ANTIBIOTICS ORDINANCE

ANTIBIOTICS ORDINANCE

LAWS OF HONG KONG

ANTIBIOTICS ORDINANCE

CHAPTER 137





CHAPTER 137

ANTIBIOTICS ORDINANCE

ARRANGEMENT OF SECTIONS

Section Page
1. Short title ..........................2
2. Interpretation .......................2
3. Substances to which this Ordinance applies 2
4. Control of sale and supply of substances to which this Ordinance applies 3
5. Prohibition of possession of substances to which this Ordinance applies 4
6. Permits to deal in and to possess substances to which this Ordinance applies 5
7. Maintenance of records ................................................................................. 5
8. Notification that no scheduled antibiotics may be sold 6
9. Inspections and enforcement of Ordinance 7
10. Offences and penalties ..............7
11. Forfeiture ........................................................................................................... 8
12. Regulations ......................... 8





CHAPTER 137

ANTIBIOTICS

To control the sale and supply of certain antibiotic substances.

(Amended40 of 1969 s. 2)

[4 June 1948]

Originally 21 of 1948 (Cap. 137,1950) -G.N.A. 15 of 1951, G.N.A. 25 of 1951,50 of 1955,23 of
1962, 14 of 1964, 40 of 1969, L.N. 215 of 1981, 45 of 1984, R. Ed. 1984, 69 of 1986, 62
of 1987, L.N. 76 of 1989

1. Short title

This Ordinance may be cited as the Antibiotics Ordinance.

(Amended40 of 1969 s. 3)

2. Interpretation

In this Ordinance, unless the context otherwise requires

,,authorized seller of poisons' has the meaning assigned to it by the Pharmacy and
Poisons Ordinance (Cap. 138);

'Director of Agriculture and Fisheries' includes the senior veterinary officer and
any veterinary officer; (Added 23 of 1962 s. 3)

'penicillin' has the meaning assigned to it by the regulations made under this
Ordinance;

'registered dentist' means a person registered in the dentists register and a person
deemed to be a registered dentist under the Dentists Registration
Ordinance(Cap. 156); (Amended 62 of 1987s. 10)

'registered medical practitioner' means a person registered or deemed to be
registered under the Medical Registration Ordinance (Cap. 161);

'registered pharmacist' means a person registered in the register of pharmaceutical
chemists or the register of chemists and druggists under the Pharmacy and
Poisons Ordinance (Cap. 138);

,'veterinary surgeon' means any member of the Royal College of Veterinary
Surgeons of Great Britain, or any other person holding the diploma of such
British or Colonial veterinary institution or examining body as the Governor in
Council may from time to time approve.

3. Substances to which this Ordinance applies

The substances to which this Ordinance applies are penicillin and such

other anti-microbial organic substances produced by living organisms as may





be prescribed by regulations made by the Governor in Council under section 12
and, where such regulations prescribe a substance produced by living
organisms, the regulations may include any substance the chemical properties
of which are identical with or similar to those of the substances so prescribed
but which is not produced by living organisms: (Amended50 of 1955 s. 2)
Provided that this Ordinance shall not apply to antibiotic substances
contained in foods for livestock or to such substances which have been specially
manufactured for the purpose of supplementing foods for livestock. (Added
50 of 1955 s. 2)

4. Control of sale and supply of substances
to which this Ordinance applies
(1) Subject to the provisions of this section, no person shall sell or
otherwise supply any substance to which this Ordinance applies or any
preparation of which any such substance is an ingredient or part unless he is-
(a)a registered medical practitioner, a registered dentist or a
veterinary surgeon or a person acting in accordance with the
directions of any such medical practitioner, dentist or veterinary
surgeon, and the substance or preparation is sold or supplied for
the purpose of treatment by or in accordance with the directions
of that medical practitioner, dentist or veterinary surgeon; or
(b)a person who, although not a registered medical practitioner,
practises medicine in a clinic in such circumstances that, by virtue
of section 8(8) of the Medical Clinics Ordinance (Cap. 343), he is
not by reason solely of such practice guilty of an offence under
section 28 of the Medical Registration Ordinance (Cap. 161) and
the substance or preparation is sold or supplied by him solely in
the course of his practice in that clinic for the purpose of
treatment by him or treatment in accordance with his directions;
or (Added 14 of 1964 s. 2)
(e)a registered pharmacist or an authorized seller of poisons, and
the substance or preparation is sold or supplied under the
authority of a prescription signed and dated by such medical
practitioner, dentist or veterinary surgeon as aforesaid.
(2) No person shall administer by way of treatment any such substance or
preparation unless he is such a medical practitioner, dentist or veterinary
surgeon or a person acting in accordance with the written directions of any such
medical practitioner, dentist or veterinary surgeon, or a holder of a valid permit
issued by the Director of Agriculture and Fisheries under section 6(2), or a
person acting under the direction of a holder of such permit, or a person
referred to in subsection (1)(b) and such substance or preparation is admin-
istered in the course of his practice in the clinic concerned. (Amended50 of
1955 s. 3; 23 of 1962 s. 3; 14 of 1964 s. 2)





