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Chapter 34:02 - Antibiotics

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L.R.O. 1/2012
LAWS OF GUYANA
ANTIBIOTICS ACT
CHAPTER 34:02
Act
40 of 1951
Amended by
5 of 1955 36 of 1958 18 of 1973

Current Authorised Pages
Pages
(inclusive)
Authorised
by L.R.O.
1 – 16 ... 1/2012





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2 Cap. 34:02 Antibiotics
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Index
of
Subsidiary Legislation
Page

Antibiotics Regulations
(O. in C. 7/1952)
12
Declaration of Antibiotics Order
(O. in C. 33/1952, 84/1953, 92/1953, 5/1954, 73/1956, 34/1957,
49/1958, 72/1960)
14





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CHAPTER 34:02
ANTIBIOTICS ACT
ARRANGEMENT OF SECTIONS
SECTION
1. Short title.
2. Interpretation.
3. Restriction on manufacture of antibiotics.
4. Restriction on importation of antibiotics.
5. Licences to import antibiotics.
6. Licences to store antibiotics.
7. Authority for captains of ocean-going vessels to be supplied with
antibiotics.
8. Appointment of Licensing Officer.
9. Form of licences.
10. Cancellation of licences.
11. Restriction of sale or transfer of antibiotics.
12. Right of entry on premises to ensure compliance with Act.
13. Taking samples of antibiotics.
14. Further restriction on issue of antibiotics.
15. Administering of antibiotics.
16. Identification marks or numbers on containers.
17. Licence holder to keep records.
18. Examination of records.
19. Lists of approved pharmaceutical firms.
20. Variation of lists of approved pharmaceutical firms.
21. Regulations.
22. Offences.
23. Penalty.
__________________________

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4 Cap. 34:02 Antibiotics
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1953 Ed.
c. 143 _______________________________________________________
40 of 1951
CHAPTER 34:02
ANTIBIOTICS ACT
An Act to regulate the importation, storage, distribution,
sale and use of antibiotics.
[1ST MARCH, 1952]
Short title.
Interpretation.

c. 134
1953 Ed.
c. 32:03
1. This Act may be cited as the Antibiotics Act.
2. In this Act—
“antibiotic” means penicillin, all compounds of penicillin,
and all medicinal preparations containing penicillin,
streptomycin, all compounds of streptomycin,
aureomycin, all compounds of aureomycin,
chloromycetin, all compounds of chloromycetin, and
any other anti-microbial organic substance produced by
living organisms or synthetically with the same
structural formula as the natural product of the organism
which the Minister may from time to time, by order
published in the Gazette, declare to be an antibiotic to
which this Act applies;
“the Board” means the Pharmacy and Poisons Board
established by section 3 of the Pharmacy and Poisons
Ordinance;
“captain” means the person who is the commanding officer
or master of any ocean-going vessel;
“dentist” means a person registered as a dentist under the
Dental Registration Act;

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c. 32:02

Restriction on
manufacture of
antibiotics.

Restriction on
importation of
antibiotics.
Licences to
import
antibiotics.

Licences to
store
antibiotics.
Authority for
captains of
ocean-going
vessels to be
supplied with
antibiotics.
[5 of 1955]

“health officer” means any officer appointed under section
3(2) of the Quarantine Ordinance;
“medical practitioner” means a person registered as a
medical practitioner under the Medical Practitioners Act;
“ocean-going vessel” means every description of ocean-
going ship registered in Guyana or foreign, plying
between Guyana and any other country;
“veterinarian” means a duly registered practitioner of
veterinary medicine.
3. No person shall manufacture any antibiotic in
Guyana unless he is the holder of a licence granted by the
Board to manufacture such antibiotic.
4. No person shall import into Guyana any antibiotic
other than an antibiotic manufactured by a pharmaceutical
firm approved by the Minister.
5. No person shall import any antibiotic into Guyana
unless he is the holder of a licence granted by the Board to
import such antibiotic.
6. No person shall store any antibiotic for the purpose
of sale unless he is the holder of a licence granted by the
Board to store such antibiotic.
7. Notwithstanding anything contained in this Act, it
shall be lawful for any person who is licensed to import or
store any antibiotics to supply such antibiotic as may be
required by any captain of any ocean-going vessel subject to
the following conditions –
(a) no antibiotic shall be supplied to any
captain of any ocean-going vessel
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Appointment of
Licensing
Officer.
Form of
licences.

