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Regulation of Health and Social Care Professionals Consultation

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Medicines Act 1968. 4 The definition <strong>of</strong> a retail pharmacy business is any business<br />

that includes the sale <strong>of</strong> medicinal products other than those on a general sales<br />

list. 5<br />

11.9 The relevant rules require that the register must contain certain information such<br />

as the address <strong>of</strong> the premises, the name <strong>and</strong> address <strong>of</strong> the person carrying on<br />

a retail pharmacy business at the premises <strong>and</strong> any conditions to which<br />

registration is subject. 6 The rules also specify the contents <strong>of</strong> the application form<br />

for registration <strong>and</strong> renewal, <strong>and</strong> the procedures for annotation <strong>and</strong> voluntary<br />

removal from the register. 7 Other aspects <strong>of</strong> the legal framework include statutory<br />

powers for the Registrar to remove a registered pharmacy from the register if it<br />

fails to meet the relevant st<strong>and</strong>ards or its entry has been fraudulently procured or<br />

incorrectly made, <strong>and</strong> restore it to the register. 8<br />

St<strong>and</strong>ards<br />

11.10 The General Pharmaceutical Council is required to make rules about the<br />

st<strong>and</strong>ards that are to be met for carrying on a retail pharmacy business at a<br />

registered pharmacy. Owners <strong>and</strong> superintendent pharmacists are responsible<br />

for ensuring that the published st<strong>and</strong>ards for retail pharmacy business are met.<br />

These st<strong>and</strong>ards apply to matters such as record keeping, operating procedures,<br />

staff training, incident reporting, h<strong>and</strong>ling <strong>and</strong> storage <strong>of</strong> medicinal products, the<br />

condition <strong>of</strong> the premises, conducting <strong>of</strong> clinical procedures, <strong>and</strong> management <strong>of</strong><br />

waste. 9 Any question about the fitness to practise <strong>of</strong> individuals operating within<br />

the premises is dealt with by the normal fitness to practise procedures, although<br />

all pr<strong>of</strong>essionals operating within the retail pharmacy must comply with the set<br />

st<strong>and</strong>ards. Thus the st<strong>and</strong>ards for retail pharmacy business detail what is<br />

required within the retail pharmacy business, rather than simply the duties <strong>of</strong> the<br />

owner or superintendent. The Council also makes rules specifying the st<strong>and</strong>ards<br />

needed in order for an annotation in the register in respect <strong>of</strong> a specialism. 10<br />

11.11 The General Pharmaceutical Council must also make provision in rules requiring<br />

any person carrying on a retail pharmacy business to provide information to the<br />

Council. Such information includes the details <strong>of</strong> the person carrying on the retail<br />

pharmacy business <strong>and</strong> any relevant criminal <strong>of</strong>fences that such an individual<br />

has been charged with whether or not the charge has resulted in a caution or<br />

conviction. 11<br />

11.12 Although the General Pharmaceutical Council is not a product regulator, the<br />

regulation <strong>of</strong> medicines is an important aspect <strong>of</strong> the overall legal framework for<br />

st<strong>and</strong>ard setting through the provisions <strong>of</strong> the Medicines Act 1968 <strong>and</strong> Poisons<br />

4 Pharmacy Order 2010, SI 2010 No 231, art 19(1).<br />

5 Medicine Act 1968, s 132.<br />

6<br />

General Pharmaceutical Council (Registration Rules) Order <strong>of</strong> Council 2010, SI 2010 No<br />

1617, r 6(1).<br />

7 As above, rr 21 to 30.<br />

8 Pharmacy Order 2010, SI 2010 No 231, arts 29(3)(b) <strong>and</strong> 37(2).<br />

9 As above, art 7(1).<br />

10 As above, art 27(1)(f).<br />

11 As above, art 7(4) to (7).<br />

205

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