To control the sale and supply of certain antibiotic substances.
(Amended 40 of 1969 s. 2)
[4 June 1948]
(Format changes—E.R. 1 of 2021)
In this Ordinance, unless the context otherwise requires—
authorized seller of poisons (獲授權毒藥銷售商) has the meaning assigned to it by the Pharmacy and Poisons Ordinance (Cap. 138); Director of Agriculture, Fisheries and Conservation (漁農自然護理署署長) includes the senior veterinary officer and any veterinary officer; (Added 23 of 1962 s. 3. Amended L.N. 331 of 1999) penicillin (青霉素) has the meaning assigned to it by the regulations made under this Ordinance;registered dentist (註冊牙醫) means—
a registered dentist as defined by section 2(1) of the Dentists Registration Ordinance (Cap. 156); or
a person deemed to be a registered dentist under that Ordinance; (Replaced 22 of 2024 s. 123)
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 Director of Health 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: (Amended 50 of 1955 s. 2; 84 of 1992 s. 12)
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)
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 registered medical practitioner, a registered dentist or a registered 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 (Amended 96 of 1997 s. 37)
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)
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.
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, Fisheries and Conservation 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 administered in the course of his practice in the clinic concerned. (Amended 50 of 1955 s. 3; 23 of 1962 s. 3; 14 of 1964 s. 2; L.N. 331 of 1999)
Subsection (1) shall not apply to the sale or supply of any such substance or preparation—
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)
to any person who is a holder of a valid permit issued by the Director of Agriculture, Fisheries and Conservation under section 6(2), if any substance or preparation so sold or supplied is clearly labelled “for veterinary purposes only” and “只限醫治禽畜用”; (Added 23 of 1962 s. 3. Amended 80 of 1997 s. 115; L.N. 331 of 1999)
to any such medical practitioner, dentist or veterinary surgeon as aforesaid;
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)
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
to any public department.
The person dispensing a prescription shall comply with the following requirements—
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;
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;
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.
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.
Subsection (1) of this section shall not apply to the following—
a registered medical practitioner;
a person referred to in section 4(1)(b); (Added 14 of 1964 s. 3)
a registered dentist;
a registered veterinary surgeon; (Amended 96 of 1997 s. 38)
a registered pharmacist;
an authorized seller of poisons;
a department of Government;
any person acting under the direction of a registered medical practitioner, registered dentist or registered veterinary surgeon; (Amended 45 of 1984 s. 2; 96 of 1997 s. 38)
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)
a person who is the holder of a valid permit issued by the Director of Agriculture, Fisheries and Conservation under section 6(2); or (Added 23 of 1962 s. 4; 45 of 1984 s. 2. Amended L.N. 331 of 1999; E.R. 1 of 2021)
a person in bona fide possession of a substance supplied to him in conformity with section 4. (Added 45 of 1984 s. 2)
(Added 50 of 1955 s. 4)
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. (Amended L.N. 76 of 1989)
The Director of Agriculture, Fisheries and Conservation 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. Amended L.N. 331 of 1999)
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.
(Added 50 of 1955 s. 4. Amended 23 of 1962 s. 8)
Every person, other than the holder of a valid permit issued by the Director of Agriculture, Fisheries and Conservation 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; L.N. 331 of 1999) Provided that such records need not be maintained by a person to whom such substance has lawfully been supplied for the purpose of treatment. (Added 40 of 1969 s. 4)
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— (Amended 23 of 1962 s. 6)
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;
quantity received or supplied;
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. (Added 40 of 1969 s. 4)
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—
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;
quantity received;
date received.
Entries made in records to be maintained under this section shall be supported in every case by invoice, order note or other voucher.
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.
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 at level 2. (Amended 84 of 1992 s. 13; E.R. 1 of 2021)
(Added 50 of 1955 s. 4)
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. A) may not be sold on such premises.
(Added 40 of 1969 s. 5. Amended E.R. 1 of 2021)
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)
Any inspector authorized under this section shall, for the purpose of enforcing the provisions of this Ordinance and any regulations made thereunder have power—
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;
at any time to enter any premises in which he has reason to suspect that an offence against this Ordinance has been committed;
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;
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)
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)
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 at level 2. (Amended 84 of 1992 s. 14; E.R. 1 of 2021)
(Added 50 of 1955 s. 4)
Any person who contravenes section 4 or 5 commits an offence and is liable to a fine at level 5 and to imprisonment for 12 months. (Replaced 69 of 1986 s. 2. Amended 84 of 1992 s. 15; E.R. 1 of 2021)
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.
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)
A magistrate, on application made on behalf of the Government, 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 Government whether any person has been convicted of such offence or not.
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 Government free from the rights of any person.
(Added 50 of 1955 s. 6. Amended 60 of 2000 s. 3)
The Director of Health 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.
(Amended 84 of 1992 s. 16)