The Minister for Health, in exercise of the powers conferred on him by sections 4 , 5 , 18 and 38 of the Misuse of Drugs Act, 1977 (No. 12 of 1977), and section 5 of the Misuse of Drugs Act, 1984 (No. 18 of 1984), hereby makes the following Regulations:

PART IGENERAL

1 Citation.

1. These Regulations may be cited as the Misuse of Drugs Regulations, 1988.

2 Revocations.

2. The Misuse of Drugs Regulations, 1979 ( S.I. No. 32 of 1979 ) and the Misuse of Drugs (Amendment) Regulations, 1987 ( S.I. No. 263 of 1987 ) are hereby revoked.

3 Interpretation.

3. (1) In these Regulations—

"the Act" means the Misuse of Drugs Act, 1977 :

"the Acts relating to merchant shipping" means the Merchant Shipping Acts, 1894 to 1983 and the Mercantile Marine Act, 1955 (No. 29 of 1955);

"authorised as a member of a group" means authorised by virtue of being a member of a class in respect of which the Minister has granted an authority which is in force under and for the purposes of article 8(2) and "his group authority" in relation to a person who is a member of such a class means the authority so granted to that class;

"health board" means a board established under section 4 of the Health Act, 1970 (No. 1 of 1970);

"health prescription" and "health service requisition" means a prescription or a requisition issued in connection with arrangements made under section 59 of the Health Act, 1970 upon a form supplied by or on behalf of a health board;

"installation manager" "offshore installation" and "Industrial Medical Adviser (Offshore Installations)" have the same meaning as in the Safety, Health and Welfare (Offshore Installations) Act, 1987 (No. 18 of 1987);

"master" has the same meaning as in the Acts relating to merchant shipping;

"matron or acting matron" includes any male nurse occupying a similar position;

"medical preparation" has the same meaning as in section 65 of the Health Act, 1947 (No. 28 of 1947) as amended by section 39 of the Health Act, 1953 (No. 26 of 1953);

"the Minister" means the Minister for Health;

"officer of customs and excise" means an officer within the meaning of the Customs Acts;

"person keeping open shop for the dispensing or compounding of medical prescriptions or for the sale of poisons" means a person lawfully keeping open shop for the dispensing or compounding of medical prescriptions or for the sale of poisons under the Pharmacy Acts 1875-1977 as amended by the European Communities (Recognition of Qualifications in Pharmacy) Regulations, 1987 ( S.I. No. 239 of 1987 );

"An Post" means the company referred to in section 10 (1) (a) of the Postal and Telecommunications Services Act, 1983 (No. 24 of 1983);

"practitioner" means a registered medical practitioner, a registered dentist and a registered veterinary surgeon;

"prescription" means a prescription issued by a registered medical practitioner for the medical treatment of an individual, by a registered dentist for the dental treatment of an individual or by a registered veterinary surgeon for the purposes of animal treatment;

"produce", where the reference is to producing a controlled drug, means producing it by cultivation, manufacture, synthesis or by any other method;

"register" means a bound book and does not include any form of loose leaf register or card index;

"sister or acting sister" includes any male nurse occupying a similar position;

"the State Chemist" means the head of the State Laboratory;

"wholesaler" means a person who carries on the business of selling drugs to persons for the purpose of resale.

(2) In these Regulations any reference to an article or Schedule shall be construed as a reference to an article contained in these Regulations or, as the case may be, to a Schedule thereto; any reference in an article to a sub-article shall be construed as a reference to a sub-article of that article; and any reference in a Schedule to a paragraph shall be construed as a reference to a paragraph of that Schedule.

PART IIProduction, Supply, Importation and Exportation of Controlled Drugs.

4 General prohibition.

4. (1) Subject to the provisions of these Regulations a person shall not—

(a) produce a controlled drug,

(b) supply or offer to supply a controlled drug, or

(2) (a) Sub-article (1) (c) shall not apply to any drug specified in Schedule 4 or 5.

(b) Sub-article (1) (b) shall not apply to poppy straw.

5 Licences.

5. A person so authorised by a licence granted by the Minister under section 14 of the Act and for the time being in force may, under and in accordance with the terms of the licence and in compliance with any conditions attached thereto—

(a) produce, supply, offer to supply, import, export or have in his possession any controlled drug to which the licence relates or

(b) cultivate opium poppy or any plant of the genus Cannabis, or any plant of the genus Erythroxylon as may be specified in the licence.

6 Administration.

6. It shall not be a contravention of the provisions of article 4 (1) (b) for—

(a) any person to administer to another any drug specified in Schedule 5,

(b) a registered medical practitioner or registered dentist to administer to a patient any drug specified in Schedules 2, 3 or 4.

(c) any person, other than a registered medical practitioner or registered dentist, to administer to a patient, in accordance with the directions of a registered medical practitioner or registered dentist, any drug specified in Schedules 2, 3 or 4.

7 Exemption for practitioners, pharmacists, etc.

7. (1) A practitioner or pharmacist may, when acting in his capacity as such, for the purpose of his profession or business—

(a) supply or offer to supply any drug specified in Schedules 2, 3, 4 or 5 to any person who may lawfully have that drug in his possession, or

(b) manufacture or compound any such drug.

