(1) These regulations may be cited as the Misuse of Drugs Regulations 1977.

(2) Except as provided in regulation 28(6), these regulations shall come into force on 1 June 1977.

(1) In these regulations, unless the context otherwise requires,—

(2) Any power conferred on the Director-General by these regulations may be exercised by any officer of the Ministry of Health nominated by the Director-General for the purpose subject to the general control of the Director-General.

(1) Except with the written approval of the Minister given in relation to a particular case, no licence may be granted to deal in a controlled drug for the time being named in—

• (a) Schedule 1 of the Act:

• (b) Part 1 of Schedule 2 of the Act:

• (c) Part 1 of Schedule 3 of the Act.

(1A) However, the approval of the Minister under subclause (1) is not required for the grant of a licence to deal in—

• (a) cocaine, or in anything to which any of clauses 2 to 5 of Schedule 1 of the Act for the time being applies in relation to cocaine:

• (b) morphine or opium, or in anything to which any of clauses 2 to 5 of Part 1 of Schedule 2 of the Act for the time being applies in relation to morphine or opium.

(2) Every person who desires to obtain a licence under these regulations shall apply therefor to the Director-General on a form to be provided by the Ministry of Health, or, with the approval of the Medical Officer of Health, otherwise in writing.

(3) The Director-General or the Medical Officer of Health may require any applicant for a licence to furnish information, by statutory declaration or otherwise, as to the nature of his business, the extent to which he proposes to deal in or otherwise utilise controlled drugs, and any other matter that appears to the Director-General or the Medical Officer of Health to be relevant.

(4) Subject to section 14 of the Act and to subclauses (2) to (4) of regulation 7, the Director-General, if he is satisfied as to the propriety of the application, and, in the case of an applicant other than a government department or a corporate body, as to the character of the applicant, and if he is also satisfied that the granting of a licence will not conflict with the international obligations of New Zealand, shall, upon the payment of the appropriate licence fee set out in Schedule 1AA, grant to the applicant a licence, for the purposes stated in the application, in terms required or permitted by these regulations and subject to such conditions, in addition to the conditions prescribed by or inserted in the licence pursuant to these regulations, as the Director-General sees fit to impose:

provided that the Director-General may, at his discretion, remit the whole or part of such fee in any particular case or class of cases or in relation to any particular licence or class of licences.

(5) Particulars of every licence shall be entered in a register kept for the purpose in the Ministry of Health.

(6) Subject to these regulations, every licence shall be in such form as the Director-General may from time to time determine generally or in relation to any particular licence or class of licences.

(7) Every licence shall be subject to the condition that the licensee will not contravene any provision of regulations 22 to 28, 31 to 33, 38, 40, 42, and 47, and will comply with every such provision so far as it is applicable.

(8) For the purposes of section 14(6) of the Act and subclause (7) of this regulation, every contravention of or failure to comply with any provision of any regulation referred to in that subclause shall be a separate offence.

The fees fixed by these regulations are inclusive of goods and services tax under the Goods and Services Tax Act 1985.

(1) No licence under these regulations may be issued in respect of industrial hemp.

(2) Despite subclause (1), a licence may, in accordance with regulation 7, be issued to import or export industrial hemp.

(1) Without prejudice to the generality of the expression “the propriety of the application” in regulation 3(4), the following matters shall be relevant to the propriety of any application for a dealer's licence:

• (a) the necessity or expediency of the applicant holding a dealer's licence for the purpose of carrying on his lawful affairs:

• (b) the situation and construction of the premises at which the applicant intends to deal in controlled drugs:

• (c) the conditions under which the applicant intends to deal in controlled drugs:

• (d) the kind or class of controlled drugs in which the applicant intends to deal and also, if he intends to manufacture controlled drugs, the amounts of the controlled drugs that he intends to manufacture.

(2) Every dealer's licence—

• (a) shall specify the kind or kinds of dealing authorised by the licence; and

• (b) shall state that the licensee is authorised to deal in all controlled drugs, or, if that is not the case, shall specify, either by reference to a schedule of the Act or to a Part of any such schedule or by naming or otherwise identifying particular controlled drugs, the controlled drugs in which the licensee is authorised to deal; and

• (c) shall specify, where the licence confers authority to manufacture controlled drugs, the amounts of the controlled drugs (other than exempted drugs) that the licensee is entitled to manufacture; and

• (d) shall specify the full address of the premises at which the licensee may deal in controlled drugs.

(3) No dealer's licence shall have the effect of authorising any manner of dealing in controlled drugs other than the manner specified or described in the licence, and no licence in which any controlled drug is specified shall have the effect of authorising the licensee to deal in any controlled drug not so specified.

(4) A separate dealer's licence shall be necessary in respect of each different address at which the licensee intends to deal in controlled drugs, and no dealer's licence shall have the effect of authorising the licensee to deal in controlled drugs elsewhere than at the address specified in the licence.

(5) Subject to regulation 20, no dealer's licence shall authorise the supply of a controlled drug otherwise than pursuant to a prescription or order issued by a practitioner, midwife, or designated prescriber nurse, or the administration of a controlled drug otherwise than in accordance with the advice of the practitioner, midwife, or designated prescriber nurse who supplied or prescribed it.

(1) Every holder of a dealer's licence who wishes to deal in any controlled drug not specified in his licence, or to deal in any controlled drug in a manner not specified in his licence, shall apply in that behalf to the Director-General, and shall deliver his licence for endorsement.

(2) Every holder of a dealer's licence who wishes to deal in controlled drugs at any premises instead of the premises named in his licence shall apply in that behalf to the Director-General, specifying in his application the full address of the proposed substituted premises, and shall deliver his licence for endorsement.

(3) If the Director-General approves an application under subclause (1) or subclause (2), he shall endorse the licence accordingly and enter particulars of the endorsement in the register referred to in regulation 3(5), and the licence thereafter shall have effect according to the tenor of the endorsement.

(4) No fee shall be payable in respect of an application under this regulation.

(1) Unless sooner revoked under regulation 11, and subject to the succeeding provisions of this regulation, every dealer's licence shall continue in force for a period of 1 year, and shall then expire.

(2) Any licence issued within the period of 2 months prior to the date of expiration of an existing licence that it is intended to supersede shall continue in force for a period of 1 year from that date.

(3) If a licensee applies for a new licence not more than 3 months and not less than 1 month before the date of expiration of an existing licence that the new licence is intended to supersede, and the new licence is not granted before that date, the existing licence shall continue in force until the new licence is granted or refused.

(4) Every holder of a dealer's licence who desires to be licensed in the same terms after the expiration of a current licence shall apply in that behalf to the Director-General and pay the appropriate licence fee set out in Schedule 1AA at least 1 month before the expiration of his current licence, and it shall not be necessary to specify in the application the controlled drugs to which it is desired that the licence shall relate:

provided that the Director-General may, at his discretion, remit the whole or part of the licence fee in any particular case or class of cases, or in relation to any particular licence or class of licences.

(1) Without prejudice to the generality of the expression “the propriety of the application” in regulation 3(4), the purpose specified in any application for a licence to import or a licence to export controlled drugs as the purpose for which the controlled drugs are intended to be used after they have been imported or exported shall be relevant to the propriety of the application.

(2) Except with the written approval of the Minister given in relation to a particular case, no licence may be granted to import or export a controlled drug for the time being named in—

• (a) Schedule 1 of the Act:

• (b) Part 1 of Schedule 2 of the Act:

• (c) Part 1 of Schedule 3 of the Act.

