DANGEROUS DRUGS REGULATIONS

DANGEROUS DRUGS REGULATIONS

DANGEROUS DRUGS REGULATIONS.

(Cap. 134, section 51).

[17th January, 1969.1

1. These regulations may be cited as the Dangerous Drugs
Regulations.

2. In these regulations, unless the context otherwise requires

-Pharmacy and Poisons Ordinance book means either of the books
required to be kept by subsection (2) of section 19 or subsection (3)
of section 20 of the Pharmacy and Poisons Ordinance;

'recognized preparation' means a preparation contained in the British
Pharmacopoeia or the British Pharmaceutical Codex;

'retail business' means the business of retailing, dispensing or
compounding dangerous drugs carried on at a shop;

',retail dealer' means a person who carries on a retail business.

3. (1) A person by whom a prescription prescribing a dangerous
drug is given shall comply with the following requirements, that is to
say, the prescription shall

(a)be in writing and signed by the person giving it with his usual
signature, and be dated by him;

(b) be in ink or otherwise so as to be indelible;

(c) specify the address of the person giving it;

(d)specify the name and address of the person for whose
treatment it is given or, if it is given by an approved veterinary
surgeon, of the person to whom the article prescribed is to be
delivered;

(e) have written thereon-

(i) if given by a registered dentist, the words 'For local
dental treatment only'; and

(ii) if given by an approved veterinary surgeon, the words
'For animal treatment only';

(f)if the dangerous drug prescribed is a recognized preparation,
or if all the dangerous drugs prescribed are recognized
preparations,

(i) specify the total amount of the preparation or of each
preparation, as the case may be; or

(ii) when the preparation is packed in ampoules, either
specify as aforesaid or specify the total amount of the
preparation or. of each preparation, as the case may be,
intended to be administered or injected; and





(g)if the dangerous drug is not a recognized preparation,
specify-
(i) the total amount of the drug to be supplied; or
(ii) when the drug is packed in ampoules, either the
total amount as aforesaid or the total amount intended
to be administered or injected.

2) In the case of a prescription given for the treatment of
a patient in a prescribed hospital or a health centre maintained
by the Crown, sub-paragraph (d) of paragraph (1) shall be deemed
to have been complied with if the prescription is written on the
patient's bed card or case sheet, and in such a case the initials of
the person giving the prescription shall be a sufficient signature
for the purposes of sub-paragraph (a) of paragraph (1).

4. (1) Save as provided in paragraph (2), no person shall-

(a)supply a dangerous drug, other than a preparation, unless
the package or bottle in which it is contained is plainly
marked with the amount of the dangerous drug contained
therein; or
(b)supply a preparation, unless the package or bottle in
which it is contained is plainly marked-
(i) in the case of a powder, solution or ointment, with
the total amount thereof in the package or bottle and
the percentage of the dangerous drug contained in the
powder, solution or ointment; or
(ii) in the case of cachets, single dose injections,
lozenges, suppositories, pills, tablets or similar articles,
with the amount of the dangerous drug in each article
and the number of articles in the package or bottle.

(2) Paragraph (1) does not apply-

(a)in a case where a preparation is lawfully supplied by a
registered medical practitioner;

(b)in a case where a preparation is lawfully supplied on a
prescription lawfully given by a registered medical
practitioner; or

(e)in relation to the supply of a dangerous drug specified
in Part 111 of the First Schedule to the Ordinance.

(3) Any person who contravenes paragraph (1) shall be guilty
of an offence and shall be liable on conviction to a fine of ten
thousand dollars and to imprisonment for twelve months.

5. (1) Every person authorized by or licensed under the
Ordinance to supply a dangerous drug, except a sister authorized
by section 22 of the Ordinance, shall comply with the following
provisions, that is to say-





(a)he shall, in accordance with this regulation and regula-
tion 6, keep a register and enter therein in chronological
sequence in the form specified in the First Schedule true
particulars with respect to every quantity of a dangerous
drug, other than a preparation specified in Part II of the
First Schedule to the Ordinance, obtained by him and
with respect to every quantity of a dangerous drug, other
than a preparation specified in Part 11 of the First Schedule
to the Ordinance, supplied by him, whether to persons
within or outside Hong Kong;

(b)he shall use a separate register or separate part of the
register for entries made with respect to each of the
dangerous drugs specified in paragraph 1 of Part I of
the First Schedule to the Ordinance or in paragraph 2,
3, 4, 5, 6 or 7 thereof, and for this purpose-
(i) each such drug shall be deemed to comprise its
salts and any preparation, admixture, extract or other
substance containing any proportion of it or its salts; and
(ii) any isomer of a dangerous drug the existence of
which is possible within its specific chemical designation
shall be deemed to be identical with that drug.

