FALKLAND ISLANDS
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Misuse of Drugs Regulations Order 1997
(S.R. & O. No. 5 OF 1997)
1 Citation and commencement
2 Interpretation
2A Application
3 Specification of controlled drugs for purposes of Regulations
4 Exceptions for drugs in Schedules 4 and 5 and poppy-straw
5 Licences to produce etc. controlled drugs
6 General authority to supply and possess
7 Administration of drugs in Schedules 2, 3, 4 and 5
8 Production and supply of drugs in Schedules 2 and 5
9 Production and supply of drugs in Schedules 3 and 4
10 Possession of drugs in Schedules 2, 3 and 4
11 Exemption for midwives
12 Documents to be obtained by supplier of controlled drugs
13 Form of prescriptions
14 Provisions as to supply on prescription
15 Marking of bottles and other containers
16 Recording-keeping requirements in respect of drugs in Schedules 1 and 2
17 Requirements as to registers
18 Record-keeping requirements in respect of drugs in Schedule 2 in particular cases
19 Record-keeping requirements in respect of drugs in Schedules 3 and 4
20 Preservation of registers, books and other documents
21 Preservation of records relating to drugs in Schedules 3 and 5
22 Furnishing of information with respect to controlled drugs
23 Destruction of controlled drugs
24 Misuse of Drugs Regulations 1985
Schedule 1 - Controlled Drugs subject to the requirements of regulations 12, 13, 14, 15, 16, 17, 20, 22 and 23
Schedule 2 - Controlled Drugs subject to the requirements of regulations 12, 13, 14, 15, 16, 17, 20, 22 and 23
Schedule 3 - Controlled Drugs subject to the requirements of regulations 12, 13, 14, 15, 16, 17, 20, 22 and 23
Schedule 4 - Controlled Drugs excepted from the prohibition on importation, exportation and, when in the form of a medicinal product, possession and subject to the requirements of regulations 19, 20, 22 and 23
Schedule 5 - Controlled Drugs excepted from the prohibition on importation, exportation and possession and subject to the requirements of regulations 22 and 23
Schedule 6 - Form of Register Part I: Entries to be made in case of obtaining
Part II: Entries to be made in case of supply
FALKLAND ISLANDS
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Misuse of Drugs Regulations Order 1997
[DATE OF COMMENCEMENT: 1ST APRIL 1997]
IN EXERCISE of my powers under section 7, 11 of the Misuse of Drugs Ordinance 1987, I make the following Order —
[Order49.3.4s1]1 Citation and commencement
This Order may be cited as the Misuse of Drugs Regulations Order 1997 and shall come into operation on 1st April 1997.
[Order49.3.4s2]2 Interpretation
(1) In these Regulations, unless the context otherwise requires, the expression-
"the Ordinance" means the Misuse of Drugs Ordinance 1987;
"document" has the same meaning as in Part I of the Civil Evidence Act 1968;
"health prescription" means a prescription issued by a medical practitioner;
"installation manager" and "offshore installation" have the same meaning as in the Offshore Minerals Ordinance 1994;
"master" and "seamen" have the same meanings as in the Merchant Shipping Act 1894;
"medicinal product" has the same meaning as in the Medicines Act 1968;
"the Merchant Shipping Acts" means the Merchant Shipping Acts 1894 to 1984;
"customs officer" has the same meaning as it has in the Customs Ordinance 2003;
"prescription" means a prescription issued by a doctor for the medical treatment of a single individual, by a dentist for the dental treatment of a single individual or by a veterinary surgeon or veterinary practitioner for the purposes of animal treatment;
"register" means a bound book and does not include any form of loose leaf register or card index;
"retail dealer" means a person lawfully conducting a retail pharmacy business;
"sister or acting sister" includes any male nurse occupying a similar position;
"wholesale dealer" means a person who carries on the business of selling drugs to persons who buy to sell again.
(2) In these Regulations any reference to a regulation or Schedule shall be construed as a reference to a regulation contained in these Regulations or, as the case may be, to a Schedule thereto; and any reference in a regulation or Schedule to a paragraph shall be construed as a reference to a paragraph of that regulation or Schedule.
(3) Nothing in these Regulations shall be construed as derogating from any power or immunity of the Crown, its servants or agents.
2A Application
This Regulations Order does not apply to a controlled drug that is an excepted product under the Misuse of Drugs (Exception of Controlled Drugs - Tetrahydrocannabinol) Order 2022.
[S.R.&O. 15/2022/ w.e.f. 05/08/2022]
[Order49.3.4s3]3 Specification of controlled drugs for purposes of Regulations
Schedules 1 to 5 shall have effect for the purpose of specifying the controlled drugs to which certain provisions of these Regulations apply.
[Order49.3.4s4]4 Exceptions for drugs in Schedules 4 and 5 and poppy-straw
(1) Section 3(1) of the Ordinance (which prohibits the importation and exportation of controlled drugs) shall not have effect in relation to the drugs specified in Schedules 4 and 5.
(2) Section 5(1) of the Ordinance (which prohibits the possession of controlled drugs) shall not have effect in relation to-
(a) any drug specified in Schedule 4 which is contained in a medicinal product;
(b) the drugs specified in Schedule 5.
(3) Sections 4 (which prohibits the production and supply of controlled drugs) and 5(1) of the Act (Ordinance) shall not have effect in relation to poppy-straw.
[Order49.3.4s5]5 Licences to produce etc. controlled drugs
Where any person is authorised by a licence of the Governor issued under this regulation and for the time being in force to produce, supply, offer to supply or have in his possession any controlled drug, it shall not by virtue of section 4 or 5(1) or (2) of the Ordinance be unlawful for that person to produce, supply, offer to supply or have in his possession that drug in accordance with the terms of the licence and in compliance with any conditions attached to the licence.
[Order49.3.4s6]6 General authority to supply and possess
(1) Notwithstanding the provisions of section 4(c) of the Ordinance, any person who is lawfully in possession of a controlled drug may supply that drug to the person from whom he obtained it.
(2) Notwithstanding the provisions of section 4(c) of the Ordinance, any person who has in his possession a drug specified in Schedule 2, 3, 4 or 5 which has been supplied by or on the prescription of a practitioner for the treatment of that person, or of a person whom he represents, may supply that drug to any doctor, dentist or pharmacist for the purpose of destruction.