(2A) However, the approval of the Minister under subclause (2) is not required for the grant of a licence to import or export—

• (a) cocaine, or in anything to which any of clauses 2 to 5 of Schedule 1 of the Act for the time being applies in relation to cocaine:

• (b) morphine or opium, or in anything to which any of clauses 2 to 5 of Part 1 of Schedule 2 of the Act for the time being applies in relation to morphine or opium.

(3) A licence to export controlled drugs shall be granted only on production of a certificate from the competent authority of the country to which the controlled drugs are to be exported to the effect that the importation into that country of the controlled drugs specified therein is approved.

(4) A licence to export controlled drugs for the purpose of placing them in a bonded warehouse shall be granted only if the Government of the importing country certifies on the certificate referred to in subclause (3) that it has approved the importation for the purpose of being placed in a bonded warehouse.

(5) Every licence to import and every licence to export controlled drugs shall specify the name or description of the controlled drug that is the subject of the licence, the quantity of the controlled drug permitted to be imported or exported, the name and address of the importer or exporter, the period within which the importation or exportation must be effected, and the address (not being a post office or a telegraphic or code address) to which the controlled drugs are to be consigned.

(6) Every licence to export controlled drugs shall identify the import certificate referred to in subclause (3) by reference to the number and date of the certificate and the authority by whom it was issued and, in every case where the controlled drugs are being exported for the purpose of being placed in a bonded warehouse, the licence shall specify that the controlled drugs are being exported for that purpose.

(7) Every licence to export controlled drugs shall be subject to the condition that a copy of the licence will accompany each consignment of the controlled drugs to which the licence relates.

(8) Every licence to import and every licence to export controlled drugs shall cease to have effect on the expiration of the period stated therein as the period within which importation or exportation must be effected.

(1) Every licence to cultivate a prohibited plant shall specify the prohibited plant that the licensee may cultivate, and, without prejudice to the power of the Director-General to impose conditions to which the licence is subject, shall describe the land or specify the full address of the premises on which such cultivation is authorised and specify either the area of that land or the number of plants that may be cultivated thereon or at such premises at any one time.

(2) No licence to cultivate a prohibited plant shall authorise the cultivation—

• (a) of any plant of the species Lophophora williamsii or Lophophora lewinii for the purpose of the production of mescaline:

• (b) of any plant of the species Psilocybe mexicana or Psilocybe cubensis for the purpose of the production of psilocine or psilocybine.

(3) A licence to cultivate a prohibited plant shall cease to have effect on the expiration of the period, if any, specified therein in that behalf, but any such licence may be granted for an indefinite period.

(1) Subject to section 14 of the Act, a licence to possess controlled drugs may be granted—

• (a) to any person, specified by name or office, in charge of or employed at a field research station, or in charge of or employed in a laboratory maintained for the purpose of research and study at a university or other institution; or

• (b) to any other person if the Director-General is of the opinion that—

  • (i) that person may not be entitled by or under any other provision of these regulations to possess controlled drugs for the purpose for which that person requires controlled drugs; and

  • (ii) that purpose is a proper purpose.

(2) A licence to possess controlled drugs—

• (a) shall specify the paragraph of subclause (1) under which it is granted:

• (b) shall specify the purpose for which it is granted:

• (c) shall specify the controlled drugs to which it applies:

• (d) may specify the quantities of controlled drugs that may be in the possession of the licensee at any one time.

(3) A licence to possess controlled drugs shall not have the effect of authorising the possession of controlled drugs of a kind other, or in greater quantity than, the kind or quantity (if any) specified in the licence, or the kind or quantity required for the purpose of the field research station or laboratory or other purpose specified in the licence.

(4) A licence to possess controlled drugs shall cease to have effect on the expiration of the period (if any) specified therein in that behalf, but any such licence may be granted for an indefinite period.

(1) No licence, and no right thereby conferred, shall be exercised by any person other than the licensee, or be assigned, charged, or alienated to or in favour of, or be capable of devolving upon, any person, whether by act of the parties or by operation of law.

(2) Notwithstanding anything in subclause (1), where a licence is granted to an officer of a government department or other instrument of the Crown, or to a person pursuant to regulation 9(1)(a), in the name of his office, any person holding or acting in that office for the time being, but no other person, shall be the licensee.

(1) The Minister may at any time, by notice in the Gazette, revoke a licence—

• (a) if the licensee is convicted of an offence against the Act or these regulations; or

• (b) if the Minister is satisfied that the licensee has contravened or failed to comply with any condition contained in the licence whether imposed by these regulations or by the terms of that licence; or

• (c) if it appears to the Minister that the licence has been granted in error or through any misrepresentation or fraud, or has been granted without his approval to a person to whom, or in respect of a controlled drug in relation to which, the licence should not have been granted without the approval of the Minister.

(2) Every person whose licence is revoked shall deliver his licence to the Director-General within 1 month after that revocation.

(3) Every person who fails to comply with subclause (2) commits an offence against these regulations.

(1) The several permissions conferred by this Part may be exercised without any licence in that behalf, but nothing herein contained shall prevent the grant of a licence to any person.

(2) This Part shall be read subject to Parts 4, 5, and 6.

(3) Every person, other than a licensee, who contravenes any provision of regulations 21 to 26, 28, 29, 31 to 33, 35, 37, 38, 40, 42 to 45, or 47, or fails to comply with any such provision to the extent that it is applicable, commits an offence against these regulations.

(1) A designated prescriber nurse is, for the purposes of section 8(2A)(a) of the Act, authorised by this regulation to prescribe a controlled drug specified in Schedule 1A (and so may, under section 8(2A)(a) of the Act, prescribe, supply, or administer the controlled drug).

(2) The authority given by subclause (1) is subject to sections 22 to 25 of the Act and to any prohibitions, limitations, restrictions, or conditions imposed by or under those sections or any regulations made under the Act (for example, the restrictions in regulation 21(4B)).

(1) Any pharmacist may produce, manufacture, or supply a controlled drug pursuant to a prescription issued by a designated prescriber nurse in accordance with these regulations.

(2) Any person for whom a controlled drug is supplied by a designated prescriber nurse, or prescribed by a designated prescriber nurse and lawfully supplied, may administer that drug to himself or herself in accordance with the advice of the designated prescriber nurse who supplied or prescribed it.

(3) Any person having the care of a patient for whom a controlled drug is supplied by a designated prescriber nurse, or prescribed by a designated prescriber nurse and lawfully supplied, may administer that drug to that patient in accordance with the advice of the designated prescriber nurse who supplied or prescribed it.

(4) Subclauses (1), (2), and (3) contain permissions that—

• (a) are exceptions to the prohibitions in sections 6(1) and 7(1) of the Act; but

• (b) are subject to sections 22 to 25 of the Act and any prohibitions, limitations, restrictions, or conditions imposed by or under those sections or any regulations made under the Act.

(1) Any person may use an exempted drug in the manufacture of another exempted drug, or of a product that is not a controlled drug.

(2) Any medical practitioner or dentist may use any controlled drug in the manufacture of any other controlled drug required for the treatment of a patient under his care.

(3) Any veterinarian within the meaning of section 4 of the Veterinarians Act 2005 may use any controlled drug in the manufacture of any other controlled drug required for the treatment of an animal under his care.

(4) Any pharmacist may use any controlled drug in the manufacture of any other controlled drug that he is authorised to produce or manufacture by section 8(2)(b) of the Act.

(5) Nothing in subclauses (2) to (4) shall apply to any practitioner or pharmacist who is for the time being prohibited under section 23 of the Act from prescribing, producing, manufacturing, or supplying controlled drugs.

(1) Any person who is licensed under these regulations to import or export a controlled drug or to deal in a controlled drug may possess that drug in the manner and for the purpose expressed or implied in the licence.

