FOOD AND DRUGS
THE FOOD AND DRUGS ACT
REG~LA~ONS
(under section 21)
THE FOOD AND DRUGS REGULATIONS, 1975
(Made by the Minister on the 3rd day of March, 1975) L.N. 65/15
Amdts:
L.N. 908193
[4th August, IW gj;;
PART I . Definitions
1. These Regulations may be cited as the Food and Drugs Regula-
tions. 1975.
1 Io these Regulations unless the context otherwise requires-
"can" means any hermetically sealed container;
"cubic centimetre" and its abbreviated form "cc" shall be inter-
changeable with the term "millilitre" and its abbreviated form
U" .
"d~larcd'' means written on the label attached to or accompany-
ing the food, drug or substance in respect of which the
declaration is required, in letters of the prescribed size;
'ice" means the product obtained by freezing potable water which
has been kept, stored and delivered under such hygienic
conditions as to prevent contamination;
"inner label" means the label on or afllxed to an immediate can
or package of food. drug, cosmetic or device;
"main panel" means the principal label afked to the package or
container identifying its contents by stating the name of the
food. drug. cosmetic or device, the ingredients. weight. manu-
facturer, place of mufacture and such other infamation as
may be required by these Regulations;
"official method" means a method of analysis or examination
designated as such by the Minister for use in the administra-
tion of the Act;
.'The indusion of chir pace b authorired by L.N. 54/2000]
THE FOOD AND DRUGS REGULATIONS, 1975
"outer label" means the label on or affixed to the outside of a
package of a food, drug, cosmetic or device;
"parts per million" means part by weight per million parts by
weight except where otherwise stated;
"per cent" means per cent by weight (weight in weight) except
where otherwise stated;
"potable water" means water which is clear. colourless and free
from any pathogenic micro-organism.
PART U. Foods, Drugs, Cosmetics and Devices
Division I . General
3.41) A person shall not advertise any food, drug, cosmetic or
device unless such advertisement complies with the requirements of
the Act and these Regulations.
(2) Unless specifically required to do so by any enactment, no
label or advertisement shall either directly or indirectly make reference
to the Ministry of Health and Environmental Control or these Regula-
tions.
4 - 4 1 ) A person shall not advertise any drug unless he has first been
granted approval in writing by the Minister to do so, and such approval
has not been withdrawn at the time of publication of the advertisement.
(2) The Minister may refuse to grant approval, or may withdraw
the approval granted in respect of any advertisement by notifying in
writing the applicant for the approval or the person to whom the
approval was granted, as the case may be, in cases where-
(a) he has reasonable grounds to believe that the application on
which approval in respect of any such advertisement was
granted contained false or misleading statements; or
(b) the advertisement in respect of which approval was given
does not comply with the requirements of these Regulations.
5 .41) Any information required by these Regulations to be included
on a label shall be clearly and prominently displayed thereon, so as
to be readily discernible to the public under normal conditions of
pkchase and of use.
(2) For the purposes of paragraph (1). the name by which any
food, drug, cosmetic or device is generally known consisting of more
than one word shall be deemed to be clearly and prominently dis-
played on the main panel of the label if each word other than articles.
me inclusion of thir page ir aulhorbd by L.N. 5412000)
THE FOOD AND DRUGS REGULATIONS, 1975 5
conjunctions and prepositions, is in identical type and identically dis-
played.
6. All information required by these Regulations to be declared shall
be in durable characters, and in boldfaced capital letters written in
such colour or colows as to afford a distinct contrast with the back-
ground.
Division 11. Food
7. In this Division-
"artificial (non-nutritive) sweetening agent" means any chemical
compound which is sweet to the taste but does not include
sugar or other carbohydrate or polyhydric alcohols;
"bulk container" means a container in which more than one duly
labelled package of a food and its contents are placed for
wholesale purposes, but in which the packages and their con-
tents are not intended to be retailed;
"close proximity" means with reference to a common name, written
or graphic matter placed immediately adjacent to that com-
mon name;
"common name" means with reference to a food, the name by
which the food is generally known;
"food additive" means any substance, including any source of
radiation, the use of which results, or may reasonably be
expected to result, in it or its by-products becoming a part
of or affecting the characteristics of a food excepting-
(a) any nutritive material that is used, recognized, or
commonly sold as an article or ingredient of food;
(b) vitamins, minerals, and amino acids unless added for
flavourings;
(c) spices, seasoning, flavouring preparations essential
oils, oleoresins and natural extractives;
(6) pesticides;
(e) food packaging materials and components thereof;
and
drugs recommended for administration to animals
that may be a source of food for human beings;
"unstandardized food" means any food for which a standard has
not been prescribed.
8. A person shall not prepare, pack, store or transport any food
intended for sale in any manner which renders it injurious to health,
induoion of this Page is authorized by L.N 286119761
THE FOOD AND DRUGS REGULATIONS. 1975
or which injuriously affects its nutritive properties, or which renders
it unwholesome, nor shall a person sell any fwd which has become
injurious to health, which has had its nutritive properties injuriously
affected, or which has become unwholesome.
9. A person shall not sell any canned food the container of which
is blown or punctured, or any frozen f w d which has been thawed
in the package and subsequently refrozen.
10. A person shall not use water other than potable water as an
ingredient in the manufacture or preparation of any food.
Labelling
11.41) A person shall not sell a package of food which is not
labelled or which bears a label that does not comply with the pro-
visions of these Regulations.
(2) The provisions of paragraph (I) shall not apply to food
packaged from bulk on the premises where that food is retailed, so.
however, that where any fwd so packaged bears any statement, mark
or device regarding the ingredients or the substances contained therein
other than the name of the food, the name and address of the retailer
and the net contents, it shall be labelled as required by the Act.
1 2 4 1 ) Unless otherwise specifically provided in these Regulations.
every package of food offered for sale shall bear a label stating legibly
and conspicuously in conformity with regulations 5 and 6-
(a) on the main panel-
(i) the brand name or trade name, if any; and
(ii) the common name of the food; and
(iii) a statement of the weight, volume, number or measure
of contents; and
(b) on the remainder of the label-
(i) a declaration of added colour, if present; and
(ii) the name and address of the manufacturer, packer, im-
porter, vendor or of any person who assumes the
responsibilities of the manufacturer, packer, importer
or vendor and indicates in conjunction with his name
and address that he is not the manufacturer, packer.
importer or vendor.
[The Inclusion of thia page ir authorized by L.N 286/19761
THE FOOD AND DRUGS REGULATIONS. 1915
(2) Notwithstanding paragraph (i) of subparagraph (b) of
paragraph (1). a list of ingredients is not required to indicate the
presence of caramel as a food wlour in-
(a) nonexcisable fermented beverages;
(b) spirituous liquors other than gin;
(c) wine.
13. Except where the quantity of the contents marked on a package
of food is stated in terms of minimum weight, volume, number or
measure, there shall be permitted from the stated quantity, variations-
(a) due exclusively to weighing, measuring or counting that occur
in packaging conducted in compliance with good commercial
practice;
(b) due exclusively to difference in the capacities of containers
resulting solely from unavoidable factors in manufacturing;
(c) due exclusively to the ordinary and customary exposut of
the package to evaporation under usual atmospheric con-
ditions.
14. Unless otherwise specifically permitted by these Regulations, a
person shall not sell a synthetic food as substitute for any food unless-
(a) it is clearly indicated on the label or in any advertisement
in respect thereof that it is a substitute, imitation, artificial
or synthetic food; and
(b) the label of every package of such food other than imitation
flavouring preparations, includes legibly and conspicuously,
the common names of all the ingredients of that food in
descending order of their proportionate content.
15. A person shall not sell any food bearing a label which suggests
or implies the presence of one or more vitamins, that the food contains
vitamins, or that it is rich in vitamins, unless there is written on the
label in letters of not less than eight points, the actual vitamin content
per 100 grammes of food.
16. Where any colouring or any flavouring has been added to any
food, every package to which that colouring or flavouring has been
added shall bear a label including the words "artificially coloured",
"artificially flavoured" or "artificially coloured and flavoured'', as the
case may require.
THE FOOD AND DRUGS REGULATIONS, I975
17. Any colouring substance or mixture of colouring substances
which is sold or packaged for use in food shall bear a label on
which shall be written legibly and prominently-
(a) the name or names of the colouring substance or substances
present; and
(b) the words "food colour" in letters of not less than 4 inch in
height.
Adulteration of Foods and Special Foods.
18. A person shall not add any colouring, flavouring, preservative.
or anti-oxidant to any food, extender, stabilizing or modifying agent
other than to food in its natural form, or of a standard specified in
these Regulations, or add any such substance to any food or sell any
food containing any such substance unless the addition or presence of
any such substance is specifically permitted by these Regulations.
19.+1) A person shall not add any artificial sweetening agent,
mineral oil, parffi, mineral salt (except sodium chloride), resin, glycol
derivative, coumarin or any substance containing coumarin, to any
fwd, or sell any food containing any such substance unless the addition
or presence is permitted by these Regulations.
(2) The provisions of this Regulation with respect to paraflin
shall not apply to chewing gum.
20. A person shall not use or sell for use in or upon a food, any
ingredient, unless it is of a purity that renders it safe and appropriate
for we in foods.
21. A food shall be deemed to be adulterated if any of the following
substances or classes of substances are present therein or have been
added thereto-
(a) mineral oil, p a r e wax, or any preparation thereof;
(b) coumarin, extracts of tonka beans, the seed of Dipteryx odorata
Willd, or Dipteryx oppositi-folia Willd;
(c) synthetic sweetening agents other than saccharin;
(4 cottonseed flour that contains more than four hundred and
fifty parts per million of free gossypol;
(e) fatty-acids and their salts containing toxic factors;
(f) dihydrosafarole;
(g) isosafrole;
(h) oil of American sassafras from sassafras alkidum (nut) Nees;
(i) oil of Brazilian sassafras from Ocotca cymbarum H.B.K.;
me inclusion of tbh page u authorized by L.N 286/1976]
THE FOOD AND DRUGS REGULATIONS, 1975 9
(j) oil of camphor sassafras from Cinnamon camphorum sieb;
(k) oil of micranthum Hyata; or
(0 safrole;
Provided that-
(i) a food shall not be adulterated if it contains not more than
0.3 per cent mineral oil, where the normal manufacturing
practices require the use of mineral oil;
(ii) chewing gum shall not be adulterated if it contains a paraffin
wax base;
(iii) fresh fruits and vegetables (with the exception of turnips)
shall not be adulterated if they are coated with not more
than 0.3 per cent p a r a h wax and petrolatum, where normal
manufacturing practices require the use of such coating; and
(iv) turnips and cheese shall not be adulterated if they are coated
with para& wax in accordance with normal manufacturing
practice.
22 Except in the case of special formulae, bakery products, and
special dietary foods, a person shall not sell a food that is represented
as W i g for babies if that food contains a fwd additive.
23. Where a statement or claim implying a special dietary use is
made on the label of, or in any advertisement for a food, the type
of diet for which that food is recommended shall be included in such
label or advertisement.
24.41) Special dietary foods recommended for carbohydrate or
sugar reduced diets shall be foods that contain not more than 50%
of the glycogenic carbohydrates normally present in foods of the same
class, except that confectionery and pudding powders shall contain
not more than 70% of the glycogenic carbohydrates normally present
in such foods.
(2) For the purpose of these Regulations a food may be de-
scribed as "sugarless", "sugar-free" or by any other synonymous term
if that food contains not more than 0.25 per cent glycogenic carbohy-
drates.
(3) Where a statement of claim relating to the carbohydrate.
sugar or starch content of any food is made on the label of, or in
any advertisement for that food, such label or advertisement shall in-
clude a statement of the carbohydrate content in grammes per 100
grammes or on a percentage basis.
inclusion of this p a p Is authorized by L.N 286119761
THE FOOD AND DRUGS REGULATIONS, 1975
25.41) Special dietary foods recommended for calorie reduced diets
shall be foods that contain not more than 50 per cent of the total
calories normally present in foods of that same type.