Cancellation of
licences.

Restriction of
sale or transfer
of antibiotics.
except on a written order signed by
him and counter-signed by a health
officer;
(b) any person who supplies an antibiotic
in accordance with this Act shall
retain the written order referred to in
paragraph (a), and shall mark it with
the date on which the antibiotic was
supplied, and shall keep it on his
premises available at all times for
inspection within a period of two
years from the date of supply;
(c) where an antibiotic is supplied by any
captain for the treatment of a member
of the crew of an ocean-going vessel,
an entry of the medical treatment in
the official logbook shall be sufficient
record of the supply, and such entry
shall specify the antibiotic supplied.
8. The Board may appoint a fit and proper person to
be Licensing Officer under this Act.
9. Licences issued under this Act shall be in such form
as the Board may from time to time approve.
10. The Board may cancel any licence issued under
this Act if the holder thereof fails to comply with this Act or
of any regulations made under this Act.
11. No importer of antibiotics shall sell or transfer any
antibiotic to any person other than a medical practitioner,
dentist or veterinarian, unless such person is the holder of
a licence to store antibiotics granted under this Act.

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Right of entry
on premises to
ensure
compliance
with Act.


Taking samples
of antibiotics.

Further
restriction on
use of
antibiotics.
12. Any person authorised in writing by or on behalf
of the Board may at any time between the hours of 6 a.m. and
6 p.m. enter any premises in which he has reason to believe
that any antibiotic is being kept which has been acquired or is
being kept in contravention of this Act or of any regulations
hereunder, and may carry out such inspection of the premises
as he may consider necessary, and may require the occupier
or person in charge of the premises to furnish him with such
information in connection with such antibiotic as he may
consider necessary. Any antibiotic in respect of which there
has been a breach of this Act or of any regulations hereunder
may be seized by such person authorised as aforesaid and on
conviction of the offender shall be forfeited to the Board if the
court so orders.
13. Any person authorised in writing by or on behalf
of the Board may require the holder of a licence to store
antibiotics granted under this Act to produce samples of any
antibiotic which may be in his possession and, on payment of
the current market value of any sample, may require that it be
delivered to him for purposes of assay. If any such sample is
found on assay to have deteriorated to an extent or to contain
toxic substances in amounts which, in the opinion of the
Board, render it ineffective or unfit for use as a therapeutic
substance, or not to contain the antibiotic or to contain the
antibiotic in a lesser degree of potency than it purports to
possess, the Board may require to be destroyed the entire
stock of the antibiotic in the possession of the licensee which
bears the same batch identification number of the sample.
14.(1) Subject to section 6, no antibiotic shall be issued
to any person except on the prescription of a medical
practitioner, dentist or veterinarian except that the Minister
may on the recommendation of the Board exempt any
antibiotic or any medical preparation containing an antibiotic
from this subsection. The name of the antibiotic or
preparation so exempted shall be published in the Gazette.
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(2) Every such prescription as is referred to in
subsection (l) shall—
(a) be in indelible writing or typescript
and be signed by the person giving it
with his usual signature in indelible
writing and be dated by him;
(b) specify the address of the person
giving it;
(c) specify the name and address of the
person for whose treatment it is given
or, if it is given by a veterinarian, of
the person to whom the medicine is
to be delivered.
(3) Every person dispensing any such prescription
shall comply with the following requirements –
(a) the prescription shall not be dispensed
otherwise than in accordance with the
prescription or more than once unless
the prescription contains a direction
in accordance with paragraph (b);
(b) if the prescription contains a direction
that it may be dispensed a stated
number of times or at stated intervals
it shall not be dispensed otherwise
than in accordance with such
direction;
(c) there must be noted on the
prescription at the time of
dispensing, immediately above the
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Administering
of antibiotics.
[18 of 1973]

