Hong Kong Regulations

DANGEROUS DRUGS REGULATIONS - REGULATION 5

Keeping of register or other records

(Past version on 30/06/1997).

(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 regulation 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 II 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;

   (c)  he shall use a separate page within the register or separate part of
        the register for entries made with respect to different dangerous
        drugs and different strengths of preparations comprised within the
        class of dangerous drugs to which that register or separate part
        relates. (L.N. 191 of 1996)

(2) (Repealed L.N. 191 of 1996)

(3) Where a registered medical practitioner, a registered dentist, a
registered veterinary surgeon or a specified person obtains or supplies any
dangerous drug (which, in the case of the specified person, means a specified
dangerous drug) packed in ampoules, he shall be deemed to have complied with
the requirements- (2 of 1992 s. 13; L.N. 556 of 1997)

   (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)  (Repealed L.N. 191 of 1996) 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)-(5) (Repealed L.N. 191 of 1996)

(6) (a) Subject to sub-paragraph (c), a manufacturer of any preparation
specified in Part II of the First Schedule to the Ordinance and a wholesale
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 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 preparation
        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) or (6) shall be guilty of an offence and shall be liable on conviction to
a fine of $450000 and to imprisonment for 3 years. (L.N. 191 of 1996; L.N. 201
of 1996)

(8) It is a defence for a person charged with committing an offence under
paragraph (7) in relation to paragraph (1) to show that he took all reasonable
steps and exercised all due diligence to avoid committing the offence. (L.N.
288 of 1996) [cf. S.I. 1964/1811 reg. 17 U.K.]