
p.000033:
p.000033:
...
General/Other / Public Emergency
Searching for indicator emergency:
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p.000029: written authority from the Minister to conduct investigations relating to that new drug, and obtains in
p.000029: writing from that person an undertaking that the new drug will be used solely by him or under
p.000029: his direction for investigational purposes.
p.000029: {The incluéon of this page is authorized by L.H. 144/ 1995)
p.000029:
p.000029:
p.000029:
p.000029: (2) A person who imports a new drug for the purpose of sale to any other person authorized by the
p.000029: Minister to carry out investiga- tions in relation to that new drug, shall keep accurate records
p.000029: of such sales, and shall make these records available for inspection by inspectors duly designated
p.000029: under the Act.
p.000029: 72. Notwithstanding anything to the contrary in these Regulations, the Minister may grant permission
p.000029: in writing to any person to import any specified quantity of a new drug, for submission as
p.000029: a sample with an application for a licence in relation to that new drug.
p.000029: 73. NOtWithst2nding any other provision in these Regulations. the Minister may grant any
p.000029: emergency licence to a practitioner for the importation of a new drug, the application for which
p.000029: does not comply with the requirements of these Regulations, if that drug is required for the
p.000029: treatment of an urgent case, and the Minister is satisfied that it is in the best interest of the
p.000029: patient for whom the drug is intended, that the importation be elected without delay.
p.000029:
p.000029:
p.000029: 74. In this Division—
p.000029: “controlled drug” means any drug listed in the Fifth Schedule and includes a mixture
p.000029: containing any such drug;
p.000029: “licensed dealer" means any person licensed to manufacture or sell a controlled drug, authorized
p.000029: by the Minister to have a controlled drwg in his possession, or granted a permit to import
p.000029: or export a controlled drug pursuant to regulations 75 and 76 respectively.
p.000029: 75.—(1) A person shall not manufacture or sell a controlled drug unless he has been granted a
p.000029: licence to do so by the Minister nor shall a person have a controlled drug in his possession unless
p.000029: he has authorization from the Minister to do so.
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000025: regulation 69; and
p.000025: (b) tte has paid an initial fee of five thousand dollars in respect of that licence instead of the
p.000025: registration lee imposed pursuant to regulation 40.
p.000025: (2) Any person desirous of obtaining a licence in accordance with paragraph (1) shall make an
p.000025: application to the Minister contain-
p.000025: g—
p.000025: (o) a description of the new drug, ineluding the name and address of the manufacturer thereof, and a
p.000025: declaration of the proper name, il any, and the name under which it is proposed to be sold;
p.000025: (b) a statement of all the ingredients. the route of administration, the proposed dosage. the
p.000025: therapeutie or diagnostic claims for the new drug. if known, a description of the pharmaceutical dosage
p.000025: form in which the new drug is to be sold, and any known contra-indications and side affects thereofi
p.000025: (c) details of the tests condueted to control the potency, purity and safety of the new dmg;
p.000025: (d) a dratt of every label proposed to be uscd in connection with the new drug;
p.000025: (e) samples of the new drug in the finished and pharmaceutical form in which it is to be sold;
p.000025: IJ) such samples of the eomponents of the new drug as the Minister may require;
p.000025: (g) a certificats from the competent authority in the country of manufacture or export certifying that
p.000025: the new drug is approved for use in that country and the conditions under which it may be used or sold in
p.000025: that country; and
p.000025: (A) a certifieate in the English language in addition to any other latiguage. from the manufacturer,
p.000025: respecting the safety of the new drug conditions of use recommended, and giving the conditions
p.000025: under which it may be sold. issued by an official
p.000025: ' body or goV'ernfrient department having authority to issue such certificate, such official body
p.000025: or government department
p.000025:
p.000029: 29
p.000029:
p.000029: having the experience and facilities for testing the safety of a new drug that are considered by the
p.000029: Minister as adequate to ensure the safety of the new drug under the conditions of use
p.000029: recommended.