(2) A person keeping open shop for the dispensing or compounding of medical prescriptions or for the sale of poisons may, when acting in his capacity as such, for the purpose of his profession or business, at the premises at which he keeps open shop—

(a) supply or offer to supply any drug specified in Schedules 2, 3, 4 or 5 to any person who may lawfully have that drug in his possession, or

(b) manufacture or compound any such drug

provided that nothing in this article shall be construed as authorising a registered druggist to supply or offer to supply a controlled drug on foot of a medical prescription.

8 Supply in hospitals. etc.

8. (1) A person may supply or offer to supply any drug specified in Schedules 2, 3, 4 or 5 to any person who may lawfully have that drug in his possession where the person so supplying or offering to supply the drug is a person acting in his capacity as—

(a) the matron or acting matron 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, and the drug is a medical preparation,

(b) 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 where the drug is a medical preparation supplied to her by a person responsible for the dispensing and supply of medicines at such hospital or nursing home,

(c) a person in charge of a laboratory the recognised activities of which consist in, or include, the conduct of scientific education or research and which is attached to a university or a hospital referred to in paragraph (a) of this sub-article, or a person in charge of any other laboratory engaged in the conduct of scientific education or research and which is attached to any other institution approved for the purpose by the Minister,

(d) the State Chemist,

(e) the Director of the Forensic Science Laboratory of the Department of Justice,

(f) a public analyst appointed under section 10 of the Sale of Food and Drugs Act, 1875,

(g) the Medical Director of the National Drugs Advisory Board,

(h) a person employed or engaged in connection with any arrangements made for testing the quality or amount of the drugs, medicines and appliances supplied for the purpose of section 59 of the Health Act, 1970 ,

(i) a person employed or engaged as an inspector in connection with a scheme for the licensing of manufacturers or wholesalers of medical preparations under the Health Acts 1947 to 1985,

(j) a person authorised under and in accordance with Regulations made under section 65 of the Health Act, 1947 (as amended by section 39 of the Health Act, 1953 and by section 36 of the Act) for the purpose of enforcement and execution of the said Regulations,

(k) a person appointed as an inspector by the Pharmaceutical Society of Ireland, acting under the directions in writing of the Registrar of the said Society;

provided that nothing in this sub-article shall be construed as authorising—

(i) the matron or acting matron 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, or

(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 registered medical practitioner or a registered dentist.

(2) 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, supply or offer to supply any drug specified in Schedules 2, 3, 4 or 5 which is a medical preparation to any person who may lawfully have that drug in his possession.

(3) The owner of a ship, or the master of a ship which does not carry on board as part of her complement a registered medical practitioner, may supply or offer to supply any drug specified in Schedules 2, 3, 4 or 5 which is a medical preparation—

(a) to any member of the crew,

(b) to any person who may lawfully supply that drug; or

(4) The installation manager of an offshore installation may supply or offer to supply any drug specified in Schedules 2, 3, 4 or 5 which is a medical preparation —

(a) to any person on that installation, whether present in the course of his employment or not,

(b) to any person who may lawfully supply that drug; or

(5) A person whose name is for the time being entered in a register kept for the purposes of this sub-article by the Minister may, at the premises in respect of which his name is entered in the register and in compliance with any conditions subject to which his name is so entered, supply or offer to supply any drug specified in Schedules 3, 4 or 5 to any person who may lawfully have that drug in his possession.

PART IIIPossession of Controlled Drugs

9 General exemptions.

9. (1) A person who, by virtue of these Regulations, is authorised to produce, supply or offer to supply any drug specified in Schedules 2, 3, or 4 may in accordance with the provisions of the Regulations have such drug in his possession.

(2) A person may have in his possession any drug specified in Schedules 2 or 3 for administration for medical, dental or veterinary purposes in accordance with the directions of a practitioner;

provided that this sub-article shall not have effect in the case of a person to whom the drug has been supplied by or on the prescription of a registered medical practitioner if—

(a) that person was then being supplied with any controlled drug by or on the prescription of another registered medical practitioner and failed to disclose that fact to the first mentioned registered medical practitioner before the supply by him or on his prescription; or

(b) that person 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) A person whose name is for the time being entered in a register kept for the purposes of this sub-article by the Minister may, in compliance with any conditions subject to which his name is so entered, have in his possession any drug specified in Schedules 3 or 4.

(4) The master of a foreign ship which is in a port in the State may have in his possession any drug specified in Schedules 2 or 3 so far as is necessary for the equipment of his ship.

(5) A person who is authorised as a member of a group may, under and in accordance with his group authority and in compliance with any conditions attached thereto, have any drug specified in Schedules 2 or 3 which is a medical preparation in his possession.

10 Exemption for midwives in respect of pentazocine and pethidine.

10. (1) Subject to the provisions of this article a midwife who is employed by a health board or a hospital authority to provide community based maternity services or who has in accordance with the provisions of section 57 of the Nurses Act, 1985 , (No. 18 of 1985) notified to a health board her intention to practise may so far as is necessary for her practice as a midwife, have in her possession or administer any medical preparation which contains pentazocine or pethidine.

