S.I. No. 321/1982:

MISUSE OF DRUGS (SAFE CUSTODY) REGULATIONS, 1982

MISUSE OF DRUGS (SAFE CUSTODY) REGULATIONS, 1982

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

1. These Regulations may be cited as the Misuse of Drugs (Safe Custody) Regulations, 1982.

2. These Regulations shall come into operation on the 1st day of March, 1983.

3. (1) In these Regulations--

"the Principal Regulations" means the Misuse of Drugs Regulations, 1979 ( S.I. No. 32 of 1979 ).

(2) In these Regulations every reference to an article shall, except where the context otherwise indicates, be construed as a reference to an article contained in these Regulations and any reference in an article to a sub-article shall be construed as a reference to a sub-article of that article.

4. (1) Subject to the provisions of these Regulations, a person lawfully having in his possession any controlled drug specified in Schedule 1, 2 or 3 of the Principal Regulations shall ensure that, so far as circumstances permit, such drug is kept in a locked, fixed receptacle which can be opened only by him or by a person authorised by him.

(2) Sub-article (1) shall not apply as respects--

( a ) a person to whom the drug has been supplied by or on the prescription of a practitioner for his own treatment or that of another person or of an animal;

( b ) a person engaged in the business of a carrier when acting in the course of that business;

( c ) a person engaged in conveying the drug to a person authorised by virtue of the Principal Regulations to have that drug in his possession;

( d ) a person engaged in connection with the Postal Services provided by the Minister for Posts and Telegraphs when acting in the course of his duty as a person so engaged.

5. (1) Subject to sub-article (2), a person keeping open shop for the dispensing or compounding of medical prescriptions or for the sale of poisons in accordance with the Pharmacy Acts, 1875 to 1977, shall ensure that any controlled drug specified in Schedule 1, 2 or 3 of the Principal Regulations which he has in his possession is ordinarily kept in a locked safe or cabinet which is so constructed and maintained as to prevent unauthorised access to the drugs.

(2) Subject to article 6, every safe or cabinet in which controlled drugs are kept in pursuance of sub-article (1) shall be constructed and maintained in accordance with a standard which is at least equivalent to the requirements set out in the Schedule to these Regulations.

6. (1) Article 5 (2) shall not apply as respects a safe or cabinet where a certificate has been issued under sub-article (2) in respect of that safe or cabinet and is for the time being in force.

(2) A member of the Garda Síochána, not below the rank of Superintendent, may, on receipt of an application in writing--

( a ) inspect or cause to be inspected any safe or cabinet in which controlled drugs are to be kept and the premises in which such safe or cabinet is located, and

( b ) if such safe or cabinet provides a degree of security which, in his opinion, in all the circumstances of the case, is at least equivalent to that which would be provided by a safe or cabinet which complies with the requirements set out in the Schedule to these Regulations, issue a certificate in respect of that safe or cabinet.

(3) Every certificate issued under sub-article (2) shall specify any conditions which the member of the Garda Síochána considers necessary to ensure that each such safe or cabinet will provide an adequate degree of security.

(4) A certificate issued under sub-article (2) may be revoked by a member of the Garda Síochána, not below the rank of Superintendent, where--

( a ) there has been a breach of any condition specified in the certificate, or

( b ) as a result of any change of circumstances, any safe or cabinet to which the certificate relates no longer provides an adequate degree of security, or

( c ) the occupier has refused entry to any member of the Garda Síochána seeking such entry for the purpose of ascertaining whether any such breach or change has occurred.

(5) A certificate shall, unless revoked in pursuance of sub-article (4), remain in force for a period of two years but may from time to time be renewed for a further period of two years.

7. An officer of the Pharmaceutical Society of Ireland, with a written authorisation of that Society, may carry out such inspection as may be necessary for the purpose of ascertaining whether the provisions of Article 5 are being complied with.

8. Article 22 of the Principal Regulations is hereby revoked.

SCHEDULE

REQUIREMENTS IN RELATION TO SAFES AND CABINETS USED FOR KEEPING DRUGS

1. In this Schedule, the expression--

"two-leaf door" means a door having two leaves which either close on to each other or on to a central pillar, and the two leaves of any such door shall be treated for the purposes of this Schedule as a single door;

"sheet steel" means mild steel sheet being not lighter than 16 gauge.

2. (1) A safe or cabinet shall be constructed of--

( a ) pressed and welded sheet steel; or

( b ) pressed and welded steel mesh; or

( c ) sheet steel or steel mesh welded upon an angle-iron frame of at least 25 millimetres by 25 millimetres section and of at least 5 millimetres thickness.

(2) The clearance between the door and jamb or, in the case of a two-leaf door, between the two leaves of each leaf and a central pillar shall not be greater than 3 millimetres.