(2) Where a statement or claim relating to the calorie content
of any food is made on the label of, or in any advertisement for that
food, such label or advertisement shall include a statement of the
calorie content in calories per 100 grammes.
(3) For the purpose of these Regulations, a food may be de-
scribed as "low-caloried" or by any other synonymous term if it
contains not more than 15k calories per average serving and 30k
calories in a reasonable daily intake.
26.41) Where a statement or claim relating to the sodium content
of any food is made on the label of, or in any advertisement for that
food, such label or advertisement shall include a declaration of the
sodium content in milligrammes per 100 grammes.
(2) The number of milligrammes of sodium contributed by a
reasonable daily intake of a special dietary food recommended for a
sodium reduced diet shall not exceed one-sixth the number of mil&
grammes contained in a reasonable daily intake of the same food.
(3) For the purposes of these Regulations, a food may be
described as "low-sodium" or by any synonymous term if it contains
not more than 10 milligrammes sodium in an average serving and
20 milligrammes in a reasonable daily intake.
27.41) A person shall not sell a food containing a non-nutritive
sweetening agent unless-
(a) the label bears a declaration that contains a non-nutritive
artificial sweetener and the name of that sweetener;
(b) the label includes a statement specifying a special dietary
use;
(c) that food meets the requirements for special dietary foods
prescribed in these Regulations; and
(6) the label includes a warning that the food should only be
used on the advice of a registered medical practitioner.
(2) The substances listed in the First Schedule may be used as
artificial (non-nutritive) sweetening agents in foods.
28.--(I) Where a standard for a 'food is prescribed in these Regula-
tions-
pike inclusion of thin page u authorized by L.N 2861 19761
THE FOOD AND DRUGS REGULATIONS, 1975 11
(a) that food shall conform to the requirements prescribed in
that standard;
(b) each ingredient shall be incorporated in the food in a quantity
within the limits prescribed for that ingredient; and
(c) if the standard includes an ingredient to be used as a food
additive for a specified purpose, that ingredient shall be a
food additive approved by the Minister for use as an additive
to that food for that purpose.
(2) Where a standard for a food is not prescribed in these
Regulations-
(a) the food shall not contain any food additives other than
food additives approved by the Minister for use as additives
to that food for that purpose; and
(b) each food additive so approved shall be incorporated in the
food in a quantity within the limits approved for that food
and that food additive.
(3) The provisions of sub-paragraph (c) of paragraph (1) and
sub-paragraph (a) of paragraph (2) shall not apply-
(a) the spices, seasonings, flavouring preparations essential oils,
oleoresins and natural extractives; or
(b) in any case where a standard has been prescribed under any
other enactment.
Preservatives
29.--(1) A person shall not use as a preservative in or upon food, or
sell as a preservative for food, any substance other than those specified
in these Regulations as Class I. Class II. Class III or Class IV
preservatives, respectively.
(2) Where any Class II. Class 111 or Class IV preservative, as
the case may be, is sold for use on food, the label thereof shall
include adequate directions for use in accordance with the limits
prescribed for that preservative in these Regulations.
30.--(I) The following preservatives shall be Class I preservatives
for the purposes of these Regulations-
(a) alcohol;
. (b) ascorbic acid and its salts;
(c) dextrose;
(d) erythorbic acid and its salts;
LThe iadusion of thin page k authorized by L.N 286/1976]
THE FOOD AND DRUGS REGULATIONS. 1975
(e) glucose;
(f) potassium nitrate;
(g) common salt;
(h) sodium nitrate;
(0 spices;
Q sugar;
(k) vinegar; and
( I ) wood smoke.
(2) Notwithstanding paragraph (1). sodium nitrate or potassium
nitrate shall be a Class I preservative in relation to preserved meats
if used in quantities not exceeding 200 parts per million of the finished
product.
31.-41) The following preservatives shall be Class I1 preservatives
for the purposes of these Regulations-
(a) benzoic acid, including the salts thereof;
(b) sulphurous acid, including the salts thereof: and
(c) sorbic acid, including the salts thereof.
(2) A person shall not use more than one Class I1 preservative
in or upon any food, except in the case of methyl-p-hydroxybenzoate
and propyl-p-hydroxybenzoate. where a mixture of both may be used.
(3) A person shall not use in or upon any food more than-
(a) 1.000 parts per million of benzoic acid or its salts calculated
as benzoic acid; or
(b) 1,000 parts per million of sorbic acid or its salts calculated
as sorbic acid.
(4) A person shall not use sulphurous acid or its salts calculated
as sulphur dioxide, in amounts greater than-
(a) 100 parts per million in beverages prepared for consumption
in accordance with label directions;
(b) 2,500 parts per million in or upon dried fruits and vegetables;
or
(c) 500 parts per million in or upon other food.
3 2 . 4 1 ) The following preservatives shall be Class 111 preservatives
for the purposes of these Regulations-
(a) propionic acid, including the salts thereof;
(b) sodium diacetate; and
(c) sorbic acid, including the salts thereof.
[The inclusion of rhis page is authorized by L.N 2861197q
THE FOOD AND DRUGS REGULATIONS, 1975 13
(2) A person shall not use in or upon a food, more than 2.000
parts per million of propionic acid or its salts calculated as propionic
acid.
(3) No quantitative declaration is required on the label of any
Class 111 preservative used on bread, bakery products. cheese, or
processed cheese.
33.-(1) The following preservatives shall be Class IV preservatives
for the purposes of these Regulations-
(i) gum quaiacm;
(ii) vegetable oils containing tocopherols;
(iii) lecithin;
(iv) citric, tartaric, or ascorbic acid;
(v) monoisopropyl citrate;
(vi) ascorbyl palmitate;
(vii) n-propyl gallate, or n-octyl gallate, or n-dodecyl gallate;
(viii) butylated hydroxyanisole; and
(ix) butylated hydroxytoluene.
(2) A person shall not sell a food containing-
(a) any combination of Class IV preservatives that includes both
propyl gallate and nordihydroguaiaretic acid;
(b) any combination of Class IV preservatives, including the sub-
stance in which they are dissolved, in an amount greater than
0.2 per cent of the finished product;
(c) a combination of Class IV preservatives that includes more
than three of the following preservatives-
(i) butylated hydroxyanisole;
(ii) butylated hydroxytoluene;
(iii) propyl gallate; or
(d) any combination of the Class IV preservatives listed in para-
graph (c) in an amount greater than 0.02 per cent of the
finished prodpct.
34. A person shall not sell or use as a preservative on food-
(a) benzoic acid, including the salts thereof;
(b) sulphurous acid, including the salts thereof;
(c) propyl gallate;
(4 butylated hydroxyanisole;
(e) butylated hydroxytoluene,
p l ~ Inclusion of this page is authorized by L.N 286/1976]
14 THE FOOD AND DRUGS REGULATIONS, 1975
unless the label of each package includes a quantitative declaration
of tach of the preservatives present.
Food Additives
35. A person shall not sell a food containing a food additive except
as provided in these Regulations.
36. A person shall not sell any substance or mixture of substances
for use as a food additive unless the label includes a quantitative
statement of the amount of each substance present, and a complete
list of the food additives present in descending order of their pro-
portions, as well as directions for their use, which if followed, shall
produce a food containing such additives in accordance with the
maximum levels of use permitted by these Regulations.
Poisonous Substances in Food
37. A person shall not sell any food in a container that may transmit
to its contents any substance that may be injurious to the health of
a consumer of the food.
38. Notwithstanding paragraph (a) of Section 5 of the Act. the foods
Second
Schedule.
listed in the Second Schedule may contain in or upon them-
(a) any or all of the poisonous or harmful substances listed in
that Schedule opposite to that food in amounts not exceeding
the quantities stated therein in parts per million @.p.m.) for
that food, as determined by the official method; and
(b) other poisonous or harmful substances in amounts not con-
sidered by the Minister likely to be injurious to health.
Division 111. Drugs
39. In this Division-
"adequate directions for use" includes a l l information as may be
necessary for proper use, including cautions as to the possible
adverse reactions and contra-indications;
"antibiotic" means any drug or combination of drugs prepared
from certain micro-organisms, or which formerly was pre-
pared from micro-organisms but is now made synthetically
and which possesses inhibitory action on the growth of other
micro-organisms;
"common name" means. with reference to a drug. the name in the
English language by which the drug is commonly known;
inslurion of this p.ge is authorized by L.N 286119761
THE FOOD AND DRUGS REGULATIONS, 1975
"expiration date" means any date prescribed in relation to a
particular drug, as the date after which that drug is not
recommended for use;
"generic drug" means an unpatented drug product, including a
drug whose patent has expired and one which has never been
patented;
"generic name" means the official name or international non-
proprietary nomenclature;
"internal use" means ingestion by mouth or application for systemic
effect to any part of the body in which the drug comes into
contact with mucous membrane;
"parenteral use" means administration of a drug by means of a
hypodermic syringe, needle or other instrument through or
into the skin or mucous membrane;
"pharmacist" or "druggist" means any person registered as such
under any enactment for the time being in force relating to
the registration of druggists or pharmacists;
"medical practitioner" means any person registered as such under
the Medical Act or any enactment for the time being in force
relating to practise of medicine;
"pr" means, when used in relation to a List 4 Drug, to be sold
on prescription only;
"practitioner" means any dentisf medical practitioner, veterinary
surgeon or veterinary practitioner registered respectively as
such under any relevant enactment for the time being in force;
"prescription" means an order given by a practitioner directing
that a stated amount of any drug or mixture of drug specified
therein be dispensed for a person named in the order;
"proper name" means, with reference to a drug, the name in the
English language of that drug;
"teaspoon" means for the purpose of calculation of dosage, a
volume of five cubic oentimetres.
40.41) A person shall not sell, manufactwe, import or distribute
a W g unless-
(a) that drug has been registered with the Ministry of Health; and
(b) a fee of $25.00 has been paid in respect of such registration.
(2) The Minister may, in his discretion, exempt any person or
any drug from the requirements of paragraph (1).
m e inclusion of this page is authorized by L.N. 144/19951
16 T H E FOOD AND DRUGS REGULATIONS, 1975
41.-41) A person shall not manufacture a drug unless he has applied
for and been granted a permit to do so by the Minister.
'IhLd
Schedule. (2) A permit to manufacture a drug shall be in the form set
~ ~ r m A. out as Form A in the Third Schedule.
(3) A fee of one thousand dollars ($1.000) shall be paid in
respect of each product for which a permit to manufacture is sought.
42-41) A person licensed to manufacture a drug pursuant to
regulation 41 shall not sell a drug in dosage form unless the drug has
been prepared, manufactured, preserved. packaged, stored, labelled
and tested under suitable conditions.
(2) For the purposes of paragraph (1) "suitable conditions"
r e q u i r e
(a) that the construction, fittings and furnishings in a building
where a drug is processed and packaged shall be of such
material and finish as to permit the ready and efficient clean-
ing of all surfaces, to prevent the introduction of extraneous
materials into drugs during their processing and testing, and
to prevent the migration of dust. in accordance with good
pharmaoeutical practices;
(b) that the premises used for the processing, testing, finishing.
distribution and storage of the drug, and all auxiliary facilities,
shall be maintained in a clean, sanitary and orderly con-
dition, free from vermin, infestation, accumulated waste or
debris;
(c) in cases where d.rugs for parenteral use are processed, that
all fillings and aseptic processes shall be carried out in a
separate and enclosed area designed for the processing and
filling of such drugs and operated in a manner that will
prevent contamination of the drug to be compounded and
filled;
(4 that the personnel used as supervisors in the formulation.
processing, testing, packaging and labelling of drugs, and
the personnel responsible for the maintenance of machinery.
equipment and sanitation shall have such technical training
as is deemed necessary by the Minister, having regard to
the duties and the responsibilities involved;
(e) that each lot or batch of raw bulk material used in the
processing of a drug in dosage form shall be tested to ensure
the identity and purity of such raw bulk materials;
m e inclusion of this paw u a u t h d z d by L.N. 1441199SJ
THE FOOD AN^ DRUGS REGULATIONS, 1975
0 that each lot or batch of a drug in dosage form shall be
tested to ensure its identity, potency and purity for its re-
commended use;
(g) that adequate quality controls shall be used, having regard
to the nature of each drug;
(h) that a system of control shall be applied which will permit
a complete and rapid recall of any lot or batch of the drug
from the market, if necessary; and
(0 thal records shall be maintained relating to each drug, in a
form and manner satisfactory to the Minister showing-
(i) the tests canied out on each lot or batch of raw
bulk materials used in the processing of the drugs;
(ii) the tests carried out on each lot or batch of drugs
in the dosage form;
(iii) the quality controls applied;
(iv) all information received pertaining to the quality or
hazards of any drug;
(v) the results of tests to determine the stability of each
drug; and
(vi) the measures taken to ensure the recall of unsatisfactory
lots or batches of drugs from the market.
