Misuse of Drugs Regulations, 1979

• Jurisdiction: Ireland
• Year: 1979
• Citation: IR SI 32/1979

S.I. No. 32 of 1979.
MISUSE OF DRUGS REGULATIONS, 1979
ARRANGEMENT OF REGULATIONS
PART I
General
1. Citation.
2. Commencement.
3. Interpretation.
PART II
Production, Supply, Importation and Exportation of Controlled Drugs
4. General prohibition.
5. Licences.
6. Administration.
7. Exemption for practitioners, pharmacists, etc.
8. Supply in hospitals, etc.
PART III
Possession of Controlled Drugs
9. General exemptions.
10. Exemption for midwives in respect of pethidine.
11. General authority.
PART IV
Documentation and Record Keeping
12. Documents to be obtained by a supplier.
13. Form of prescriptions.
14. Supply on prescription.
15. Marking of containers.
16. Keeping of registers.
17. Record-keeping in particular cases
18. Preservation of registers, etc.
19. Preservation of records for drugs in Schedule 4.
PART V
Miscellaneous
20. Destruction of certain drugs.
21. Disposal of certain drugs on cessation of business.
22. Safe custody.
23. Forged, etc. prescriptions.
24. Transitional provisions.
SCHEDULES
Schedule 1
Controlled drugs subject to the requirements of articles 12, 13, 14, 15, 16, 18 and 20.
Schedule 2
Controlled drugs subject to the requirements of articles 12, 13, 14, 15, 16, 17, 18, 20, 21 and 22.
Schedule 3
Controlled drugs subject to the requirements of articles 12, 13, 14, 15, 21 and 22.
Schedule 4
Controlled drugs exempted from the prohibition on importation and exportation and subject to the requirements of article 19.
Schedule 5
Form of register.
S.I. No. 32 of 1979.
MISUSE OF DRUGS REGULATIONS, 1979
The Minister for Health, in exercise of the powers conferred on him by sections 4 , 5 , 18 , 38 and 42 of the Misuse of Drugs Act, 1977 (No. 12 of 1977), hereby makes the following Regulations:—
PART I General
	1 Citation	1. These Regulations may be cited as the Misuse of Drugs Regulations, 1979.
	2 Commencement	2. These Regulations shall come into operation on the 1st day of May, 1979.
	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 1968 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" means a prescription 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" is a person appointed to be in charge or act as manager of an offshore installation;
"master" has the same meaning as in the Acts relating to merchant shipping;
"matron or acting matron" includes any male nurse acting in that capacity;
"officer of customs and excise" means an officer within the meaning of the Customs Acts;
"offshore installation" means any installation which is maintained for underwater exploitation or exploration in the waters in or adjacent to the State up to the seaward limits of territorial waters, and the waters in any designated area within the meaning of the Continental Shelf Act, 1968 (No. 14 of 1968);
"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;
"prescription" means a perscription 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 acting in that capacity;
"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 II Production, 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
( c ) import or export a controlled drug.
(2) ( a ) Sub-article (1)(c) shall not apply to any drug specified in Schedule 4.
( 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 this article 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, produce, supply, offer to supply, import, export or have in his possession any controlled drug to which the licence relates.
	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 4,
( b ) a registered medical practitioner or registered dentist to administer to a patient any drug specified in Schedule 2 or 3,
( 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 Schedule 2 or 3.
	7 Exemptions 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 Schedule 2, 3 or 4 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 Schedule 2, 3 or 4 to any person who may lawfully have that drug in his possession, or
( b ) manufacture or compound any such drug.
(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, 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, produce any drug specified in Schedule 3 or Part I of Schedule 4;
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 Schedule 2, 3 or 4 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,
( 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 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 consists 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, research or analysis approved for the purpose by the Minister,
( d ) the State Chemist,
( e ) a public analyst appointed under section 10 of the Sale of Food and Drugs Act, 1875,
( f ) the Medical Director of the National Drugs Advisory Board,
( g ) 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 ,
( h ) 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 1977,
( i ) 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

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