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Regulation 217C Original pack dispensing: medicinal products containing a relevant substanceF1

England, Wales and Scotland

(1)

Subject to paragraph (2) and for the purposes of this Part, the sale or supply of a prescription only medicine containing a relevant substance is not in accordance with a prescription unless—

(a)

it is sold or supplied in its manufacturer’s original outer packaging; and

(b)

if the sale or supply is of a quantity that is different to the quantity which has been ordered on the prescription, it is sold or supplied in a quantity which is as close as possible to the quantity in which it has been ordered on the prescription.

(2)

Paragraph (1) does not apply where—

(F2a)

the sale or supply is—

(i)

by or under the supervision of or pursuant to an authorisation (under regulation 220B) given by a pharmacist, or

(ii)

in Great Britain, by or under the supervision of a registered pharmacy technician, pursuant to an authorisation (under regulation 220A) given by a pharmacist; and

(b)

the pharmacist F3(in a case to which paragraph (a)(i) applies) or registered pharmacy technician (in a case to which paragraph (a)(ii) applies) is satisfied that—

(i)

a risk assessment is in place that refers to the need for the patient to be sold or supplied the medicine containing a relevant substance in different packaging from its manufacturer’s original outer packaging (for example in a monitored dosage system); and

(ii)

unless the medicine containing a relevant substance is unauthorised (other than by reason of it being an authorised product that has ceased to be so as a result of a process of assembly), processes are in place to ensure the supply to or for the patient of the package leaflet.

(3)

In this regulation, “relevant substance” means any of the following—

(a)

sodium valproate;

(b)

valproic acid;

(c)

valproate semisodium.

Annotations

Textual amendments

F1

Regs. 217B, 217C inserted (E.W.S.) (11.10.2023) by The Human Medicines (Amendment Relating to Original Pack Dispensing) (England and Wales and Scotland) Regulations 2023 (S.I. 2023/1015), regs. 1(2), 2(2)

F2

Reg. 217C(2)(a) substituted (7.1.2026) by The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 (S.I. 2025/1249), arts. 1(2)(5)(c), 12(9)(a) (with reg. 12(19)(c))

F3

Words in reg. 217C(2)(b) inserted (7.1.2026) by The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 (S.I. 2025/1249), arts. 1(2)(5)(c), 12(9)(b)

Notes on Part 12

Modifications

C1

Pt. 12 modified (E.W.) (1.10.2015) by The Nicotine Inhaling Products (Age of Sale and Proxy Purchasing) Regulations 2015 (S.I. 2015/895), regs. 1(3), 4(2)