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

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

In these regulations, unless the context otherwise requires,—

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.

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—

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

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.

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 or her business, the extent to which he or she 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.

Subject to section 14 of the Act and to subclauses (2) to (4) of regulation 7, the Director-General, if he or she 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 or she 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:

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

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.

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.

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.

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

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

A licence to cultivate a prohibited plant, or to possess controlled drugs, must not be issued under these regulations in respect of any of the following, as defined by the Misuse of Drugs (Medicinal Cannabis) Regulations 2019:

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:

Every dealer’s licence—

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.

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.

A dealer’s licence may not authorise—

Subclause (5) is subject to regulation 20.

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

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

If the Director-General approves an application under subclause (1) or subclause (2), he or she 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.

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

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.

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.

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.

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 or her 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:

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.

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—

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

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.

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.

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.

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.

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.

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.

A licence to import, or a licence to export, controlled drugs must not be granted in respect of any starting material, cannabis-based ingredient, or medicinal cannabis product (all as defined by the Misuse of Drugs (Medicinal Cannabis) Regulations 2019) unless—

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.

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

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.

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

A licence to possess controlled drugs—

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.

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.

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.

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 or her office, any person holding or acting in that office for the time being, but no other person, shall be the licensee.

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

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

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

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.

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

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.

For the purposes of section 8(1)(m) of the Act,—

The authorities given in subclause (1) are subject to—

This section applies to any person (a patient) for whom a controlled drug is—

The controlled drug may be administered to the patient by—

Subclauses (1) and (2) contain permissions that—

In this section, prescriber means any of the following authorised prescribers who prescribes a controlled drug in accordance with an authority given under regulation 12A:

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

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 or her care.

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 or her care.

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

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.

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.

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.

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

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 or her official duties.

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.

The master of any vessel for the time being within the territorial limits of New Zealand, and any person acting under his or her directions and on his or her 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 or her.

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

The person in charge of any aircraft for the time being within the territorial limits of New Zealand, and any person acting under his or her directions and on his or her 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 or her.

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

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—

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 or her.

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.

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.

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 or her control.

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 or her 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.

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.

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—

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—

Without prejudice to any provision of section 8 of the Act—

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:

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.

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 or her care, unless the medical practitioner is acting in the course of his or her employment in the service of the Crown.

No dentist may give a prescription for the supply of a controlled drug—

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

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

No midwife may (within the authority given by regulation 12A(1)(c)) give a prescription for the supply of a controlled drug otherwise than for the treatment of a patient under the midwife’s care.

No nurse practitioner may (within the authority given by regulation 12A(1)(d)) give a prescription for the supply of a controlled drug—

No veterinarian may give a prescription for the supply of a controlled drug otherwise than for administration to an animal under the veterinarian’s care.

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.

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—

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

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—

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

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

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

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.

No person shall supply a controlled drug pursuant to a prescription otherwise than by delivery, by himself or herself or by a person in his or her 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—

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:

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

Subclause (1) does not apply,—

Subclause (1) does not apply in respect of any controlled drug supplied pursuant to a prescription signed by a controlled drug prescriber.

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:

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:

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.

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.

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:

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

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).

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—

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—

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.

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 or she 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.

Nothing in this regulation shall apply with respect to—

This regulation does not apply in respect of the possession of a product by a person who holds a licence to operate a pharmacy under the Medicines Act 1981 if the product—

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

A prescription for the supply of a controlled drug that is intended for human use and that is a Class A controlled drug, a Class B controlled drug, or a specified Class C controlled drug must be—

Notwithstanding subclause (1), a prescription for the supply of methadone given by a medical practitioner, nurse practitioner, or designated prescriber nurse working in a place for the time being specified by the Minister under section 24(7)(b) of the Act may also be in any paper form approved by the Director-General.

Every prescription for the supply of a Class C controlled drug, not being a specified Class C controlled drug, must be on paper and in handwriting, in print, or both.

Every prescription for a controlled drug must—

In this regulation,—

This regulation does not apply—

This regulation applies if there is imposed on a licence a condition prohibiting the acquisition of controlled drugs otherwise than pursuant to the prescription of—

The following regulations 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 the condition imposed on the licence:

A person may not supply a controlled drug on a prescription—

Subclause (1) is subject to regulation 31A.