(3) Notwithstanding the provisions of section 4(c) of the Ordinance, any person who is lawfully in possession of a drug specified in Schedule 2, 3, 4 or 5 which has been supplied by or on the prescription of a veterinary practitioner or veterinary surgeon for the treatment of animals may supply that drug to any veterinary practitioner, veterinary surgeon or pharmacist for the purpose of destruction.
(4) Notwithstanding the provisions of section 4(c) of the Ordinance, any of the persons specified in paragraph (6) may supply any controlled drug to any person who may lawfully have that drug in his possession.
(5) Notwithstanding the provisions of section 5(1) of the Ordinance, any of the persons so specified may have any controlled drug in his possession.
(6) The persons referred to in paragraphs (4) and (5) are-
(a) a police officer when acting in the course of his duty as such;
(b) a person engaged in the business of a carrier when acting in the course of that business;
(c) a person engaged in the business of the Falkland Islands Post Office when acting in the course of that business;
(d) an officer of customs and excise when acting in the course of his duty as such;
(e) a person engaged in the work of any laboratory to which the drug has been sent for forensic examination when acting in the course of his duty as a person so engaged;
(f) a person engaged in conveying the drug to a person who may lawfully have that drug in his possession.
[Order49.3.4s7]7 Administration of drugs in Schedules 2, 3, 4 and 5
(1) Any person may administer to another any drug specified in Schedule 5.
(2) A doctor or dentist may administer to a patient any drug specified in Schedule 2, 3 or 4.
(3) Any person other than a doctor or dentist may administer to a patient, in accordance with the directions of a doctor or dentist, any drug specified in Schedule 2, 3 or 4.
[Order49.3.4s8]8 Production and supply of drugs in Schedules 2 and 5
(1) Notwithstanding the provisions of section 4(a) of the Ordinance-
(a) a practitioner or pharmacist, acting in his capacity as such, may manufacture or compound any drug specified in Schedule 2 or 5.
(b) a person lawfully conducting a retail pharmacy business and acting in his capacity as such may, at the registered pharmacy at which he carries on that business, manufacture or compound any drug specified in Schedule 2 or 5.
(2) Notwithstanding the provisions of section 4(c) of the Ordinance, any of the following persons, that is to say-
(a) a practitioner;
(b) a pharmacist;
(c) a person lawfully conducting a retail pharmacy business;
(d) the person in charge or acting person in charge of a hospital or nursing home which is wholly or mainly maintained by a public authority out of public funds or by a charity or by voluntary subscriptions;
(e) in the case of such a drug supplied to her by a person responsible for the dispensing and supply of medicines at the hospital or nursing home, the sister or acting sister for the time being in charge of a ward, theatre or other department in such a hospital or nursing home as aforesaid,
may, when acting in his capacity as such, supply or offer to supply any drug specified in Schedule 2 or 5 to any person who may lawfully have that drug in his possession:
Provided that nothing in that paragraph authorizes-
(i) the person in charge or acting person in charge of a hospital or nursing home, having a pharmacist responsible for the dispensing and supply of medicines, to supply or offer to supply any drug;
(ii) a sister or acting sister for the time being in charge of a ward, theatre or other department to supply any drug otherwise than for administration to a patient in that ward, theatre or department in accordance with that directions of a doctor or dentist.
(3) Notwithstanding the provisions of section 4(c) of the Ordinance, a person who is authorised by a written authority issued by the Governor under and for the purposes of this paragraph and for the time being in force may, at the premises specified in that authority and in compliance with any conditions so specified, supply or offer to supply any drug specified in Schedule 5 to any person who may lawfully have that drug in his possession.
(4) Notwithstanding the provisions of section 4(c) of the Ordinance-
(a) the owner of a ship, or the master of a ship which does not carry a doctor among the seamen employed in it;
(b) the installation manager of an offshore installation,
may supply or offer to supply any drug specified in Schedule 2 or 5-
(i) for the purpose of compliance with any of the provisions specified in paragraph (5), to any person on that ship or installation;
(ii) to any person who may lawfully supply that drug to him;
(iii) to any constable for the purpose of the destruction of that drug.
(5) The provision referred to in paragraph (4) are any provision of, or of any instrument which is in force under-
(a) the Merchant Shipping Acts;
(b) the Offshore Minerals Ordinance 1994; or
(c) the Health and Safety at Work etc. Act 1974.
[Order49.3.4s9]9 Production and supply of drugs in Schedules 3 and 4
(1) Notwithstanding the provisions of section 4 of the Ordinance-
(a) a practitioner or pharmacist, acting in his capacity as such, may manufacture or compound any drug specified in Schedule 3 or 4;
(b) a person lawfully conducting a retail pharmacy business and acting in his capacity as such may, at the registered pharmacy at which he carries on that business, manufacture or compound any drug specified in Schedule 3 or 4;
(c) a person who is authorised by a written authority issued by the Governor under and for the purposes of this sub-paragraph and for the time being in force may, at the premises specified in that authority and in compliance with any conditions so specified, produce any drug specified in Schedule 3 or 4.
(2) Notwithstanding the provisions of section 4(c) of the Ordinance, any of the following persons, that is to say-
(a) a practitioner,
(b) a pharmacist,
(c) a person lawfully conducting a retail pharmacy business.
(3) Notwithstanding the provisions of section 4(c) of the Ordinance-
(a) a person who is authorised as a member of a group, under and in accordance with the terms of his group authority and in compliance with any conditions attached thereto;
(b) the person in charge or acting person in charge of a hospital or nursing home;
(c) in the case of such a drug supplied to her by a person responsible for the dispensing and supply of medicines at that hospital or nursing home, the sister or acting sister for the time being in charge of a ward, theatre or other department in a hospital or nursing home,
may, when acting in his capacity as such, supply or offer to supply any drug specified in Schedule 3, or any drug specified in Schedule 4 which is contained in a medicinal product, to any person who may lawfully have that drug in his possession:
Provided that nothing in this paragraph authorizes-
(i) the person in charge or acting person in charge of a hospital or nursing home, having a pharmacist responsible for the dispensing and supply of medicines, to supply or offer to supply any drug;
(ii) a sister or acting sister for the time being in charge of a ward, theatre or other department to supply any drug otherwise than for administration to a patient in that ward, theatre or department in accordance with the directions of a doctor of dentist.
