The Human Medicines Regulations 2012

Pharmacy records U.K.

253.—(1) A person lawfully conducting a retail pharmacy business must, in respect of every sale or supply of a prescription only medicine, make or cause to be made an entry in a written or computerised record kept for that purpose.

(2) An entry required by paragraph (1)—

(a) must state the particulars specified in Schedule 23; and

(b) subject to paragraph (3), must be made—

(i) on the day of the sale or supply, or

(ii) if that is not reasonably practicable, on the day following that day.

(3) Where the sale or supply is made under regulation 224 (emergency sale etc by pharmacist: prescriber unable to provide prescription), the particulars specified in paragraph 2(e) and (f) of Schedule 23 may be entered on the day that the prescription is received.

(4) Paragraphs (1) to (3) do not apply if any of the following apply—

(a) the sale or supply is in pursuance of a health prescription or a prescription for oral contraceptives;

(b) a separate record of the sale or supply is made in accordance with the Misuse of Drugs Regulations 2001 or the Misuse of Drugs Regulations (Northern Ireland) 2002;

(c) the sale is by way of wholesale dealing and the order or invoice relating to the sale or a copy of the order or invoice is retained by the person lawfully conducting the retail pharmacy business who makes the sale;

(d) in Scotland, the sale or supply is to a doctor for use in the circumstances referred to in paragraph 45 of Schedule 5 to the National Health Service (General Medical Services Contracts) (Scotland) Regulations 2004 M1 (provision of drugs, medicines and appliances for immediate treatment or personal administration);

(e) in Northern Ireland, the sale or supply is to a doctor for use in the circumstances referred to in paragraph 47 of Schedule 5 to the Health and Personal Social Services (General Medical Services Contracts) Regulations (Northern Ireland) 2004 M2 (provision of drugs, medicines and appliances for immediate treatment or personal administration).

(5) A person lawfully conducting a retail pharmacy business must preserve for a period of two years beginning immediately after the relevant date—

(a) the record kept under paragraphs (1) to (3);

(b) a prescription in pursuance of which a prescription only medicine has been sold or supplied other than—

(i) a health prescription, or

(ii) a prescription for a [F1 product subject to special medical prescription];

(c) an order or invoice referred to in paragraph (4)(c) or a copy of the order or invoice; and

(d) orders referred to in column 3 of Parts 1 to 3 of Schedule 17, except orders referred to in paragraph 3 of Part 1 of that Schedule.

(6) In paragraph (5) “the relevant date” means—

(a) in relation to sub-paragraph (a), the date on which the last entry is made in the record;

(b) in relation to sub-paragraphs (b), (c) and (d)—

(i) where the prescription only medicine was sold or supplied in accordance with a repeatable prescription, the date of the final sale or supply pursuant to that prescription, and

(ii) otherwise, the date on which the prescription only medicine was sold or supplied.

Textual Amendments

F1 Words in reg. 253(5)(b)(ii) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 5(2)(h) and words in reg. 253(5)(b)(ii) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 5(2)(h)

Marginal Citations

M1 S.S.I. 2004/115

M2 S.R. (NI) 2004 No. 140.