Antibiotics and Therapeutic Substances (CAP. 17 1

CHAPTER 17

THE ANTIBIOTICS AND THERAPEUTIC
SUBSTANCES ACT

Arrangement of Sections
Section

1. Short title.
2. Drugs to which Act applies.
3. Licence for manufacture or sale.
4. Restriction on sale or supply of drugs, etc.
5. No drugs to be imported without a licence.
6. Licence to store drugs.
7. Form of licence.
8. Cancellation of licence.
9. Sale of drugs to medical practitioners, dentists and

veterinary surgeons.
10. Right to enter and inspect premises.
11. Authority to take samples of drugs.
12. Indentification numbers and date of manufacture on

containers.
13. Licence holder to keep records,
14. Authority to enter and examine records.
15. Regulations.
16. Offences.
17. Offence by body corporate.
18. Penalty.

SCHEDULE.

LAWS OF ANTIGUA AND BARBUDA

Antibiotics and Therapeutic Substances (CAP. 17 3

ANTIBIOTICS AND THERAPEUTIC SUBSTANCES

911950.
( I s t June' .) S.R.O. 2511953.

S.R.O. 2211956.
1811989.

1. This Act may be cited as the Antibiotics and short title.
Therapeutic Substances Act.

2. This Act shall apply to the antibiotics and Drugstowhich
Act applies. therapeutic substances specified in the Schedule and to any Schedule.

antibiotic or therapeutic substances which may from time
to time be added to the Schedule by regulations made under
this Act.

3. ( 1 ) NO person shall manufacture for sale or supply Licence manufacture for or
any antibiotic or therapeutic substance to which this Act ,,I,.
applies unless he is the holder of a licence granted for this
purpose by the Licensing Authority.

(2) For the purposes of this Act and the administration
thereof the Licensing Authority shall be such person as is
appointed in that behalf by the Governor-General.

4. ( 1 ) Subject to the provisions of this section, no per- Restriction on
son shall sell or supply any antibiotic or therapeutic substance ~~B~~ : E ~ ~ ~ ~
specified in the Schedule or any preparation of which any Schedule.
antibiotic or therapeutic substance is an ingredient or part
unless-

( a ) he is a registered medical practitioner or a
registered dentist or a veterinary surgeon or a person
acting in accordance with the directions of any such prac-
titioner, dentist or surgeon, and the antibiotic,
therapeutic substance or preparation is sold or supplied
for the purposes of treating by and in accordance with
the directions of the practitioner, dentist or surgeon, or

( 6 ) he is a registered chemist and druggist and the
antibiotic, therapeutic substance or preparation is sold
or supplied under the authority of a prescription signed
and dated by any such practitioner, dentist or surgeon,
as aforesaid:

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4 C A P . 17) Antibiotics and Therapeutic Substances

Provided that this subsection shall not apply to the sale
or supply of any such antibiotic, therapeutic substance or
preparation-

( a ) by way of wholesale dealing; or

( b ) for the purpose of being exported; or

( c ) to any such practitioner, dentist or surgeon as
aforesaid; or

(6) to any authority or person carrying on a
hospital, clinic, nursing home or other institution pro-
viding medical, surgical, dental or veterinary treatment;
or

(e) to any government department the head of
which is in possession of a permit issued by the Licens-
ing Authority authorizing him to obtain and use for the
purposes specified in such permit any such antibiotic,
therapeutic substance or preparation.

(2) A prescription signed by any such practitioner, dent-
ist or surgeon, authorizing the sale or supply of any such
antibiotic, therapeutic substance or preparation shall not,
unless it expressly so directs, be dispensed on more than one
occasion or more than three months after the date on which
it was signed:

Provided that, if the prescription expressly directs that
it may be dispensed on a specified number of occasions or
at specified intervals within a specified period it shall on the
last time of dispensing be retained for a period of one year
by the person last dispensing it and be made available for
inspection by the Licensing Authority or by any person duly
authorized by him to make inspections under this Act.

No drugs to be
imported without

5 . It shall not be lawful to import into Antigua and
a licence. Barbuda any antibiotic or therapeutic substance to which

this Act applies unless-

(a) the person is the holder of a licence granted
by the Licensing Authority to import such antibiotic
or therapeutic substance; and

(6 ) the antibiotic or therapeutic substance has been
manufactured by a pharmaceutical firm approved by
the Licensing Authority; and

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Antibiotics and Therapeutic Substances (CAP. 17 5

(6) the antibiotic or therapeutic substance complies
with such standard of strength, quality and purity as
may be prescribed by regulations made under this Act.