(4) Notwithstanding the provisions of section 4(c) of the Ordinance-
(a) a person who is authorised by a written authority issued by the Governor under and for the purposes of this sub-paragraph and for the time being in force may, at the premises specified in that authority and in compliance with any conditions so specified, supply or offer to supply any drug specified in Schedule 3 or 4 to any person who may lawfully have that drug in his possession;
(b) a person who is authorised under paragraph (1)(c) may supply or offer to supply any drug which he may, by virtue of being so authorised, lawfully produce to any person who may lawfully have that drug in his possession.
(5) Notwithstanding the provisions of section 4(c) of the Ordinance
(a) the owner of a ship, or the master of a ship which does not carry a doctor among the seamen employed in it;
(b) the installation manager of an offshore installation,
may supply or offer to supply any drug specified in Schedule 3, or any drug specified in Schedule 4 which is contained in a medicinal product-
(i) for the purpose of compliance with any of the provisions specified in regulation 8(5), to any person on that ship or installation; or
(ii) to any person who may lawfully supply that drug to him.
(6) Notwithstanding the provisions of section 4(c) of the Ordinance, a person in charge of a laboratory may, when acting in his capacity as such, supply or offer to supply any drug specified in Schedule 3 which is required for use as a buffering agent in chemical analysis to any person who may lawfully have that drug in his possession.
[Order49.3.4s10]10 Possession of drugs in Schedules 2, 3 and 4
(1) Notwithstanding the provisions of section 5(1) of the Ordinance-
(a) a person specified in one of sub-paragraphs (a) to (e) of regulation 8(2) may have in his possession any drug specified in Schedule 2;
(b) a person specified in one of sub-paragraphs (a) to (c) of regulation 9(2) may have in his possession any drug specified in Schedule 3 or 4;
(c) a person specified in regulation 9(3)(b) or (c) or regulation 9(6) may have in his possession any drug specified in Schedule 3,
for the purpose of acting in his capacity as such a person:
Provided that nothing in this paragraph authorizes-
(i) a person specified in sub-paragraph (e) of regulation (8)2;
(ii) a person specified in sub-paragraph (c) of regulation 9(3); or
(iii) a person specified in regulation 9(6),
to have in his possession any drug other than such a drug as is mentioned in the paragraph or sub-paragraph in question specifying him.
(2) Notwithstanding the provisions of section 5(1) of the Ordinance, a person may have in his possession any drug specified in Schedule 2 or 3 for administration for medical, dental or veterinary purposes in accordance with the directions of a practitioner:
Provided that this paragraph shall not have effect in the case of a person to whom the drug has been supplied by or on the prescription of a doctor if-
(a) that person was then being supplied with any controlled drug by or on the prescription of another doctor and failed to disclose that fact to the first mentioned doctor before the supply by him or on his prescription; or
(b) that or any other person on his behalf made a declaration or statement, which was false in any particular, for the purpose of obtaining the supply or prescription.
(3) Notwithstanding the provisions of section 5(1) of the Ordinance, a person who is authorised as a member of a group may, under and in accordance with the terms of his group authority and in compliance with any conditions attached thereto, have any drug specified in Schedule 2 or 3 in his possession.
(4) Notwithstanding the provisions of section 5(1) of the Ordinance-
(a) a person who is authorised by a written authority issued by the Governor under and for the purposes of this sub-paragraph and for the time being in force may, at the premises specified in that authority and in compliance with any conditions so specified, have in his possession any drug specified in Schedule 3 or 4;
(b) a person who is authorised under regulation 9(1)(c) may have in his possession any drug which he may, by virtue of being so authorised, lawfully produce;
(c) a person who is authorised under regulation 9(4)(a) may have in his possession any drug which he may, by virtue of being so authorised, lawfully supply or offer to supply.
(5) Notwithstanding the provisions of section 5(1) of the Ordinance-
(a) any person may have in his possession any drug specified in Schedule 2 or 3 for the purpose of compliance with any of the provisions specified in regulation 8(5);
(b) the master of a foreign ship which is in a port in the Falkland Islands may have in his possession any drug specified in Schedule 2 or 3 so far as necessary for the equipment of the ship.
(6) The foregoing provisions of this regulation are without prejudice to the provisions of regulation 4(2)(a).
[Order49.3.4s11]11 Exemption for midwives
(1) Notwithstanding the provisions of sections 4(c) and 5(1) of the Ordinance, a registered midwife may, subject to the provisions of this regulation-
(a) so far as necessary to her professional practice, have in her possession;
(b) so far as necessary as aforesaid, administer; and
(c) surrender to the appropriate medical officer such stocks in her possession as are no longer required by her of,
any controlled drug which she may lawfully administer.
(2) Nothing in paragraph (1) authorises a midwife to have in her possession any drug which has been obtained otherwise than on a midwife's supply order signed by the Chief Medical Officer.
(3) In this regulation, the expression "midwife's supply order" means an order in writing specifying the name and occupation of the midwife obtaining the drug, the purpose for which it is required and the total quantity to be obtained.
[Order49.3.4s12]12 Documents to be obtained by supplier of controlled drugs
(1) Where a person (hereafter in this paragraph referred to as "the supplier"), not being a practitioner, supplies a controlled drug otherwise than on a prescription, the supplier shall not deliver the drug to a person who-
(a) purports to be sent by or on behalf of the person to whom it is supplied (hereafter in this paragraph referred to as "the recipient"); and
(b) is not authorised by any provision of these Regulations other than the provisions of regulations 6(5) and (6)(f) to have that drug in his possession,
unless that person produces to the supplier a statement in writing signed by the recipient to the effect that he is empowered by the recipient to receive that drug on behalf of the recipient, and the supplier is reasonably satisfied that the document is a genuine document.