(3) The records required to be maintained by sub-paragraph (i)
of paragraph (2) shall be kept until the expiration of three years from
the date of the testing of each lot or batch of each drug, or until the
expiration date of that drug, whichever first occurs, and an adequate
sample of each such batch or lot shall be submitted to the Minister, on
his request, for analysis and examination.
43.-41) A person shall not import a drug unless he has applied
for and obtained permission to do so from the Minister and has paid
a fee of two hundred dollars ($200) in respect of each permit bearing
a maximum of ten products.
(2) A person applying for permission to import a drug pursuant
to paragraph (1) may be required by the Minister-
(a) to furnish information and evidence satisfactory to establish
that the conditions of manufacture described in paragraph (2)
of regulation 42 have been met in respect to such drug; and
(b) before such drug is released for sale. to conduct tests in
Jamaica by an acceptable method, on that drug in the form
in which it is sought to be imported.
p c inclusion of (hi page is authorized by L.N. 144119951
THE FOOD AND DRUGS REGULATIONS, 1975
(3) Where, in the opinion of the Minister, a drug, or lot or
batch of drugs, does not conform with the requirements of these
Regulations, the drug, or the lot or batch thereof, as the case may
be. shall not be admitted into the Island for use as a drug.
44.-41) Except as otherwise provided in these Regulations, the label
of a drug shall include--
(a) on the main panel of both the inner and the outer labels-
(i) the proper name; or
(ii) where there is no proper name, the common name;
(6) on both the inner and the outer labels-
(i) the name of the manufacturer or distributor of the drug;
(ii) the address of the manufacturer or distributor, except
in cases where the immediate container contains 5
millilitres or less, when this statement need not be
made on the inner label;
(iii) where a drug is intended for parenteral use. the lot
number thereof;
(iv) a quantitative list of the medicinal ingredients contained
therein by their proper names, or if they have no
proper names, by their common names, except in the
case of drugs sold on prescription; and
(v) adequate directions for use;
(c) on the outer label-
(i) a correct statement of net contents in terms of weight;
and
(ii) where the drug is intended for parenteral use, the
name and proportion of any preservative present there-
in.
(2) All the information required by this regulation to be included
on a label shall be clearly and prominently displayed thereon, and
shall be readily discernible to the public under the customary con-
ditions of pwhase and use.
(3) Where a package of a drug has only one label, that label
shall include the information required by these Regulations to be
shown on both the h e r and outer labels.
inclusion of this p ~ s e is authorized by L.N. 144119953
THE FOOD AND DRUGS REGULATIONS, 1975
(4) The provisions of paragraph (1) shall not apply to the label
of a drug package from bulk on the premises where the drug is
retailed. except that the name of the drug shall be included on the
label and where the package of a drug bears a statement, mark or
device regarding the ingredients declared therein, in addition to the
name of the drug, including the name and address of the retailer, the
net contents and adequate directions for use, the package shall be
labelled as required by these Regulations.
(5) The provisions of this regulation shall not apply to drugs
supplied on prescription.
45. Except as otherwise provided in these Regulations, a person
shall not sell to the general public for human use, a drug, other than
a preparation solely for external use. unless both the inner and outer
labels on such drug include a statement of the quantitative content
of each drug and the recommended single and daily adult dosage, and
where the drug is recommended for children, the statement "dose for
children, as directed by the physician".
46.41) Both the inner and the outer labels of a drug for which
a single or daily dosage or a statement of concentration in excess of the
limits herein provided has been recommended shall include a caution
that the product is to be used only on the advice of a physician.
(2) The provisions of paragraph (I) shall not apply to a drug
supplied on prescription, or to the inner label of a single dose container.
47. The label of every prepacked drug shall include the cautionary
phrase"keep out of the reach of children".
48-41) A person shall not sell a drug containing-
(a) salicylic acid or its salts, acetylsalicylic acid or its salts or
salicylamide, unless, where the drug is recommended for
children, both its inner and outer labels include cautionary
statements to the & a t that the drug may be administered
to children under two years of age only on the advice of a
physician;
(b) hyoscine (scopolamine) or its salts, unless both its inner and
outer labels include a cautionary statement to the effect that
the drug is not to be used by persons d e r i n g from glaucoma
or where the drug causes blurring of the vision or pressure
pain within the eye: and
(c) phenacetin, either singly or in combination with other drugs,
unless its label bears tbe following statement- - irlurion d thk wee in euchaiosd by L.N. 144/1995l
THE FOOD AND DRUGS REGULATIONS, 1975
"CAUTION: May be injurious if taken in large doses
or for a long time. Do not exceed the recommended dose
without consulting a physician."
(2) The provisions of paragraph (1) shall not apply to any pre-
paration containing a drug that is required by anyone to be sold on
prescription, or for parenteral or injectable use.
49.-41) A person shall not sell a corticosteroid drug for ophthalmic
use unless-
(a) the outer label of the package insert includes as part of the
directions for use, the following statements-
"Contraindications-
Viral disease of the cornea and conjuctiva;
Tuberculosis of the eye;
Fungal disease of the eye;
Acute purulent mtreated infection of the eye, whch like
other diseases caused by micro-organisms may be
masked or enhanced by the presence of the steroid.
Side eflecrs
Extended ophthalmic use of oorticosteroid drugs may
cause increased intraocular pressure in certain individuals
and in those diseases causing thinning of the cornea, per-
foration has been known to occur"; and
(b) the inner label includes the statement required by sub-
paragraph (a) of paragraph (1) or instructions to refer to
the outer label or package insert for idormation about con-
traindications and side effwts.
(2) The provisions of paragraph (1) shall not apply to a coni-
costeroid drug that is dispensed by a registered pharmacist pursuant
to a prescription.
(3) A person shall not disseminate to a practitioner promo-
tional literature about corticosteroid drugs for ophthalmic use unless
the statements required by sub-paragraph (a) of paragraph (1) are
included in the literature.
(4) The provisions of paragraphs (1) and (3) shall not apply
to a drug sold solely for veterinary use.
List 4 Drugs
Faunb
Sfhcdulc.
SO.+) The drugs listed in the Fourth Schedule (hereinafter referred
to as List 4 Drugs) arc heteby prohibited from being retailed except
on or in accordance with a prescription from a practitioner.
me inclwion of tbis page L authorized by L.N. 144/199fl
THE FOOD AND DRUGS REGD'L.ATIONS, 1975
(2) A person shall not advertise any List 4 Drugs to the general
public.
51.-41) Subject to regulations 52 and 58, a person shall not sell a
List 4 Drug unless he has received a prescription therefor, either in
writing or verbally.
(2) A person selling a List 4 Drug pursuant to a written
prescription shall retain such prescription for at least two years from
the date of the filling thereof.
(3) A person to whom a prescription for a List 4 Drug has
been communicated verbally by a practitioner shall forthwith reduce
the prescription to writing (which shall be validated by the practitioner
within thirty-six hours) and shall upon the filling therefor, retain that
written and validated prescription for a period of at least two years from
the date of filling thereof.
(4) The person reducing a verbal prescription for a List 4
Drug to writing shall indicate on the written prescription-
(a) the date and number of the prescription;
(b) the name and address of the person for whom the drug was
prescribed;
(c) the name and quantity of the drug prescribed;
(d) the name and address of the practitioner prescribing the drug;
(e) the directions for me given with the prescription, and if that
prescription is to be repeated, the number of times and
intervals of time at which it may be repeated;
(0 the name and address of the person receiving the prescription.
if given verbally: and
(g) the name and address of the person dispensing the drug
pursuant to a verbal prescription which has been reduced
to writing.
(5) A person repeating a prescription for a List 4 Drug shall
record on the original prescription therefor, in respect of each repeat.
the date of the repeat, the quantity of the drug dispensed, and the
name and address of the person who dispensed the drug.
51A.41) Where a prescription directs the dispensing of a named
List 4 Drug and there is available a bioequivalent generic drug which
is less costly than the named drug. the registered pharmacist shall.
before supplying the drug. inform the person for whom the drug is
supplied or the person presenting the prescription-
'.. ._. .
me inclusion of this page is authorized by L.N. 144119951
THE FOOD A N D D R U G S REGULATIONS. 1975
(a) that there is available a bioequivalent generic drug whch is
hterchangeable with the named drug;
(b ) that it is less costly than the named drug; and
(c) that the generic drug will be dispensed for the one prescribed.
except where the person objects or declines to accept the
generic presentation.
(2) This regulation shall not apply where there is a direction
from the person who issued the prescripton that there shall not be
any substitution.
(3) Where a person is supplying a drug for which a prescrip-
tion is not required and there is available a generic drug which is less
costly than the one requested, the pharmacist shall, before supplying
the drug, inform the person requesting the drug-
(a) that there is available a generic drug which is interchangeable
with the drug requested;
(b) that is less costly than the drug requested.
52.-31) A person may sell a List 4 Drug on the strength of a
written order duly signed, to-
(a) a drug manufacturer;
(b) a practitioner;
(c) a registered pharmacist;
(4 a hospital or any nursing home duly registered under any
law for the time being in force relating to the registration
of nursing homes;
(e) any person to whom a written order signed by the Minister
has been issued.
(2) A person selling a List 4 Drug in accordance with para-
graph ( 1 ) shall, prior to effecting the sale, verify the signature of the
person signing the order if there are grounds for reasonable doubt as
to the authenticity thereof.
(3) A person selling a List 4 Drug in accordance with paragraph
(1) shall retain the order on the strength of which the List 4 Drug
was sold, for a period of at least two years from the date on which
the sale was effected.
[The inclusion of this page is authorized by L.N. 144119951
THE FOOD AND DRUGS REGULATIONS, 1975
53. A List 4 Drug shall not be imported other than by or for the
use of-
(a) a practitioner;
(b) a drug manufacturer;
(c) a registered pharmacist; or
(4 a public hospital as defined under the Hospitals (Public) Act
or any enactment for the time being in force relating to
public hospitals.
54.41) Both the inner and outer labels of a package containing
a drug represented for use primarily as a disinfectant, germicide, or
antiseptic, shall include-
(a) the chemical name and proportion or amount of each drug
contained therein;
(b) the batch number;
(c) directions for use;
(d) the words "For external use only" or "For internal use only";
(e) for preparations of phenolic type of natural oils other than
soaps and ointments, as a declaration of the phenol co-
efficient of the preparation as determined by the official
method;
(0 for preparations containing available chlorine. a declaration
of the percentage of the available chlorine content.
55.41) A person shall not sell aminopyrine or dipyrone (a deriva-
tive of aminopyrine) for oral or parenteral use, unless-
(a) the inner label includes the following statement-
"WARNING: Fatal agranulocytosis may be associated
with the use of arninopyrine and dipyrone. It is essential
that adequate blood studies be made. (See enclosed wam-
ings and precautions)"; and
(b) the outer label or the package insert includes the following
statements-
"WARNING: Fatal and even serious agranulocytosis is
known to occur after the administration of aminopyrine or
dipyrone. Fatal agranulocytosis has occurred after short
term, intermittent and prolonged therapy with the drug;
therefore, the use of these drugs should be as brief as
possible. Bearing in mind the possibility that such reactions
may occur, aminopyrine or dipyrone should be used only
when other less potentially dangerous agents are ineffective".
me inclusion of this page is authorized by L.N. 144l19951
THE FOOD AND DRUGS REGULATIONS. 1975
"PRECAUTIONS: It is essential that frequent white
blood cell counts and differential counts be made during
treatment with these drugs. However, it is emphasized that
agrandocytosis may occur suddenly without prior waming.