(3) Subsection (1) shall not apply to the sale or supply of any such
substance or preparation-
(a)to any person who is a holder of a valid permit issued under this
Ordinance to deal in such substance or preparation; (Replaced
50 of 1955 s. 3)
(b)to any person who is a holder of a valid permit issued by the
Director of Agriculture and Fisheries under section 6(2), if any
substance or preparation so sold or supplied is clearly labelled
'for veterinary purposes only'; (Added 23 of 1962 s. 3)
(c)to any such medical practitioner, dentist or veterinary surgeon as
aforesaid;
(d)to any authority or person carrying on a hospital, clinic, nursing
home or other institution providing medical, surgical or
veterinary treatment:
Provided that this paragraph shall not apply to any hospital,
clinic, nursing home or other institution which is required to be
registered under the Medical Clinics Ordinance (Cap. 343) unless
it is so registered; (Replaced 14 of 1964 s. 2)
(e)to any person carrying on an institution or business which has
among its recognized activities the conduct of scientific education
or research, for use by persons engaged in that education or
research; or
(f) to any public department.
(4) The person dispensing a prescription shall comply with the following
requirements-
(a)if the prescription contains a direction that it may be dispensed a
stated number of times or, at stated intervals, it must not be
dispensed otherwise than in accordance with the direction;
(b)at the time of dispensing there must be noted on the prescription
the signature of the prescriber, the name and address of the seller
and the date on which the prescription was dispensed;
(c)except in the case of a prescription which may be dispensed on
more than one occasion, the prescription must for a period of 2
years be retained and kept on the premises on which it was
dispensed, in such manner as to be readily available for reference.

5. Prohibition of possession of substances
to which this Ordinance applies
(1) Subject to the provisions of subsection (2), no person shall have in his
possession or under his control any substance to which this Ordinance applies
or any preparation of which any such substance is an ingredient or part.
(2) Subsection (1) of this section shall not apply to the following-
(a) a registered medical practitioner;





(b) a person referred to in section 4(1)(b); (Added 14 of 1964 s. 3)
(c) a registered dentist;
(d) a veterinary surgeon;
(e) a registered pharmacist;
(f) an authorized seller of poisons;
(g) a department of Government;

(h) any person acting under the direction of a registered medical

practitioner, registered dentist or veterinary surgeon; (Amended
45 of 1984 s. 2)

(i) a person who is the holder of a valid permit issued under this

Ordinance to deal in such substance or preparation; (Amended
23 of 1962 s. 4; 45 of 1984 s. 2)

(j) a person who is the holder of a valid permit issued by the

Director of Agriculture and Fisheries under of section 6(2); or
(Added 23 of 1962 s. 4; 45 of 1984 s. 2)

(k) a person in bona fide possession of a substance supplied to him in

conformity with section 4. (Added45 of 1984s. 2)
(Added 50 of 1955 s. 4)

6. Permits to deal in and to possess substances

to which this Ordinance applies

(1) The Director of Health or any person authorized by him in that behalf may in
his absolute discretion issue to any person a permit in writing to deal in any
substance to which this Ordinance applies or any preparation of which any such
substance is an ingredient or part. (AmendedL.N. 76of1989)

(2) The Director of Agriculture and Fisheries may in his absolute discretion
issue to any person a permit in writing to possess for the purposes of veterinary
treatment any substance to which this Ordinance applies or any preparation of which
any such substance is an ingredient or part. (Added 23 of 1962 s. 5)

(3) Every permit in writing issued under the provisions of this section shall be
given a serial number and any such permit may contain such conditions as the
issuing authority may think necessary or expedient to impose and any such permit
may be revoked by the issuing authority at any time.