(2) Where a person (hereafter in this paragraph referred to as "the supplier") supplies a controlled drug, otherwise than on a prescription or by way of administration, to any of the persons specified in paragraph (4), the supplier shall not deliver the drug-
(a) until he has obtained a requisition in writing which-
(i) is signed by the person to whom the drug is supplied (hereafter in this paragraph referred to as "the recipient");
(ii) states the name, address and profession or occupation of the recipient;
(iii) specifies the purpose for which the drug supplied is required and the total quantity to be supplied; and
(iv) where appropriate, satisfies the requirements of paragraph (5);
(b) unless he is reasonably satisfied that the signature is that of the person purporting to have signed the requisition and that that person is engaged in the profession or occupation specified in the requisition:
Provided that where the recipient is a practitioner and he represents that he urgently requires a controlled drug for the purpose of his profession, the supplier may, if he is reasonably satisfied that the recipient so requires the drug and is, by reason of some emergency, unable before delivery to furnish to the supplier a requisition in writing duly signed, deliver the drug to the recipient on an undertaking by the recipient to furnish such a requisition within the twenty-four hours next following.
(3) A person who has given such an undertaking as aforesaid shall deliver to the person by whom the controlled drug was supplied a signed requisition in accordance with the undertaking.
(4) The persons referred to in paragraph (2) are-
(a) a practitioner;
(b) the person in charge or acting person in charge of a hospital or nursing home;
(c) a person who is in charge of a laboratory;
(d) the owner of a ship, or the master of a ship which does not carry a doctor among the seamen employed in it;
(e) the master of a foreign ship in a port in the Falkland Islands;
(f) the installation manger of an offshore installation.
(5) A requisition furnished for the purposes of paragraph (2) shall-
(a) where furnished by the person in charge or acting person in charge of a hospital or nursing home, be signed by a doctor or dentist employed or engaged in that hospital or nursing home;
(b) where furnished by the master of a foreign ship, contain a statement, signed by the Chief Medical Officer that the quantity of the drug to be supplied is the quantity necessary for the equipment of the ship.
(6) Where the person responsible for the dispensing and supply of medicines at any hospital or nursing home supplies a controlled drug to the sister or acting sister for the time being in charge of any ward, theatre or other department in that hospital or nursing home (hereafter in this paragraph referred to as "the recipient") he shall-
(a) obtain a requisition in writing, signed by the recipient, which specifies the total quantity of the drug to be supplied; and
(b) mark the requisition in such manner as to show that it has been complied with,
and any requisition obtained for the purposes of this paragraph shall be retained in the dispensary at which the drug was supplied and a copy of the requisition or a note of it shall be retained or kept by the recipient.
(7) Nothing in this regulation shall have effect in relation to the drugs specified in Schedule 4 and 5 or poppy-straw.
[Order49.3.4s13]13 Form of prescriptions
(1) Subject to the provisions of this regulation, a person shall not issue a prescription containing a controlled drug other than a drug specified in Schedule 4 or 5 or temazepam unless the prescription complies with the following requirements, that is to say, it shall-
(a) be in ink or otherwise so as to be indelible and be signed by the person issuing it with his usual signature and dated by him;
(b) insofar as it specifies the information required by sub-paragraph (e) and (f) below to be specified, be written by the person issuing it in his own handwriting;
(c) except in the case of a health prescription, specify the address of the person issuing it;
(d) have written thereon, if issued by a dentist, the words "for dental treatment only" and, if issued by a veterinary surgeon or a veterinary practitioner, a declaration that the controlled drug is prescribed for an animal or herd under his care;
(e) specify the name and address of the person for whose treatment it is issued or, if it is issued by a veterinary surgeon or veterinary practitioner, of the person to whom the controlled drug prescribed is to be delivered;
(f) specify the dose to be taken and-
(i) in the case of a prescription containing a controlled drug which is a preparation, the form and, where appropriate, the strength of the preparation, and either the total quantity (in both words and figures) of the preparation or the number (in both words and figures) of dosage units, as appropriate, to be supplied;
(ii) in any other case, the total quantity (in both words and figures) of the controlled drug to be supplied;
(g) in the case of a prescription for a total quantity intended to be supplied by instalments, contain a direction specifying the amount of the instalments of the total amount which may be supplied and the intervals to be observed when supplying.
(2) Paragraph (1)(b) shall not have effect in relation to-
(a) a prescription issued by a person approved (whether personally or as a member of a class) for the purposes of this paragraph by the Governor; or
(b) a prescription containing no controlled drug other than-
(i) phenobarbitone;
(ii) phenobarbitone sodium; or
(iii) a preparation containing a drug specified in paragraph (i) or (ii) above.
(3) In the case of a prescription issued for the treatment of a patient in a hospital or nursing home, it shall be a sufficient compliance with paragraph (1)(e) if the prescription is written on the patient's bed card or case sheet.
[Order49.3.4s14]14 Provisions as to supply on prescription
(1) A person shall not supply a controlled drug other than a drug specified in Schedule 4 or 5 on a prescription-
(a) unless the prescription complies with the provisions of regulation 15;
(b) unless the address specified in the prescription as the address of the person issuing it is an address within the Falkland Islands;
(c) unless he either is acquainted with the signature of the person by whom it purports to be issued and has no reason to suppose that it is not genuine, or has taken reasonably sufficient steps to satisfy himself that it is genuine;
(d) before the date specified in the prescription;
(e) subject to paragraph (3), later than thirteen weeks after the date specified in the prescription.
(2) Subject to paragraph (3), a person supplying on prescription a controlled drug other than a drug specified in Schedule 4 or 5 shall, at the time of the supply, mark on the prescription the date on which the drug is supplied and, unless it is a health prescription, shall retain the prescription on the premises from which the drug was supplied.
(3) In the case of a prescription containing a controlled drug other than a drug specified in Schedule 4 or 5, which contains a direction that specified instalments of the total amount may be supplied at stated intervals, the person supplying the drug shall not do so otherwise than in accordance with that direction and-
(a) paragraph (1) shall have effect as if for the requirement contained in sub-paragraph (e) thereof there were substituted a requirement that the occasion on which the first instalment is supplied shall not be later than thirteen weeks after the date specified in the prescription;
(b) paragraph (2) shall have effect as if for the words "at the time of the supply" there were substituted the words "on each occasion on which the instalment is supplied".