The drug should be discontinued at the first evidence of
any alteration of the blood count or sign of agranulocytosis.
and the patient should be instructed to discontinue use
of the drug at the first indication of sore throat or sign of
other infection in the mouth or throat (pain, swelling,
tenderness, ulceration)."
(2) A person shall not disseminate to a practitioner promotional
literature about aminopyrine or dipyrone unless the statements specified
in paragraph (1) are included in such literature.
(3) The provisions of paragraphs (1) and (2) shall not apply to
preparations containing aminopyrine or dipyrone that are dispensed
by a pharmacist pursuant to a prescription, or sold for veterinary
use only.
5 6 4 1 ) A person shall not sell coated tablets containing potassium
salts, with or without thiazide diuretics, unless the inner label of
the package or the package insert includes the following statement-
"WARNING: A probable association exists between the
use of coated tablets containing potassium salts, with or
without thiazide diuretics, and the incidence of serious
small bowel ulceration. Such preparations should be used
only when adequate dietary supplementation is not practical,
and should be discontinued if abnormal pain. - distention.
nausea, vomiting or gastrointestinal bleeding occur."
(2) A person shall not disseminate to a practitioner promotional
literature about coated tablets containing potassium salts, with or
without thiazide diuretics, unless the statement specified in paragraph
(1) is included in such literature.
(3) The provisions of paragraphs (1) and (2) shall apply to
coated tablets containing potassium salts with or .pithout thiazide
diuretics that are sold for veterinary use only, or are dispensed by a
pharmacist pursuant to a prescription. t
57. A person shall not sell a drug for veterinary ;He unless both
the inner and the outer labels include, in addition to the requirements
of regulation 61, the quantitative content of the drug: G d except for
[The inclusion of this page is authorized by L.N. 144/1995f;
THE FOOD AND DRUGS REGULATIONS, 1975
drugs in a form not suitable for human use, the words "For Veterinary
Use Only".
58. A person may sell a List 4 Drug on the strength of a prescription
from a veterinary surgeon provided that-
(a) the drug is in a form not suitable for human use; or
(b) the main panel of both the inner and outer labels carries the
words "For Veterinary Use Only", immediately following
or preceding the proprietary or brand name, proper name or
common name, in type not less than one-half as large as
the largest type on the label.
59. Both the inner and the outer labels of a veterinary drug repre-
sented as containing one or mort vitamins shall include in addition
to the requirements of regulation 61-
(a) a statement of the amount of each vitamin present in the
drug, expressed in terms of the proper name of the vitamin
in-
(i) international units per gramme or per millilitre in the
case of vitamin A, provitamin A, vitamin D and
vitamin E;
(ii) milligrammes per gramme in the case of solid or
viscous liquids, or per millilitre in the case of other
liquids, thiamine, riboflavin, niacin, niacinamide, pyri-
doxine, d-pantothenic acid, d-panthenol. folic acid,
ascorbic acid and vitamin K;
(iii) microgrammes per gramme in the case of solid or
viscous liquids, per millilitre in the case of other
liquids, biotin and Vitamin B12;
(iv) oral units for vitamin B12 with intrinsic factor con-
centrate; and
(v) the specified units per individual dose or dispensing
form in the case of vitamin products put up in in-
dividual doses or dispensing forms;
(b) except for drugs in a form not suitable for human use, the
words "For Veterinary Use Only".
60. A person may sell an antibiotic preparation for the treatment
of cattle if-
(a) the preparation is not to be used for lactating cattle and
the inner and outer labels of the preparation include a
statement to that effect; or
me iuclwion of this page is authorized by L.N. 144/19951
T H E FOOD AND DRUGS REGULATIONS, 1975
(b) where the preparation may be used for lactating cattle-
(i) there has been submitted to the Minister on request.
evidence acceptable to him, to show the period of
time required to elapse after the last treatment with
the preparation. in order that the milk from lactating
animals so treated shall not contain residues of anti-
biotics, and that period does not exceed ninety-six
hours;
(ii) the main panel of the outer label of the preparation
and either the inner label or a packaging insert describ-
ing the antibiotic preparation includes the words :
''WARNING : MILK TAKEN FROM TREATED ANIMALS
WITHIN.. . . . .72.. . . .. . . .HOURS AFTER THE LATEST TREAT-
MENT WITH AN INTR.ZMAMMARY MEDICATION SHALL NOT
BE USED IN FOOD"; and
(iii) the relevant space on the label is filled in with the
appropriate figure.
61. A person shall not sell any substance having oestrogenic activity
For administration to podtry which may be used as food for human
consumption.
62.--(I) The Minister may from time to time require the manu-
facturer of a drug recommended for administration to animals which
may be used as food for human consumption-
(a) to file with him in respect of that drug, a submission in
writing, in form and content satisfactory to the Minister,
describing in detail, tests camed out to determine that no
residues of the drug, other than residues within the limits
prescribed by these Regulations remain in meat. meat by-
products, eggs or milk obtained from animals treated with
that drug; and
(b) to print on the main panel of the outer label of any drug
recommended for administration to animals which may be
used for human consumption and on either the inner label
or on a package insert describing the drug, a warning that
meat, meat-products, eggs or milk obtained from animals to
which the drug has been administered cannot be sold as food
for human consumption if they are obtained within such
time after administration as may be specified by the Minister.
(2) A manufacturer shall not sell a drug in respect of which
the Minister has required a warning to be printed pursuant to paragraph
(b) of subsection (1). unless that requirement has been complied with.
me inclusion of this page is authorized by L.N. 144/19951
THE FOOD A N D DRUGS REGULATIONS, 1975
63.-41) A person shall not sell a drug in tablet form, the label
of which indicates that it carries an enteric coating or a coating designed
to have a similar purpose, unless the tablet-
(a) does not disintegrate when exposed to simulated gastric juice
for sixty minutes; and
(b) disintegrates in not more than an additional sixty minutes in
simulated intestinal juice when tested by the official method.
(2) Where a standard of disintegration has not been prescribed
for a drug in any of the publications listed in the Second Schedule
to the Act or in paragraph (1) of this regulation, a person shall not
sell a drug in the form of a tablet that is intended to be swallowed
whole, unless the tablet disintegrates in not more than sixty minutes
when tested by the official method.
(3) The provisions of paragraphs (1) and (2) shall not apply to
tablets containing a drug which has been demonstrated by the official
method to the satisfaction of the Minister to be assimilable by the
body.
(4) Paragraph (2) shall not apply to tablets that are described
on their label as releasing the drug at timed intervals or in sustained
quantities over a period of time.
New Drugs
64. In this Division "new drug" means-
(a) a drug that contains or consists of a substance, whether as
an active or inactive ingredient, carrier, coating. excipient.
menstrum or other component, that has not been imported
into the Island for u'se as a drug for a sufficient time and
in sufficient quantities prior to the 4th of August. 1975 to
establish its efficacy and safety. or is a new drug in the
country in which it was manufactured;
fb) a combination of two or more drugs. with or without other
ingredients which have not been imported into the island prior
to the 4th of August, 1975, in that combination or in the
proportion in which those drugs are combined;
(c) a drug in relation to which the manufacturer prescribes,
recommends, proposes or claims a use as a drug, or a
condition of use as a drug, including dosage, demonstration
or duration of action, and which has not been imported into
the Island prior to the 4th of August. 1975, for that use
or condition of use; or
me inclusion of this page is authorized by L.N. 144/1995]
(d) any other drug which the Minister may prescribe.
65.-(1) A person shall not 'import; sell; advertise for sale, or manu-
facture, a new drug unless- ., ,
(a) he has been issued a licence by the Minister 'in respect of the
importing, sale, or manufacture, as the case may require, of
that new drug, and which licence has not been withdrawn in
accordance with regulation 69; and
(b) he has paid an initial fee of five thousand dollars in respect
of that licence instead of the registration fee imposed pursuant
to regulation 40.
(2) Any person desirous of obtaining a licence in accordance
with paragraph (1) shall make an application to the Minister contain-
ing-
(a) a description of the new drug, including the name and address
of the manufacturer thereof, and a declaration of the proper
name, if any, and the name mder which it is proposed to be
sold;
(b) a statement of all the ingredients, the route of administration,
the proposed dosage, the therapeutic or diagnostic claims for
the new drug, if known, a description of the pharmaceutical
dosage form in which the new drug is to be sold, and any
known contra-indications and side effects thereof;
(c) details of the tests conducted to control the potency, purity
and safety of the new drug;
(4 a draft of every label proposed to be used in connection
with the new drug;
(e) samples of the new drug in the finished and pharmaceutical
form in which it is to be sold;
(f) such samples of the components of the new drug as the
Minister may require;
(g) a certificate from the competent authority in the country of
manufacture or export certifying that the new drug is approved
for use in that country and the conditions under which it may
be used or sold in that country; and
(h) a certificate in the English language in addition. to any other
langdage, from the manufacturer, respecting 'the safety of the
new drug conditions of use recommended, and giving the
conditions under which it may be sold, issued by an official
" body or gotkmfient department having authority to issue
such certificate, such official body or government department
lThe mclusion of ths page' is authorized by L N. 144119951
THE FOOD AND DRUGS REGULATIONS, I975
having the experience and facilities for testing the safety of a
new drug that are considered by the Minister as adequate to
ensure the safety of the new drug under the conditions of
use recommended.
(3) The Minister may in his discretion, refuse any application
for a licence made pursuanr to this regulation, or grant any such
application which does not comply with the requirements of sub-
paragraph (g) of paragraph (2) but is accompanied by-
(a) detailed reports of the tests made to establish the safety
of the new drug for the purpose and under the conditions
of use for which it is recommended; and
(b) such other information and material as the Minister may in
any particular case require.
66. A person shall not import, sell, advertise for sale or manufacture
a new drug in respect of which he has been granted a licence, if any
material change has been made in respect of that new drug, in-
(a) the strength, purity or quality;
(b) the pharmaceutical dosage form in which it is sold;
(c) the conditions of use, including indications for use and the
route of administration;
(6) the dosage; or
(e) the label,
unless he makes application for a new licence in respect thereof,
giving full details of the changes and the manner in which the new
drug in respect of which the original licence was granted, is affected
by the change.
67. Where a person wishes to import, sell, advertise for sale or
manufacture, a new drug in respect of which a licence has been
previously granted to another applicant, that person shall make a
separate application in accordance with regulation 65.
68. The Minister shall, within one hundred and twenty days after
the filing of an application for a licence to import, sell, advertise
for sale. or manufacture a new drug-
(a) notify the applicant whether or not his application is satis-
factory; and
(b) if so, may grant a Licence to the applicant in accordance
therewith.
69.-41) The Minister may withdraw a licence in respect of any
new drug by sending a notice in writing to that effect to the person to
me inclusion of this page is authorized by L.N. 144/19951
THE FOOD AND DRUGS REGULATIONS, I f l5
whom a licence has been granted in respect of that new drug, and
such a withdrawal may be made where-
(a) evidence obtained from clinical or other experience, or from
tests by new methods or by methods not used before the
approval was gven, reveal that the new drug is not shown to
be safe for the use represented in the application made to
the Minister in respect of that new drug and on which the
approval by the Minister was based; or
(b) the submission filed with the Minister in relation to that
new drug and on which approval by the Minister was based,
contained any untrue statement of material fact; or
(c) the withdrawal is necessary in the public interest.
(2) Notice of withdrawal of approval in respect of any new
drug shall be published for three consecutive weeks in the Gazette
and in at least one issue of a daily newspaper printed and circulating
in Jamaica, for three consecutive weeks.
