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The Human Medicines Regulations 2012

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Emergency sale etc by pharmacist: at patient's requestU.K.
This section has no associated Explanatory Memorandum

225.—(1) Regulation 214(1) does not apply to the sale or supply of a prescription only medicine by a person lawfully conducting a retail pharmacy business if conditions A to E are met.

(2) Condition A is that the pharmacist by or under whose supervision the prescription only medicine is to be sold or supplied has interviewed the person requesting it and is satisfied—

(a)that there is an immediate need for the prescription only medicine to be sold or supplied and that it is impracticable in the circumstances to obtain a prescription without undue delay;

(b)that treatment with the prescription only medicine has on a previous occasion been prescribed by a relevant prescriber for the person requesting it; and

(c)as to the dose which in the circumstances it would be appropriate for that person to take.

(3) Condition B is that for a prescription only medicine shown in column 1 of the following table, the quantity of the product that is sold or supplied does not exceed that shown in column 2 for that prescription only medicine—

Prescription only medicineMaximum quantity

A prescription only medicine that—

(a)is a preparation of insulin, an aerosol for the relief of asthma, an ointment or cream, and

(b)has been made up for sale in a package elsewhere than at the place of sale or supply.

The smallest pack that the pharmacist has available for sale or supply.

An oral contraceptive.A quantity sufficient for a full treatment cycle.
An antibiotic for oral administration in liquid form.The smallest quantity that will provide a full course of treatment.
A controlled drug within the meaning of Schedule 4 or 5 of the Misuse of Drugs Regulations 2001 or Schedule 4 or 5 of the Misuse of Drugs Regulations (Northern Ireland) 2002.Five days' treatment.
Any other prescription only medicine.30 days' treatment.

(4) Condition C is that the prescription only medicine—

(a)does not consist of or contain a substance specified in Schedule 18; and

(b)is not a [F1product subject to special medical prescription], other than a prescription only medicine that—

(i)consists of or contains phenobarbital or phenobarbital sodium, and

(ii)is sold or supplied for use in the treatment of epilepsy.

(5) Condition D is that an entry is made in the record kept under regulation 253 within the time specified in that regulation stating the particulars required under paragraph 4 of Schedule 23.

(6) Condition E is that the inner or outer packaging of the prescription only medicine is labelled to show—

(a)the date on which the prescription only medicine is sold or supplied;

(b)the name, quantity and (unless apparent from the name) the pharmaceutical strength of the prescription only medicine;

(c)the name of the person requesting the prescription only medicine;

(d)the name and address of the registered pharmacy from which the prescription only medicine is sold or supplied; and

(e)the words “Emergency Supply”.

(7) In this regulation “aerosol” means a product that is dispersed from its container by a propellant gas or liquid.

Textual Amendments

F1Words in reg. 225(4)(b) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 5(2)(e) and words in reg. 225(4)(b) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 5(2)(e)

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