6. No person shall store any antibiotic or therapeutic Licence to store
drugs. substance to which this Act applies for the purpose of sale

unless he is the holder of a licence granted by the Licensing
Authority to store such antibiotic or therapeutic substance
and no such licence shall be granted except on proof to the
satisfaction of the Licensing Authority that the storage
facilities of the applicant are adequate.

7. Licences issued under this Act shall be in such form Form licence.
as may be prescribed in regulations made under this Act.

8. The Licensing Authority may cancel or suspend Cancellation of
licence.

for such period as he thinks fit any licence issued under this
Act if the holder thereof fails to comply with any of the pro-
visions of this Act or of any regulations made thereunder
or of any of the conditions contained in such licence:

Provided that on such cancellation or suspension the
licensee may appeal to the Cabinet whose decision shall be
final.

9. No importer of any antibiotic or therapeutic sale of drugs to
medical substance to which this Act applies shall sell or transfer any practitioners,

such antibiotic or therapeutic substance to any person other dentists v terinary and
than a registered medical practitioner or to a registered dentist surgeons.
or to a veterinary surgeon unless such person is the holder
of a licence to store such antibiotic or therapeutic substance
granted under the provisions of this Act.

10. Any person authorized in writing by or on behalf :T:$p:ter
of the Licensing Authority may at any time between the hours ,remises. -
of 6 a.m. and 6 p.m. enter any premises in which he has
reason to believe that any antibiotic or therapeutic substance
to which this Act applies is being kept which has been
acquired or is being kept in contravention of the provisions
of this Act or of any regulations made thereunder, and may
carry out such inspection of the premises as he may con-
sider necessary, or may require the occupier or person in
charge of the premises to furnish him with such information
in connection with such antibiotic or therapeutic substance

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6 CAP. 17) Antibiotics and Therapeutic Substances

as he may consider necessary. Any antibiotic or therapeutic
substance in respect of which there has been a breach of any
of the provisions of this Act or of any regulations made
thereunder may be seized by such person authorized as
aforesaid and on conviction of the offender shall be forfeited
to Her Majesty and shall be dealt with as the Governor-
General may direct.

Authority to take
samples of drugs.

1 . Any person authorized in writing by or on behalf
of the Licensing Authority may require the holder of a licence
to store antibiotic or therapeutic substances granted under
the provisons of this Act to produce samples of any antibiotic
or therapeutic substance to which this Act applies 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 such an extent, or to contain toxic
substances in such amounts, as in the opinion of the Licens-
ing Authority to render it ineffective or unfit for use as an
antibiotic or therapeutic substance, or to be of a lesser degree
of potency than it purports to be, the Licensing Authority
may require to be destroyed the entire stock of the antibiotic
or therapeutic substance in the possession of the licensee
which bears the same batch identification number as the
sample:

Provided that any licensee whose entire stock of
antibiotics or therapeutic substances is so required by the
Licensing Authority to be destroyed, may appeal against such
requirement to the Cabinet whose decision shall be final.

Identification
numbers and

12. (1) Every container of an antibiotic or therapeutic
date of substance to which this Act applies shall carry a batch iden-
manufacture On tification number and the date of manufacture of such
containers.

antibiotic or therapeutic substance; and the contents of any
such container supplied by any person and bearing the same
identification marks shall be deemed to have been manufac-
tured at the same time and under identical conditions until
the contrary is proved.

(2) No person shall sell, transfer or dispense any
antibiotic or therapeutic substance to which this Act applies
after the date of expiry endorsed on the container thereof,
except to a registered medical practitioner, registered dentist

LAWS OF ANTIGUA AND BARBUDA

Antibiotics and Therapeutic Substances (CAP. 17

or veterinary surgeon, who has been informed in writing
of such date by the person selling, transferring or dispens-
ing such antibiotic or therapeutic substance.