70. Where any person receives any report of any unexpected side
effects, injury, toxicity or sensitivity reaction associated with clinical
uses, studies, investigation and tests respecting any new drug, he
shall immediately inform the Minister thereof, furnishing him with
the full information available.
71.-41) Notwithstanding anything to the contrary in these Regula-
tions, a new drug may be imported for the use of investigators having
such technical qualifications as is deemed necessary by the Minister
in the circumstances for the sole purpose of obtaining clinical and
scientific data with respect to its safety, stability, dosage or efficiency,
if--
(a) the investigators have written authority from the Minister to
carry out investigations on the new drug and the facilities
for so doing:
(b) before the importation, the Minister is informed of the identify-
ing name or mark by which the new drug may be recognized;
(c) both the inner and outer labels on any package of such new
drug bear the statement "To be used for investigational pur-
poses only";
(6) before the sale, the importer ensures that any person to whom
the new drug is to be sold has written authority from the
Minister to conduct investigations relating to that new drug.
and obtains in writing from that person an undertaking that
the new drug will be used solely by him or under his
direction for investigational purposes.
(The inclusion of this page is authorized by L.N. 144119951
THE FOOD AND DRUGS REGULATIONS, 1975
(2) A person who imports a new drug for the purpose of sale
to any other person authorized by the Minister to carry out investiga-
tions in relation to that new drug, shall keep accurate records of
such sales. and shall make these records available for inspection by
inspectors duly designated under the Act.
72. Notwithstanding anything to the contrary in these Regulations.
the Minister may grant permission in writing to any person to import
any specified quantity of a new drug, for submission as a sample
with an application for a licence in relation to that new drug.
73. Notwithstanding any other provision in these Regulations, the
Minister may grant any emergency licence to a practitioner for the
importation of a new drug, the application for which does not comply
with the requirements of these Regulations, if that drug is required
for the treatment of an urgent case, and the Minister is satisfied that
it is in the best interest of the patient for whom the drug is intended,
that the importation be effected without delay.
Controlled Drugs
74. In this Division-
"controlled drug" means any drug listed in the Fifth Schedule &edule.
and includes a mixture containing any such drug;
"licensed dealer" means any person licensed to manufacture or
sell a controlled drug, authorized by the Minister to have a
controlled drug in his possession, or granted a permit to
import or export a controlled drug pursuant to regulations
75 and 76 respectively.
75.-41) A person shall not manufacture or sell a controlled drug
unless he has been granted a licence to do so by the Minister nor
shall a person have a controlled drug in his possession unless he has
authorization from the Minister to do so.
(2) A person shall not import or export a controlled drug
unless he has first obtained a permit to do so from the Minister.
76.-(1) The Minister may. on application therefor-
(a) issue a licence in the form set out as Form B in the Third Ed",.
Schedule to any person to manufacture or sell a controlled
drtDg; or
(h ) issue a permit to any person to import or export a controlled
drug subject to such terms and conditions as he may think
fit.
tThe inclusion of this page is authorized by L.N. 144/19951
THE FOOD AND DRUGS REGULATIONS, 1975
(2) A fee of $10.00 is payable by the applicant in respect of
each licence or permit, as the case may be, issued pursuant to para-
graph (1). in addition to any registration fee payable in respect of
that drug pursuant to regulation 40.
(3) The Minister may revoke'or suspend a licence or a permit
issued pursuant to paragraph (1) if. in his opinion, the person to whom
it is issued, or any person in his employ. has violated or failed to
comply with any term or condition of such licence or permit or any
provision of these Regulations.
(4) A licence issued pursuant to paragraph (1). unless it is sooner
revoked, shall expire on the 31st day of March next following the
date on which it is issued and may be renewed by the Minister on
the appropriate application being made to the Minister in respect
thereof. Where a licence has been suspended it has no validity during
the period of suspension.
77. Subject to the terms and conditions of his licence, and to the
requirements of these Regulations a licensed dealer may supply a
controlled drug-
(a) to another licensed dealer or to a practitioner, if he receives
a written order therefor from such dealer or practitioner, and
he verifies the signature afixed to the order prior to supplying
same; and
(b) to a hospital. if he receives a written order signed by a
pharmacist, practitioner or other official duly authorized by
the hospital to place such an order, and he verifies the signa-
ture affixed to the order prior to supplying same.
78.--(I) A licensed dealer who is a pharmacist carrying on the
business of a pharmacy, or a pharmacist employed by him for the
purposes of conducting that business, may supply a controlled drug
to any person if-
(a) the drug forms part of the stock in trade of the pharmacy:
(b) he has first received a prescription in writing authorizing the
dispensing of that drug;
(c) the prescription has been dated and signed by the practitioner
who issued it;
(4 the prescription includes the full name and address of the
prescribing practitioner; and
(e) the signature of the practitioner is verified prior to effecting
the sale.
[The inclusion of this page is authorized by L.N. 144/1995]
THE FOOD AND DRUGS REGULATIONS, 1975
(2) A pharmacist shall not repeat a prescription for a con-
trolled drug unless the practitioner issuing the original prescription
specifies therein the number of times it may be repeated, and the
intervals at which i t may be repeated.
79.--(I) Every licensed dealer and every pharmacist in control of
a place of business carrying on the business of a pharmacy shall keep
a separate register in relation to controlled drugs in which he shall
enter or cause to be entered within 48 hours of every receipt or
dispensation of any controlled drug, the following-
(a) the name, quantity and form of any controlled dmg received
by him, the name and address of the person from whom he
received it, and the date on which it was received;
(b) the name, quantity and form of any controlled drug supplied,
the name and address of the person to whom it was supplied.
the date on which it was supplied, and if supplied pursuant
to a prescription, the name and address of the person for
whom it was prescribed and the name and address of the
practitioner who issued the prescription;
(c) the name and quantity of any conuolled drug used in manu-
facturing, the name and quantity of any controlled drug
manufactured, and the date any manufactured controlled drug
was placed in stock; and
(6) the name, quantity and form of all controlled drugs in his
stock at the end of each month.
(2) A licensed dealer in both the business of a wholesaler
dealing in drugs and the business of a pharmacy, shall keep separate
registers as required by paragraph (I), in relation to each business.
(3) Every licensed dealer and every pharmacist shall maintain
all vouchers relative to receipts and disposals of controlled drugs in
separate files, in sequence of number and date, for a period of at least
two years from the date on which each transaction took place and
such vouchers shall be kept in a manner that will enable an audit
thereof- to be made at any time.
80. Eyery licensed dealer shall take all necessary steps to protect
controlled., drugs in his possession or under his control against loss
or theft &d shall report to the Minister any such loss or theft of a
controlled dmg within ten days of the discovery of such loss or theft.
' i!
... Division IV. Cosmetics
81.-(1) A Qerson shall not sell a cosmetic which is not labelled
in accordance wi'th these Regulations.
- [T-~lusion of this page is authorized by L.N. 144119951
3 4
THE FOOD AND DRUGS REGULATIONS, I975 I
(2) Except as otherwise provided in these Regulations there shall
be included-
(a) on both the inner and outer labels of a cosmetic-
(i) the name, if any, of the cosmetic, and the identification
thereof; and
(ii) the name and address of the place of business of the
manufacturer or distributor and if he tias more than one
place of business, the address of his principal place
of business;
(b) on the label of a cosmetic a declaration of the net contents
expressed in terms of-
(i) weight for solids;
(ii) fluid measure for liquids; and
(iii) weight for semi-solids.
so, however, that in all cases fluid measurement may be used
if it conveys accurate information in respect of the net content,
and is in accordance with established commercial practice,
and where a hazard exists, adequate directions for safe use
shall be included as well as any warning, cauticn or special
direction required by these Regulations.
82. A person shall not sell a cosmetic on the label or in any
advertisement for which is included any symbol or device suggesting
that the cosmetic has been prepared or compounded in accordance
with a prescription.
PART UL Administration
83. A certificate of designation to be furnished to an inspector
pursuant to subsection (4) of section 19 of the Act, shall be in the
form set out as Form C in the Third Schedule.
84. When taking a sample in accordance with the provisions of
section 19 of the Act, an inspector shall, after procuring a suitable
quantity of the article in question, forthwith notify the owner thereof
or the person from whom the sample was obtained, of his intention
to have that sample examined or analysed and-
(a) where in his opinion, division of the procured quantity would
not interfere with analysis or examination, the inspector shall-
(i) divide the quantity into three parts;
(ii) identify the three parts as the owner's portion, the
sample, and the duplicate sample, and where only one
part bears the label, that part shall be identified as the
sample;
me inclusion of this page is authorized by L.N. 144/19951
THE FOOD AND DRUGS REGULATIONS. 1975
(iii) seal each part in such a manner that it cannot be
opened without breaking the seal;
(iv) deliver the part identified as the owner's portion to the
owner or to the person from whom the sample was
obtained, and have the sample and the duplicate
analysed or examined; or
(b) where, in his opinion division of the procured quantity would
interfere with analysis or examination, the inspector shall-
(i) identify the entire quantity as the sample;
(ii) seal the sample in such a manner that it cannot be
opened without breaking the seal; and
(iii) have the sample analysed or examined:
(c) where the owner or the person from whom the sample was
obtained objects to the procedure followed by an inspector at
the time the sample was obtained, the inspector shall follow
both procedures specified in this regulation, if the owner or
the person from whom the sample was obtained supplies
him with a sufficient quantity of the article to do so.
85.-(1) A certificate of examination or analysis of an article or
sample detained by an inspector shall be in the form set out as Form g,"dU,e.
D in the Third Schedule. F O ~ I ~ D.
(2) Where as a result of an examination or analysis it is reported
that a food, dmg. cosmetic or device. would, if sold in the Island.
constitute a violation of the Act or these Regulations, that food, drug,
cosmetic or device, shall not be admitted into the Island, for use as a
food, drug, cosmetic or device, and the inspector shall send a written
report of the analysis or examination to the Collector-General and a
copy of such report to the importers.
86. Where a food, drug, cosmetic or device sought to be admitted
into the Island, would, if sold in the Island, be contrary to the
provisions of the Act or these Regulations, the food, drug, cosmetic
or device may be admitted into the Island for the purpose of being
relabelled or reconditioned under the supervision of an inspector in
compliance with such conditions as may be specified in the report, and
where such relabelling or reconditioning is not satisfactorily carried out
within three months after the report is made or such lesser period as
may be specified in the report, such food, drug, cosmetic or device
Cn.2 indusi0n of this page is authorized by L.N. 144/1995]
THE FOOD AND DRUGS REGULATIONS, 1975
shall be re-exported and, if not reexported within a further period of
three months shall be disposed of as the Minister may direct, so.
however, that the Minister may, in his discretion, extend the time
for complying with the conditions for re-exporting the said goods.
PART N. Offences and Penalties
87. Any person who fails to comply with any of these Regulations
shall be guilty of an offence, and upon summary conviction before a
Resident Magistrate shall be liable to a fine not exceeding two thousand
dollars or to a term of imprisonment not exceeding twelve months.
[The inclusion of thic page is authorized by L.N. 14441995l
T H E FOOD AND DRUGS REGULATIONS, 1975 37
FIRST SCHEDULE (Regdation 27 (2))
Artificial non-numtndve sweetening agents
Item Additive - -
1. Ammonium
Saccharin
2. Saccharin
3. Sodium
Saccharin
Preparation usually added to Max. Level
of Use
Special dietary foods recommended
for carbohydrate or sugar reduced diets,
and special dietary food recommended
for reduced diets. Good manu-
f acturing
practice.