(2) Any person who is licensed under these regulations to cultivate a prohibited plant may possess the seed and fruit of that plant in the manner and for the purpose expressed or implied in that licence.

Without prejudice to any provision of section 8(2) of the Act, every manager of a hospital, and every manager of an institution for the care of the sick or aged that is for the time being approved by the Director-General for the purposes of this regulation, may possess any controlled drug named or described in Part 2 of Schedule 3 of the Act and any partially exempted drug.

(1) This regulation applies to seeds and fruit, not being controlled drugs, of prohibited plants.

(2) Any person in the service of the Crown may possess any seed or fruit to which this regulation for the time being applies for the purposes of and in connection with his official duties.

(3) Any carrier, and any agent or servant of a carrier, may possess any seed or fruit to which this regulation for the time being applies in the course of carriage to such extent as is necessary or incidental to the business of the carrier.

(1) The master of any vessel for the time being within the territorial limits of New Zealand, and any person acting under his directions and on his behalf, may possess, import, export, and administer any controlled drug authorised or required to be carried on that vessel by any law to which that vessel is subject, and lawfully supplied to him.

(2) Nothing in subclause (1) shall authorise the master of any vessel or any other person—

• (a) to possess controlled drugs elsewhere than on the vessel of which the first-mentioned person is the master, except while the controlled drugs are being conveyed from the place where they were procured by either of those persons to that vessel; or

• (b) to import, export, administer, or otherwise use controlled drugs except for the purpose of treating sick or injured persons on that vessel.

(1) The person in charge of any aircraft for the time being within the territorial limits of New Zealand, and any person acting under his directions and on his behalf, may possess, import, export, and, in any case where the administration of a controlled drug is expedient for the purpose of treating a sick or injured person in an emergency, administer to that person any controlled drug authorised or required to be carried on the aircraft by any law to which that aircraft is subject, and lawfully supplied to him.

(2) Nothing in subclause (1) shall authorise the person for the time being in charge of any aircraft or any other person—

• (a) to possess controlled drugs elsewhere than on the aircraft of which the first-mentioned person is for the time being in charge, except while the controlled drugs are being conveyed from the place where they were procured by either of those persons to that aircraft or while the aircraft is being surveyed, examined, or overhauled; or

• (b) to import, export, administer, or otherwise use controlled drugs except for the purpose of treating sick or injured persons in an emergency.

(1) In this regulation the expression approved first-aid kit means a first-aid kit that is held for ready use in the event of emergency in a place, locality, vessel, or vehicle approved in writing by the Medical Officer of Health, and that is—

• (a) under the control of a person in an isolated locality where workers are employed; or

• (b) under the control of a nurse appointed as an occupational health nurse in any place where a first-aid post or similar post is established for the benefit of workers employed there; or

• (c) under the control of a person representing an organisation established for search and rescue in mountainous or isolated areas; or

• (d) under the control of a person belonging to a class approved by the Director-General or under the control of any person in a place, locality, vessel, or vehicle so approved.

(2) Any approval for the purposes of subclause (1) shall be deemed to be given upon and subject to such terms and conditions as may be specified therein, and may at any time be revoked by the Director-General, whether or not the approval was given by him.

(3) Subject to the provisions of this regulation and to any conditions that may from time to time be imposed by the Medical Officer of Health in any particular case, any person for the time being having control of an approved first-aid kit may possess and administer to any person any controlled drug lawfully contained in that kit.

(4) Nothing in subclause (3) shall authorise any person to administer controlled drugs except for the purpose of treating a sick or injured person in an emergency arising in the locality, vessel, or vehicle for which the controlled drugs were supplied.

(5) The permission conferred by subclause (3) shall extend to any person nominated in writing in that behalf by the person having the approved first-aid kit under his control.

(6) Every person in possession of controlled drugs by virtue of subclause (3) who, except as may be permitted by the Medical Officer of Health, keeps those controlled drugs, or causes or permits them to be kept, elsewhere than in an approved first-aid kit under his control or under the control of a person nominated in that behalf pursuant to subclause (5), or who contravenes or fails to comply with any condition imposed by the Medical Officer of Health under subclause (3), commits an offence against these regulations.

(7) Every nomination under subclause (5), and any controlled drug possessed by virtue of this regulation, shall be available at any time for inspection by any constable or any officer.

(8) Any person having control of an approved first-aid kit, and wishing to obtain controlled drugs for the purposes of that kit, shall apply in writing to the Medical Officer of Health in that behalf, specifying—

• (a) the name and quantity of the controlled drugs required:

• (b) in the case of a first-aid kit in a place where workers are employed, the number of workers to be served:

• (c) details of the locality where the work is to be performed, or of the area in which the first-aid kit is likely to be used, and the period for which the supply is required:

• (d) such other particulars as the Medical Officer of Health may require.

(1) Notwithstanding anything in section 8(2)(b) of the Act or regulation 4(5), a controlled drug may be supplied, otherwise than pursuant to a prescription, to or for—

• (a) a person licensed or otherwise authorised to export, use in manufacture, or supply that drug:

• (b) a person to whom the drug is supplied in an emergency in accordance with regulation 34:

• (c) a person authorised to possess that drug by paragraph (g) or paragraph (i) of section 8(2) of the Act:

• (d) a person licensed to possess the drug or authorised to possess the drug by any of regulations 15, 17, and 18:

• (e) a person authorised to possess the drug by regulation 19 if the person supplying the drug has been authorised in writing by the Medical Officer of Health to supply the drug, on the particular occasion, to the person procuring it.

(2) Without prejudice to any provision of section 8 of the Act—

• (a) any person may supply, otherwise than pursuant to a prescription, or administer, any partially exempted drug, subject to subclause (3):

• (b) any person may administer, subject to and in accordance with regulation 36(2), a controlled drug to a maternity patient.

(3) For the purposes of subclause (2)(a), the following restrictions apply to the supply of any preparation of pseudoephedrine described in paragraph (b) of the definition of partially exempted drug:

• (a) the preparation may be sold by retail, or supplied in circumstances corresponding to retail sale, only in the circumstances set out in paragraphs (a) and (b) of the definition of pharmacy-only medicine in section 3 of the Medicines Act 1981; and

• (b) the package in which the preparation is sold or supplied must not contain more than 1.8 g of pseudoephedrine.

(1) Nothing in section 8 of the Act or in these regulations, or in any licence granted under these regulations, shall authorise any dealing in a controlled drug contrary to any provision of these regulations or of section 20 or section 24 of the Medicines Act 1981.

(2) No medical practitioner shall give a prescription for the supply of a controlled drug otherwise than for the medical treatment of a patient under his care, unless the medical practitioner is acting in the course of his employment in the service of the Crown.

(3) No dentist shall give a prescription for the supply of a controlled drug otherwise than for the dental treatment of a patient under his care.

(4) No dentist shall give a prescription for the supply of a controlled drug in any quantity greater than the quantity reasonably required for the treatment of the patient for a period of 7 days.

(4A) No midwife shall give a prescription for the supply of pethidine under section 8(2)(aa) of the Act otherwise than for the treatment of a patient under his or her care.

(4B) No designated prescriber nurse may (within the authority given by regulation 12A(1)) give a prescription for the supply of a controlled drug—

• (a) otherwise than for the treatment of a patient under the nurse's care; or

• (b) in circumstances that are not cases of emergency; or

• (c) in any quantity greater than the quantity reasonably required for the treatment of the patient for a period of 3 days.

(5) No veterinarian within the meaning of section 4 of the Veterinarians Act 2005 shall give a prescription for the supply of a controlled drug otherwise than for administration to an animal under his care.