(Added50 of 1955 s.4. Amended23of 1962s. 8)

7. Maintenance of records

(1) Every person, other than the holder of a valid permit issued by the Director
of Agriculture and Fisheries under section 6(2), who is permitted by section 5(2) to
have in his possession or under his control any substance to which this Ordinance
applies or any preparation of which any such substance is an ingredient or part shall
maintain written records, as prescribed in





subsections (2) and (3), of transactions entered into by him in respect of such
substance or preparation: (Amended 23 of 1962 s. 6)

Provided that such records need not be maintained by a person to whom such
substance has lawfully been supplied for the purpose of treatment. (Added40 of
1969 s. 4)

(2) The records to be maintained under this section by registered pharmacists,
authorized sellers of poisons and holders of permits issued under section 6(1) shall
include- (Amended23 of 1962s. 6)

(a)name and address of person from whom received or to whom supplied,
and if received from or supplied to the holder of a permit issued under
this Ordinance the serial number of such permit;

(b) quantity received or supplied;

(c) date received or supplied:

Provided that such records need not be maintained by an authorized seller of
poisons in respect of such substances supplied on a prescription if

(i) the prescription is retained by the authorized seller of poisons for a
period of 2 years; or

(ii) in the case of a prescription which may be dispensed on more than
one occasion, a copy of that prescription is made in a book
maintained for that purpose, which book is retained by him for a
period of 2 years. (Added40 of 1969s. 4)

(3) The records to be maintained under this section by persons other than
registered pharmacists, authorized sellers of poisons and holders of permits issued
under this Ordinance shall include

(a)name and address of person from whom received and if received from
the holder of a permit issued under this Ordinance the serial number of
such permit;

(b) quantity received;

(c) date received.

(4) Entries made in records to be maintained under this section shall be
supported in every case by invoice, order note or other voucher.

(5) All records to be maintained under this section and documents which
support entries in such records shall be open to inspection by an inspector
appointed under section 9.

(6) Any person who contravenes the provisions of this section shall be guilty
of an offence and shall be liable on summary conviction to a fine of 51,000.

(Added 50 of 1955 s. 4)

8. Notification that no scheduled antibiotics may be sold

Any person who sells by retail pharmaceutical products on premises at which
no registered pharmacist is employed shall cause to be displayed in such





premises in a prominent place so as to be clearly visible to the public, a notice in the
English and Chinese languages to the effect that the antibiotics specified in the
Schedule to the Antibiotics Regulations (Cap. 137 sub. leg.) may not be sold on
such premises.

(Added40 of 1969 s. 5)

9. Inspections and enforcement of Ordinance

(1) The Director of Health may in writing authorize any public officer to be an
inspector for the purposes of this Ordinance. (Amended L.N. 76 of 1989)

(2) Any inspector authorized under this section shall, for the purpose of
enforcing the provisions of this Ordinance and any regulations made thereunder
have power

(a)at all reasonable times to enter the premises of any registered
pharmacist, any authorized seller of poisons and any person who is
the holder of a permit under this Ordinance;

(b)at any time to enter any premises in which he has reason to suspect
that an offence against this Ordinance has been committed;

(c)to make such examination and inquiry and to do such other things,
including the taking on repayment therefor of samples, as may be
necessary for the purposes of inspection;

(d)to seize and detain any substance to which this Ordinance applies or
any preparation of which any such substance is an ingredient or part
which he has reasonable cause to suspect is liable to forfeiture under
this Ordinance; and (Amended 23 of 1962 s. 7)

(e)to seize and detain any document, record or article which appears to
him to constitute or contain evidence of the commission of an offence
under this Ordinance. (Added 23 of 1962 s. 7)

(3) If any person wilfully resists or obstructs an inspector in the exercise of his
powers under this section, or refuses to allow any sample to be taken in accordance
with the provisions of this section, or fails without reasonable excuse to give any
information which is duly required under this section to give, he shall be guilty of an
offence and shall be liable on summary conviction to a fine of $1,000.

(Added 50 of 1955 s. 4)

10. Offiences and penalties

(1) Any person who contravenes section 4 or 5 commits an offence and is liable
to a fine of 510,000 and to imprisonment for 12 months. (Replaced 69 of 1986s.2)





(2) Where an offence under this Ordinance has been committed 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 corporate, or
was purporting to act in any such capacity, shall be deemed to 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.

(3) Notwithstanding any provision in any Ordinance prescribing the period
within which summary proceedings may be commenced, proceedings for an offence
under this Ordinance may be commenced at any time within the period of 12 months
next after the date of the commission of the offence:

Provided that this subsection shall not apply to an offence under section 9.
(Added 69 of 1986 s. 2)

11. Forfeiture

(1) A magistrate, on application made on behalf of the Crown, shall order that
any substance to which this Ordinance applies or any preparation of which any
such substance is an ingredient or part, with respect to which any offence under this
Ordinance has been committed, shall be forfeited to the Crown whether any person
has been convicted of such offence or not.

(2) Upon the making of an order of forfeiture under this section, the substance
or preparation to which such order relates shall be deemed to be the property of the
Crown free from the rights of any person.

(Added 50 of 1955 s. 6)

12. Regulations

The Governor in Council may by regulation prescribe the substances and
definitions thereof to which this Ordinance applies and generally for carrying the
provisions of this Ordinance into effect.

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