Special dietary foods recommended
for carboh drate or sugar reduced diets,
and qcd dietary food recanmended
for calone reduced he&. -do--
SECOND SCHEDULE (Regulation 38)
Citric Acid . . . . ..I 1
Tartaric Acid . . . . 1
Cram of Tartar . . . . 2
Sodium Bicarbonate . . 2
Baking Powder . . . . 2
Phosphoric Acid . . 4
Calcium Phosphate . . 4
Sodium Potassium and Ammonium
Phosphates . . . . 4
Zinc
parts ptr
million
Fluorine
Parts pcr
million
[The inclusion of this page is suthoriocd by L.N. 144/19951
38 7HE FOOD AND DRUGS REGULATIONS, 1975
SECOND SCHEDULB. contd.
Poxso~ous S v s s ~ ~ ~ c a s PPRMITIED, contd.
I
Sodium and Potassium Nitrates . .
Sodium Nitrite . . . . . .
Aluminium Compounds . . . .
Marine and Fresh Water Animal Products
Liver . . . . . .
FreshFNits .. . . . .
Fresh VegetabIcs . . . .
Gelatin . . . . . .
Gelling Agents exapt Gelatin . .
Dried Herb and Spices . . . .
Apple J u i a , Cider, Wine and B a r . .
Fruit Juice exapt Apple J u i c e . .
Bev-as Coasumed mdBo#led
Wata . . . . . .
Tea .. . . . . . .
Edible Bone Meal . . . .
Lead
%g
Zinc
P- pu
million
Fluorine
%E
W e inclusion of tbb page is authorized by L.N. 144119953
THE FOOD AND DRUGS REGULATIONS. 1975
THIRD SCHEDULE
FORM A (Regulation 41 (2) )
The Food and Drugs Act
Permit to Manufacture a Drug
Name and ...............................................................................................................
address of
of. Licensee. ......................................................................................
Is HEREBY LICENSED, subject to the provisions of the Food and Drugs Act,
and the Regulations made thereunder, and to the subjoined conditions, to
manufacture at premises situated at-
...............................................................................................................
the following-
Conditions
1. This Licence shall expirc on the ............... day of .................................
19 ............
2. This licence is not transferable.
3. The Minister of Health may at any time revoke this licence upon the
failure of the licensee to comply with all or any of the conditions contained
therein, or in the Regulations.
4. Nothing in this licence shall be deemed to authorize the licensee to keep
any drugs or poisons for the purpose of sale.
................................. .......... Dated at ........................ this ............ y of 19
.....................................................................
Minister of Health and Environmental Control.
FORM B (Regulation 76 (1) )
The Food and Drugs Act
Licence to Manufacture or Sell a Controlled Drug
Name and ............................................................................................................... address of
Licensee.
of. ......................................................................................
Is HEREBY Lrc~~sm, subject to the provisions of the Food and D ~ g s Act
and the Regulations made thereunder, and to the subjoined condlbons, to
manufacture/sell the controlled drugs set out hercund-
Wile inclusion of this page is authorized by L.N. 144/19951
THE FOOD AND DRUGS REGULATIONS, 1975
THIRD SCHEDULE, contd.
Exact
description
of drugs
'to be
manufac- ...............................................................................................................
tured/sold.
Quantity of
drugs to be
manufac- Qred,sold. ...............................................................................................................
Conditions
1. This Licence shall expire on the 31st day of March. 19 ........................
2. The Minister may revoke at any tirqe this Licence upon failure to comply
with dl or any of the conditions mmtamai therein, or in the Regulaaions.
3. This Licence is not transferable.
Dated at.. ...................... this.. .......... day of.. .............................. .19.. ........
.....................................................................
Minister of Health and Environmental Control.
FORM C (Regulation 84)
The Food and Drugs Act
Certificate of Designation of Inspector
This is to certify that
.......................................................................................... Mr./Mrs./Miss
has becn designated an Inspector for the purposes of section 17 of the Food
and Drugs Act
.....................................................................
Signature of Inspector
Minister of Health and Environmental Control.
(OmaAL *AMP)
FORM D (Regulation 86)
The F d and Dmga A d
Certificate of Examination or Analysis
person duly designated an inspector/a~lyst under the Food and Drugs Act
do hueby certify-
[The inclusion of this page ie euthorizcd by L.N: 144/19951
THE FOOD AND DRUGS REGULATIONS. 1975
THIRD SCHEDULE, contd.
(I) that on the ........................... day of .......................................... I9 ............
I received from. ........................................................ a sealed package, which
said package was unopened and the seals thereon unbroken;
(2) that I broke the seals and opened the said package and removed therefrom
a sample, submitted as a sample of .................................................................
taken from ................................................... of ..................................................
(3) that I duly analysed or examined the said sample for the purpose of determining
if same conformed to the requirements of the Food and Drugs Act, and the Regulations made
thereunder, and I obtained the following results-
Dated this ........................... day of ................................................... 19............
................................................................................
Inspector / Analyst
FOURTH SCHEDULE (Regulation 50)
LIST 4 DRUGS
Part I
A
Acebutolol Hydrochloride
Acetocoumarol
Acepromazine
Acetanilide: Alkyl Acetanilides
Acetazolamide Sodium
Acetohexamide
Acetomenaphthone
Acetrizoic Acid and its salts
Acetyl Choline
Acyclovir
Adenosine and its salts
Adipiodone and its salts
Adrenaline Tartrate ( 1- 1000 Injection)
Adrenocorticotmphic Hormone and its derivatives
Alclofenac
Allopurinol
Allylisopropylaoetylurea
Almitrine Dimesylate
Alphadolone Acetate
Alphaxalone and its salts
Alprazolam
Alprenolol Hydrochloride
Amantadine Hydrochloride and Sulphate
[Tk Inclusion of thu p s ~ c u au~horizui by L.N. 33N2003)
THE FOOD AND DRUGSREGULATIONS, 1975
FOURTH SCHEDULE, confd.
Amidopyrine; its Salts and Derivatives; except when contained in ointments or in preparations
for the prevention and treatment of disease in poultry.
Amiloride Hydrochloride
Amino-Acids, preparations for Intravenous Administration
Aminocaproic Acid
Amin~~l~tethimide
Aminopentamide and its salts
Aminophylline
Aminopromazine Fumarate
Aminopterin and its salts
Aminosalicyclic Acid and its salts
Amitriptyline Hydrochloride
Amoxapine
Amphetamine and its salts
Amrinone
Anaesthetics; for ophthalmic or parenteral use, including-
Amethocaine and its salts
Benzocaine and its salts
Butacaine and its salts
Cinchocaine and its salts
Cyclomethycaine and its salts
Dimethisoquin and its salts
Diperodon and its salts
Lidocaine and its salts
Piperocaine and its salts
Pramoxine and its salts
Proxymetacaine and its salts
Androgenic, Oestrogenic and Progestational Substances; their Esters (except when
combined as an Oral Contraceptive) including-
Allyloestrenol Benzoestrol
Boldenone Chlomadinone
Clomiphene Conjugated Estrogens
Dienoestrol Diethylstilboestrol
Dimethistemne Dydrogesterone
Epioestriol Ethinyloestradiol
Ethisterone Ethyloestrenol
Ethynodiol Fluoxymestemne
Gestronol Hexoestrol
Gestodene Medrogestrone
Hydroxyprogestemne Megestrol
Lyngestrenol Mestranol
Medroxyprogesterone Methandriol
Mesterolone Methyloestradiol
Methandienone Nandrolone
Methenolone Norethynodrel
Methyltestosterone
[The Inclusion of this page is authorized by L.N. 33A/2M)5]
THE FOOD AND DRUGS REGULATIONS, I975
FO'URm NX-ZBDU'LE, c o d .
A, cowd.
Notethandmlone Oeatmdiol
Norethisterone Oestmne
Ncugeatrel Oxyanetholone
Oestriol Brogresterone
Oxymesterone S ~ w l o l
P&razine Oe&one Subhate Testos~ronc
Quinestrol
Stilboestrol
Antazoline and its salts
Antihaemophilic Factor
Apramyoin
Atemlo1 and its salts
Atxucrium Besylate
Atropine and it6 d b
Auranofin
Azacyclonol Hydrochloride
AzapePone
Aztrconam
B ~ o p r o p y l ~ b e n z e a c and B-Arminow-Pmpylbenzene; their ddvatives,
and analogues except Ephadrine, Methylephsdrine, Ethylphcdnne,
nore ephedrine and h.nalyf~he.
Baclofen
Bamethan Sdphate
Banbaaclone
Barbituric Acid, its salts; derivatives of Bd6turic Acid, thdr dta hclud- *
Allo'ba~bitone
h y l a b ~ ~ b i t o w
Biuibitone
Sacbutoba&itone
Virhafitone
me inclusion of this page is autharip4 by L.N. 144119951
THE FOOD AND DRUGS REGULATIONS, 1975
FOURTH SKXIEDm, conrd.
B, conrd.
Barium Sulphab
Beclamide
Belladonna and its alkaloids
Benactyzine Hydrochloride
Bencyclane and its salts
Bendazac and its salts
Bendrofluazide
Benfluorex Hydrochloride
Benserazide Hydrochloride
Benzetimide Hydrochloride
Benzhexol Hydrochloride
Benzocaine
Benzoctamine
Benzoyl Peroxide (10%)
Benzphetamine Hydrochloride
Benztropine and its Homologues, their salts
Benzydamie Hydrochloride
Bemegride
Betahistine and its salts
Betaxolol and its salts
Bethanidhe and its salts
Biperiden and its salts
Bitolterol and its salts
Bretylium Twylate
Bromazepam
Bromhexine and its salts
Bromocryptine and its salts
Branvaletone
Broxaldine
Broxyquinohe
Buclosamide
Buflomedil Hydrochloride
Bumetanide
Buphenine Hydrochloride
Busgirone Hydrochloride
Busulphan Hydrochloride
Butaperazhe Hydrochloride
Butorphan01 Tartrate
Butryptiline H y d r d o r i d e
-
me incwon of this page ir suthoribd by L.N. 144119951
THE FOOD AND DRUGS REGULATIONS, 1975
ROURTN SCHEDULE, contd.
Calcif erol
Calcium Disodium Versenate Injection
Calcium Gluconate Injection
Calcium Iodide Injection
Calcium Sodium Edetate
Cannabinoids (of Cannabis Sativa)
Captodiamine and its salts
captopril
Carbamazepine
Carbachol
Carbamide
Oarbenoxolone and its salts
Carbimamle
Carbidopa
Carbromal and its demivativ~
Acetyloarbromal
Garieoprodol
Carphenazine and its salts
Cefroxadine
Cef triaxone
Cefuroxime
Cephapkin Sodium
Cetylpyridinium
Chenodeoxycholic Acid
Choml and its derivatives
Chloralose
Chloral Hydrate
Ohloralamide
Chloralodol
Chlorambucil and its salts and derivatives
Chloracyzine (except preparations for external Use only)
Chloradiazepoxide and its salt6
Chlorhexidine and it8 salts
Chlorisondamine and itr salts
Chlorrnethiazole and its salts
Chlorrneaanone
Ohloroquin and i b salts
Chlorothiazide and its dtP and derivatives
[The inclusion of this page is authorized by L.N. 144/1Y951
TFIE FOOD AND DRUGS REGULATIONS, 1915
Cblorphentermine 'Hydrochloride
Chlorphenoxamine
Chlorprodne and its salts
Chlorpropaonide and its salts
Chlorprothixene and its aalhs
Chlorquinaldol
Ohlorthalidone
Qnnarizine
Clebopnide Acid Maleate
Clemastine and its sa19
Clemizole
Clidimum Bromide
Clioquinol
Cloba!4aln
Cldbe~lzorcx
Cloaazcpam
Clonidine Hydrochloride
Clopenthixol Hydrochloride
Clorampate Sodium
me inclusion of this p . ~ e t authorind by L.N. 144119951
THE FOOD AND DRUGS REGULATIONS, 1975
FOURTH SCHEDULE, contd.
C, conrd.
