Medicines Act 1968

Changes over time for: Section 10

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Changes to legislation:

Medicines Act 1968, Section 10 is up to date with all changes known to be in force on or before 21 December 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.

Changes to Legislation

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Changes and effects yet to be applied to Section 10:

s. 69(1A)(1B) added (prosp.) by 1997 c. 19 s. 1 Sch. para. 5(b)
s. 84B inserted by S.I. 2016/372 art. 12

Changes and effects yet to be applied to the whole Act associated Parts and Chapters:

Whole provisions yet to be inserted into this Act (including any effects on those provisions):

s. 69(1A)(1B) added (prosp.) by 1997 c. 19 s. 1 Sch. para. 5(b)
s. 84B inserted by S.I. 2016/372 art. 12

10 Exemptions for pharmacists. U.K.

(1)F1 ... The restrictions imposed by [F2regulations 17(1) (manufacturing of medicinal products) and 46 (requirement for authorisation) of the 2012 Regulations] do not apply to anything which is done in a registered pharmacy, a hospital [F3, a care home service ] or a health centre and is done there by or under the supervision of a pharmacist and consists of—

(a)preparing or dispensing a medicinal product in accordance with a prescription given by [F4an appropriate practitioner], or

(b)assembling a medicinal product [F5provided that where the assembling takes place in a registered pharmacy—

(i)it shall be in a registered pharmacy at [F6or from] which the business in medicinal products carried on is restricted to retail sale or to supply in circumstances corresponding to retail sale and the assembling is done with a view to such sale or supply either at [F6or from] that registered pharmacy or at [F6or from] any other such registered pharmacy forming part of the same retail pharmacy business, and

(ii)the medicinal product has not been the subject of an advertisement]; and those restrictions do not apply to anything done by or under the supervision of a pharmacist which consists of procuring the preparation or dispensing of a medicinal product in accordance with a prescription given by a practitioner, or of procuring the assembly of a medicinal product.

F7(2). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3)Those restrictions do not apply to the preparation or dispensing in a registered pharmacy of a medicinal product by or under the supervision of a pharmacist in accordance with a specification furnished by the person to whom the product is or is to be sold or supplied, where—

(a)the product is prepared or dispensed for administration to that person or to a person under his care, F8 ...

F8(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4)Without prejudice to the preceding subsections, the restrictions imposed by [F9regulations 17(1) (manufacturing of medicinal products) and 46 (requirement for authorisation) of the 2012 Regulations] do not apply to anything which is done in a registered pharmacy by or under the supervision of a pharmacist and consists of—

(a)preparing or dispensing a medicinal product for administration to a person where the pharmacist is requested by or on behalf of that person to do so in accordance with the pharmacist’s own judgment as to the treatment required, and that person is present in the pharmacy at the time of the request in pursuance of which that product is prepared or dispensed, or

(b)preparing a stock of medicinal products with a view to dispensing them as mentioned in subsection (1)(a) or subsection (3) of this section or in paragraph (a) of this subsection [F10provided that such stock is prepared with a view to retail sale or to supply in circumstances corresponding to retail sale and the preparation is done with a view to such sale or supply either at [F11or from] that registered pharmacy or at [F11or from] any other registered pharmacy forming part of the same retail pharmacy business];

and those restrictions do not apply to anything which is done in a hospital or a health centre by or under the supervision of a pharmacist and consists of preparing a stock of medicinal products with a view to dispensing them as mentioned in subsection (1)(a) of this section.

[F12(5)Without prejudice to the preceding subsections, the restrictions imposed by [F13 regulation 46 of the 2012 Regulations] do not apply to the preparation or dispensing in a registered pharmacy of a medicinal product by or under the supervision of a pharmacist where—

(a)the medicinal product is prepared or dispensed otherwise than in pursuance of an order from any other person, and

(b)the medicinal product is prepared with a view to retail sale or supply in circumstances corresponding to retail sale at [F14or from] the registered pharmacy at which it is prepared, and

(c)the medicinal product has not been the subject of an advertisement.

(6)Without prejudice to the preceding subsections, the restrictions imposed by [F15regulation 17(1) of the 2012 Regulations] do not apply to anything which is done in a registered pharmacy by or under the supervision of a pharmacist and consists of preparing a medicinal product with a view to retail sale or to supply in circumstances corresponding to retail sale at [F16or from] that registered pharmacy.

F17(6A). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F18(7). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F19(7A)The F20 ... Ministers may make regulations prescribing conditions which must be complied with if a thing is to be considered for the purposes of this section as done under the supervision of a pharmacist.

(7B)Conditions prescribed under subsection (7A) may relate to supervision in the case where the pharmacist is not at the place where the thing is being done, and in that case the thing is not to be so considered if no such conditions are prescribed.

(7C)In any case, compliance with any applicable conditions is sufficient for the thing to be so considered.]

(8)For the purposes of this section “advertisement" shall have the meaning assigned to it by [F21regulation 7 (advertisements relating to medicinal products) of the 2012 Regulations].]

[F22(9)In subsection (1) of this section, “care home service" has the meaning given by [F23paragraph 2 of schedule 12 to the Public Services Reform (Scotland) Act 2010 (asp 8) ]. ]

Textual Amendments

F1Words in s. 10(1) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 10(a) (with regs. 2(4), 3)

F2Words in s. 10(1) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 3(b) (with Sch. 32)

F3Words in s. 10(1) inserted (S.) (1.4.2002) by 2001 asp 8, s. 79, Sch. 3 para. 5(a); S.S.I. 2002/162, art. 2(h) (subject to arts. 3-13)

F4Words in s. 10(1) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 3(a) (with Sch. 32)

F5Words added by S.I. 1971/1445, art. 3(a)

F6Words in s. 10(1)(b)(i) inserted (1.12.2022) by The Pharmacy (Responsible Pharmacists, Superintendent Pharmacists etc.) Order 2022 (S.I. 2022/849), art. 1(3), Sch. 2 para. 2(a); S.I. 2022/1023, art. 2

F7S. 10(2) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 10(b) (with regs. 2(4), 3)

F8S. 10(3)(b) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 10(c) (with regs. 2(4), 3)

F9Words in s. 10(4) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 3(b) (with Sch. 32)

F10Words added by S.I. 1971/1445, art. 3(b)

F11Words in s. 10(4)(b) inserted (1.12.2022) by The Pharmacy (Responsible Pharmacists, Superintendent Pharmacists etc.) Order 2022 (S.I. 2022/849), art. 1(3), Sch. 2 para. 2(b); S.I. 2022/1023, art. 2