(2) Nothing in sub-article (1) shall be construed as authorising a midwife to have pentazocine or pethidine in her possession unless it has been obtained on foot of a written order signed by the midwife and an appropriate medical practitioner setting out the name and address of the midwife, the purpose for which the drug is required and the quantity to be obtained.

(3) In this article—

"appropriate medical practitioner" means a registered medical practitioner practising in the area in which the midwife practises;

"midwife" means a person registered in the midwives division of the register of nurses maintained under section 27 of the Nurses Act, 1985 .

11 General authorities.

11. (1) Any of the following persons may have a controlled drug in his possession, that is to say—

(a) a member of the Garda Síochána when acting in the course of his duty as such;

(b) an officer of customs and excise when acting in the course of his duty as such;

(c) a person authorised in writing by the Minister in accordance with section 24 of the Act, when acting in the course of his duty as such;

(d) a person engaged in connection with the Postal Services provided by An Post when acting in the course of his duty as a person so engaged;

(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 the business of a carrier when acting bona fide in the course of that business;

(g) a person engaged in conveying the drug to a person authorised by these Regulations to have in his possession.

(2) A person who is lawfully in possession of a controlled drug may supply that drug to a person from whom he obtained it.

PART IV Documentation and Record Keeping

12 Documents to be obtained by a supplier.

12. (1) Where a person (in this sub-article referred to as "the supplier"), not being a practitioner, supplies a controlled drug otherwise than on a prescription, he 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 to be supplied (in this sub-article referred to as "the recipient"), and

(b) is not authorised by any provision of these Regulations other than the provisions of article 11(1) (g) to have that drug in his possession,

unless the person produces to the supplier a statement in writing signed by the recipient to the effect that the person is empowered by the recipient to receive that drug on his behalf, and the supplier is reasonably satisfied that the document is a genuine document.

(2) Where a person (in this sub-article 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 sub-article (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 to be supplied (in this sub-article referred to as "the recipient"),

(ii) states the name, address and occupation of the recipient,

(iii) specifies the purpose for which the drug to be supplied is required and the total quantity to be supplied, and

(iv) where appropriate, satisfies the requirements of sub-article (5); and

(b) unless he is reasonably satisfied that the signature on the requisition referred to at (a) is that of the recipient and that the recipient is engaged in the 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 unable by reason of urgency to furnish such requisition, deliver the drug to the recipient on an undertaking by the recipient to furnish such a requisition within twenty-four hours of such delivery.

(3) A practitioner who has given an undertaking in accordance with sub-article (2) 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 sub-article (2) are—

(a) a practitioner;

(b) the matron or acting matron of a hospital or nursing home;

(d) the owner of a ship, or the master of a ship which does not carry a registered medical practitioner on board as part of her complement;

(e) the master of a foreign ship in a port in the State;

(f) the installation manager of an offshore installation.

(5) A requisition furnished for the purpose of sub-article (2) shall—

(a) where it is furnished by the matron or acting matron of a hospital or nursing home, be signed by a registered medical practitioner or a registered dentist employed or engaged in that hospital or nursing home;

(b) where it is furnished by the master of a foreign ship, contain a statement, signed by a medical officer of health of the health board within whose functional area the ship is, that the quantity of the drug to be supplied is the quantity necessary for the equipment of the ship;

(c) where it is furnished by the installation manager of an offshore installation, contain a statement signed by the Industrial Medical Adviser (Offshore Installations) that the quantity of the drug to be supplied is the quantity necessary for the equipment of that installation.

(6) Where the person responsible for the dispensing and supply of medicines at any hospital or nursing home supplies a controlled drug to a sister or acting sister for the time being in charge of a ward, theatre or other department in that hospital or nursing home he shall—

(a) obtain a requisition in writing, signed by the sister or acting sister, 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 sub-article 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 sister or acting sister for the time being in charge of that ward, theatre or other department.

(7) A person who supplies a controlled drug to—

(a) a person keeping open shop for the dispensing or compounding of medical prescriptions or for the sale of poisons,

(b) a pharmacist responsible for the dispensing and supply of medicines in a hospital or nursing home, or

(c) the matron or acting matron of a hospital or nursing home, shall furnish with each consignment of such drug a form of receipt.

(8) The pharmacist or, as the case may be, the matron or acting matron on receipt of controlled drugs in the manner provided for in sub-article (7) shall—

(i) check the statements on the form of receipt,

(ii) enter thereon any deviations observed in the drugs received,

(iii) enter the date of receipt of the drugs,

(iv) sign the receipt document with his usual signature, and

(v) return the receipt to the supplier not later than three working days from the date of receipt of the said drugs.

(9) Nothing in this article shall have effect in relation to any drug specified in Schedule 4 or 5 or poppy straw.

