A summary of The Misuse of Drugs Act (Safe Custody Regulations 1975)

The following is an extract from the above act and is intended for Pharmacautical medical use only. Guidelines are constantly being updated and we recommend contacting your inspectorates if you are refurbishing your premises with new cabinets.

** For example Ketamine a substance used by Veterinaries is now a Controlled Drug Substance. Recently added.  

(We accept no responsibility for use by third parties.)

Made 19th April 1973

Authority: Misuse of Drugs Act 1971,ss 10(2) (a), 31

1. These regulations may be cited as the Misuse of Drugs (safe custody) regulations 1973 and (with the exception of regulations 3 and 4 and Schedule 2 which shall come into operation on the 1st April 1975) shall come into operation on 1st July 1973.

NOTES

Amendment

Words in square brackets substituted by St1974/1449, reg.

2. (1) in these regulations, unless the context otherwise requires the expression-

“the act” means the Misuse of drugs act 1971;

“retail dealer” means a person lawfully conducting a retail pharmacy business or a pharmacist engaged in supplying drugs to the public at a health centre within the meaning of the medicines act 1968

(3) the interpretation act 1889 shall apply for the interpretation of these regulations as it applies for the interpretation of an act of Parliament.

3. (1) This regulation applies to the following premises, that is to say;-

(a) any premises occupied by a retail dealer for the purpose of his business:

(b) any nursing home within the meaning of part V1 of the public health act 1936 or the nursing homes registration (Scotland) act 1938;

(c) any residential or other establishment provided under or by virtue of section 59 of the social work (Scotland) act 1968;

(d) any mental nursing home within the meaning of part III of the mental health act 1959;

(e) any private hospital within the meaning of the mental health act (Scotland) act 1960.

(2) Subject to paragraph (4) of this regulation, the occupier and every person concerned in the management of any premises to which this regulation applies shall ensure that all controlled drugs ( other than those specified in schedule 1 to these regulations) on premises are, so far as circumstances permit, kept in a locked safe, cabinet or a room which is so constructed and maintained as to prevent unauthorized access to the drugs.

(3) Subject to regulations 4 of these regulations, the relevant requirements of schedule 2 to these regulations shall be completed within relation to every safe, cabinet or room in which controlled drugs are kept in pursuance of paragraph (2) of this regulation.

(4) It shall not be necessary to comply with the requirements of paragraph (2) of this regulation in respect of any controlled drug which is for the time being under the direct personal supervision of-

(a) in the case of any premises falling within paragraph (1) (a) of this regulation, a pharmacist in respect of whom no direction under section 12(2) of the act is for the time being in force.

(b) In the case of premises falling within paragraph(1)(b) to(e) of this regulation, the person in charge of the premises or any member of his staff designated by him for the purpose.

4.

1) Paragraph (3) of regulation 3 of these regulations shall not have effect in relation to a safe, cabinet or room situated on any premises occupied for the purpose of his business by a person lawfully conducting a retail pharmacy business ( hereafter in this regulation referred to as “the occupier”) if a certificate has been issued in pursuance of paragraph (2) of this regulation (hereafter in this regulation referred to as a certificate”)

(2) On receiving written application in that behalf from the occupier, the chief of police for the police area in which the premises in question are situated may-

(a) cause the said premises and, in particular, any safe, cabinet or room in which controlled drugs are to be kept, to be inspected; and

(3) If satisfied that, in all the circumstances of the case, the safes, cabinets, or rooms in which the controlled drugs (other that those specified in schedule1 to these regulations) are kept provide and adequate degree of security, issue a certificate in respect of those safes cabinets or rooms.

(4) Where a certificate is in force in respect of any safe, cabinet or room on any premises, the chief officer in respect of police may cause the premises to be inspected at any reasonable time for the purpose of ascertaining whether any conditions specified in the certificate are being observed and whether as a result any change of circumstances the safes, cabinets and rooms to which the certificate relates have ceased to provide an adequate degree of security.

(4) A certificate may be cancelled by the chief officer of police if it appears to him that:-

a) There has been a breach of any condition specified in the certificate.

b) As a result of any change of circumstances, the safes, cabinets, or room to which the certificate relates no longer provides and adequate degree of security.

c) The occupier has refused entry to any police officer acting in pursuance of paragraph(4) of this regulation.