p.000029: (3) The Minister may in his discretion, refuse any application for a licence made pursuant to
p.000029: this regulation. or grant any such application which does not comply with the requirements
p.000029: of sub- paragraph (g) of paragraph f2) but is accompanied by—
p.000029: (a) detailed reports of the tests made to establish the safety of the new drug for
p.000029: the purpose and under the conditions of use for which it is recommended; and
p.000029: (b) such other information and material as the Minister may in
p.000029: any particular case require.
p.000029: 66. A person shall not import, sell, advertise for sale or manufacture a new drug in respect of which
p.000029: he has been granted a licence. if any material change has been made in respect of that new
p.000029: drug. in—
p.000029: (a) the strength, purity or quality:
p.000029: b) the pharmaceutical dosage form in which it is sold;
p.000029: (c) the conditions of use, including indications for use and the route of administration:
...
p.000029: which the approval by the Minister was based; or
p.000029: b) the submission filed with the Minis'••-r in relation to that new drug and on which approval
p.000029: by the Minister was based, contained any untrue Statement of material fact; or
p.000029: (c) the withdrawal is necessary in the public interest.
p.000029: (2) Notice of withdrawal of approval in respect of any new drug shall be published for three
p.000029: consecutive weeks in the Gazette and in at least one issue of a daily newspaper printed and
p.000029: circulating in Jamaica. for three consecutive weeks.
p.000029: 7ti. Where any person receives any report of any unexpected side effects, injury. toxicity or
p.000029: sensitivity reaction associated with clinical uses, studies. investigation and tests respecting
p.000029: any new drug, he shall immediately inform the Minister thereof, furnishing him with the full
p.000029: information available.
p.000029: 71.—(1) Notwithstanding anything to the contrary in these Regula- tions, a new drug may be imported for
p.000029: the use of investigators having such technical qualifications as is deemed necessary by the Minister in
p.000029: the circumstances for the sole purpose of obtaining clinical and scientific data with respect to
p.000029: its safety. stability, dosage or efficiency, if—-
p.000029: a) the investigators have written authority from the Minister to carry out investigations on the new
p.000029: drug and the facilities for so doing;
p.000029: (b) before the importation. the Minister is informed of the identify- ing name or mark by which the new drug
p.000029: may be recognized;
p.000029: (c) both the inner and outer labels on any package of such new drug bear the statement “To be used
p.000029: for investigational pur- poses only”;
p.000029: (d) before the sale, the importer ensures that any person to whom the new drug is to be sold has
p.000029: written authority from the Minister to conduct investigations relating to that new drug, and obtains in
p.000029: writing from that person an undertaking that the new drug will be used solely by him or under
p.000029: his direction for investigational purposes.
p.000029: {The incluéon of this page is authorized by L.H. 144/ 1995)
p.000029:
p.000029:
p.000029:
p.000029: (2) A person who imports a new drug for the purpose of sale to any other person authorized by the
p.000029: Minister to carry out investiga- tions in relation to that new drug, shall keep accurate records
p.000029: of such sales, and shall make these records available for inspection by inspectors duly designated
p.000029: under the Act.
p.000029: 72. Notwithstanding anything to the contrary in these Regulations, the Minister may grant permission
p.000029: in writing to any person to import any specified quantity of a new drug, for submission as
p.000029: a sample with an application for a licence in relation to that new drug.
p.000029: 73. NOtWithst2nding any other provision in these Regulations. the Minister may grant any
p.000029: emergency licence to a practitioner for the importation of a new drug, the application for which
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| age | Age |
| authority | Relationship to Authority |
| children | Child |
| conviction | Religion |
| drug | Drug Usage |
| emergency | Public Emergency |
| hazard | Natural Hazards |
| home | Property Ownership |
| language | Linguistic Proficiency |
| opinion | philosophical differences/differences of opinion |
| single | Marital Status |
| substance | Drug Usage |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| drug | ['substance'] |
| substance | ['drug'] |
Trigger Words
protect
Applicable Type / Vulnerability / Indicator Overlay for this Input