13. Every holder of a licence under this Act shall keep Licence holder to
keep records. records showing-

(a ) the quantities of antibiotic and therapeutic
substances to which this Act applies, which he has
imported into Antigua and Barbuda and the identifica-
tion marks or numbers of the consignments;

(6 ) the date of the importation into Antigua and
Barbuda of any antibiotic or therapeutic substance to
which this Act applies which he has imported;

(c ) the names of the manufacturers of any such
antibiotic or therapeutic substance;

(4 the names and addresses of the persons to whom
any such antibiotic or therapeutic substance has been
issued, sold or otherwise disposed of by him and the
quantity and date of every such issue, sale or disposal.

14. Any person authorized in writing by or on behalf Authority to
enter and

of the Licensing Authority may at any time during business
hours enter the premises of any holder of a licence under
this Act and call for and examine any records required to
be kept by such holder.

15. The Cabinet may make regulations for the follow- Regulations-
ing purposes-

(a) for prescribing the standard of strength, quality
and purity of any antibiotic or therapeutic substance
to which this Act applies;

(6 ) for prescribing the test to be used for determin-
ing whether the standard prescribed as aforesaid has
been maintained;

(c) for adding to the Schedule any antibiotic or Schedule.
therapeutic substance;

(d) for prescribing the form of licences under this
Act and of applications therefor, and of notices to be
given in connection therewith;

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8 CAP. 17) Antibiotics and Therapeutic Substances

(e) for prescribing the conditions subject to which
licences may be issued;

(f) for excluding from the operation of this Act or
of any of the provisions thereof, any antibiotic or
therapeutic substance intended to be used solely for
veterinary purposes;

(g) for regulating the storage and transport of any
antibiotic or therapeutic substance;

( h ) for controlling or prohibiting any process which
may affect the potency, sterility or toxicity of any
antibiotic or therapeutic substance.

Offences. 16. Any person obstructing any person authorized
in writing by or on behalf of the Licensing Authority in the
performance of any duty imposed by or under this Act, or
refusing to give any information lawfully demanded by such
authorized person or otherwise contravening or failing to
comply with any of the provisions of this Act shall be guilty
of an offence under this Act.

Offence by body
corporate.

17. Where an offence under this Act has been com-
mitted by a body corporate, every person who at the time
of the commission of the offence was a director, general
manager, secretary or other similar officer of the body cor-
porate, or was purporting to act in any such capacity, shall
be guilty of that offence, unless he proves that the offence
was committed without his consent or connivance and that
he exercised all such diligence to prevent the commission
of the offence as he ought to have exercised having regard
to the nature of his functions in that capacity and to all the
circumstances.

Penalty. 18. Any person guilty of an offence under this Act
shall be liable on summary conviction to a fine not exceeding
five thousand dollars or to imprisonment for six months or
to both such fine and imprisonment.

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Antibiotics and Therapeutic Substances (CAP. 1 7 9

SCHEDULE Ss. 2 , 4, 15.

1. "Penicillin"-
which term shall include any anti-infective acid produced
by penicillin notatum whether obtained from penicillin
notatum or not, and any salt or derivative obtained from
any such acid, and any solution containing such salt or acid
or derivative.

2. "Streptomycin"-
which term shall include all compounds of streptomycin and
all medicinal preparations containing streptomycin.

3. " Aureomycin"--
which term shall include all compounds of aureomycin and
all medicinal preparations containing aureomycin.

4. "Chloromycetin"-
which term shall include the antibiotic and the synthetic pro-
duct of that name.

Derivatives of para-aminobenzenesulphonamide having one
or both of the hydrogen atoms of the para-amino group or
of the Sulphonamide group, substituted by other radicals.

The derivations shall include-
Sulphonamidochrysoidin
Azosulphamide
Benzylsulphanilamide
Sulphanilyldimethysulphanilamide
Sulphapyridine
Sulphathiazole
Sulphacetamide
Sulphadiazine
Sulphaguanidine
Sulphamezathine
Succinylsulphathiazole
Sulphamerazine
Phthalylsulphathiazole.

6. Terramycin

7 . Bacitracin.

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10 CAP. 17) Antibiotics and Therapeutic Substances

8. Aureotracin.

9. Neomycin.

10. Tyrothricin.

11. Gramicidin

12. Niomycin

13. Iso-Nicotinic Acid Derivatives

14. Deoxycortoni Acetas and all other Adrenal Cortical Hormones.

15. Amino-salicylic acid and its derivatives.

16. Cycloserine, which term shall include all compounds of
cycloserine and all medicinal preparations containing
cycloserine.