13 Form of prescriptions.

13. (1) Subject to the provisions of this article, a person shall not issue a prescription for a controlled drug other than a drug specified in Schedule 4 or 5 unless he is satisfied as to the identity of the person for whose treatment the prescription is to be issued and 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-paragraphs (f) and (g) below to be specified, be written by the person issuing it in his own handwriting;

(d) clearly indicate the name of the person issuing it and state whether he is a registered medical practitioner, registered dentist or registered veterinary surgeon;

(e) specify the telephone number at which the person issuing it may be contacted;

(f) specify the name (including the given name) and address of the person for whose treatment it is issued or, if it is issued by a registered veterinary surgeon, of the person to whom the controlled drug prescribed is to be delivered;

(g) specify the dose to be taken and—

(i) in the case of a prescription for 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;

(h) in the case of a prescription for a total quantity intended to be dispensed by instalments, contain a direction specifying the amount of the instalments and the intervals at which the instalments may be dispensed.

(2) 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 sub-article (1) (e) and (f) if the prescription is written on the patient's bed card or case sheet and such card or sheet shall be sufficient evidence of identity for the purposes of sub-article (1).

14 Supply on prescription.

14. (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 article 13;

(b) unless the address specified in the prescription as the address of the person issuing it is an address within the State;

(c) unless he either is acquainted with the signature of the person by whom it purports to be issued and has no reason to believe that the signature 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 sub-article (3), later than fourteen days after the date of the prescription;

(f) unless he is satisfied as to the identity of the person for whose treatment the prescription is issued and in the case of the supply being made to a representative of the said person, unless he is satisfied that the said representative is a bona fide representative of the said person.

(2) Subject to sub-article (3) and (4), 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—

(a) mark thereon the date on which the drug is supplied, and

(b) retain the prescription on the premises from which the drug was supplied.

(3) In the case of a prescription for 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 dispensed at stated intervals, the person dispensing it shall not supply the drug otherwise than in accordance with that direction and—

(a) sub-article (1) shall have effect as if for the requirement contained in paragraph (e) thereof there were substituted a requirement that the occasion on which the first instalment is dispensed shall not be later than fourteen days after the date specified in the prescription;

(b) sub-article (2) shall have effect as if for the words "at the time of supply" there were substituted the words "on each occasion on which an instalment is supplied";

provided that no instalment shall be supplied later than two months after the date specified in the prescription.

(4) Sub-article (2) shall apply to a health prescription on the basis that the duplicate copy thereof, made by the practitioner at the time of writing the original, shall be treated for the purposes of this article as if it were the original document.

15 Marking of containers.

15. (1) Subject to sub-article (2), a person shall not supply a controlled drug otherwise than in a bottle, package or other container which—

(a) in the case of a controlled drug other than a preparation, is clearly marked with the amount of the drug contained therein;

(b) in the case of a controlled drug which is a preparation made up into tablets, capsules or other dosage units, is clearly marked 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; and

(c) in the case of a controlled drug which is a preparation not so made up, is clearly marked 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 article shall have effect in relation to—

(a) a drug specified in Schedule 4 or 5 or poppy straw;

(b) the supply of a controlled drug by or on the prescription of a practitioner.

16 Keeping of registers for drugs in Schedules 1 and 2.

16. (1) Subject to sub-articles (4) and (6) and article 17, every person authorised by or under article 5, 7 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 article, keep a register and shall enter therein in chronological sequence and in a manner which will show a running stock balance, particulars of every quantity of such a drug 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 State;

(b) he shall use a separate register or separate part of a register for entries made in respect of each class of drug;

(i) in the form specified in Schedule 6, or

(ii) as the case may require, in the form specified in Part I or Part II of Schedule 7.

(2) For the purposes of sub-article (1) (b) 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 and any stereoisomeric form of a drug or its salts shall be treated as being in the same class as that drug.

(3) Nothing in sub-article (1) shall be taken as preventing the use of a separate section within a register or a 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.

(4) The foregoing provisions of this article shall not have effect in relation to—

(a) a person licensed under section 14 of the Act to supply any drug, where the licence so directs; or

(b) the sister or acting sister for the time being in charge of a ward, theatre or other department in a hospital or nursing home.

(5) Any person required to keep a register under this article 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 this article in a register shall, where it is reasonably practicable to do so, be made on the day on which the drug is obtained or on which the transaction in respect of the supply of the drug by the person required to make the entry takes place or, in any case, 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) a register shall not be used for any purpose other than the purposes of these Regulations;

(f) subject to sub-article (5) (g) not more than one register shall be kept at one time in respect of each class of drug in respect of which he is required to keep a separate register;

(g) 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 and where the business is carried on in separate departments within a premises a separate register may, with the approval of the Minister, be kept in respect of each such department;

(h) every such register in which entries are currently being made shall be kept at the premises to which it relates and shall be readily available for inspection under section 24 of the Act.

(6) Sub-article (1) (a) insofar as it relates to the showing of a running stock balance shall not come into force until 1st day of May, 1989.

17 Record-keeping in particular cases for drugs in Schedule 2.

17. (1) Where a drug specified in Schedule 2 is supplied in accordance with article 8 (3) (a) to a member of the crew of a ship, an entry in the official log book required to be kept under the Acts relating to merchant shipping, or in the case of a ship which is not required to carry such an official log book, 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 the superintendent of a merchantile marine office established and maintained under the Acts relating to merchant shipping.