(6) Paragraph (c) of section 8(2) of the Act shall not apply where the person for whose benefit the controlled drug is supplied or prescribed is in the course of being supplied with the same controlled drug for the same purpose by another practitioner, or pursuant to a prescription given by another practitioner, and does not disclose that fact to the practitioner referred to in that paragraph before the supply of the controlled drug, or the giving of the material prescription, by that practitioner.

(1) Except to the extent and in the circumstances approved by the Minister either generally or in relation to any particular case or class of cases, no person may supply or administer to any other person, or may prescribe, any controlled drug for the time being named or described in—

• (a) Schedule 1 of the Act:

• (b) Part 1 or Part 2 of Schedule 2 of the Act:

• (c) Part 1 of Schedule 3 of the Act.

(2) However, the approval of the Minister under subclause (1) is not required for the supply, administration, or prescribing of—

• (a) cocaine, or anything to which any of clauses 2 to 5 of Schedule 1 of the Act for the time being applies in relation to cocaine:

• (b) morphine or opium, or anything to which any of clauses 2 to 5 of Part 1 of Schedule 2 of the Act for the time being applies in relation to morphine or opium.

(1) No person other than a practitioner shall supply any Class A controlled drug or Class B controlled drug, not being a controlled drug supplied pursuant to a prescription, to any other person, unless the person supplying the controlled drug holds a written authority—

• (a) setting out the name and address of the person for whom the controlled drug is to be supplied; and

• (b) specifying by name and quantity the controlled drug to be supplied; and

• (c) specifying or describing the intended method of delivery to the person for whom the controlled drug is to be supplied; and

• (d) signed by the person for whom the controlled drug is to be supplied:

provided that in cases of emergency a controlled drug may be supplied without the written authority, but in that event the person to whom the controlled drug is supplied shall give the supplier the written authority within 48 hours after delivery, and, if the supplier fails to receive the authority within that period, he shall report the circumstances forthwith in writing to the Medical Officer of Health.

(2) Every person supplying a controlled drug pursuant to subclause (1) shall—

• (a) before supplying the controlled drug (except where it is supplied pursuant to the proviso to that subclause) satisfy himself that the authority referred to in that subclause has been duly completed, and, in particular, that it has been signed by the person for whom the controlled drug is to be supplied; and

• (b) endorse on the face of that authority at the time of supply or at the time when he receives the authority, as the case may require, above the signature of the person for whom the controlled drug is to be supplied, the name and address of the premises from which, and the date on which, the controlled drug is or was supplied; and

• (c) sign that endorsement; and

• (d) retain that authority or cause that authority to be retained, in an orderly and consecutive manner in relation to other such authorities, at the premises from which the controlled drug was supplied for a period of 4 years from the date on which that controlled drug was supplied; and

• (e) permit any constable and any officer to examine that authority and make copies thereof.

(3) No person shall supply any controlled drug for delivery through the post except for delivery by registered or insured post.

(4) This regulation shall not apply in respect of any exempted drug.

(1) Subject to regulation 30, no person shall supply a controlled drug pursuant to a prescription that does not conform in all respects with regulation 29.

(2) No person shall supply a controlled drug pursuant to a prescription otherwise than by delivery, by himself or by a person in his employment, to the person for whom the drug is intended or at the premises where that person resides, or by delivery by registered post, or by delivery through a carrier, unless—

• (a) the person to whom he makes delivery gives to him a written authority in the terms that would have been required by regulation 23(1) if the controlled drug had not been dispensed pursuant to a prescription; or

• (b) he is otherwise satisfied that the person to whom he makes delivery has the care of the person for whom the controlled drug is intended or is authorised by the last-mentioned person to accept delivery of the controlled drug.

(1) Except in the case of a container to which subclause (3) applies, no person shall supply any controlled drug (other than an exempted drug) unless the container containing the controlled drug bears a label setting out, in letters of a colour contrasting clearly with the colour of the background, the following:

• (a) in the upper part of the principal display panel, printed in conspicuous block capital letters, the words “CONTROLLED DRUG”, followed immediately by the appropriate designation specified in subclause (2); and

• (b) the name of the controlled drug supplied; and

• (c) directions for use, or, in the case of a drug for internal use, the recommended dose and frequency of the dose; and

• (d) where the controlled drug is in the form of a preparation, mixture, or article, the name (if any) of the preparation, mixture, or article, together with a statement of the proportion that the controlled drug bears to the total ingredients of the preparation, mixture, or article, indicating (if the proportion is stated as a percentage) whether the percentage is calculated on the basis of weight in weight, or weight in volume, or volume in volume; and

• (e) the name and address of the manufacturer, or the packer, or the seller by wholesale or by retail.

(2) For the purposes of subclause (1), the appropriate designation, in relation to a controlled drug, is as follows:

(3) Subclause (1) does not apply,—

• (a) in respect of ephedrine or pseudoephedrine, if—

  • (i) the drug is enclosed in a primary container that complies with regulation 15(2) of the Medicines Regulations 1984; and

  • (ii) the larger container in which the strips of primary containers are contained complies with subclause (1); and

• (b) in respect of all other controlled drugs, if—

  • (i) the drug is contained in a safety container within the meaning of regulation 2(1) of the Medicines Regulations 1984; and

  • (ii) the labelling of the safety container complies with the Medicines Regulations 1984.

(3A) Subclause (1) shall not apply in respect of any controlled drug supplied pursuant to a prescription signed by a medical practitioner or a designated prescriber nurse or a dentist or a veterinarian within the meaning of section 4 of the Veterinarians Act 2005.

(4) No person shall, in the course of any profession or business, supply any controlled drug (other than an exempted drug) as a medicine for human use, with reference to the needs of a particular patient, unless the container of the controlled drug bears a label setting out the following:

• (a) either—

  • (i) the general nature of the medicine, and a recognised code that indicates the precise nature of the contents or consists of a reference to a prescription book or similar record; or

  • (ii) the name or a description of the nature of the contents; and

• (b) either—

  • (i) in the case of a medicine for internal use, the dose and frequency of the dose; or

  • (ii) in the case of a medicine for external use, the directions for use; and

• (c) the name of the patient; and

• (d) the name and address of the supplier.

(5) No person shall, in the course of any profession or business, supply any controlled drug (other than an exempted drug) as a remedy for the treatment of an animal, unless the container of the controlled drug bears a label setting out the following:

• (a) either—

  • (i) the general nature of the remedy, and a recognised code that indicates the precise nature of the contents or consists of a reference to a prescription book or similar record; or

  • (ii) the name or a description of the nature of the contents; and

• (b) the directions for use; and

• (c) the name of the person in charge of the animal; and

• (d) the words “Not for Human Use” or the words “For Veterinary Use Only”.

(6) Notwithstanding anything in subclause (1), nothing in that subclause shall apply during the period of 12 months commencing with the date of the commencement of the Act with respect to any controlled drug that, immediately before that date, was a poison within the meaning of the Poisons Act 1960 and that, at that date, was part of the existing stock-in-trade in New Zealand of any person lawfully carrying on business there, if the controlled drug is contained in a container labelled in accordance with all of those requirements of the Poisons Regulations 1964 (SR 1964/64) that were applicable to it at the said date. For the purposes of this subclause any controlled drug purchased before the said date for importation into New Zealand shall be deemed to be part of the purchaser's stock-in-trade in New Zealand.

(7) In any proceedings in respect of an alleged contravention of subclause (1) in which subclause (6) is pleaded in defence, the burden of proving that the provisions of that subclause afford a defence to the particular charge shall lie on the person charged.