(3) Each door shall be fitted with an effective lock--

( a ) having at least 5 levers differing from each other or, in the case of a pin and tumbler mechanism, at least 6 pins;

( b ) designed to permit at least 1,000 effective key-differs independent of wards or any other fixed obstruction to the movement of the key; and

( c ) provided with a dead-bolt which is either of mild steel of at least 19 millimetres by 8 millimetres section or incorporates a suitable anti-cutting device and which has a total throw of at least 12 millimetres.

(4) Where the length of the vertical closing edge of a door exceeds 914 millimetres and the length of the horizontal edge exceeds 457 millimetres the door shall be fitted with two such locks as are specified in sub-paragraph (3) above, one situated at not more than one third of the length of the vertical closing edge from the top and the other at not more than one third from the bottom, but otherwise the lock required by sub-paragraph (3) above shall be situated in the centre of the vertical closing edge.

(5) Where a safe or cabinet is fitted with a two-leaf door, either--

( a ) the lock or locks required by sub-paragraphs (3) and (4) above shall be fitted with an integrated espagnolette bolt which is of at least 19 millimetres by 8 millimetres section and which has a total throw, at both the top and bottom, of at least 12 millimetres; or

( b ) the second opening leaf shall be secured at the top and bottom by means of internal bolts of mild steel of at least 6 millimetres by 6 millimetres section or 6 millimetres diameter, each of which has a total throw of at least 12 millimetres, the bolt handles being returnable into a holding recess.

(6) A safe or cabinet shall be rigidly and securely fixed to a wall or floor which is soundly constructed by means of at least two rag-bolts each passing through an internal anchor plate of mild steel which is of at least 3 millimetres thickness and which has a surface area of at least 19,355 square millimetres.

(7) Nothing shall be displayed outside a safe or cabinet to indicate that drugs are kept in it.

(8) For the purposes of sub-paragraph (6) "soundly constructed", in respect of a wall or floor, means constructed of solid brick, concrete block or mass concrete, of sufficient thickness, depth and strength to provide a firm and secure anchor.

3. (1) Subject to sub-paragraph (2) below where sheet steel is used in the construction of a safe or cabinet, its edges shall be lapped inwards around the margins of apertures and around the edges of doors in such manner as to be inaccessible from the outside; and where sheet steel is fixed on a framework, it shall be so fixed as to prevent removal from outside the safe or cabinet of which the framework forms part.

(2) Where sheet steel is used in the construction of the door or the leaf of a door of a safe or cabinet, its edges shall not be required to be lapped inwards as required by sub-paragraph (1) above where the sheet steel used is not lighter than 10 gauge and the door or leaf of the door fits flush, or is recessed, so that no edge protrudes when the door is closed.

(3) Steel mesh used in the construction of a safe or cabinet shall be--

( a ) welded steel mesh not lighter than 10 standard wire gauge having rectangular apertures not exceeding 75 millimetres by 12 millimetres; or

( b ) expanded steel not lighter than 12 gauge having diamond apertures not exceeding 44 millimetres by 19 millimetres.

(4) Except where otherwise specified in this Schedule, the edges of each panel of sheet steel or steel mesh used in the construction of a safe or cabinet shall be arc-welded to a steel frame along their entire length, or, in the absence of a steel frame, continuously arc-welded along the entire length of all joints.

(5) Each hinged door in a safe or cabinet shall be fitted with at least two hinges.

(6) If any part of the hinges of such a door is on the outside of the door, it shall be fitted with at least two dog-bolts of mild steel of similar gauge and dimensions to the frame of the safe or cabinet or an internal flange or rebate running the entire length of the door and so fitted as to prevent access without unlocking in the event of damage to the hinges.

(7) Each lock, bolt assembly and other means of securing doors in a safe or cabinet shall be fitted internally.

(8) The bolt of each lock and each other bolt or catch securing the cover of any aperture in a safe or cabinet shall be protected against cutting or manipulation from the outside.

(9) Each screw, bolt or other fixing device used in the construction of a safe or cabinet shall be such as to be incapable of being removed from the outside and shall be of a strength at least equal to that of the component part which it fixes.

GIVEN under the Official Seal of the Minister for Health this 28th

day of October 1982.

MICHAEL WOODS,

Minister for Health.

EXPLANATORY NOTE.

The Regulations prescribe a minimum standard for the safes and cabinets to be used in retail pharmacies for the safe custody of drugs specified in Schedules 1, 2 and 3 to the Misuse of Drugs Regulations, 1979. The Regulations also impose an obligation on persons lawfully having possession of controlled drugs to keep such drugs in a locked, fixed container so as to prevent unauthorised access to them. The Regulations come into operation on 1st March, 1983.