(2) Where a drug specified in Schedule 2 is supplied in accordance with article 8 (4) (a) to a person on an offshore installation, an entry in the installation log book which specifies the drug supplied shall, notwithstanding anything in these Regulations, be a sufficient record of the supply.

(3) A midwife authorised under article 10 to have pethidine in her possession shall—

(a) on each occasion on which she obtains a supply of pethidine, enter in a book kept by her and used solely for the purposes of this sub-article 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 pethidine 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.

18 Keeping of records for drugs in Schedules 3 and 4.

18. (1) A person who is authorised by a licence granted by the Minister for Health under section 14 of the Act:

(a) to produce any drug specified in Schedules 3 or 4 shall make a record of each quantity of such a drug produced by him,

(b) to import or export any drug specified in Schedule 3 shall make a record of each quantity of such drug imported or exported by him.

(2) A person who is authorised under article 8(5) to supply any drug specified in Schedule 4 shall make a record of each quantity of such drug imported or exported by him.

19 Preservation of registers, etc.

19. (1) All registers and books kept in pursuance of article 16 or 17 (3) shall be preserved for a period of two years from the date on which the last entry therein is made.

(2) Every order, prescription or requisition 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 supply of a controlled drug was made on such order, prescription or requisition.

(3) Sub-article (2) shall apply to a health prescription or, as the case may be, to a health service requisition on the basis that the keeping of the duplicate copy thereof, made by the practitioner at the time of writing the original, shall be treated as if it were the keeping of the original document.

(4) Every receipt made and returned in pursuance of article 12 (7) and (8) shall be preserved for a period of two years from the date entered on the document as the date of receipt of the drugs to which the document relates.

(5) Every record made in pursuance of article 18 shall be preserved for a period of two years from the date on which the record was made.

20 Preservation of records for drugs in Schedules 3 and 5.

20. (1) A producer of any drug specified in Schedule 3 or 5 and a wholesaler of any such drug shall keep every invoice or other like record issued in respect of each quantity of such drug obtained by him and in respect of each quantity of such drug supplied by him.

(2) A person who is authorised under article 8 (5) to supply any drug specified in Schedule 3 shall keep every invoice or other like record issued in respect of each quantity of such drug obtained by him and in respect of each quantity of such drug supplied by him.

(3) A matron or acting matron of a hospital or nursing home or, as the case may be, a pharmacist responsible for the dispensing and supply of medicines in such hospital or nursing home and a person in charge of a laboratory shall, in respect of any drug specified in Schedule 3, keep every invoice or other like record issued in respect of each quantity of such drug obtained by him and in respect of each quantity of such drug supplied by him.

(4) A person keeping open shop for the dispensing or compounding of medical prescriptions or for the sale of poisons shall—

(a) in the case of any drug specified in Schedule 3, keep every invoice or other like record issued in respect of each quantity of such drug obtained by him and in respect of each quantity of such drug supplied by him, and

(b) in the case of any drug specified in Schedule 5, keep every invoice or other like record issued in respect of each quantity of such drug obtained by him.

(5) Every invoice or other record which is required by this article to be kept in respect of a drug specified in Schedule 3 shall contain information sufficient to identify the date of the transaction and in the case of a drug obtained, the person by whom such drug was supplied and in the case of a drug supplied, the person to whom such drug was supplied.

(6) Every document kept in pursuance of this article shall be preserved for a period of two years from the date on which it was 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 article as if it were the keeping of the original document.

21 Furnishing of information with respect to controlled drugs.

21. (1) The persons referred to in paragraph (3) shall on demand made by the Minister or by any person authorised in writing by the Minister 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 in his possession which is required to be kept under these Regulations in respect of any dealings in controlled drugs.

(2) Where the demand referred to in sub-article (1) is made in writing the particulars, or confirmation thereof, shall be furnished not later than fourteen days from the date of the said demand.

(3) The persons referred to in paragraph (1) are—

(a) any person authorised by or under these Regulations or by a licence granted under section 14 of the Act, to produce, import or export any controlled drug;

(b) a wholesaler;

(d) a practitioner;

(e) the matron or acting matron of a hospital or nursing home or, as the case may be, the pharmacist responsible for the dispensing and supply of medicines in such hospital or nursing home;

(f) a person in charge of a laboratory;

(g) a person who is authorised under article 8(5) to supply any controlled drug.

(4) Nothing in this article 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 but does not include any register, book, prescription or other document required to be kept under these Regulations relating to any dealings in controlled drugs.

PART VMiscellaneous

22 Destruction of certain drugs.

22. (1) A person who is required by any provision of these Regulations, or by any term or condition of a licence having effect under section 14 of the Act to keep records with respect to a drug specified in Schedules 1, 2, 3 or 4 shall not destroy such drug or cause such 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 sub-article by the Minister (in this article referred to as an "authorised person").

(2) An authorised person may, for the purpose of analysis, take a sample of a drug specified in Schedules 1, 2, 3 or 4 which is to be destroyed.

(3) Where a drug specified in Schedules 1, 2, 3 or 4 is destroyed in pursuance of sub-article (1) by or at the instance of a person who is required by any provision of these Regulations, or by any term or condition of a licence having effect under section 14 of the Act, 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 give it to a member of the Garda Siochana, an officer of customs and excise or to a person who may lawfully supply that drug to him.