(1) [Revoked]

(2) Subject to subclause (3), no person shall supply to a pharmacy a controlled drug of any type or kind specified in any of paragraphs (a) to (e) in a container that contains a quantity of that drug in excess of the amount so specified:

• (a) powders:

  • cocaine hydrochloride:

  • methadone hydrochloride:

  • morphine hydrochloride:

  • morphine sulphate:

  • an amount per container not exceeding 2 grams:

• (b) liquid dose form of methadone or morphine:

  an amount per container not exceeding 100 millilitres or, where the total amount of morphine or methadone in a container does not exceed 2 grams, an amount per container not exceeding 200 millilitres:

• (c) liquid dose form of nepenthe or opium tincture:

  an amount per container not exceeding 100 millilitres:

• (d) solid dose form:

  • dextromoramide:

  • levorphanol:

  • methadone:

  • morphine sulphate:

  • papaveretum:

  • pethidine:

  • an amount per container not exceeding 10 items in solid dose form:

• (e) ampoules (whether or not the controlled drug is mixed with any other substance):

  • dextromoramide:

  • levorphanol:

  • methadone:

  • morphine:

  • papaveretum:

  • pethidine:

  • an amount per container not exceeding 5 ampoules.

(3) Subclause (2) shall not apply to a controlled drug packed for supply in its original container to a hospital or other institution.

(1) No person who is licensed to deal in any controlled drug for the purpose of manufacturing an exempted drug shall use any such controlled drug in any such manufacture in contravention of a direction given under subclause (2).

(2) The Director-General may, by notice in writing, served either personally or by registered post on a person licensed as aforesaid, direct that person not to use any such controlled drug in the manufacture of an exempted drug unless—

• (a) notice has been given to the Medical Officer of Health specified in the direction, at least 7 days before the date on which it is intended to manufacture the exempted drug, of the time and place of the proposed manufacture; and

• (b) the use of such controlled drug in the manufacture is supervised by an officer.

(1) Subject to subclause (4), and to any conditions that may be imposed under regulation 3 or regulation 19, every person in possession, for the purposes of sale, or in the course of any profession, or in the course of carriage, or for the purposes of use in any ship, aircraft, or motor vehicle, of a controlled drug that is not required for immediate use shall—

• (a) keep it in a locked cupboard, or a locked compartment, that is constructed of metal or concrete or both, and that, in the case of any cupboard or compartment installed in a building after the commencement of these regulations, is of an approved type; and

• (b) ensure that the cupboard or compartment is securely fixed to, or is part of, the building, ship, aircraft, or vehicle within which the controlled drug is kept for the time being; and

• (c) ensure that the key of the cupboard or compartment is kept in a safe place when not being used. Where the building, ship, aircraft, or vehicle within which the controlled drug is kept for the time being is left unattended, that safe place shall not be within that building, ship, aircraft, or vehicle:

  provided that this paragraph shall not apply if the cupboard or compartment is fitted with a combination lock and is of an approved type.

(2) In paragraph (a) and paragraph (c) of subclause (1) approved type means a type that, at the date of installation, has, for the time being been approved by the Medical Officer of Health after consultation with such constable as may be charged at that date with the function of advising the Medical Officer of Health for the purposes of that paragraph.

(3) Subject to subclause (4), no person in possession, in circumstances to which subclause (1) applies, of a controlled drug that is kept for the time being within any building, ship, aircraft, or vehicle, shall leave that building, ship, aircraft, or vehicle unattended, unless he has taken all reasonable steps to secure that building, ship, aircraft, or vehicle, and the part of it in which the controlled drug is kept, against unlawful entry.

(4) Nothing in this regulation shall apply with respect to—

• (a) an exempted drug:

• (b) any of the following preparations, namely:

  • codeine phosphate syrup:

  • codeine phosphate linctus:

  • pholcodine linctus:

  • pholcodine linctus, strong:

• (c) [Revoked]

• (d) any controlled drug for the time being named or described in Part 5 of Schedule 3 of the Act:

• (e) a preparation of pseudoephedrine as described in paragraph (b) of the definition of partially exempted drug.

(5) For the purposes of subclauses (1) and (3), building includes a room in a building:

provided that a room shall be deemed to be attended—

• (a) in the case of a room forming part of a dwelling (being residential accommodation occupied by 1 person living alone, or by 2 or more persons living together but independently of other persons, if any, residing in or using other rooms in the same building) so long as a person who lives in that dwelling is within that dwelling or on adjacent land occupied or used in connection therewith; or

• (b) in any other case, so long as a person who works in or otherwise uses that room is within another room communicating therewith; or

• (c) in any case, if the room, and any room communicating therewith, is not vacated for a longer period than 10 minutes at any one time by all persons working in or otherwise using the room.

(6) [Revoked]

(1) Every prescription for the supply of a controlled drug, shall, except in the case of emergency as provided by regulation 34,—

• (a) in the case of a controlled drug intended for human use, be written on a form provided by the Director-General, if the drug is—

  • (i) a Class A controlled drug or a Class B controlled drug; or

  • (ii) amobarbital, amobarbital sodium, buprenorphine, butobarbitone, glutethimide, ketamine, secobarbital, or secobarbital sodium, or a combination of any 2 or more of those substances:

  provided that this paragraph shall not apply in respect of any substance or combination of substances referred to in subparagraph (ii) if that substance or combination is combined with any other pharmacologically active substance or substances, none of which are included in clause 1 of Part 4 of Schedule 3 of the Act:

• (b) be legibly and indelibly written or, where the controlled drug prescribed is methadone and the prescription is given by a medical practitioner who works in a place for the time being specified by the Minister under section 24(5)(b) of the Act, be either legibly and indelibly written or in a form approved from time to time by the Director-General of Health:

• (c) in the case of a controlled drug that is not a Class C controlled drug,—

  • (i) be given by a practitioner, midwife, or designated prescriber nurse who is not for the time being prohibited under section 23 of the Act from issuing prescriptions for the supply of controlled drugs; and

  • (ii) be indelibly signed by the practitioner, midwife, or designated prescriber nurse giving it with his or her usual signature, personally and directly handwritten and not affixed by means of any stamping, stencilling, duplicating, or other contrivance; and

  • (iii) except where it is given by a medical practitioner who works in a place for the time being specified by the Minister under section 24(5)(b) of the Act, be in the handwriting of the practitioner, midwife, or designated prescriber nurse giving it:

• (d) set out the date on which it is signed:

• (e) set out the address of the person by whom it is signed:

  provided that the address may be stamped on the prescription:

• (f) set out the surname, initials of the first names, and address and, in the case of a child under the age of 12 years, the age in years and months in words, of the person to whom the controlled drug is intended to be administered, or, in the case of a prescription given by a veterinarian within the meaning of section 4 of the Veterinarians Act 2005, of the person having the custody of the animal to which the controlled drug is intended to be administered:

• (g) if given by a dentist, bear the words “for dental treatment only”:

• (h) if given by a midwife, bear the words “for midwifery use only”:

• (i) if given by a veterinarian within the meaning of section 4 of the Veterinarians Act 2005, bear the words “for animal treatment only”:

• (j) set out the name of the controlled drug to be supplied:

• (k) not be written in cipher, or abbreviated, otherwise than by abbreviations recognised in the British Pharmacopoeia, the British Pharmaceutical Codex, or other standard reference books on materia medica or pharmacy:

• (l) indicate the total amount of the controlled drug that may be sold or dispensed on the one occasion, or on each of the several occasions, authorised by that prescription:

• (m) set out the dose and frequency of the dose, or, in the case of a controlled drug for external use, directions for use:

• (n) where it prescribes an unusual dose, or what may be regarded as a dangerous dose, of any controlled drug, have the amount of the dose emphasised by being underlined, with the initials of the practitioner, midwife, or designated prescriber nurse set out in the margin opposite thereto.

