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

Accountable officers to secure the safe management and use of controlled drugs

9.—(1) An accountable officer must—

(a) both—

(i) establish and operate, or ensure that his designated body establishes and operates, appropriate arrangements for securing the safe management and use of controlled drugs by the designated body, and

(ii) ensure that a body or person acting on behalf of, or providing services under arrangements made with, his designated body establishes and operates appropriate arrangements for securing the safe management and use of controlled drugs by that body or person; and

(b) both—

(i) review, or ensure that his designated body reviews, arrangements established by him or his designated body in accordance with sub-paragraph (a)(i), and

(ii) ensure that a body or person acting on behalf of, or providing services under arrangements made with, his designated body reviews arrangements established by it or him in accordance with sub-paragraph (a)(ii).

(2) In particular, an accountable officer must, as part of these arrangements—

(a) establish or ensure that his designated body (and any body or person acting on behalf of, or providing services under arrangements made with, his designated body) establishes appropriate arrangements to comply with misuse of drugs legislation; and

(b) ensure that his designated body (and any body or person acting on behalf of, or providing services under arrangements made with his designated body) has adequate and up-to-date standard operating procedures in place in relation to the management and use of controlled drugs.

(3) The standard operating procedures must, in particular, cover the following matters—

(a) who has access to the controlled drugs;

(b) where the controlled drugs are stored;

(c) security in relation to the storage and transportation of controlled drugs as required by misuse of drugs legislation;

(d) disposal and destruction of controlled drugs;

(e) who is to be alerted if complications arise; and

(f) record keeping, including—

(i) maintaining relevant controlled drugs registers under misuse of drugs legislation, and

(ii) maintaining a record of the controlled drugs specified in Schedule 2 to the Misuse of Drugs Regulations 2001(1) (specified controlled drugs to which certain provisions of the Regulations apply) that have been returned by patients.

(1)

2001/3998; the relevant amending instrument is S.I.2003/1432.