(2)(a) Nothing in paragraph (1) shall be construed as
preventing the use of a separate section within a register
or a separate part of a register with respect to difrerent
dangerous drugs or strengths of preparations comprised
within the class of dangerous drugs to which that register
or separate part relates.

(b)So much of paragraph (1) as requires a person to enter
in the register required to be kept under that paragraph
particulars with respect to a dangerous drug supplied by
him shall not apply to-
(i) a registered medical practitioner if he enters in a
day book true particulars of every dangerous drug
supplied by him to any person, together with the name
and address of that person and the date of the supply,
and enters in a separate book kept for the purposes of
this regulation a proper reference to each entry in the
day book which relates to the supply of a dangerous drug;
or
(ii) an authorized seller of poisons if he enters in a
separate book kept for the purposes of this regulation a
proper reference to each entry in a Pharmacy and Poisons
Ordinance book which relates to the supply of a dangerous
drug,
and if, in either case, sub-paragraphs (c) and (d) are
complied with.
(c)References in the said separate book shall be made in
chronological sequence and the book shall be kept in





separate parts relating respectively to the several classes
of dangerous drugs specified in and under sub-paragraph
(b) of paragraph (1) and shall not be used for any purpose
other than the purposes of this paragraph.
(d)The entries in the said day book and in the said separate
book shall be made on the day on which but for this
paragraph an entry would under regulation 6 have been
required to be made in the said register, and paragraph
(e) of regulation 6 shall apply as respects any such entry
as aforesaid as if it were an entry in the said register.
(e)In this paragraph, the expression 'a proper reference-
means a reference which is entered in the said separate
book under the same date as that on which the entry in
the said day book or in the Pharmacy and Poisons
Ordinance book was made and is otherwise such as to
enable that entry to be easily identified.

(3) Where a registered medical practitioner, a registered
dentist or an approved veterinary surgeon obtains or supplies any
dangerous drug packed in ampoules, he shall be deemed to have
complied with the requirements-
(a)of paragraph (1) in regard to entry in the register required
to be kept under that paragraph of true particulars with
respect to every quantity of every dangerous drug obtained
or supplied; or
(b)in the case of a registered medical practitioner supplying
a dangerous drug to any person, of paragraph (2) in
regard to entry in the day book referred to in that para-
graph of particulars of any dangerous drug supplied by
him,
if he enters as the amount which he has obtained or supplied, as
the case may be, true particulars as to either the total quantity
of the dangerous drug or the total quantity thereof intended to
be administered or injected.

(4) Every-
(a) separate book kept tinder paragraph (2);
(b)day book in which an entry is made under paragraph
(2); and
(c)Pharmacy and Poisons Ordinance book containing an
entry which is referred to in such separate book,
shall be kept on the premises to which the register or book relates,
or, in the case of a book referring to a prescription, where the
prescription was dispensed, and so as to be at all times available
for inspection.

(5) For the purposes of paragraphs (1), (2), (3) and (4), a
dangerous drug administered by, or under the direct supervision
and in the presence of, a registered medical practitioner or a
registered dentist shall be deemed not to have been supplied by
him.





(6)(a) Subject to sub-paragraph (c), a manufacturer of any
preparation specified in Part 11 of the First Schedule to
the Ordinance and a wholesale dealer in any such prep-
aration shall keep every invoice or other like record
issued in respect of each quantity of any such prepara-
tion obtained by him and in respect of each quantity of
any such preparation supplied by him.

(b)A retail dealer in any such preparation shall keep every
invoice or other like record issued in respect of each
quantity of any such preparation obtained by him.

(c)Sub-paragraph (a) does not apply in the case of a prep-
aration manufactured by a registered medical practitioner,
or by a person referred to in subsection (5) of section 22
of the Ordinance, under the authority conferred by sub-
section (4) or (5) of the said section 22, as the case may be.

(7) Any person who contravenes any of the provisions of
paragraph (1), (4) or (6) shall be guilty of an offence and shall
be liable on conviction to a fine of fifty thousand dollars and to
imprisonment for three years.