(2) No person (other than a medical practitioner, midwife, or designated prescriber nurse, acting in a case of emergency under regulation 34) may give a prescription for the supply of a controlled drug that does not conform to the requirements of subclause (1).

(3) Nothing in this regulation shall apply in respect of exempted drugs or partially exempted drugs.

If a condition prohibiting the acquisition of controlled drugs otherwise than pursuant to the prescription of a practitioner, midwife, or designated prescriber nurse (a prescriber), or of a particular prescriber, or of a prescriber belonging to a particular class of prescriber, is imposed on a licence, regulations 21(2), (3), (4A), (4B), and (5) and 29(1)(f), (g), (h), (i), (m), and (n) do not apply to the extent that they are inconsistent with the terms of the licence in respect of anything done for the purpose of enabling compliance with that condition.

(1) Except as provided in subclauses (2) to (5), no person shall supply any controlled drug on more than 1 occasion on the same prescription, or more than 7 days after the date of this prescription, or in a quantity, having regard to the dose and frequency of the dose or the directions given by the prescriber, greater than a quantity sufficient for use for a period of 1 month.

(2) If the medical practitioner signing a prescription so directs on the prescription,—

• (a) any controlled drug (not being a Class C controlled drug) may be supplied on not more than 2 occasions, at an interval to be specified by the medical practitioner on the prescription, the first such occasion being not more than 7 days after the date of the prescription and the second such occasion being not more than 7 days after the termination of that interval:

  provided that in no case shall the total quantity supplied, having regard to the dose and frequency of the dose or the directions given by the prescriber, be greater than a quantity sufficient for use for a period of 1 month:

• (b) any Class C controlled drug may be supplied on not more than 3 occasions, at such intervals as may be specified by the medical practitioner on the prescription or, if no intervals are so specified, at monthly intervals:

  provided that in no case shall the total quantity supplied, having regard to the dose and frequency of the dose or the directions given by the prescriber, be greater than a quantity sufficient for use for a period of 3 months.

(2A) If the midwife signing the prescription so directs on the prescription, pethidine may be supplied under section 8(2)(aa) of the Act on not more than 2 occasions, at an interval to be specified by the midwife on the prescription, the first such occasion being not more than 4 days after the date of the prescription and the second such occasion being not more than 4 days after the termination of that interval:

provided that in no case shall the total quantity supplied, having regard to the dose and frequency of the dose or the directions given by the prescriber, be greater than a quantity sufficient for use for a period of 1 month.

(3) A prescription for a Class C controlled drug shall not be dispensed on any occasion after 6 months have elapsed from the date on which it was written.

(4) If, for special reasons relating to the protection of the patient, or for the purpose of limiting the quantity of any controlled drug in the possession of any person, the medical practitioner, midwife, or designated prescriber nurse signing a prescription directs on the prescription that the controlled drug is to be dispensed daily or at such other regular intervals as he or she considers necessary for a stated period not exceeding a period of 1 month, the controlled drug may be supplied on not more than the number of occasions indicated, and not more frequently than the intervals indicated by the medical practitioner, midwife, or designated prescriber nurse.

(5) If a Medical Officer of Health has issued to a person a notice under section 25 of the Act authorising him to supply a controlled drug for a named patient on more than 2 occasions on any prescription, that person may supply the controlled drug in such quantity, at such frequency, and for such period as the notice shall specify.

(6) If the prescription has been given orally in accordance with regulation 34 the prescription shall not be dispensed on more than 1 occasion before the written confirmation is received by the person who dispensed the prescription.

(7) On the first occasion of dispensing a prescription or, where a controlled drug has been dispensed in accordance with an oral prescription as provided in regulation 34, on the subsequent receipt of the written prescription, there shall be written or stamped on the face of the prescription, above the signature of the prescriber, in such manner and place that no part of the prescription is obliterated—

• (a) the name of the proprietor of the business at which the prescription is dispensed; and

• (b) the address of the premises from which, and the date on which, the prescription is dispensed.

(8) On each subsequent occasion of dispensing a prescription, if any, there shall be written or stamped on the face or back of the prescription, in such manner or place that no part of the prescription is obliterated, a further endorsement that, together with any earlier endorsement, clearly indicates—

• (a) the name of the proprietor of the business at which the prescription is dispensed; and

• (b) the address of the premises from which, and the date on which, the prescription or any indicated part or portion of the prescription is dispensed.

(1) No person may supply a controlled drug pursuant to a prescription purporting to be signed by a practitioner, midwife, or designated prescriber nurse, with whose signature the person is not acquainted, until the person has satisfied himself or herself that the signature is genuine.

(2) No person may—

• (a) alter any prescription appearing to be signed by a practitioner, midwife, or designated prescriber nurse, that purports to authorise the supply of any controlled drug; or

• (b) alter any prescription in such a manner that it purports to authorise the supply of any controlled drug.

(3) However, subclause (2) does not apply to an alteration made by a practitioner, midwife, or designated prescriber nurse in a prescription given by him or her if, in accordance with regulation 29(1)(c)(ii), there is written beside the alteration the signature of the practitioner, midwife, or designated prescriber nurse.

(4) A person authorised to deal in controlled drugs must keep a prescription purporting to authorise the supply of a controlled drug and notify immediately the officer in charge of the nearest Police station or the Medical Officer of Health if the person believes on reasonable grounds—

• (a) that any signature purporting to be that of a practitioner, midwife, or designated prescriber nurse, and appearing on the prescription, is not genuine; or

• (b) that the prescription has been altered by an unauthorised person.

(1) No person shall supply any controlled drug (other than a Class C controlled drug) pursuant to any written prescription except on condition that the prescription is retained by him.

(2) Every person so supplying any such controlled drug shall retain the prescription for a period of 4 years from the date on which the controlled drug is supplied, or, if the controlled drug is supplied pursuant to the same prescription on more than 1 occasion, from the last of the dates on which it is so supplied. All such prescriptions shall be retained on the premises in an orderly and consecutive manner, and shall at all times be available to any constable or any officer, who may inspect them and make copies thereof:

provided that, if the proprietor of the business from which the controlled drug was supplied vacates those premises, the prescriptions shall be stored at such place as is approved in writing by the Medical Officer of Health for the purpose.

(1) In cases of emergency, a pharmacist may, at the direction of a medical practitioner, midwife, or designated prescriber nurse personally known to him or her, supply to any person a controlled drug that is dispensed pursuant to a prescription communicated by that medical practitioner, midwife, or designated prescriber nurse orally or by telephone.

(2) Every medical practitioner, midwife, or designated prescriber nurse who communicates orally or by telephone to a pharmacist a prescription for the supply of a controlled drug shall forthwith reduce the prescription to writing so as to comply with regulation 29, and shall, within 2 business days, deliver it to the pharmacist whom he or she authorised to dispense it, with an indication written thereon to the effect that it is intended only in confirmation of a prescription already communicated orally or by telephone on a date stated in that indication; and thereupon the prescription, and the pharmacist in respect thereof, shall be subject to all the provisions of these regulations relating to prescriptions for the supply of controlled drugs and to the duties of persons in respect of such prescriptions.

(1) Every practitioner, midwife, or designated prescriber nurse shall answer in writing, to the best of his or her knowledge and belief, any questions addressed to him or her by the Medical Officer of Health with respect to his or her prescribing, administering, or supplying controlled drugs and in respect of the identification of the person for whom they were prescribed or to whom they were administered or supplied.