[Order49.3.4s15]15 Marking of bottles and other containers
(1) Subject to paragraph (2), no person shall supply a controlled drug otherwise than in a bottle, package or other container which is plainly marked-
(a) in the case of a controlled drug other than a preparation, with the amount of the drug contained therein;
(b) in the case of a controlled drug which is a preparation-
(i) made up into tablets, capsules or other dosage units, with the amount of each component (being a controlled drug) of the preparation in each dosage unit and the number of dosage units in the bottle, package or other container;
(ii) not made up as aforesaid, with the total amount of the preparation in the bottle, package or other container and the percentage of each of its components which is a controlled drug.
(2) Nothing in this regulation shall have effect in relation to-
(a) the drugs specified in Schedules 4 and 5 or poppy-straw; or
(b) the supply of a controlled drug by or on the prescription of a practitioner.
(3) In this regulation, the expressions "clinical trial" and "medicinal test on animals" have the same meanings as in the Medicines Act 1968.
[Order49.3.4s16]16 Recording-keeping requirements in respect of drugs in Schedules 1 and 2
(1) Subject to paragraph (3) and regulation 18, every person authorised by or under regulation 5 or 8 to supply any drug specified in Schedule 1 or 2 shall comply with the following requirements, that is to say-
(a) he shall, in accordance with the provisions of this regulation and of regulation 20, keep a register and shall enter therein in chronological sequence in the form specified in Part I or Part II of Schedule 6, as the case may require, particulars of every quantity of a drug specified in Schedule 1 or 2 obtained by him and of every quantity of such a drug supplied (whether by way of administration or otherwise) by him whether to persons within or outside the Falkland Islands;
(b) he shall use a separate register or separate part of the register for entries made in respect of each class of drugs, and each of the drugs specified in paragraphs 1 and 3 of Schedule 1 and paragraphs 1, 3 and 6 of Schedule 2 together with its salts and any preparation or other product containing it or any of its salts shall be treated as a separate class, so however that any stereoisomeric form of a drug or its salts shall be classed with that drug.
(2) Nothing in paragraph (1) shall be taken as preventing the use of a separate section within a register or separate part of a register in respect of different drugs or strengths of drugs comprised within the class of drugs to which that register or separate part relates.
(3) The foregoing provisions of this regulation shall not have effect in relation to-
(a) in the case of a drug supplied to him for the purpose of destruction in pursuance of regulation 6(2) or (3), a practitioner or pharmacist;
(b) a person licensed under regulation 5 to supply any drug, where the licence so directs; or
(c) the sister or acting sister for the time being in charge of a ward, theatre or other department in a hospital or nursing home.
[Order49.3.4s17]17 Requirements as to registers
Any person required to keep a register under regulation 16 shall comply with the following requirements, that is to say-
(a) the class of drugs to which the entries on any page of any such register relate shall be specified at the head of that page;
(b) every entry required to be made under regulation 16 in such a register shall be made on the day on which the drug is obtained or, as the case may be, on which the transaction in respect of the supply of the drug by the person required to make the entry takes place or, if that is not reasonably practicable, on the day next following that day;
(c) no cancellation, obliteration or alteration of any such entry shall be made, and a correction of such an entry shall be made only by way of marginal note or footnote which shall specify the date on which the correction is made;
(d) every such entry and every correction of such an entry shall be made in ink or otherwise so as to be indelible;
(e) such a register shall not be used for any purpose other than the purposes of these Regulations;
(f) a separate register shall be kept in respect of each premises at which the person required to keep the register carries on his business or occupation, but subject to that not more than one register shall be kept at one time in respect of each class of drugs in respect of which he is required to keep a separate register, so, however, that a separate register may, with the approval of the Governor, be kept in respect of each department of the business carried on by him;
(g) every such register in which entries are currently being made shall be kept at the premises to which it relates.
[Order49.3.4s18]18 Record-keeping requirements in respect of drugs in Schedule 2 in particular cases
(1) Where a drug specified in Schedule 2 is supplied in accordance with regulation 8(5)(a)(i) to any person on a ship, an entry in the official log book required to be kept under the Merchant Shipping Acts or, in the case of a ship which is not required to carry such an official logbook, a report signed by the master of the ship, shall, notwithstanding anything in these Regulations, be a sufficient record of the supply if the entry or report specifies the drug supplied and, in the case of a report, it is delivered as soon as may be to a superintendent at a Marine Office established and maintained under the Merchant Shipping Acts.
(2) Where a drug specified in Schedule 2 is supplied in accordance with regulation 8(5)(b)(i) to a person on an offshore installation, an entry in the installation logbook required to be maintained under the Offshore Installations (Logbooks and Registration of Death) Regulations 1972 (SI 1972/1542) in their application to the Falkland Islands which specifies the drug supplied shall, notwithstanding anything in these Regulations, be a sufficient record of the supply.
[Revision w.e.f. 31/07/2017]
(3) A midwife authorised by regulation 11(1) to have any drug specified in Schedule 2 in her possession shall-
(a) on each occasion on which she obtains a supply of such a drug, enter in a book kept by her and used solely for the purposes of this paragraph the date, the name and address of the person from whom the drug was obtained, the amount obtained and the form in which it was obtained; and
(b) on administering such a drug to a patient, enter in the said book as soon as practicable the name and address of the patient, the amount administered and the form in which it was administered.
[Order49.3.4s19]19 Record-keeping requirements in respect of drugs in Schedules 3 and 4
(1) Every person who is authorised under regulation 5 or 9(1)(c) to produce any drug specified in Schedule 3 or 4 shall make a record of each quantity of such a drug produced by him.
(2) Every person who is authorised by or under any provision of the Ordinance to import or export any drug specified in Schedule 3 shall make a record of each quantity of such a drug imported or exported by him.
(3) Every person who is authorised under regulation 9(4) to supply any drug specified in Schedule 4 shall make a record of each quantity of such a drug imported or exported by him.
(4) Paragraph (2) shall not have effect in relation to a person licensed under the Ordinance to import or export any drug where the licence so directs.
[Order49.3.4s20]20 Preservation of registers, books and other documents
(1) All registers and books kept in pursuance of regulation 16 or 18(3) shall be preserved for a period of two years from the date on which the last entry therein is made.
(2) Every record made in pursuance of regulation 19 shall be preserved for a period of two years from the date on which the record was made.
(3) Every requisition, order or prescription (other than a health prescription) on which a controlled drug is supplied in pursuance of these Regulations shall be preserved for a period of two years from the date on which the last delivery under it was made.