(5) A certificate shall unless previously cancelled in pursuance of paragraph (5) of this regulation, remain in force for a period of one year from the date of issue thereof, but may be from time to time renewed for a further twelve months.

5.

1) Where any controlled drug( other than a drug specified in Schedule 1 to these regulations) is kept otherwise than in a locked safe’ cabinet or room which is so constructed and maintained as to prevent unauthorized access to the drug, any person to whom this regulation applies having possession of the drug shall ensure that, so far as circumstances permit, it is kept in a locked receptacle which can be opened only by him or by a person authorized by him.

2) Paragraph (1) of this regulation applies to any person other than;

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

or

b. a person engaged in the business of a carrier when acting in the course of that business; or

c. a person engaged in the business of [a postal operator( within the meaning of the postal services act 2000)] when acting in the course of that business.

NOTES

Amendment

Para(2): in sub para-(c) words “ postal operator ( within the meaning of the postal services act 2000)” in square brackets substituted by SI 2001/1149, art 3(1), sch 1 para 37. date in force ; 26 march 2011: see SI 2001/1149, art 1(2).

SCHEDULE 1

EXEMPTED DRUGS

Amendment

Substituted by SI 1986/2332. reg 2. Regulation 3(2), 4(2)(b),5

a) Any controlled drug specified in schedule 4 or 5 to the Misuse of drugs regulations 1985.

b) Any liquid preparation designed for administration otherwise than by injection which contains any of the following substances and products, that is to say;-

(a) Amphetamine

(b) Benzphetamine

(c) Chlorphentermine

(d) Fenethylline

(e) Mephentermine

(f) Methaqualone

(g) Methylamphetamine

(h) Methylphenidate

(i) Phendimetrazine

(j) Phenmetrazine

(k) Pipradrol

(l) Any stereosisomeric form of a substance specified in any paragraph (a)

to ( k) above.

3

Any of the following substances ad products, that is to say:-

(a) Any 5,5 distributed barbituric acid

(b) cathine

(c) Ethchlorvynol

(d) Ethinamate

(e) mazindol

(f) Meprobamate

(g) Methylphenobarbitone

4

Any preporation or any other product consisting or one or more component parts, any of which contains a controlled drug, where-

(a) The preporation or other product is not designed for administration of the controlled drug to a human being or animal

(b) The controlled drug in any component part is packaged in such a form, or in combination with any other active or inert substances in such a manner, that it cannot be recovered by readily applicable means or in a yield which constitutes a risk to health; and

(c) no one component part of the product or preparation contains more than one milligram of the controlled drug or one microgram in the case of lysergide or any other N-alkyl derivative of lysergamide.

NOTES

Amendment

Substituted by Si 1986/2332, reg2

Para 4: inserted by SI 1999/1403, reg 2

Date in force: 1 July 1999: see SI 1999/1403, reg1

SCHEDULE 2

STRUCTURAL REQUIREMENTS IN RELATION TO SAFES CABINETS AND ROOMS USED FOR KEEPING DRUGS

1

In this schedule, the expression_

“ external wall”, in relation to any room, means a wall which forms part of the outside of the building in which the room is situated.

“party wall”, in relation to any room, means a wall dividing the premises in which the room is situated from other premises under different occupation.” the standard of 1963” means the British standard specification for a thief resistant locks for hinged doors BS 3621: 1963, as published on 6th May 1963:

“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.

Safes and cabinets.

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 upon an angle – iron frame of at least 25mm by 235mm section and of at least 5mm thick.

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

3. Each door shall be fitted with an effective lock-

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

(b) designed to permit at least 1000 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 19mm by 8mm section or incorporates a suitable anti-cutting devise and which has a total throw of at least 12mm.

4. if the length of the vertical closing edge of a door exceeds 914mm and the length of the horizontal edge exceeds 457mm 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 of the length 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. If a safe or cabinet is fitted with a two-leaf door, either-

(a) the lock or locks required by sub paragraph (3) above and (4) above shall be fitted with an integrated espagnolette bolt which is of at least 19mm by 8mm section and which has a total throw, at the top and bottom of at least 12mm: 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 6mm by 6mm section or 6mm diameter, each of which has a total throw of at least 12mm, 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 by means of at least two rag bolts each passing through an internal anchor plate of mild steel which is at least 3mm thickness and which has a surface area of at least 19355 square millimeters.

7. Nothing shall be displayed outside a safe or cabinet to indicate that the drugs are kept inside it.