Cortisone
Desoxymethasone
Dexamethasone
Diflucortolone
Fluclorolone
Flumethasone
Cotrimoxazole
Cromoglycate Sodium
Crornoglycic Acid and its salts
Crotamiton
Cyclandelate
Cyclizine
Cyclobenzaprine
Cyclopentamine Hydrochloride
Cyclopenthiazide
Cyclophospharnide
Cycrimine and its salts
Cymevene
Cyproterone and its salts
Cytarabine and its salts
Danazol
Dantrolene Sodium
Debrisoquine Sulphate
Demecarium Bromide
Deproteinised Extract of Blood
Dequalinium
Desipramine
Deslanoside
Desmopressin Acetate
Desonide
Dexfenfluramine and its salts
Dextropropoxyphene Hydrochloride
Diaphenylsulfone
Diatrizoate and its salts
Diazepam
Diazoxide and its salts
Dibasic Calcium Phosphate
Dichlorphenamide and its ealts
Dichlorvos
Hydrocortisone (other than
0.5% and 1 % Hydrocor-
tisone Cream and 0.5%
end I % Hydrocortkono
Ointment)
Methylprednisolonr
Mornetasone
Predinisolone
Prednisone
Triamcinolone
Diclofenac and its salts (other than Diclofenac topical preparation)
IT& inclusion of &is page is autborircd by L.N. 54/2000J .
HE FOOD A N D DRUGS REGULATIONS. 1975
FOURTH SCHEDULE, contd.
D, contd.
Diethylcarbamazine Citrate
Diethylpropion Hydrochloride
Diflorasone Diacetate
Diflunisal
Digitalis, its glycoside or derivatives, or reparations includinp-
Acetyldigitoxin . Digitoxin
Acety ldigoxin Digoxin
Deslanoside Lanatosido
Digitalis Leaves
Dihydroergocristine MaleatejClopamidejReserpine
Dihexyverine Hydrochloride
Dihydralazine and its salts
Diltiazem and its salts
Dimenhydrinate Inspection
Dimethyl Sulfoxide
Diminazene Aceturate
Dinoprost and its .salts
Diosmin
Diphenidol Hydrochloride
Diphenoxylate 'Hydrochloride
Dipyridamole
Dipyrone and its salts
Disopyramide and ita mlta
Disulfiram
Dobutamine
Dopamine Hydrochloride
Dothicpin Hydrochloride
Doxepin and its .salts
Droperidol and its salts
Drotaverine and its salts
Diflucortolone
Echothiophate Iodine
Econazole Nitrate
Ectylurea
Edrophonium Chloride
Electrolyte Mixtures
Emylcamate
Enalapril Maleate
Endralazine
Enprmes, including-
Amylolytic Lipol.ytic
Cellulolytic Mucolytic
Febrinol ytic Proteol y tic -
me inclrrsion of this page is authorized by L.N. 54/ZOOO1
THE FOOD AND DRUGS REGULATIONS, 1975
Ephedrine Hydrochloride doses of 30- or more
Ephedrine Sulphate Injection
Epinephrine and its salts
Fhthacrynic Acid
Ethmbutol Hydroohloride
Ethchlorvynol
E W m *
Ethionamide
Ethoheptazine atrab
Ethosuximide
Ethylchloride
Ethylenediamine
E t h y l e f ~ e and its salts
Etodolac
Etretinate
Ergot, its alkaloids and thair salts including-
Dihydroergotamine
Dilhy droergatoxine
Ergometrine
Ergohmine
Ergotoxhe
Famo tidine
Feaiproebalene
Fen~metowle
Fenoprofen and its salts
Fenoterol and its d b
Fentanyl and its salts
Fentianac and i& salm
Feprazone
Folic Acid
Flavonoids (Extracts from Rutaceae)
Flavoxate and its saltS
Flecainide and its salts
Flucytosine
Flunarizine and its salts
Fluocinlonc
Fluorouracil and its derivatives
Fluoxetine and its salts
Flupentixol and its salts
Fluphenadne and its salts
me inclusion of thii page is eutharized by LN. 144/19951
THE FOOD AND DRUGS REOULATZONS, 1975
F0~lU-I SOHEE'DULE, contd.
F, c o d .
Fluprosten01 Sodium
Flurazepam
Flurbiprofen
Fluspirilene
Flutamide
Pualtadone Hydrochloride
Furazolidone
Furosedde (Frusemide)
Gallamine and its salts
Gexn6brozil
Gestodene
Gldenine
Glibenclamide
Glicldde
Glucagon and ids d t a
Glutamic Add and its salts
Glutethimide and its salts
Glyceryl Trhha te
Glycopyrronium and its dts
Glymidine and its d a l b
Gonadorelin and its dts
Gonadotrophin
Guanabenz Acetate
Guanethidine and its salts
Gumfacine and ib salCe
Halomnetason
Haloperidol
Halothane
'Heparin and its denivativa
Hexaunethonium and its nab
Hexapropymate
Hexyldimsthylxlarrthhe
Histapyrodine $nd its
Hornatropine and its salts
Myaluronidase
'Hydantoin Derivatives
Hydralahe and its d t s
me inelusion of this p.ge is autborhd by L.N. 144/19951
THE FOOD AND DRUGS REGULA TIONS, 1975
FOURTH SCHEDULE, contd.
H, conrd.
Hydrochlorothiazide
Hydroflumethiazide
Hydroxypropyl Cellulose
Hydroxyzine and its salts
Hyoscine and its salts
Hyoscyamine and its salts
Hypromellose
Ibuprofen and its salts except strength 200mg
Idoxuridine
Eosfamide
Imipenem
Imipramine and its salts
lmrnunoglobulin
Antihepatitis B
Anti-D RHO
Tetanus Immune Globulin
Indapamide
Indomethacin
Indoramin and its salts
Inosine Pranobex
Inositol
Inosine
Insulin
Interferon (alpha 2a rbe)
Iohexol
Iopidine
Iopromide
Iotrolan
Ipratropium Bromide
Iproniazid and its salts
Iron Dextran
Iron Sorbitol
Isocarboxazide
Isoconazole Nitrate
Isoetharine Hydrochloride
Isometheptene and its salts
Isoniazid and its salts
Isoprenaline Hydrochloride
Isosorbide and its salts
Isoxsuprine Hydrochloride
Isradipine
Itraconazole
Ketamine Hydrochloride
Ketazolam
[The Incluion of this page is authorized by L.N. 33A12005]
W E FOOD AND DRUGS REGULA TIONS, 1975
FOURTH SCHEDULE, contd.
K contd.
Ketoconazole
Cream 2%
Ovules 400mgn
Shampoo 2%
Suspension 200mp/ml
Tablets 2OOmgn
Ketoprofen
Ketotifen and its salts
Labetalol Hydrochloride
Lanatoside
Latamoxef
Leucovorin Calcium
Levamphetamine and its salts
Levodopa and its salts
Levonordefiin and its salts
Lidoflazine
Liothyronine and its salts
Lisinopril and its salts
Lithium and its salts
Lomustine
Loperamide and its salts
Lorazepam
Lormetazepam
Lovastatin
Loxapine and its salts
LThyroxine Sodium
Lypressin
Mafenide and its salts
Mannitol
Maprotiline and its salts
Mazindol
Mebanazine
Mecamylamine and its salts
Meclozine (Meclizine) and its salts
Meclofenamate
Meclofenoxate
Medazepan1
Menadiol
Menaphthone (Menadione)
Mepazine
Mephenesin and its salts
Mephentermine and its salts
[The Inclusion of this page is authorized by L.N. 33N2005)
THE FOOD AND DRUGS REGULATJONS, 7975
FOU32TH SCHEI)UZE, conrd.
M, contd.
Mepindolol and its salts I
Mepivacaine
, '
Meprobamate
Meptazinol and its salts
Mequitazine
Mercaptopropionic Acid
Mercaptopurine
Murcuric Oxide
Mersalyl
Mesalazine
Mescaline and its salts
Mesoridazine land its salts
Metamizol and its salts
Mebaramino1 Tmtrate
Metaxalone
M e t f o e and its salts
Methamphetamine and its salts
Methapyrilene and its salts
Methaqualone and its wlts
Methenamine and its s a h
Methixene and its salts
Methohexit one
Mathotrexate and its salts
Methotrimenprazine and its salts
Methoxyflurane
Methoxsalen
Methyclothiazide
Mebhyldopa and its salts
MefQ~ylene Blue (Injection)
Methylergometine and its salts - .
Methylpentpol and its salts
Methyflphenidate and its salts
Methylsergide and its salts and derivatives
Methypryon
Metoclopramide and its salts
Metolazone
Metomidate Hydrochloride
Metoprolol Tartrate
Metrizamide
Metronidawle
Meconaz.de and its salts
Midazolaan
Milrinone and its aalts
Minoxidil
-.. ,
Rhe inclusian of this page is authorired by L.N. 144119951
THE FOOD AND DRUGS REGULATIONS, 1975
FOUJRllH SOHEW'LIE, contd.
M, contd.
Mhprostol
Mometasone F w t c
Mitoxantrone and its salts
Monoethanolamine Hem'isuccinate
Mupirocin
N
N a b t o n e
Nadolol
Nalidixic Aoid and its salts
Naloxone and its salts
Nkphazoline and ib salts
Narasin
Nbdocrod Sodium
Ncostigmine and its ralta
Nialamide
Nicardipine
Nifdpine
Nifiumic Acid
Nifumtel
Niketharnide m d i.ts salb
Nitrazcpam
Nitrofurantoin and ib altr
Nitrofufazone
Nomifensine and it8 ~ l t r
Noradrenalin
Norgestomet
Nomtyline and its salb
Noscapine
0
O-@-iHydroxyethyl) - Rutodde
Ondansetron
Opipramol and itr d t s
Opium Ahlaids
Orciprenalii and i b dtr
Orpotcin
Omidazole
Orphenadrine A-
Oxazcpam
OxitrSptyliie
Oxprmolol and its salts
Oxymctbolone
me iucclruioa of this page is authorized by L.N. 140/1M1
THE FOOD AND DRUGS REGULA TIONS, 1975
FOURTH SCHEDLILE, contd.
0, contd.
Oxypertine and its salts
Oxyphenbutiuone
Oxyphenonium and its salts
Oxytocin
Panaeatin
Pancwonium Bromide
Papaverine and its salts
Paramethazone and its salts
Pargyline and its salts
Pecazine
Pemoline and its salts
Penicillamine
Pentaerythrtol and its salts
Pentazocine and its salts
Pentetrazol
Pentifylline
Pentolinium
Pentoltifylline
Pericyazine and its ?Its
Permdopril
Perphenazine
Petazocine
Pelhidine and its salts
Phenaglycodol
Phenazopyridme and its salts
Phendimetrazine and its salts
Phenelzine and its salts
Phenformin and its salts
Phenrnetrazine and its salts
Phenothiazine derivatives and theu salts
Phentennine and its salts
Phentolamine and its salts
Phenylbutazone and its salts
Phenylephrine and its salts
Phenylhydansoin its derivatives a d theu salts
Pheny lpropanolamine and its salts
Phenytoin and its salts
Physostipine and its salts
Pilocatpine and its salts
Pimozine
P-Inactivated Lactobacilli
Pindolol
[The Inclusion of this page is authorized by L N. 33AiZOOJJ
THE FOOD W D DRUGS REGULATIONS, 1975
FOURTH SCHEDULE, contd.
P, contd.
Piperwoni~~m and its salts
Piperylone
Piemepine and its &s
Piroxicam (other than Piroxicam topical preparation)
Pirprofen
Pituitary Gland and its principles
Plasmin
Pol ythiazide
Potassium Iodide (Oral Dosage Forms)
Pramoxine
Rasterone
Razinamide
Razosin and its salts
Prednisolone, Prednisone
Prenylamine and its salts
Primidone
Primycinum
Pmbenecid
Procainamide and its salts
Prochlorperazine and its salts
Procyclidine and its salts
Promazine and its sahs
Promethazine and its salts
Propantheline and its salts
Propoxyphene and its salts
Propofol
Propranolol and its salts
Propylthiouracil and its salts
Prostaglandin
Protriptyline and its salts
F'yrazinamide
F'yridostigmine and its salts
Pyrrobutamine and its salts
Quiiapril and its salts
Quinethazone
Quinfimide
Quiidine and its salts
Ranitidine
Injection 50 mg/5ml
Syrup 150mg/lOml
Tablets 150mg and 300 mgn
Rauwoflia alkaloids of, and their salts, including-
[The lnclurion of lhir pegth authorled by L.N. 33AI2005)
THE FOOD AND DRUGS REGULATIONS, 1975
IWUKlW XYHEDUUE, contd.
