Commentary on Sections Part 3Chapter 2 .Medicines and Pharmacies Section 30: The responsible pharmacist
143.Section 30 inserts two new sections 72A and 72B of the Medicines Act, to make provision in relation to the “responsible pharmacist” mentioned in sections 70, 71 and 72 of the Medicines Act (as amended by this Act).
144.Section 72A(1) places a duty on the responsible pharmacist to secure the safe and effective running of the pharmacy business in question, insofar as this concerns the retail sale of medicines, or the supply of medicines in circumstances corresponding to retail sale (e.g. the supply of medicines in accordance with NHS prescriptions). Section 72A(2) states that a pharmacist may not be in charge of more than one set of pharmacy premises except in circumstances specified in regulations made by the Health Ministers (i.e. the Secretary of State for Health and the Northern Ireland Department for Health, Social Services and Public Safety), and then only if such conditions as may be specified are complied with. Section 72A(3) to (5) impose requirements relating to the procedures which must be established and maintained by the responsible pharmacist and as to record keeping.
145.Section 72A(6) provides for the Health Ministers to make further provision in regulations in relation to the responsible pharmacist. Section 72A(7) provides that those regulations may in particular make provision about the matters referred to in section 72A(1) to (4); i.e. the duties of the responsible pharmacist, the circumstances in which a person may be a responsible pharmacist in respect of more than one set of premises at a time, the duty to establish and maintain procedures and the duty to keep records. Furthermore, section 72A(7) provides that the regulations may make provision for a variety of related matters including: the qualifications and experience that a pharmacist must have to be a responsible pharmacist; the responsible pharmacist’s absence from the pharmacy (for example, to impose conditions as to how long a responsible pharmacist may be absent); his supervision of the preparation, assembly, dispensing and supply of medicines at the pharmacy when he is not present; the circumstances in which he may supervise such activities at a pharmacy when he is not the responsible pharmacist for that pharmacy; the format and content of procedures to secure the safe and effective running of the business; and the form and content of the records which must be made by the responsible pharmacist.
146.New section 72B(1) provides that where a person fails to comply with any requirements of new section 72A of the Medicines Act, or of regulations made under that section, this may constitute misconduct for the purposes of section 80 of the Medicines Act, section 8 of the Pharmacy Act 1954 and Article 20 of the Pharmacy (Northern Ireland) Order 1976; and the Statutory Committee of the Royal Pharmaceutical Society of Great Britain or the Pharmaceutical Society of Northern Ireland may deal with such a failure accordingly. Section 72B(2) provides that if a pharmacist does not have the qualifications and experience specified in the regulations, he cannot act as a responsible pharmacist. If such a person is in charge of the retail sale/supply of medicines at a pharmacy, the person carrying on the retail pharmacy business in question will not be lawfully conducting that business.
147.Under section 72B(3) and (4), if a pharmacist is absent from the pharmacy for a period longer than that permitted in the regulations, or is named as responsible pharmacist for more than one pharmacy without satisfying the requirements in the regulations which govern such matters, they cannot be considered for the purposes of these provisions as being in charge of the business at the pharmacy. Unless another responsible pharmacist is appointed for the pharmacy, the person carrying on the retail pharmacy business in question will not be lawfully conducting that business.
148.Section 30(2) makes a consequential amendment to section 77 of the Medicines Act, which deals with the annual return, which every person carrying on a retail pharmacy business must make to the registrar responsible for keeping the register of retail pharmacies under the Medicines Act. The amendment removes the requirement to send to the registrar the name of the pharmacist in personal control of the retail pharmacy business.
149.Section 30(3) amends section 84 of the Medicines Act, which relates to criminal offences under Part 4 of the Medicines Act. The new provision makes it a criminal offence for a person to fail to comply with the record keeping requirements imposed under the new section 72A. Any person guilty of the offence would be liable on conviction in the magistrates’ court to a fine not exceeding level 3 on the standard scale, currently up to £1,000.