Pharmacy Practice &

Regulations in Hong Kong

Joseph LEE
Drug Office
Department of Health
18 March 2012

Relevant Legislations
Major legislations
Pharmacy and Poisons Ordinance, Cap. 138
(including Pharmacy and Poisons Regulations,
Poisons List Regulations)
Antibiotics Ordinance, Cap 137
(including Antibiotics Regulations)
Dangerous Drugs Ordinance, Cap 134 (including
Dangerous Drugs Regulations)

Other related legislations

Public Health and Municipal Services Ordinance, Cap.
132

Drugs not of the quality demanded by the purchaser

Drugs unfit for human consumption
False labelling relating to drugs

Undesirable Medical Advertisement Ordinance, Cap.

231

Control advertisements in media, e.g. newspaper,

television, Internet as well as labels on the package

Forensic Classification of medicines

Dangerous Drugs

Antibiotics

e.g. narcotics, benzodiazepines, phentermine, cocaine, etc.

e.g. clarithromycin, penicillins, cephalosporins, tetracyclines, etc.

Part I Third Schedule Poisons

e.g. corticosteriods, statins, most cardiac drugs, most drugs for

asthma, most NSAID, drugs for chemotherapy, etc.

All the above classes of drugs are prescription only medicines

Forensic Classification of medicines

Part I First Schedule Poisons

Part I Poisons

Part I poisons, e.g. codeine cough syrup (<0.1%), clotrimazole cream,

hydrocortisone 0.1% cream, beclomethasone metered dose inhaler,
minoxidil topical solution, ibuprofen, etc.

Part II Poisons

e.g. codeine cough syrup(>0.1%), phenylpropanolamine, etc.

e.g. chlorpheniramine, loratadine (for relief of symptoms of allergic

rhinitis only), other antihistamines which are not Part I poisons

Not a poison (non-poison)

e.g. paracetamol, cimetidine, antacids, etc.

Control on Listed Sellers ()

Only sells non-poisons and Part II poisons

Only sells in original containers closed by the
manufacturer
Labelling requirements relating to poisons and
medicines apply
Possession of Part I poisons, antibiotics or dangerous
drugs prohibited

Controls on Authorized sellers ()

Premises of authorized seller must be under the

personal control of a registered pharmacist
Sale of Part I poisons under the supervision of a
registered pharmacist
Sale of Part I Third Schedule poisons, antibiotics and
dangerous drugs only on prescriptions from doctors,
dentists or vet surgeons
Labelling requirements on poisons and medicines
apply

Controls on Authorized sellers

Storage of Part I First Schedule poisons in locked

receptacles and keys kept by registered pharmacist
Sale of Part I First Schedule poisons must be
recorded and signed by purchaser and pharmacist
prior to sale e.g. some cough syrups containing
codeine, cold remedies containing
phenylpropanolamine, etc.
Record for dispensing of medicines on prescription
Keeping of dangerous drugs register

Medicines supplied by medical doctors

Medicines must be labelled with the name and

address of the doctor
The following information should be recorded in the
record of treatment of the patient if the medicines is
a First Schedule poison

Date on which the medicine was supplied

Name and address of the patient
Ingredients of the medicine, quantity, dosage and duration
of supply

Requirement of a prescription for poisons

Be in writing and signed by the prescriber with his

usual signature and be dated by him
Specify the address of the prescriber
Specify the name and address of the patient
Indicate the total amount of medicine to be supplied
and the dose to be taken
If given by dentists or vet surgeons, the words For
dental treatment only or For animal treatment
only are required

Authorization to doctors under DDO

authorized, so far as may be necessary for the

practice or exercise of his profession, function or
employment, and in his capacity as such, to be in
possession of and to supply a DD
authorized, so far as may be necessary for the
practice of his profession, to manufacture any
preparation and to be in possession of and procure
any DD required for the manufacture of such
preparation

Limitations

Authorization under the DD Ordinance does not

cover para. 8 to para. 11 of Part I of the First
Schedule (opium and opium water; coca leaves;
poppy straw; cannabis and cannabis resin)

Wholesale dealings not included in the authorization

to medical doctors

Prescription for a dangerous drug

Be in writing and signed by the prescriber

Be in ink or otherwise so as to be indelible
Specify the address of the prescriber
Specify the name, identity card number and address
of the patient (*in hospital, bed card)
Specify the amount of the preparation (for injection
in ampoules, either the amount of the preparation or
the total amount to be administered )
If given by dentists or vet surgeons, the words For
dental treatment only or For animal treatment
only are required

Records for dangerous drugs

Every quantity of dangerous drugs received or

supplied must be recorded
Records in the Form as prescribed in the Dangerous
Drug Regulations
Record has to be made on the day or on the next
following day
Records made in chronological sequence
Separate register or separate part of register for
records of each dangerous drug

Form of Dangerous Drug register

Other requirements on the DD register

At the head of each page, specify the class of

dangerous drug and the strength
Records made be in ink or otherwise to be indelible
No cancellation, obliteration or alteration (correction
has to be made by way of marginal note or footnote)
Separate register kept for each set of premises
Records, registers, or other documents to be
retained for two years from the date of last entry or
from the date of issued
Register shall be kept on the premises and available
for inspection at all times

Offences under DD Regulations

Failing to keep a register of dangerous drug is an

offence under regulation 5(1) of the Dangerous
Drugs Regulations, Cap. 134
The maximum penalty under this section is a fine of
$450,000 and imprisonment for 3 years
Failing to preserve records or documents required
under regulation 7(1) of the Dangerous Drugs
Regulations is also an offence and offenders are
liable to a maximum fine of $10,000 and
imprisonment for one year

Thank You