(2) Every person who supplies a controlled drug (not being a Class C controlled drug) on the prescription of a practitioner, midwife, or designated prescriber nurse, shall ensure that the Medical Officer of Health is advised, within 1 month after the date of the supply, of—

• (a) the name and address of the person for whom the controlled drug is supplied:

• (b) the name and address of the prescribing practitioner, midwife, or designated prescriber nurse:

• (c) the date of the prescription:

• (d) the name or description of the controlled drug supplied:

• (e) the amount of the controlled drug supplied on the occasion or on each of the occasions of supply:

• (f) each date on which the controlled drug is supplied.

(3) It shall be sufficient compliance with the requirements of subclause (2) if the person supplying the controlled drug provides the Medical Officer of Health, within 1 month after the date of the supply or, if the prescription authorises the supply of a controlled drug on more occasions than 1, the date of the first supply, with a copy of the prescription to which the supply relates.

(4) In this regulation prescription includes any written authority, order, or request for the supply of controlled drugs signed by a practitioner, midwife, or designated prescriber nurse, not being an authority, order, or request relating to a disposal by wholesale within the meaning of regulation 47; and prescribing has a corresponding meaning:

provided that subclause (2)(a) shall not apply to any such authority, order, or request not having reference to a particular patient.

(1) Where a controlled drug is required for the treatment of a patient for the time being maintained in a hospital or other institution, the medical practitioner, midwife, or designated prescriber nurse attending the patient may, instead of writing a prescription, enter on the patient's chart, or other clinical record appertaining to the patient, the particulars required by paragraphs (d), (j), and (m) of subclause (1) of regulation 29 in the manner required and subject to the limitations imposed by paragraphs (b), (c), (k), and (n) of that subclause, and such entry shall have the same effect as a prescription.

(2) In the case of a maternity hospital, the medical superintendent, if any, may generally, and any medical practitioner, midwife, or designated prescriber nurse attending a patient may in relation to any patient or patients attended by him or her, by an instruction in writing recorded in a book set aside for the purpose containing the same particulars and written in the like manner as are required in the case of an entry under subclause (1), authorise the administration, in the absence of complications requiring the presence of a medical practitioner or midwife, of a controlled drug (being a controlled drug that, if there is no medical superintendent of the hospital, the manager of the hospital is authorised to possess) to a maternity patient between the commencement and the termination of labour.

(3) Every instruction given under subclause (2) shall cease to have effect on the expiration of 6 months from the date on which it is given or renewed, as the case may require.

(1) This regulation shall apply to every person authorised by or under these regulations to deal in controlled drugs who is—

• (a) a pharmacist; or

• (b) a practitioner who dispenses his own medicines but does not deal in any controlled drug except by supply or administration to patients or animals under his care and by the compounding and dispensing of prescriptions containing controlled drugs; or

• (c) a person who is licensed to supply controlled drugs on prescription.

(2) Subject to these regulations, every person to whom this regulation applies shall keep—

• (a) a Controlled Drugs Register consisting of a bound volume of consecutively numbered pages in form 1 of Schedule 1, in which each page shall have entries relating only to 1 form of 1 controlled drug:

• (b) a Prescription Book described in subclause (3).

(3) The Prescription Book shall be a bound volume in which shall be entered a separate record of every prescription dispensed (including any repeated prescription) that contains any portion of a controlled drug showing—

• (a) the surname, initials of the first names, and address of the person for whose use the controlled drug is intended:

• (b) the surname, initials of the first names, and address of the person prescribing the controlled drug:

• (c) the proportion and total amount of the controlled drug so dispensed:

• (d) the date on which the controlled drug was delivered to the person for whose use it was dispensed or to some other authorised person on his behalf.

(4) In the case of every pharmacy, the Controlled Drugs Register and the Prescription Book kept under subclause (2) shall be retained continuously, subject to regulation 42, on the premises as a permanent record of the business carried on there.

Every person who is licensed to deal in or to possess controlled drugs shall keep, in any premises at which he is licensed to deal in or possess controlled drugs, a Controlled Drugs Register in form 1 of Schedule 1 in the manner required by regulation 37(2)(a).

(1) Notwithstanding anything in subclause (2) or subclause (3) of regulation 37 or in regulation 38, the Director-General may, either generally or specially, by notice in the Gazette or by notice in writing to the person to whom it applies, approve the use of such loose-leaf or other systems of recording as may be specified in the notice instead of the form of register or book prescribed by those provisions.

(2) The Director-General may at any time withdraw any such approval by notice given in the same manner as the notice of approval.

(1) Every person who is required under this Part to maintain a Controlled Drugs Register or a Prescription Book shall enter therein, legibly and indelibly, the particulars indicated in form 1 of Schedule 1 or in regulation 37(3), as the case may require, in relation to all controlled drugs dealt in, possessed, or dispensed by him; and the appropriate entries relating to any matter shall be made therein not later than the ordinary business day next following the day on which that matter arose.

(2) No person shall make or cause or permit to be made in any Controlled Drugs Register or Prescription Book any entry that is untrue in any particular, unless it is forthwith corrected as hereinafter provided, or obliterate, or cancel, or alter, or cause or permit to be obliterated, or cancelled, or altered, any entry made in any such register or book.

(3) Every person who is required under this Part to maintain a Controlled Drugs Register or a Prescription Book shall initial every entry made therein.

(4) Any mistake in any entry may be corrected by a marginal note or footnote giving the correct particulars and containing, as part of the note, the date on which the note is written.

(1) Notwithstanding anything in regulation 37, that regulation shall not bind any practitioner until he is notified by the Director-General in writing that that regulation shall apply in his case.

(2) The Director-General may at any time withdraw any notification under subclause (1) and thereupon the said regulation 37 shall cease to bind that practitioner.

(1) Subject to the provisions of this Part, every person who is required to maintain a Controlled Drugs Register or a Prescription Book shall keep that register or book in a neat and orderly manner in some place of security at the premises at which he is for the time being authorised to deal in or possess controlled drugs or at such other place as may be approved from time to time by the Director-General, and shall so keep every such register or book for a period of 4 years following the date of the last entry made therein:

provided that if he ceases to be so authorised he shall deliver every such register and book to, or deposit them at a place approved by, the Director-General for custody, or, after the expiration of the said period of 4 years, for destruction.

(2) Every person who is required to maintain a Controlled Drugs Register or Prescription Book shall at all times permit any constable or any officer to inspect that register or book and to make copies of any entries appearing therein.

(1) Every person who is required to maintain a Controlled Drugs Register under this Part shall—

• (a) as at the close of business on 30 June and 31 December in every year; and

• (b) as at the date on which he transfers the stock in his possession at the place where he carries on his profession, calling, or business to any other person,—

record the actual stock of all controlled drugs in his possession at that date, and prepare a quantity stock account covering the period since the previous stocktaking, and enter in the stock account a proper explanation of any variation between the calculated balance and the actual stock.

(2) The stock record, quantity stock account, and explanation of variations shall be entered on the page of the Controlled Drug Register appropriate to the controlled drug or form of controlled drug to which the information refers, and shall be completed within 14 days after the date as at which stock is taken.

(3) Where any person transfers his stock to another person the record of stock shall, as far as is practicable, be verified by the signatures of both such persons.

(4) An arrangement whereby a person who is authorised by or under these regulations to deal in a controlled drug carries on a practice or business on behalf of another person who is so authorised and who is temporarily absent therefrom, shall not constitute a transfer of stock within the meaning of this regulation, but in any such case the first-mentioned person shall, for the purposes of these regulations, be deemed to be the servant of the last-mentioned person in respect of that practice or business during the currency of that arrangement.