(5) Nothing in sub-article (1) or (3) shall apply to any person who is required to keep records only by virtue of article 18 (1) (b) or (2) or article 20 (3) or (4) (a).

23 Disposal of certain drugs on cessation of business.

23. A person who has ceased to keep open shop for the dispensing or compounding of medical prescriptions or for the sale of poisons or who becomes the legal personal representative of such a person shall on demand made by the Minister or by any person authorised in writing in that behalf by the Minister—

(i) furnish such particulars as may be requested in respect of any stock of a controlled drug in his possession;

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

(iii) produce the register and such other books or documents in his possession relating to any dealings in drugs specified in Schedules 2, 3 or 4 as may be requested.

(iv) dispose of any stock of such drugs in his possession in accordance with any directions given by the Minister or by a person authorised as aforesaid.

24 Forged, etc. prescriptions.

24. Subsection (3) of section 18 of the Act (which prohibits the possession of either a forged prescription or a duly issued prescription which has been altered with intent to deceive) shall not apply in relation to any of the following persons—

(a) a member of the Garda Siochana when acting in the course of his duty as such;

(b) a person appointed as an inspector by the Pharmaceutical Society of Ireland when acting in the course of his duty as such;

(c) a person appointed as the secretary to or member of a Committee of Inquiry established under section 8 of the Act as substituted by section 3 of the Misuse of Drugs Act, 1984 (No. 18 of 1984) when acting in the course of his duty as such;

(d) a person authorised in writing by the Minister in accordance with section 24 of the Act when acting in his capacity as such;

(e) a person who has taken into his possession a forged prescription or a duly issued prescription which has been altered with intent to deceive, for the purpose of—

(i) preventing another from committing or continuing to commit an offence under the Act, or

(ii) delivering it into the custody of a person specified in paragraph (a) or (b) of this article.

25 Publication, sale etc. of certain books, periodicals and other publications.

25. The drugs specified in Schedule 1 are hereby prescribed for the purposes of section 5 of the Misuse of Drugs Act, 1984 .

26 Amendment of the Misuse of Drugs (Safe Custody) Regulations, 1982 ( S.I. No. 321 of 1982 ).

26. (1) In the Misuse of Drugs (Safe Custody) Regulations, 1982 ( S.I. No. 321 of 1982 ) every reference to "the Principal Regulations" and every reference to a controlled drug specified in Schedules 1, 2 or 3 of the Principal Regulations shall be construed as being a reference to these Regulations, and to Schedules 1, 2 and 3 of these Regulations, respectively.

(2) Article 5 of the Misuse of Drugs (Safe Custody) Regulations, 1982 is hereby amended by the insertion of the following sub-articles—

"(3) A person keeping open shop for the dispensing or compounding of medical prescriptions or for the sale of poisons and any person acting on behalf of such a person shall not install a safe or cabinet for the custody of controlled drugs unless such safe or cabinet complies with the specifications set-out in the Standard Specification (Burglar-Resistant Cabinets for the Storage of Controlled Drugs) Declaration, 1985 (I.S. 267:1985) made by the Institute for Industrial Research and Standards.

(4) Sub-article (3) shall not apply where the arrangements made for the custody of controlled drugs are based on the installation of a cabinet or money safe which is not in compliance with sub-article 3 or a strongroom and in either case a certificate provided for in article 6 has been obtained in respect of the arrangements.".

27 Transitional provisions.

27. (1)Notwithstanding the provisions of article 2, any register, book, prescription or other document required to be preserved under articles 18 or 19 of the Misuse of Drugs Regulations, 1979 ( S.I. No. 32 of 1979 ) shall be preserved for the same period of time as if these Regulations had not been made.

(2) In the case of a prescription issued before the coming into operation of these Regulations, article 14(1) shall have effect as if—

(a) in the case of a prescription containing a controlled drug other than a drug to which the provisions of article 13 of the said Regulations of 1979 applied at the time the prescription was issued, paragraphs (a) and (b) of that article were omitted; and

(b) in any other case, for the said paragraphs (a) and (b) there were substituted the words "unless the prescription complies with the provisions of the Misuse of Drugs Regulations, 1979 relating to prescriptions".

SCHEDULE 1

1. The following substances and products, namely:—

(a) Bufotenine.

Cannabinol, except where contained in cannabis or cannabis resin.

Cannabinol derivatives.

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.

N,N-Diethyltryptamine.

N.N-Dimethyltryptamine.

N-(1-Benzyl-4-piperidyl) propionanilide.

N-[1(2-Thenyl)- 4-piperidyl] propionanilide.

2.5-Dimethoxy-∝, 4-dimethylphenethylamine.

(b) any substance (not being a substance 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 substance (not being methoxyphenamine or a substance specified in sub-paragraph (a) above) structurally derived from phenethylamine, an N-alkylphenethylamine, ∝-methyl phenethylamine, an N-alkyl-∝-methylphenethylamine, ∝-ethylphenethylamine, or an N-alkyl-∝-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 substance (not being a substance specified in Schedule 2) structurally derived from fentanyl by modification in one or more 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 substance (not being a substance specified in Schedule 2) structurally derived from pethidine by modification in one or more 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 a quarternary 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, 2 or 3.