R, contd.
Alseroxylol
Desenpidine
Raubasine
Rcscimamhe
Reserpine
Rilmenidine
Rimeterol Hydrochloride
Roxaudine and its salts
Rutoside
Roferon A
Roxatidine Acetate Hydrochlotide
Salbubaanol and its sdts
SelegiPne and its salta
Sodium Aurothiomalato
Sodium Caloimedetate
Sodium Cromoglyaato
~ u m Hyalwnate
Sodium Iodide
Sodium Nitroprusside
Sodium Polystyrene Sulfonate
Sodium Tyropan~te
Sodium Valproate
Parented Solutions of-
Dextrose
Mannitol SoIcbitol
Potassium Chloride
W u m B i d o n a t e
Sodium Chloride
Sodium LactiUte
Sorbide Nitrate
Sotalol and its saib
p e indpion gf tbis page is authorized by L.N. 144/1995]
THE FOOD AND DRUGS REGUUTIONS, 1975
FOURTH S U ~ D U L E , contd.
S, contd.
SuLndgc
Sulphonaddes a d their salts and derivatives including-
Mafenide
Sulphabezamide
Sulphadiazine
Sulphadimethoxine
Sulphadimaazine
Sulphadoxine
Sulphafurazole
Sulphaguanidine
Sulphothaz ina
Sulphamethazine
Sulphambthizole
Sulphamcthowle
Sulphamethoxypyridazine
Sulphamethoxydiazine
Sulphametrole
Sulphanilamide
SulphQnitran
Sulphaphenamle
Sulph~pyridine
Sulphaquinoxahe
Sulphasalazine
Sulphuthiazole
Sulphinpyrazone
Sulphond and al%yl sulphonals
Suprarmal Glands Medulla its active principles and their m lb
Suxamethonium and its sale
Sy rosingopine
Tamoxinfen and ita salts
Tenoxicam
remazapam
Teramsin and its salts
Tertatolol and its salb
Tetanus Antitoxins
Tetrabenazine and its dalb
Thaophylline and ita ralts
T h i a c e t a r d d e Sodium
Thiocarlide
Thiooolchicoeide
me inclusion d this page is authorized by L.N. 144119951
THE FOOD AND DRUGS REGULATIONS, 1975
Thioguantine
Thiopentone Sodium
Thioridazine
Thiottpa
Thiothixene antd its salts
Thiouracil and its derivativoa
-mro~cin
Thyroid Glands, its active principles, their ralts
Thyroxine and its salts
Tiarnulin and its salts
Tiaprofenic Acid and its salts
Ticarcillin Disodium
Ticlatone
Tirmolol a d Its salh
Tinidazole
Tolawline and it6 salts
Tolbutamide and its salta
Tamoxifen Acetate Ziltazoniurn
ToxoCara Antigun
Tranylcyprodne and i.ts salts
Tretinoin
Triacetarsarnide Sodium
Trimterene and its d t s
Triamlarn
Trichloroethylene
Triflucidine
Trifluopedne Hydrochloride
Trifluperidol and salts
Trifluproma361lt and its salts
Trihexyphenipyl and ib salts
Trilostane
~fimethaziche and i!B sah
~rirneth-
Trimapraziae and its salts
T r i n r i p d e and itr ah
Tromethamine
Tropenailine
Tropicaaniac
Trofidone -
p incl@on of this page u authorized by L.N. 144/19951
THE FOOD AND DRUGS REGULAnONS, 19?5
FOURTH WHBDULE, contd.
T, contd.
Tubocurarine Chloride
Tybamate
Tylosin Znterrnediate
Tyrothricin
v
VACCINES
Bursa1 Disease Vaccine Killed .
Canine Distemper - Adenovirus Type 2
Oanine Distemper - Hepatitis Vaccine
Canine Distenqper - Hepatitis with Leptospira
Clostridium - Chauvoei - Septicum - Novyi - Srdelli -
Perfringens Types C + D Baoterin Toxoid
Clostridium Chavvoei -Supticum Pamuella H!aemolytic Multocida
Coryza Vaccine
Diptheria and Tetanus
Distemper/Hepa~tis/iParainfluem and Jxptospira
Fowl Pox Vaccine
Gas Gangrene Antitoxin
Killed E. Coli Culture
Killed Virus Esquine Rhinopneumonitis
Marek's Disease Live Turkey. Herpea Vkua
IMedsles, Mumps, Ruebella Live Vaccine
Newcastle Bronchitis D i m e
Newcastle Disease Vaccine
,Newcastle Disease Water Vaccine
Parvovirus Vaccine
Pigeon Pox Vaccine
Pneumococal Vaccine
Tetanus Antitoxin
Tetanus Toxoid
Tetanus Vaccine
Tu'berculin RPD
Valmi trine
Vecuronium Bromide
Veraparnil and its salts
Vinblastine and its salts
Vinoarnine and its salts
Vincristine and its salts
Vitamin A for internal or qarenteral use in hutman, with a daily dosage of mom
than 10,000 international units.
Vitamin B-12, wifih Intrinsic Factor Oonccntmte (for parenteral use)
Viltamin D, for internal or parenteral use in h u m , with a daily dosage of
more than 1,000 international units.
me inclusion of this page is authorkd by L.N. 144/19951
THE FOOD AND DRUGS REGULATIONS, 1975
FOURTH SCHEDULE, contd.
V, contd.
Vitamin E, (dl-Alpha Tocopherol)
Vitamin K
Warfarin and its salts
Xantinol and its salts
zerauul
Zidovudine
zinc Sulphate
Zopiclone
Zoxazolamine and its salts
Zuclopenlhixol Acetate
inclu&g b e following and their salts and derivativea-
~otinomydn-D Cephazolin
Amikgcin Chlorampheniwl
&noxycillin Ohlortetracycline
Amphomycin Cinoxacin
~mphotericin Clindamycin
Ampicillin Cbrnocycline
Agamycin Cloxacillin
Bacampicillin Colislh
Bacitracin Cycloserine
Benethambe Peniodlin Demeclocycline
Benzathne Penicillin Dihydrcstrepbomycin
Benzyl Penicillin Doxorubidn
Candicidin Dox ycycline
Carbenicillin Erthromycin
O~rfeoiIlin Floxaoillkr
Ctfaohlor Framycetin
Cefadroxil Francomycin
Cefaandole Cephalosporine Fusidic Acid
C e f o x i ~ Gentamicin
Ccfuroxhe Gramicidin
Cephalexin Giseof ulvin
Cephaloridine Kanarnyoin
Cephalothin Lincomycin
Cephapirin Meclocycline
IThe inclusion of this Page ia authorized by L.N. ~ ~ / u K K ) ]
THE FOOD AND DRUGS REGULATIONS, 1915
POURW SCHEDULE, contd.
Methacycline
Methicillin
Minocycline
Neomycin
Novobiocin .
Nystatin except Topical Preparation
Oleandomycin
Oxy tetracycline
Paromomycin
Penid in G & V
Phenoxymethyl Penicillin
Pivarnpicillin
Pivmecillinaan
Polymyxin B
Potassium Clavulanate
Potassium Penicillin
Rifampicin
Rifamycin
Rolitetracycline
Roxithromycin
Salinomycin
Spectinom yoin
Spiramy cin
Streptomycin
Tetracycline (other than 3 %
Ta t racphe skin ointment)
Ticarcillin
Tobmycin
Ty l a in
Tyrothricin
Vamomycin
Viomycin
LIST 4 DRUGS
Part 11
Morphine and its salt., and any solution or dilution of morphine or its
salts in an inert substance whether liquid or solid containing any proportion
of morphine, and any preparation, admixture, extract or other substance (not
being such solution or dilution as aforesaid) containing not less than one-fifth
of one per cent morphine (calculated in respect of anhydrous morphine);
Cocaine (including synthetic cocaine) and ecgonine and their respective salts,
and any solution or dilution of cocaine or its salts in an inert substance,
whether liquid or solid, containing any proportion of m i n e , and any pre-
p?m?on, admxture, extraot or ot5er sate (not being m h a solution or
d d d t ~ m as &resaid) wnbining not less than one-- of one per cent of
Cocaine or any proportion of ecgonine;
htyldthydrocodeinone
Alphapmdine
&h~meprodhe
Benzyhonphine
Betameprodine
Bebpllodine
Dieth~l~thiambutene
Dihydrodesoxymorphine (also known as desomorphine)
Dihydromorphine
1 : 3-Dimethyl4-phenyl4propionyloxyhexamethy1eneimine
Dimethylthiambutene
Dioxaphetyl butyrate (4-morpholino-2: 2-diphenyl ethyl butyrate)
Didipanone
Ethylmethylthiambutene
Hydrocodone (also known as dihydrocodeinone or dicodide)
Hydromorphone (also known as dihydromorphinone or dilaudide)
Hydroxypethidine
Isomethadone (also known as isoamidone)
Ketobemidone
l The inclusion of this page is authorized by L.N. 54120001
2 S E FOOD AND DRUGS REGULATIONS, I n 5
Lcvomethorphan
Levorphanol
Methadol
Methadone (also known as amidone)
Methadyl acetate
Methyldesomorphine (6-methyl-6-ilesoxymorphine)
1-Methyl4phenylpiperidine-4-carboxylic acid isopropyl ester
Metopon (also known as rnethyldihydromorphinone)
Morphine-N-oxide (also known as genomorphine)
Normethadone
Oxycodone (also known as dihydrohydroxycodeinone or eucodal)
Pethidine
Phenadoxone
Phenomorphan (3-hydroxy-N-phenethylmorphinrn)
Racernethorphan
Racernorphan
Thebaine
The esters of morphine (other than diacetylmo hine), ecogonine, Oxycodone.
hydrocodone, hydromorphonc. acetyldihydroco%none and dihydmmorphine;
the ethers of morphine (other than bcnzylmorphine, codeine, ethylmorphine,
and pholcodine); the morphine-N-oxidc derivatives, and any other pentavalent
nitrogen morphine derivatives
hphotericin B
Baci tracin
Cephaloridine
Chlorampheniwl
Chloramphenicol and its salts
Colistin Sulphate
Cycloserine
Erythromycin
Framycetin
GriseoNvin
Kanarnycin sulphate
Lincomycin hydrochloride
Neomycin
Novobiocin
Nystatin
Paromomycin sulphate
Penicillin G
Benzyl penicillin sodium or potassium salt
Procaine penicillin
Fortified procaine, penicillin and other long-acting preparations
Benzathine penicillin
Phenoxy-methyl penicillin
Penicillin V, free base or potassium salt or calcium salt
Phenbenicillin
Phenoxybenzyl penicillin
Phenethicillin potassium
ma hcluaion of this m e u authorized by L.N. 144119951
THE FOOD AND DRUGS REGULATIONS, X9?5
DOURllH -Urn, contd.
Propicillin potassium
CloxacUin sodium
Methicillin sodium
Ampicillin
Polymyxin-B sulphate
Ristocetin
Spirarnycin
Streptomycin sulphate
Streptomycin penicillin mixture8
Diydro-streptomycin
Sulphomyxin sodium
Tetracycline3
Chlortetra-cycline
oxytetracy-
Tetracycline
Demethylcblor-tetracycline
Lymecycline
Methacycline
Triacetyloleando-rn-
Tyrothricin
Vancomycin
Viomycin sulphrta
Viomycin pantothenate and sulphatc
FIFTH SCHEDULE
Controlled Drvgs
Chenopodium Oil
Coumatin
Dinitro-8
Lysergic Acid DiethylImid,
Tetrahydrocannabhoe
