The Controlled Drugs (Supervision of Management and Use) Regulations 2006

PART 3 Entering premises, periodic inspections etc.

Accountable officers to carry out periodic inspections

19.—(1) An accountable officer, who is an accountable officer nominated or appointed by a Primary Care Trust or Health Board, must establish and operate appropriate arrangements or ensure that his designated body establishes and operates appropriate arrangements for making, in connection with the performance of functions under these Regulations, periodic inspections (in accordance with section 20 of the 2006 Act) of premises which are—

(a) used in connection with management or use of controlled drugs; and

(b) not subject to inspection by—

(i) the Healthcare Commission,

(ii) the Commission for Social Care Inspection, or

(iii) the Royal Pharmaceutical Society of Great Britain.

(2) Where a designated body has authorised in writing under section 20(5)(c) of the 2006 Act a person to carry out inspections of relevant premises (or of specific relevant premises), the arrangements under paragraph (1) may (where appropriate) provide for that person to carry out periodic inspections under the arrangements.

(3) The accountable officer, or the person referred to in paragraph (2), is not required to give notice of the inspection to the owner or occupier of the premises.

(4) The accountable officer, or the person referred to in paragraph (2), must keep a record of all the inspections carried out by him as part of the arrangements made under paragraph (1).

(5) That record of inspections may be kept in paper or electronic format.

Relevant premises

20.—(1) For the purposes of section 20 of the 2006 Act, the following are prescribed as relevant premises which may be inspected by an accountable officer who is an accountable officer nominated or appointed by a Primary Care Trust, Health Board or Special Health Board or (where appropriate) by a member of the staff of the Primary Care Trust, Health Board or Special Health Board—

(a) the premises of the Primary Care Trust, Health Board or Special Health Board for which he is the accountable officer or (where appropriate) of which he is a member of staff;

(b) the premises of a body or person acting on behalf of, or providing services under arrangements made with, that Primary Care Trust, Health Board or Special Health Board, unless those arrangements are with an NHS trust, an NHS foundation trust or an English or Scottish independent hospital; and

(c) any other premises which are covered by arrangements established by virtue of regulation 19(1) but which are not mentioned in sub-paragraphs (a) or (b).

(2) For the purposes of section 20 of the 2006 Act, the following are prescribed as relevant premises which may be inspected by an accountable officer who is an accountable officer nominated or appointed by an NHS trust or an NHS foundation trust or (where appropriate) by a member of the staff of the trust—

(a) the premises of the trust for which he is the accountable officer or (where appropriate) of which he is a member of staff; and

(b) the premises of a body or person acting on behalf of, or providing services under arrangements made with, that trust, unless those arrangements are with a Primary Care Trust, a Health Board, Special Health Board or an English or Scottish independent hospital.

(3) For the purposes of section 20 of the 2006 Act, the following are prescribed as relevant premises which may be inspected by an accountable officer who is an accountable officer nominated or appointed by an English or Scottish independent hospital or (where appropriate) by a member of the staff of the independent hospital—

(a) the premises of the independent hospital for which he is the accountable officer; and

(b) the premises of a body or person acting on behalf of, or providing services under arrangements made with, that independent hospital, unless those arrangements are with a Primary Care Trust, a Health Board, a Special Health Board, an NHS trust or a foundation trust.

(4) All the premises mentioned in paragraphs (1) to (3) are also prescribed as relevant premises in relation to constables and persons authorised by the relevant authority under section 20(5)(a) (and accordingly they may exercise the powers under section 20 of the 2006 Act as regards those premises).

(5) An authorisation given under section 20(5)(a) or (c) of the 2006 Act must be in writing.

(6) An accountable officer (“the first accountable officer”) may request in writing that an accountable officer of another designated body of the same type (or in the case of a health service body in Scotland, of another health service body in Scotland) inspect—

(a) the premises of the designated body of the first accountable officer; or

(b) the premises of a body or person acting on behalf of, or providing services under arrangements made with the designated body of the first accountable officer,

subject to an appropriate authorisation being granted.

Inspections of private dwellings not requiring the presence of a constable

21.  Section 20(3) of the 2006 Act does not apply as regards—

(a) a member of staff of, or person authorised by, the Commission for Social Care Inspection entering an English care home;

(b) an officer of the Royal Pharmaceutical Society of Great Britain entering a registered pharmacy;

(c) a member of staff of, or a person authorised by, a designated body, entering premises which are or form part of a private dwelling of a health care professional—

(i) who is providing health care (which includes the services of a pharmacist) at the private dwelling, and

(ii) the private dwelling is on a statutory register of health care premises or is designated as practice premises under arrangements with a Primary Care Trust or Health Board to provide primary medical or dental services.