5. Any preparation or other product containing any proportion of a substance or product specified in any of paragraphs 1; 2, 3 or 4, not being a preparation specified in Schedule 5.

SCHEDULE 2

1. The following substances and products, namely:—

Acetorphine.

Acetylmethadol.

Alfentanil.

Allylprodine.

Alphacetylmethadol.

Alphameprodine.

Alphamethadol.

Alphaprodine.

Anileridine.

Benzethidine.

Benzylmorphine (3-benzylmorphine).

Betacetylmethadol.

Betameprodine.

Betamethadol.

Betaprodine.

Bezitramide.

Carfentanil.

Clonitazene.

Cocaine.

Codoxime.

Desomorphine.

Dextromoramide.

Diamorphine.

Diampromide.

Diethylthiambutene.

Difenoxin.

Dihydromorphine.

Dimenoxadole.

Dimepheptanol.

Dimethylthiambutene.

Dioxaphetyl butyrate.

Diphenoxylate.

Dipipanone.

Drotebanol.

Ecgonine, and any derivative of ecgonine which is convertible to ecgonine or to cocaine.

Ethylmethylthiambutene.

Etonitazene.

Etorphine.

Etoxeridine.

Fentanyl.

Furethidine.

Hydrocodone.

Hydromorphinol.

Hydromorphone.

Hydroxypethidine.

Isomethadone.

Ketobemidone.

Levomethorphan.

Levomoramide.

Levophenacylmorphan.

Levorphanol.

Lofentanil.

Medicinal opium.

Metazocine.

Methadone.

Methyldesorphine,

Methyldihydromorphine (6-methyldihydromorphine).

Metopon.

Morpheridine.

Morpine.

Morphine methobromide, morphine N-oxide and other pentavalent nitrogen morphine derivatives.

Myrophine.

Nabilone.

Nicomorphine.

Noracymethadol.

Norlevorphanol.

Normethadone.

Normorphine.

Norpipanone.

Oxycodone.

Oxymorphone.

Pethidine.

Phenadoxone.

Phenampromide.

Phenazocine.

Phencyclidine.

Phenomorphan.

Phenoperidine.

Piminodine.

Piritramide.

Proheptazine.

Properidine.

Racemethorphan.

Racemoramide.

Racemorphan.

Sufentanil.

Thebacon.

Thebaine.

Tilidine.

Trimeperidine.

4-Cyano-2-dimethylamino-4,4-diphenylbutane.

4-Cyano-1-methyl-4-phenylpiperidine.

2- Methyl-3-morpholino-1, 1-diphenylpropanecarboxylic acid.

1-Methyl-4-phenylpiperidine-4-carboxylic acid.

1-Phenylcyclohexylamine.

4 Phenylpiperidine-4-carboxylic acid ethyl ester.

4-(1-Phenylcyclohexyl) morpholine.

1-Piperidinocyclohexanecarbonitrile.

1-[1-(2-Thienyl)cyclohexyl] pyrrolidine.

4-[1-(-2-Thienyl)cyclohexyl]morpholine.

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, 2 or 3.

5. Any preparation or other product containing any proportion of a substance or product specified in any of paragraphs 1, 2. 3 or 4, not being a preparation specified in Schedule 5.

6. The following substances and products, namely:

Acetyldihydrocodeine.

Amphetamine.

Benzphetamine.

Buprenorphine.

Butorphanol.

Codeine.

Dexamphetamine.

Dextropropoxyphene.

Dihydrocodeine.

Ethylmorphine (3-ethylmorphine).

Fenethylline.

Glutethimide.

Lefetamine,

Mecloqualone.

Methaqualone.

Methylamphetamine.

Methylphenidate.

Nalbuphine.

Nicocodine.

Nicodicodine (6-nicotinoyldihydrocodeine).

Norcodeine.

Phendimetrazine.

Phenmetrazine.

Pholcodine.

Propiram.

Quinalbarbitone.

Selegiline.

N-Ethylamphetamine.

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 any proportion of a substance or product specified in any of paragraphs 6, 7 or 8 not being a preparation specified in Schedule 5.

SCHEDULE 3

1. The following substances, namely:—

(a) Cathine.

Chlorphentermine.

Diethylpropion.

Ethchlorvnol.

Ethinamate.

Mazindol.

Mephentermine.

Meprobamate.

Methyprylone.

Pemoline.

Pentazocine.

Phentermine.

Phenylacetone.

Pipradrol.

(b) any substance (not being quinalbarbitone) structurally derived from barbituric acid by disubstitution at the 5,5 positions, whether or not there is also substitution at the 1 position by a methyl substituent.

2. Any stereoisomeric form of a substance specified in paragraph 1, not being phenylpropanolamine.

3. Any salt of a substance specified in paragraphs 1 or 2.

4. Any preparation or other product containing any proportion of a substance or product specified in paragraphs 1, 2 or 3, not being a preparation specified in Part 2 of Schedule 4 or in Schedule 5.

