Medicines Act 1968

[F1 67B. Defence to offence of contravening section 63(a) or (b): product sold or supplied U.K.

(1) This section applies in a case where—

(a) a person (“the defendant”) is charged with an offence under section 67(2) of contravening section 63(a) or (b) in respect of a medicinal product; and

(b) the product was sold or supplied in its adulterated state.

(2) It is a defence for the defendant to prove that—

[F2 (a) the adulteration took place—

(i) at a registered pharmacy, or

(ii) in the course of the provision of a relevant pharmacy service;]

(b) the person who adulterated the product—

(i) was a registrant acting in the course of his or her profession, or

(ii) was acting under the supervision of a person (“the supervising registrant”) who was a registrant acting in the course of his or her profession;

(c) the product was—

(i) sold or supplied in pursuance of a prescription or directions given by a relevant prescriber or a patient group direction, or

(ii) a prescription only medicine that was sold or supplied in circumstances where there was an immediate need for it to be sold or supplied and a prescription could not have been obtained without undue delay; and

(d) Condition A or B is met.

(3) Condition A is that before the defendant was charged—

(a) the defendant did not know that the product had been adulterated; and

(b) if the defendant is a person within subsection (4), neither the person who adulterated the product nor (in a case within subsection (2)(b)(ii)) the supervising registrant knew that the product had been adulterated.

(4) A defendant is a person within this subsection if the defendant is any of the following—

(a) the person who adulterated the product;

(b) (in a case within subsection (2)(b)(ii)) the supervising registrant;

(c) the person carrying on the retail pharmacy business [F3 , or the relevant pharmacy service,] in the course of which the product was sold or supplied.

(5) Condition B is that—

(a) before the defendant was charged, an appropriate person, on becoming aware that the product had been adulterated—

(i) promptly ensured that all reasonable steps were taken to ensure that the person to whom the product was intended to be administered was notified that the product had been adulterated, or

(ii) reasonably formed the view that it was not necessary or appropriate to do so, in the circumstances of the case; and

(b) the defendant did not know at the time that the product was sold or supplied that it had been adulterated.

(6) In subsection (5), “appropriate person” means any of the following—

(a) the person who adulterated the product or (in a case within subsection (2)(b)(ii)) the supervising registrant;

(b) the person carrying on the retail pharmacy business [F4 , or the relevant pharmacy service,] in the course of which the product was sold or supplied, or any person acting on that person’s behalf.]

Textual Amendments

F1 Ss. 67A-67E inserted (16.4.2018) by The Pharmacy (Preparation and Dispensing Errors Registered Pharmacies) Order 2018 (S.I. 2018/181), arts. 1(3), 4 (with art. 2); S.I. 2018/402, art. 2

F2 S. 67B(2)(a) substituted (1.12.2022) by The Pharmacy (Preparation and Dispensing Errors – Hospital and Other Pharmacy Services) Order 2022 (S.I. 2022/851), arts. 1(3), 6(2) (with art. 3); S.I. 2022/1024, art. 2

F3 Words in s. 67B(4)(c) inserted (1.12.2022) by The Pharmacy (Preparation and Dispensing Errors – Hospital and Other Pharmacy Services) Order 2022 (S.I. 2022/851), arts. 1(3), 6(3) (with art. 3); S.I. 2022/1024, art. 2

F4 Words in s. 67B(6)(b) inserted (1.12.2022) by The Pharmacy (Preparation and Dispensing Errors – Hospital and Other Pharmacy Services) Order 2022 (S.I. 2022/851), arts. 1(3), 6(4) (with art. 3); S.I. 2022/1024, art. 2