6. The following requirements shall be complied with by
any person required to keep a register under regulation 5, that is
to say-

(a)the class of dangerous drugs to which the entries on any
page of any such register relate shall be specified at the
head of that page;

(b)every entry required to be made under regulation 5 in
such register shall be made on the day on which the
dangerous drug is received or, as the case may be, on
which the transaction with respect to the supply of the
dangerous drug by the person required to make the entry
takes place, or, if that is not reasonably practicable, on
the day next following the said day;

(c)no cancellation, obliteration or alteration of any such
entry shall be made, and every correction of such an
entry shall be made only by way of a marginal note or
footnote which shall specify the date on which the
correction is made;

(d)every entry required to be made under regulation 5 in
such register, and every correction of such an entry, shall
be made in ink or otherwise so as to be indelible;

(e)such a register shall not be used for any purpose other
than the purposes of the Ordinance;

(f)such person shall if so required by the Director or any
public officer authorized in writing by the Director in
that behalf-





(i) furnish such particulars as may be required with respect
to the obtaining or supplying by him of any dangerous drug,
or with respect to any stock of dangerous drugs in his
possession;

(ii) for the purpose of confirming any such particulars,
produce any stock of dangerous drugs in his possession; and

(iii) produce such register and such other books or
documents in his possession relating to any dealings in
dangerous drugs as may be required;

(g)a separate register shall be kept in respect of each set of
premises at which the person required to keep the register
carries on business, but save as aforesaid not more than one
register shall be kept at one time in respect of each class of
dangerous drug in respect of which he is required to keep a
separate register or part of a register, so, however, that a
separate register may, with the approval of the Director, be
kept in respect of each department of the business carried on
by him;

(h)every such register shall be kept at the premises to which it
relates and so as to be at all times available for inspection.

7. (1) All registers, records, books, prescriptions and other
documents which are kept, issued or made pursuant to the requirements,
or for the purposes, of the Ordinance shall be preserved

(a)in the case of a register, book or other like record, for a period
of two years from the date on which the last entry therein is
made; and

(b)in the case of any other document, for a period of two years
from the date on which it is issued or made.

(2) In the case of any document kept pursuant to paragraph (6) of
regulation 5, the keeping of a copy thereof made at any time during the
said period of two years shall be treated for the purposes of paragraph
(1) as if it were the keeping of the original document.

(3) Any person who contravenes any of the provisions of
paragraph (1) shall be guilty of an offence and shall be liable on
conviction to a fine of ten thousand dollars and to imprisonment for
twelve monuns

8. (1) A licence issued under section 18 of the Ordinance shall be
valid until the 1st day of January next following the day on which it is
issued.

(2) The fees specified in the Second Schedule shall be payable on
the issue of the licences under section 18 of the Ordinance therein
specified.

9. A certificate given for the purposes of section 44 of the

Ordinance shall be in the i /form prescribed in the Third Schedule.





FIRST SCHEDULE. [reg. 5.1

FORM OF
REGISTER.

Date on whichName and address ofAmount
person or firm

supply transaction from whom to whom received. supplied.

received. was effected. obtained. supplied.

Particulars of licence or Form in which
authority of person or firm Balance.
supplied to be in possession

of- received. supplied.

SECOND SCHEDULE. [reg. 8.1

LICENCE
FEES.

Item. Licence. Fee.

1. Licence to manufacture dangerous drug w-
2. Wholesale dealer's licence to supply dangerous drug 1





THIRD SCHEDULE. [reg. 9.1

GOVERNMENT CHEMIST'S
CERTIFICATE.

Government Chemist hereby certify that
(a) on the day of 19
a sealed packet (or as the case may be) ....................................

.................................... marked (if any special mark)
........................... ........ was delivered to the Chemical

Laboratory by (name or description of officer) ...........................

.............. ..

(b) the said packet contained (quantity and nature of dangerous drug)

(e) on the day of 19
at the Chemical Laboratory, the aid (quantity and nature of dangerous

drug) ............................ ..................................................

was/were handed in a sealed packet (or as the case may be)

............................. marked (if any special mark)

.......................... to (name or description of officer)

...............

Dated this day of 19

...............

Government Chemist
L.N. 113/68. Citation. Interpretation. (Cap. 138.) Requirements with respect to prescriptions. S.I. 1964/1811, reg. 14. Marking of packages and bottles. S.I. 1964/1811, reg. 16. Keeping of register or other records. S.I. 1964/1811, reg. 17. First Schedule. Requirements as to registers. S.I. 1964/1811, reg. 25. Preservation of documents. S.I. 1964/1811, reg. 26. Validity of licence under section 18 and fee therefor. Second Schedule. Form of certificate. Third Schedule.

L.N. 113/68. Citation. Interpretation. (Cap. 138.) Requirements with respect to prescriptions. S.I. 1964/1811, reg. 14. Marking of packages and bottles. S.I. 1964/1811, reg. 16. Keeping of register or other records. S.I. 1964/1811, reg. 17. First Schedule. Requirements as to registers. S.I. 1964/1811, reg. 25. Preservation of documents. S.I. 1964/1811, reg. 26. Validity of licence under section 18 and fee therefor. Second Schedule. Form of certificate. Third Schedule.

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