Identification
marks or
numbers on
containers.
signature of the person giving the
prescription, the name and address of
the person supplying the antibiotic
and the date on which the
prescription is dispensed;
(d) if the prescription may be again
dispensed it shall on the last time of
dispensing, be retained for a period of
two years by the person last
dispensing it on the premises on
which it was last dispensed and be
made available for inspection by any
person authorised by or on behalf of
the Board.
15. An antibiotic shall not be administered to any
person except by or under the direction of a registered
medical practitioner or dentist except that where a case of
emergency arises in any area of Guyana and the services of a
medical practitioner are not available, any registered
dispenser or registered nurse stationed in that area, who
possesses a certificate issued by the Chief Medical Officer that
he is competent to administer penicillin, a compound of
penicillin or any medical preparation containing
penicillin, may administer penicillin, a compound of
penicillin, or any medical preparation containing
penicillin.
16.(1) Every container of an antibiotic shall carry a
batch identification mark or number and the date of
manufacture of such antibiotic, and the contents of any such
containers, supplied by any person and bearing the same
identification marks or numbers, shall be deemed to have
been manufactured at the same time and under identical
conditions until the contrary is proved.

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Licence holder
to keep
records.


Examination of
records.

Lists of
approved
pharmaceutical
firms.

(2) No person shall sell, transfer or dispense any
antibiotic after the date of expiry endorsed on the container
thereof, except to a medical practitioner, dentist or
17. Every holder of a licence to import antibiotics
under this Act shall keep records showing—
(a) the quantities of antibiotics which he
has imported into Guyana and the
identification marks or numbers of
the consignments;
(b) the date of importation into
Guyana of any antibiotic which he
has imported or has in stock;
(c) the names of the manufacturers of any
such antibiotics;
(d) the names and addresses of the
persons to whom any such antibiotics
have been issued by him and the
quantity and date of every such issue.
18. Any person authorised in writing by or on behalf
of the Board may, at any time during business hours enter the
premises of any holder of a licence to import antibiotics
under this Act and call for and examine any records required
to be kept by such holder.
19. It shall be the function of the Board to submit to
the Minister lists of pharmaceutical firms for approval as
manufacturing firms from whom antibiotics may be imported
into Guyana. The names of the firms so approved shall be
published in the Gazette.
the person selling, transferring or dispensing such antibiotic.
veterinarian who has been informed in writing of such date by
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Variation of
lists of
approved
pharmaceutical
firms.

Regulations.

Offences.

Penalty.
[6 of 1997]

20. The Minister may, on the recommendation of the
Board, add to or delete from the list of approved
pharmaceutical firms, and every such addition or deletion
shall be published in the Gazette.
21. The Minister may make regulations—
(a) defining the powers and duties of the
Board;
(b) providing for regulating the storage
and transport of any antibiotic;
(c) controlling or prohibiting any process
which may affect the potency, sterility
or toxicity of any antibiotic;
(d) providing the punishment for any
breach of any regulation made under
this section.
22. Any person obstructing any person authorised in
writing by or on behalf of the Board in the performance of
any duty imposed by or under this Act or refusing to give
any information lawfully demanded by any such authorised
person or otherwise contravening any of the provisions of
this Act shall be guilty of an offence against this Act.
23. Any person guilty of an offence against this Act is
liable on summary conviction to a fine of sixty-five thousand
dollars and to imprisonment for six months.
______________________

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12 Cap. 34:02 Antibiotics
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SUBSIDIARY LEGISLATION
_________________
O. in C.
7/1952. ANTIBOTIC REGULATIONS
made under section 20
Citation. 1. These Regulations may be cited as the Antibiotics
Regulations.
Interpretation.


Standards of
strength, purity
and quality of
antibiotics.


