Citation and commencement

1. These Regulations may be cited as the National Health Service (Pharmaceutical Services) Amendment Regulations 2012 and come into force on 1st July 2012.

Amendment of the National Health Service (Pharmaceutical Services) Regulations 2005

2. —(1)The National Health Service (Pharmaceutical Services) Regulations 2005( 2 ) are amended as follows.

(2) In paragraph 8 of Schedule 1( 3 ) (terms of service of pharmacists – providing ordered drugs or appliances)—

(a) in sub-paragraph (8)—

(i) omit “, subject to sub-paragraph (9),”, and

(ii) in paragraph (f), omit “calendar pack or”;

(b) omit sub-paragraph (9);

(c) omit paragraph (a) of sub-paragraph (10); and

(d) after sub-paragraph (10) insert the following sub-paragraph—

“ (10A) Where a drug is ordered by a prescriber on a prescription form or repeatable prescription in a quantity that is, or is a multiple of a quantity that is, readily available in a pack size manufactured for a holder of a marketing authorisation for the drug, the pharmacist must provide the drug in an original pack (or in original packs) of that size which has been assembled by a manufacturer of the drug for such a holder of a marketing authorisation, unless—

(a) it is not possible for the pharmacist to obtain such a pack (or packs) with reasonable promptness in the normal course of business; or

(b) it is not practicable for the pharmacist to provide such a pack (or packs) in response to the order (for example, because of patient needs or the method of administration of the drug). ” .

(3) In paragraph 13AA(2) of Schedule 3( 4 ) (terms of service of suppliers of appliances – clinical governance), for paragraph (f) substitute the following paragraph—

“ (f) an information governance programme, which provides for—

(i) compliance with approved procedures for information management and security, and

(ii) submission of an annual self assessment of compliance (to an approved level) with those procedures via approved data submission arrangements which allow the Primary Care Trust to access that assessment. ” .