Regulation of Retail Pharmacy Businesses Regulations 2008
Statutory Instruments
Source: Statutory Instruments

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paragraphs: These Regulations may be cited as the Regulation of Retail Pharmacy Businesses Regulations 2008.
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paragraphs: (1) Subject to paragraph (2), these Regulations shall come into force on 29th November 2008.
(2) Except in the case of a new retail pharmacy business, Regulation 4(3) shall come into force on 1 November 2010.
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paragraphs: (1) In these Regulations—
(2) In these Regulations, unless the context otherwise requires, any reference to a Regulation shall be construed as a reference to a Regulation contained in these Regulations, and any reference in a Regulation to a paragraph shall be construed as a reference to a paragraph in that Regulation.
(3) In these Regulations, unless the contrary intention is indicated, these Regulations apply to medicinal products other than veterinary medicinal products.
(4) A word or expression that is used in these Regulations and is used in the Act has, in these Regulations, unless the contrary intention appears, the same meaning as it has in the Act.
(5) Insofar as animal remedies are concerned, these Regulations are in addition to, and not in substitution of, the animal remedies regulations.
4. (1) (a) The pharmacy owner shall provide and maintain such staff, premises, equipment and procedures for the storage, preparation, dispensing, compounding, sale and supply of medicinal products, including veterinary medicinal products, that he or she stores, prepares, dispenses, compounds, sells and supplies in his or her retail pharmacy business, as are necessary to avoid deterioration of the products and he or she shall not use for any such purposes premises other than those that constitute his or her retail pharmacy business and which have been specified in his or her application for registration under section 17 of the Act.
(b) The pharmacy owner shall ensure that, in the conduct of his or her retail pharmacy business and in particular in making provision for the staff, premises and other matters referred to in sub-paragraph (a) of this paragraph, he or she has regard for the health, safety and convenience of the public.
(2) The pharmacy owner shall ensure that the arrangements and layout of the premises are such as to enable personal supervision to be exercised by a registered pharmacist of any preparation, dispensing or compounding and of the sale or supply of medicinal products, including veterinary medicinal products, at one and the same time.
(3) The pharmacy owner shall provide a separate and designated area conveniently located within the pharmacy premises so that a pharmacist may review and discuss in private with the person for whom a prescription has been issued, or with the carer of such a person, such matters relating to the medicine therapy as either of the said persons may request or as the pharmacist, in the exercise of his or her professional judgment, may deem necessary.
(4) The pharmacy owner shall provide and maintain a safe or cabinet that meets the requirements of Regulation 5 of the Misuse of Drugs (Safe Custody) Regulations 1982 ( S.I. No. 321 of 1982 ) (as amended by Regulation 26(2) of the Misuse of Drugs Regulations 1988 ( S.I. No. 328 of 1988 )) and shall ensure that the said safe or cabinet has a sufficient capacity to permit the orderly storage and safe keeping of all the relevant controlled drugs, including such veterinary medicinal products as are relevant controlled drugs, as required by the aforementioned Regulation 5.
(5) The pharmacy owner shall ensure that any disposal of medicinal products, including veterinary medicinal products, that may be required to be carried out in the course of conducting a retail pharmacy business, is carried out in a manner which will not result in any danger to public health or risk to the environment.
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paragraphs: (1) The pharmacy owner and the superintendent pharmacist shall, inter alia, ensure that—
(a) the part of the retail pharmacy business that consists of the management and administration of the sale and supply of medicinal products, including veterinary medicinal products, is carried out under his or her personal control and in accordance with all legal requirements,
(b) at each premises where the retail pharmacy business is carried on, there is a supervising pharmacist who has a 3 year minimum post-registration experience in whole-time charge of the carrying on of the business there,
(c) an ongoing, contemporaneous and retrievable record of any other registered pharmacist, responsible for the retail pharmacy business or for the personal supervision of the sale and supply of medicinal products, including veterinary medicinal products, at the premises, is maintained,
(d) the sale or supply of medicinal products, including veterinary medicinal products, and the preparation, dispensing and compounding of prescriptions, including veterinary prescriptions, at the premises, are carried out by or under the personal supervision of a registered pharmacist,