Listing pharma--
ceutical firms.
2. In these Regulations "pharmaceutical firm" means
a firm, company or person who possesses a valid licence to
manufacture any antibiotic issued by the appropriate
Authority either in Guyana or elsewhere.
3. (1) An antibiotic shall not be imported into
respect of its standard of strength, purity and quality as if it
were intended for the consumption of the inhabitants of the
country in which it may be manufactured and such standards
have been approved by the Board.
(2) The Board may at its discretion require proof
to its satisfaction either in respect of importations generally,
or in respect of any particular importation, that the antibiotics
imported or proposed to be imported into Guyana, conform
to the standards of strength, purity and quality as set out in
paragraph (1) and that they have been manufactured by a
pharmaceutical firm which has been approved in accordance
with the Act.
4. (1) Before submitting to the Minister the name of
any pharmaceutical firm in accordance with section 18 of the
Act the Board shall require proof to its satisfaction –
Guyana unless it conforms with the requirements in
LAWS OF GUYANA
Cap. 34:02
[Subsidiary] Antibiotics Regulations
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Storage and
transport.
(a) that the pharmaceutical firm has been
licensed in the country in which such
firm carried or carries on its
manufacturing process for the proper
authorities there, to manufacture anti-
biotics;
(b) whether such firm manufactures any
antibiotics for export which according
to the terms of any enactments or
licences under which such firm
carried or carries on its manufacturing
processes may be of a different
standard, strength and purity from
antibiotics of a same or similar name
manufactured by such firm for the
consumption of the inhabitants of that
country in which such antibiotic may
be manufactured.
(2) If it is proved to the satisfaction of the Minister
that any pharmaceutical firm which has been approved under
section 18 of the Act has not complied with or has infringed
the conditions under which its inclusion in the approved list
was allowed or has by any action by itself or persons acting
on its behalf caused or permitted such non-compliance or
infringement then the Minister may by order remove the
name of such offending pharmaceutical firm from the
approved list and the fact of such removal shall be published
in the Gazette.
5. (1) No person other than a medical practitioner, a
unless he holds a valid licence issued by the Licensing Officer
to store antibiotics.
(2) The Licensing Officer either before or after
dentist or a veterinaian shall store any antibiotic
Antibiotics 13
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14 Cap. 34:02 Antibiotics
[Subsidiary] Antibiotics Regulations
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Instructions
regarding
antibiotics.
granting such licence shall take such steps as he may deem
necessary to satisfy himself that the premises to be used or in
use for storing such antibiotics are in every way suitable
especially with regard to keeping such antibiotics at the
correct temperature.
(3) The Licensing Officer may at his discretion
give such instructions either verbally or in writing so as to
permit, regulate and safeguard the transportation of any
antibiotic from the place where is stored to the person
authorised to receive it.
6. The Board may at any time at its discretion issue
such instructions or directions as may be deemed necessary to
regard to any antibiotic which in its opinion may affect the
potency, sterility or toxicity of such antibiotic.
____________________
O. in C.
33/1952
84/1953
92/1953
5/1954
73/1956
34/1957
49/1958
72/1960
DECLARATION OF ANTIBIOTICS ORDER
made under section 2
Citation. 1. This Order may be cited as the Declaration of
Antibiotics Order.
control or prohibit any process or action with
LAWS OF GUYANA
Cap. 34:02
[Subsidiary] Declaration of Antibiotics Order
Antibiotics.

[O. in C.
33/1952]
[O. in C.
84/1953]

[O. in C.
92/1953]
[O. in C.
5/1954]
[O. in C.
73/1956]
[O. in C.
34/1957]
2. The following substances, all compounds of such
substances and all medicinal preparations containing such
substances are hereby declared to be antibiotics to which the
Act applies –
Tryrothricin, all compounds of tryrothricin and all medicinal
preparations containing tryrothricin;
Bacitracin, all compounds of bacitracin and all medicinal
preparation containing bacitracin;
Terramycin, all compounds of terramycin and all medicinal
preparation containing terramycin;
Neomycin, all compounds of neomycin and all medicinal
preparation containing neomycin;
medicinal preparation containing erythomcyin;
Ilotycin, all compounds of ilotycin and all medicinal
preparation containing ilotycin;
Kemicetine, all compounds of kemicetine and all medicinal
preparations containing kemicetine;
Albamycin, all compounds of albamycin and all medicinal
preparations containing albamycin;
Novophenicol, all compounds of novophenicol and all
medicinal preparations containing novophenicol;
Biophtal, all compounds of biophtal and all medicinal
preparations containing biophtal;
Novocillin, all compounds of novocillin and all medicinal
L.R.O. 1/2012
Erythomcyin, all compounds of erythomycin and all
Antibiotics 15
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16 Cap. 34:02 Antibiotics
[Subsidiary] Declaration of Antibiotics Order
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[O. in C.
49/1958]

[O. in C.
72/1960]
preparations containing novocillin;
Distavone, all compounds of distavone and all medicinal
preparations containing distavone;
Chloramphenical, all compounds of chloramphenical and all
medicinal preparations containing chloramphenical;
Bicomycin, all compounds of bicomycin and all medicinal
preparations containing bicomycin;
Ambramycin, all compounds of ambramycin and all
medicinal preparations containing ambramycin;
Synthomycetine, all compounds of synthomycetine and all
medicinal preparations containing synthomycetine.
____________________