SCHEDULE 4

PART I

1. The following substances, namely:—

(a) Alprazolam.

Bromazepam.

Camazepam.

Chlordiazepoxide.

Clobazam.

Clonazepam.

Clorazepic Acid.

Clotiazepam.

Cloxazolam.

Delorazepam.

Diazepam.

Estazolam.

Ethyl loflazepate.

Fencamfamin.

Fenproporex.

Fludiazepam.

Flunitrazepam.

Flurazepam.

Halazepam.

Haloxazolam.

Ketazolam.

Loprazolam.

Lorazepam.

Lormetazepam.

Medazepam.

Mefenorex.

Nimetazepam.

Nitrazepam.

Nordazepam.

Oxazepam.

Oxazolam.

Pinazepam.

Prazepam.

Propylhexedrine.

Pyrovalerone.

Temazepam.

Tetrazepam.

Triazolam.

2. Any stereoisomeric form of a substance specified in paragraph 1.

3. Any salt of a substance specified in paragraphs 1 or 2.

4. Any preparation or other product containing any proportion of a substance or product specified in any of paragraphs 1 to 3, not being a preparation specified in Schedule 5.

PART 2

Any preparation containing not more than 100 milligrams of methylphenobarbitone or of phenobarbitone (calculated in either case in terms of base) per dosage unit and no other controlled drug and which in the case of an undivided preparation has a concentration of not more than 0.5 per cent of phenobarbitone (calculated as base) and no other controlled drug.

SCHEDULE 5

1. (a) 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 ingredients and which contains a total of not more than 100 milligrammes of the substance or substances (calculated as base) per dosage unit and which in the case of an undivided preparation has a total concentation of not more than 2.5 per cent of the substance or substances (calculated as base).

(b) The substances to which this paragraph applies are acetyldihydrocodeine, codeine, ethylmorphine (3-ethylmorphine), nicocodine, nicodicodine (6-nicotinoyldihydrocodeine), norcodeine, pholcodine and their respective salts.

2. Any preparation of dihydrocodeine (not being a preparation designed for administration by injection) containing, per dosage unit, not more than 10 milligrammes of dihydrocodeine (calculated as base) and which in the case of an undivided preparation has a concentration of not more than 1.5 per cent of dihydrocodeine (calculated as base).

3. Any preparation of cocaine containing not more than 0.1 per cent of cocaine calculated as cocaine base, being a preparation which is compounded with one or more other ingredients in such a way that the cocaine cannot be readily recovered.

4. 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 which is compounded with one or more other ingredients in such a way that the opium or morphine cannot be readily recovered.

5. 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.

6. 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.

7. 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.

8. Any preparation of propiram containing, per dosage unit, not more than 100 milligrammes of propiram calculated as base and which is compounded with at least the same amount, by weight, of methylcellulose.

9. Any powder of ipecacuanha and opium comprising 10 per cent powdered opium, 10 per cent powdered ipecacuanha root, both well mixed with the remaining 80 per cent consisting of any other powdered ingredient which contains no controlled drug.

10. Any mixture containing one or more of the preparations specified in this Schedule, being a mixture of which none of the other ingredients is a controlled drug.

SCHEDULE 6

Form of Register

Class of Drug		............................................................ ............................................................ .....................
Product	............................................................ ............................................................ ...............................

(Insert name, form, strength and size as necessary)

Date on which supply received or transaction effected	Name and address of person from whom obtained or to whom supplied	Authority of person supplied to be in possession	Amount	Stock Balance
Obtained	Supplied

SCHEDULE 7

Form of Register

PART I

Entries to be made in case of obtaining.

Date on which supply received	Name	Address	Amount obtained	Form in which obtained
Of person or firm from whom

PART II

Entries to be made in case of supply

Date on which the transaction was effected	Name	Address	Particulars as to licence or authority of person or firm supplied to be in possession	Amount supplied	Form in which supplied	Stock Balance
Of person or firm supplied

GIVEN under the Official Seal of the Minister for Health this 8th day of December, 1988.

RORY O'HANLON,

Minister for Health.

EXPLANATORY NOTE.

These Regulations apply controls to the groups of drugs specified in Schedules 1 to 5 of the Regulations (being drugs to which the Misuse of Drugs Acts, 1977 and 1984 apply). The effect of the Regulations is to impose restrictions on the production, supply, importation and exportation of the drugs in question, which vary according to the extent to which these drugs are used for medical or scientific purposes and having regard to the likelihood of their being abused. Appropriate exemptions are provided to cover legitimate use for professional purposes by doctors, pharmacists etc. and in other specified circumstances.

In addition to these controls the Regulations specify the classes of persons who may have controlled drugs in their possession and the circumstances in which such possession would not be in contravention of the Act.

The Regulations contain other miscellaneous provisions such as requirements as to the form of prescriptions for controlled drugs, the keeping of books and records, arrangements for destruction or disposal of such drugs, and provisions regarding possession of forged prescriptions.

The Regulations also prescribe certain controlled drugs for the purposes of section 5 of the Misuse of Drugs Act, 1984 .