[Order49.3.4s21]21 Preservation of records relating to drugs in Schedules 3 and 5
(1) A producer of any drug specified in Schedule 3 or 5 and a wholesale dealer in any such drug shall keep every invoice or other like record issued in respect of each quantity of such a drug obtained by him and in respect of each quantity of such a drug supplied by him.
(2) A person who is authorised under regulation 9(4)(a) to supply any drug specified in Schedule 3 shall keep every invoice or other like record issued in respect of each quantity of such a drug obtained by him and in respect of each quantity of such a drug supplied by him.
(3) A retail dealer in any drug specified in Schedule 3, a person in charge or acting person in charge of a hospital or nursing home and a person in charge of a laboratory shall keep every invoice or other like record issued in respect of each quantity of such a drug obtained by him and in respect of each quantity of such a drug supplied by him.
(4) A retail dealer in any drug specified in Schedule 5 shall keep every invoice or other like record issued in respect of each quantity of such a drug obtained by him.
(5) Every invoice or other record which is required by this regulation to be kept in respect of a drug specified in Schedule 3 shall contain information sufficient to identify the date of the transaction and the person by whom or to whom the drug was supplied.
(6) Every document kept in pursuance of this regulation (other than a health prescription) shall be preserved for a period of two years from the date on which it is issued:
Provided that the keeping of a copy of the document made at any time during the said period of two years shall be treated for the purposes of this paragraph as if it were the keeping of the original document.
[Order49.3.4s22]22 Furnishing of information with respect to controlled drugs
(1) The persons specified in paragraph (2) shall on demand made by the Governor or by any person authorised in writing by the Governor in that behalf-
(a) furnish such particulars as may be requested in respect of the producing, obtaining or supplying by him of any controlled drug or in respect of any stock of such drugs in his possession;
(b) for the purpose of confirming any such particulars, produce any stock of such drugs in his possession;
(c) produce any register, book or document required to be kept under these Regulations relating to any dealings in controlled drugs which is in his possession.
(2) The persons referred to in paragraph (1) are-
(a) any person authorised by or under these Regulations to produce any controlled drug;
(b) any person authorised by or under any provision of the Ordinance to import or export any controlled drug;
(c) a wholesale dealer;
(d) a retail dealer;
(e) a practitioner;
(f) the person in charge or acting person in charge of a hospital or nursing home;
(g) a person who is in charge of a laboratory;
(h) a person who is authorised under regulation 9(4)(a) to supply any controlled drug.
(3) Nothing in this regulation shall require the furnishing of personal records which a person has acquired or created in the course of his profession or occupation and which he holds in confidence; and in this paragraph "personal records" means documentary and other records concerning an individual (whether living or dead) who can be identified from them and relating to his physical or mental health.
[Order49.3.4s23]23 Destruction of controlled drugs
(1) No person who is required by any provision of, or by any term or condition of a licence having effect under, these Regulations to keep records with respect to a drug specified in Schedules 1, 2, 3 or 4 shall destroy such a drug or cause such a drug to be destroyed except in the presence of and in accordance with any directions given by a person authorised (whether personally or as a member of a class) for the purposes of this paragraph by the Governor (hereafter in this regulation referred to as an "authorised person").
(2) An authorised person may, for the purposes of analysis, take a sample of a drug specified in Schedule 1, 2, 3 or 4 which is to be destroyed.
(3) Where a drug specified in Schedule 1, 2, 3 or 4 is destroyed in pursuance of paragraph (1) by or at the instance of a person who is required by any provision of, or by any term or condition of a licence have effect under, these Regulations to keep a record in respect of the obtaining or supply of that drug, that record shall include particulars of the date of destruction and the quantity destroyed and shall be signed by the authorised person in whose presence the drug is destroyed.
(4) Where the master or owner of a ship or installation manager of an offshore installation has in his possession a drug specified in Schedule 2 which he no longer requires, he shall not destroy the drug or cause it to be destroyed but shall dispose of it to a constable, or to a person who may lawfully supply that drug to him.
(5) Nothing in paragraph (1) or (3) shall apply to any person who is required to keep records only by virtue of regulation 19(2) or (3) or 21(3).
(6) Nothing in paragraph (1) or (3) shall apply to the destruction of a drug which has been supplied to a practitioner or pharmacist for that purpose in pursuance of regulation 6(2) or (3).
[Order49.3.4s24]24 Misuse of Drugs Regulations 1985
(1) From the commencement of this Order the Misuse of Drugs Regulations 1985(SI 1985/2066)(as amended) of the United Kingdom shall cease to have effect by virtue of Article 2 of the Misuse of Drugs Regulations Order 1989.
[Revision w.e.f. 31/07/2017]
(2) Notwithstanding paragraph (1), any register, record, book, prescription or other document required to be preserved under regulation 22 or 23 of the Misuse of Drugs Regulations 1985 shall be preserved for the same period of time as if these Regulations had not been made.
SCHEDULE 1
CONTROLLED DRUGS SUBJECT TO THE REQUIREMENTS OF REGULATIONS 12, 13,
14, 15, 16, 17, 20, 22 AND 23
Regulation 3
1. The following substances and products, namely-
|
(a) |
Bufotenine |
|
|
Cannabinol |
|
|
Cannabinol derivatives not being dronabinol or its stereoisomers |
|
|
Cannabis and cannabis resin |
|
|
Cathinone |
|
|
Coca leaf |
|
|
Concentrate of poppy-straw |
|
|
Eticyclidine |
|
|
Lysergamide |
|
|
Lysergide and other N-alkyl derivatives of lysergamide |
|
|
Mescaline |
|
|
Psilocin |
|
|
Raw opium |
|
|
Rolicyclidine |
|
|
Tenocyclidine |
|
|
4-Bromo-2,5-dimethoxy-a-methyphenethylamine |
|
|
N,N-Diethyltryptamine |
|
|
N,N-Dimethyltryptamine |
|
|
2,5-Dimethoxy-a-,4-dimethylphenethylamine |
|
|
N-Hydroxytenamphetamine |
|
|
4-Methyl-aminorex |
(b) any compound (not being a compound for the time being specified in sub-paragraph (a) above) structurally derived from tryptamine or from a ring-hydroxy tryptamine by substitution at the nitrogen atom of the sidechain with one or more alkyl substituents but no other substituent;
(c) any compound (not being methoxyphenamine or a compound for the time being specified in sub-paragraph (a) above) structurally derived from phenethylamine, an N-alkylphenethylamine, a-methylphenethylamine, an N-alkly-a-methylphenethyla-mine,a-ethylphenethylamine, or an N-alkyl-a-ethylphenethylamine by substitution in the ring to any extent with alkyl, alkoxy, alkylenedioxy or halide substituents, whether or not further substituted in the ring by one or more other univalent substituents.