(1) Every manager or other person in charge of a hospital within the meaning of the Mental Health (Compulsory Assessment and Treatment) Act 1992 or the Hospitals Act 1957 or of an institution, in which a pharmacist is employed, shall ensure that records are kept at that hospital or institution in accordance with this regulation and regulations 45 and 46.

(2) Without limiting subclause (1), every chief pharmacist, or, if there is no chief pharmacist, such person on whom a duty is imposed by that subclause as the case may require, shall—

• (a) keep a separate Main Controlled Drugs Register in form 1 of Schedule 1 in respect of each store and dispensary of the hospital or other institution; and

• (b) ensure that there is kept, in the like form, a Ward Book in respect of each ward of the hospital or other institution.

(3) In this regulation, and in regulation 45, chief pharmacist means a pharmacist employed in a hospital or other institution as a chief pharmacist or as a pharmacist in charge of a dispensary or in a similar capacity.

Every person upon whom the duty of ensuring that a Ward Book is kept is imposed by regulation 44(2) shall ensure that entries are made therein in accordance with the following requirements:

• (a) entries recording disposal shall be made immediately following the administration of the controlled drug:

• (b) each Ward Book shall be kept posted by the charge nurse or person in charge of the ward; and the manager or other person in charge of the hospital or institution shall supervise the duties of that charge nurse or person in relation thereto:

• (c) the Ward Book shall at all times show entries of receipts corresponding to entries of disposals in the appropriate Main Controlled Drugs Register; the said entries shall be made, at the time of the issue and receipt of the controlled drug, first in the Main Controlled Drugs Register (if any) and immediately afterwards in the Ward Book; the entries in both cases shall be signed by both the person receiving and the person issuing the controlled drug; and those persons shall be persons expressly authorised in that behalf by the manager or chief pharmacist or other person in charge, as the case may require:

• (d) once in every week the Ward Book shall be checked, and compared with any balance of the controlled drug on hand, jointly by the person in charge of the ward and the principal nurse, or the manager or other person in charge, or the chief pharmacist, as the case may be, and the principal nurse, manager, other person, or chief pharmacist shall indicate by signing their names and entering the date, that the checking has been so done.

Regulations 38, 39, 40, 42, 43, and 47 shall apply with any necessary modifications to the persons and records to whom or which regulations 44 and 45 apply:

provided that regulation 47 shall apply only in respect of controlled drugs disposed of from the store or dispensary of the hospital or other institution to a person outside that hospital or other institution.

(1) In this regulation disposal by wholesale means—

• (a) export or supply by a person licensed under these regulations to deal in controlled drugs:

• (b) supply to any person (other than a practitioner) who is authorised to use in manufacture, supply, or export controlled drugs or is licensed under regulation 9(1)(a), or is authorised by any of regulations 17 to 19, to possess controlled drugs.

(2) Every person who is authorised to supply controlled drugs shall, immediately upon the disposal by wholesale of any controlled drug, and in addition to any entry required by these regulations to be made in a register, enter in 2 documents, each being in form 2 of Schedule 1 or in such other form as may be approved from time to time by the Director-General, the particulars relating to that disposal indicated in that form, and shall, within 7 days after the end of each month, forward one of those documents, verified by his signature or the signature of his employee, to the Medical Officer of Health:

provided that—

• (a) where such disposal by wholesale is not a regular part of the business of that person, the information, instead of being recorded and furnished in the said form, may be recorded and furnished to the Medical Officer of Health in writing:

• (b) where the controlled drug is supplied with the intention that it shall be replaced within 15 days after the original transaction, it shall not be necessary for information of the transaction to be recorded in the said form, or furnished to the Medical Officer of Health, unless, on the expiration of the said period of 15 days, the said controlled drug has not been replaced by or on behalf of the person to whom it was supplied.

(1) Nothing in this Part shall apply in relation to the acquisition, possession, supply, or administration of any Class C controlled drug by a person to whom any of paragraphs (a), (b), and (f) of subsection (2) of section 8 of the Act applies.

(2) Nothing in this Part shall apply in respect of any exempted drug, or any controlled drug for the time being named or described in any of Parts 2 to 5 of Schedule 3 of the Act.

Every person who is licensed under these regulations to deal in any controlled drug for the time being named or described in Schedule 1 or Schedule 2 or Part 2 of Schedule 3 of the Act, or in any partially exempted drug shall, before 31 January in each year, notify the Medical Officer of Health of the amount of each such controlled drug held in stock by that person at 31 December of the preceding year, and the total amount of any such controlled drug used, during that preceding year, in the manufacture of an exempted drug.

(1) Subject to subclauses (2) and (4), no person shall publish, or cause or permit to be published, any advertisement.

(2) Nothing in subclause (1) shall apply to any advertisement that is distributed only to practitioners or pharmacists, or that is contained in a publication that, in the ordinary course, circulates solely or mainly, or is distributed solely or mainly, to practitioners or pharmacists, and that—

• (a) states the true name and address of the place of business of the person by whom or at whose request the advertisement is published; and

• (b) contains a conspicuous statement sufficient to indicate that the advertisement relates to a controlled drug, or, if the advertisement is comprised in a price list or similar publication, contains the abbreviation “CD”.

(3) Every person who contravenes subclause (1) commits an offence against these regulations.

(4) Nothing in this regulation shall apply in respect of any exempted drug or any partially exempted drug.

Except in the case of an application for a licence to import a controlled drug or for a licence to export a controlled drug or of a communication relating to any such application, every application, return, and other communication, required or intended to be made or delivered to the Director-General by any person under these regulations, shall be made through the Medical Officer of Health in charge of the health district in which are situated the premises to which the communication relates, or, if there are no such premises, in which the controlled drug to which the communication relates for the time being is or, at the material time, was or will be.

Every person who commits an offence against these regulations shall be liable to a fine not exceeding $500, and, where the offence is a continuing one, to a further fine not exceeding $20 for every day or part of a day during which the offence has continued.

(1) Without limiting any provision of the Acts Interpretation Act 1924,—

• (a) in relation to any controlled drug that, immediately before the commencement of the Act, was a narcotic within the meaning of the Narcotics Act 1965, every subsisting licence granted under the Narcotics Regulations 1966 (SR 1966/82) shall be deemed to be a licence granted under these regulations, and shall continue, subject to the provisions of these regulations, to have the same force and effect as it would have continued to have if the Act had not been enacted:

• (b) every subsisting licence to cultivate a prohibited plant granted under the Narcotics Regulations 1966 (SR 1966/82) shall be deemed to be a licence granted under these regulations, and shall continue, subject to the provisions of these regulations, to have the same force and effect as it would have continued to have if the Act had not been enacted:

• (c) in relation to any controlled drug that, immediately before the commencement of the Act, was a poison within the meaning of the Poisons Act 1960, every subsisting licence granted under the Poison Licences Regulations 1961 (SR 1961/39) shall be deemed to be a licence granted under these regulations, and shall continue, subject to the provisions of these regulations, to have the same force and effect (except to the extent, if any, that it permits the hawking of poisons) as it would have continued to have if the Act had not been enacted.

(2) Notwithstanding anything in subclause (1), any licence to which that subclause applies may be surrendered by the licensee, by writing addressed to the Director-General, at any time, whereupon that licence shall cease to have effect.

(3) Notwithstanding any other provision of these regulations, every licence to which subclause (1) applies shall, unless it is sooner surrendered or revoked under these regulations, continue in force until the date on which it would have expired if the Act had not been enacted, or, if there is no such date, until 1 April 1978.

The regulations specified in Schedule 2 are hereby revoked.