A person may not supply a controlled drug on an oral prescription more than once before receiving the written confirmation of that prescription under regulation 34(4).

On the first occasion of dispensing a prescription or, in the case of an oral prescription, on receipt of the written confirmation of that prescription, there must be written or stamped on the face of the prescription, above the signature of the controlled drug prescriber, in such manner and place that no part of the prescription is obliterated,—

On every subsequent occasion of dispensing a prescription, there must be written or stamped on the face or back of the prescription, in such manner and place that no part of the prescription is obliterated,—

In this regulation, oral prescription means a prescription communicated under regulation 34(1).

A medical practitioner or nurse practitioner who signs a prescription for a Class A controlled drug or a Class B controlled drug may direct on the prescription that the drug be supplied on 2 occasions at a specified interval, with—

In the case of a controlled drug supplied pursuant to a direction under subclause (1), the total quantity supplied, having regard to the dose and frequency of dose or the directions of the medical practitioner or nurse practitioner, must not be greater than a quantity sufficient for use for a period of 1 month.

A medical practitioner or nurse practitioner who signs a prescription for a Class C controlled drug may direct on the prescription that the drug be supplied on not more than 3 occasions, which, unless specified otherwise, are to be at monthly intervals.

In the case of a controlled drug supplied pursuant to a direction under subclause (3), the total quantity supplied, having regard to the dose and frequency of dose or the directions of the medical practitioner or nurse practitioner, must not be greater than a quantity sufficient for use for a period of 3 months.

A midwife who signs a prescription for a controlled drug specified in Schedule 1C may direct on the prescription that the drug be supplied on 2 occasions at a specified interval, with—

In the case of a controlled drug supplied pursuant to a direction under subclause (5), the total quantity supplied, having regard to the dose and frequency of dose or the directions of the midwife, must not be greater than a quantity sufficient for use for a period of 1 month.

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 controlled drug prescriber (not being a dentist or veterinarian) who signs a prescription directs on the prescription that the controlled drug is to be dispensed daily or at such other regular intervals as the controlled drug prescriber considers necessary for a specified period not exceeding 1 month, the controlled drug may be supplied on not more than the number of occasions indicated, and not more frequently than the intervals directed.

If a Medical Officer of Health has issued to a person a notice under section 25 of the Act that authorises him or her to supply a controlled drug for a restricted person 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 specifies.

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

No person may—

However, subclause (2) does not apply to a controlled drug prescriber who, after signing a prescription, alters that prescription in his or her own handwriting and then signs the prescription again beside the alteration.

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—

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 or her.

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:

In the case of an emergency, a prescriber may communicate orally or by telephone a prescription for a controlled drug to a pharmacist who personally knows the prescriber (an oral prescription).

A pharmacist may supply a controlled drug to any person on an oral prescription.

Immediately after communicating an oral prescription, a prescriber must—

Not later than 2 business days after the date of the oral prescription, the prescriber must deliver the prescription to the pharmacist to whom the oral prescription was communicated.

After delivery of the prescription in accordance with subclause (4), the prescription and the pharmacist are subject to all provisions in these regulations relating to prescriptions for the supply of controlled drugs and to the duties of persons in respect of such prescriptions.

In this regulation, prescriber means any of the following persons:

Every controlled drug prescriber must 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.

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

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.

In this regulation, prescription includes any written authority, order, or request for the supply of controlled drugs signed by a controlled drug prescriber, 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:

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, nurse practitioner, midwife, designated prescriber nurse, or designated prescriber pharmacist 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 regulation 29(4)(c), (j), and (m), in the manner required and subject to the limitations imposed by paragraphs (a), (b), (k), and (n) of that subclause, and such entry shall have the same effect as a prescription.

In the case of a maternity hospital, the medical superintendent, if any, may generally, and any medical practitioner, nurse practitioner, midwife, designated prescriber nurse, or designated prescriber pharmacist 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.

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.

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

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

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—

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 or she 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).

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.

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

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 or her; 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.

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.

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

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.

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

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.

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 or she 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:

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.

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

record the actual stock of all controlled drugs in his or her 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.

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.

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

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.

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.

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—

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:

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:

In this regulation disposal by wholesale means—

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 or her signature or the signature of his or her employee, to the Medical Officer of Health:

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.

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.

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

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—

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

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.

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

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.

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.