(d) any compound (not being a compound for the time being specified in Schedule 2) structurally derived from fentanyl by modification in any of the following ways, that is to say,
(i) by replacement of the phenyl portion of the phenethyl group by any heteromonocycle whether or not further substituted in the heterocycle;
(ii) by substitution in the phenethyl group with alkyl, alkenyl, alkoxy, hydroxy, halogeno, haloalkyl, amino or nitro groups;
(iii) by substitution in the piperidine ring with alkyl or alkenyl groups;
(iv) by substitution in the aniline ring with alkyl, alkoxy, alkylenedioxy, halogeno or haloalkyl groups;
(v) by substitution at the 4-position of the piperidine ring with any alkoxycarbonyl or alkoxyalkyl or acyloxy group;
(vi) by replacement of the N-propionyl group by another acyl group;
(e) any compound (not being a compound for the time being specified in Schedule 2) structurally derived from pethidine by modification in any of the following ways, that is to say,
(i) by replacement of the 1-methyl group by an acyl, alkyl whether or not unsaturated, benzyl or phenethyl group, whether or not further substituted;
(ii) by substitution in the piperidine ring with alkyl or alkenyl groups or with a propano bridge, whether or not further substituted;
(iii) by substitution in the 4-phenyl ring with alkyl, alkoxy, aryloxy, halogeno or haloalkyl groups;
(iv) by replacement of the 4-ethoxycarbonyl by any other alkoxycarbonyl or any alkoxyalkyl or acyloxy group;
(v) by formation of an N-oxide or of a quaternary base.
2. Any stereoisomeric form of a substance specified in paragraph 1.
3. Any ester or ether of a substance specified in paragraph 1 or 2.
4. Any salt of a substance specified in any of paragraphs 1 to 3.
5. Any preparation or other product containing a substance or product specified in any of paragraphs 1 to 4, not being a preparation specified in Schedule 5.
SCHEDULE 2
CONTROLLED DRUGS SUBJECT TO THE REQUIREMENTS OF REGULATIONS 12, 13,
14, 15, 16, 17, 20, 22 AND 23
Regulation 3
1. The following substances and products, namely:-
|
Acetorphine |
Levophenacylmorphan |
|
Alfentanil |
Levorphanol |
|
Allylprodine |
Lofentanil |
|
Alphacetylmethadol |
Medicinal opium |
|
Alphameprodine |
Metazocine |
|
Alphamethadol |
Methadone |
|
Alphaprodine |
Methadyl acetate |
|
Anileridine |
Methyldesorphine |
|
Benzethidine |
Methyldihydromorphine |
|
Benzylmorphine |
(6-methyldihydromorphine) |
|
(3-benzylmorphone) |
|
|
Betacetylmethadol |
Metopon |
|
Betameprodine |
Morpheridine |
|
Betamethadol |
Morphine |
|
Betaprodine |
Morphine methobromide, morphine |
|
Bezitramide |
N-oxide and other pentavalent |
|
Carfentanil |
nitrogen morphine derivatives |
|
Clonitazene |
Myrophine |
|
Cocaine |
Nicomorphine |
|
Desomorphine |
Noracymethadol |
|
Dextromoramide |
Norlevorphanol |
|
Diamorphine |
Normethadone |
|
Diampromide |
Normorphine |
|
Diethylthiambutene |
Norpipanone |
|
Difenoxin |
Oxycodone |
|
Dihyrocodeinone |
Oxymorphone |
|
O-carboxymethyloxime |
Pethidine |
|
Dihydromorphine |
Phenadoxone |
|
Dimenoxadole |
Phenampromide |
|
Dimepheptanol |
Phenazocine |
|
Dimethylthiambutene |
Phencyclidine |
|
Dioxaphetyl butyrate |
Phenomorphan |
|
Diphenoxylate |
Phenoperidine |
|
Dipipanone |
Piminodine |
|
Dronabinol |
Piritramide |
|
Drotebanol |
Proheptazine |
|
Ecgonine, and any derivative of |
Properidine |
|
ecgonine which is convertible |
Racemethorphan |
|
to ecgonine or to cocaine |
Racemoramide |
|
Ethylmethylthiambutene |
Racemorphan |
|
Etonitazene |
Sufentanil |
|
Etorphine |
Thebacon |
|
Etoxeridine |
Thebaine |
|
Fentanyl |
Tilidate |
|
Furethidine |
Trimeperidine |
|
Hydrocodone |
4-Cyano-2-dimethylamino-4, |
|
Hydromorphinol |
4-diphenylbutane |
|
Hydromorphone |
4-Cyano-1-methyl-4-phenylpiperidine |
|
Hydroxypethidine |
1-Methyl-4-phenylpiperidine-4- |
|
Isomethadone |
carboxylic acid |
|
Ketobemidone |
2-Methyl-3-morpholino-1, |
|
Levomethorphan |
1-diphenylpropanecarboxylic acid |
|
Levomoramide |
4-Phenylpiperidine-4-carboxylic acid |
|
|
ethyl ester |
2. Any stereoisomeric form of a substance specified in paragraph 1 not being dextromethorphan or dextrorphan.
3. Any ester or ether of a substance specified in paragraph 1 or 2, not being a substance specified in paragraph 6.
4. Any salt of a substance specified in any of paragraphs 1 to 3.
5. Any preparation or other product containing a substance or product specified in any of paragraphs 1 to 4, not being a preparation specified in Schedule 5.
6. The following substances and products, namely-
|
Acetyldihydrocodeine |
Methylphenidate |
|
Amphetamine |
Nicocodine |
|
Codeine |
Nicodicodine (6-nicotinoyldihydrocodeine) |
|
Dextropropoxyphene |
Norcodeine |
|
Dihydrocodeine |
Phenmetrazine |
|
Ethylmorphine (3-ethylmorphine) |
Pholcodine |
|
Fenethylline |
Propiram |
|
Glutethimide |
|
|
Lefetamine |
|
|
Mecloqualone |
|
|
Methaqualone |
|
|
Methylamphetamine |
|
7. Any stereoisomeric form of a substance specified in paragraph 6.
8. Any salt of a substance specified in paragraph 6 or 7.
9. Any preparation or other product containing a substance or product specified in any of paragraphs 6 to 8, not being a preparation specified in Schedule 5.
SCHEDULE 3
CONTROLLED DRUGS SUBJECT TO THE REQUIREMENTS OF REGULATIONS 12, 13,
14, 15, 16, 17, 20, 22 AND 23
Regulation 3
1. The following substances, namely:-
|
(a) |
Benzphetamine |
Meprobamate |
|
|
Cathine |
Methylphenobarbitone |
|
|
Chlorphentermine |
Methyprylone |
|
|
Diethylpropion |
Pentazocine |
|
|
Ethchlorvynol |
Phendimetrazine |
|
|
Ethinamate |
Phentermine |
|
|
Mazindol |
Pipradol |
|
|
Mephentermine |
Temazepam |
(b) any 5,5 disubstituted barbituric acid.
2. Any stereoisomeric form of a substance specified in paragraph 1, not being phenylpropanolamine.
3. Any salt of a substance specified in paragraph 1 or 2.
4. Any preparation or other product containing a substance specified in any of paragraphs 1 to 3, not being a preparation specified in Schedule 5.
SCHEDULE 4
CONTROLLED DRUGS EXCEPTED FROM THE PROHIBITION ON IMPORTATION,
EXPORTATION AND, WHEN IN THE FORM OF A MEDICINAL PRODUCT,
POSSESSION AND SUBJECT TO THE REQUIREMENTS OF REGULATIONS 19, 20,
22 AND 23
Regulation 3
1. The following substances and products, namely:-
|
Alprazolam |
Haloxazolam |
|
Bromazepam |
Ketazolam |
|
Camazepam |
Loprazolam |
|
Chlordiazepoxide |
Lorazepam |
|
Clobazam |
Lormetazepam |
|
Clonazepam |
Medazepam |
|
Clorazepic acid |
Mefenorex |
|
Clotiazepam |
Midazolam |
|
Cloxazolam |
Nimetazepam |
|
Delorazepam |
Nitrazepam |
|
Diazepam |
Nordazepam |
|
Estazolam |
Oxazepam |
|
Ethyl loflazepate |
Oxazolam |
|
Fencamfamin |
Pinazepam |
|
Fenproporex |
Prazepam |
|
Fludiazepam |
Pyrovalerone |
|
Flunitrazepam |
Tetrazepam |
|
Flurazepam |
Triazolam |
|
Halazepam |
N-Ethylamphetamine |
2. Any stereoisomeric form of a substance specified in paragraph 1.
3. Any salt of a substance specified in paragraph 1 or 2.
4. Any preparation or other product containing a substance or product specified in any of paragraphs 1 to 3, not being a preparation specified in Schedule 5.
SCHEDULE 5
CONTROLLED DRUGS EXCEPTED FROM THE PROHIBITION ON IMPORTATION,
EXPORTATION AND POSSESSION AND SUBJECT TO THE REQUIREMENTS OF
REGULATIONS 22 AND 23
Regulation 3
1.(1) Any preparation of one or more of the substances to which this paragraph applies, not being a preparation designed for administration by injection, when compounded with one or more other active or inert ingredients and containing a total of not more than 100 milligrammes of the substance or substances (calculated as base) per dosage unit or with a total concentration of not more than 2.5 per cent. (calculated as base) in undivided preparations.
(2) The substances to which this paragraph applies are acetyldihydrocodeine, codeine, dihydrocodeine, ethylmorphine, nicocodine, nicodicodine (6-nicotinoyldihydrocodeine), norcodeine, pholcodine and their respective salts.
2. Any preparation of cocaine containing not more than 0.1 per cent. of cocaine calculated as cocaine base, being a preparation compounded with one or more other active or inert ingredients in such a way that the cocaine cannot be recovered by readily applicable means or in a yield which would constitute a risk to health.
3. Any preparation of medicinal opium or of morphine containing (in either case) not more than 0.2 per cent. of morphine calculated as anhydrous morphine base, being a preparation compounded with one or more other active or inert ingredients in such a way that the opium or, as the case may be, the morphine, cannot be recovered by readily applicable means or in a yield which would constitute a risk to health.
4. Any preparation of dextropropoxyphene, being a preparation designed for oral administration, containing not more than 135 milligrammes of dextropropoxyphene (calculated as base) per dosage unit or with a total concentration of not more than 2.5 per cent. (calculated as base) in undivided preparations.
5. Any preparation of difenoxin containing, per dosage unit, not more than 0.5 milligrammes of difenoxin and a quantity of atropine sulphate equivalent to at least 5 per cent. of the dose of difenoxin.
6. Any preparation of diphenoxylate containing, per dosage unit, not more than 2.5 milligrammes of diphenoxylate calculated as base, and a quantity of atropine sulphate equivalent to at least 1 per cent. of the dose of diphenoxylate.
7. Any preparation of propiram containing, per dosage unit, not more than 100 milligrammes of propiram calculated as base and compounded with at least the same amount (by weight) of methylcellulose.
8. Any powder of ipecacuanha and opium comprising-
10 per cent. opium, in powder,
10 per cent. ipecacuanha root, in powder, well mixed with
80 per cent. of any other powdered ingredient containing no controlled drug.
9. Any mixture containing one or more of the preparations specified in paragraphs 1 to 8, being a mixture of which none of the other ingredients is a controlled drug.
SCHEDULE 6
FORM OF REGISTER
Regulation 3
PART I
Entries to be made in case of obtaining
|
Date on which |
NAME |
ADDRESS |
Amount |
Form in |
|
Of person or firm from |
||||
|
|
|
|
|
|
PART II
Entries to be made in case of supply
|
Date on which |
NAME |
ADDRESS |
Particulars as to licence or authority of person or firm supplied to be in possession |
Amount |
Form in |
|
Of person or firm |
|||||
|
|
|
|
|
|
|