The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2005

Explanatory Note

(This note is not part of the Regulations)

This Order makes amendments to certain Orders relating to the prescribing and supply of medicines.

Part 2 amends the Medicines for Human Use (Prescribing) Order 2005 (“the Prescribing Order”). Article 2 of that Order created a new exemption from the restrictions imposed by sections 7 and 8 of the Medicines Act 1968 (general provisions as to dealing with medicinal products and provisions as to manufacture and wholesale dealing). It provides that the restrictions imposed by those sections shall not apply to the preparation or dispensing or to procuring the preparation or dispensing of a medicinal product for human use in accordance with a presciption given by a supplementary prescriber where this is done by or under the supervision of a pharmacist in a registered pharmacy, hospital or health care centre or, in Scotland, in a care home service.

Article 2 amends the definition of “supplementary prescriber” to include certain registered optometrists, and makes certain other related amendments to the definitions in the Prescribing Order.

Part 3 amends the Prescription Only Medines (Human Use) Order 1997 (“the POM Order”) which specifies the description and classes of medicines (“prescription only medicines”) which may be sold or supplied only in accordance with the prescription of an “appropriate practitioner”, and may be administered only in accordance with the directions of such a practitioner. Article 3 amends article 2 of the POM Order to extend the definition of “supplementary prescriber” to include certain registered optometrists and makes various other related amendments to the definitions in the POM Order. Article 4 makes changes to the list of medicines in article 7 of the POM Order which may be administered parenterally by any person in an emergency.

Article 5 amends article 13A of the POM Order so that a pharmacist may supply a prescription only medicine in accordance with a prescription given by a registered optometrist if, having exercised all due diligence he believes on reasonable grounds that person is a supplementary prescriber. Article 6 amends Schedule 3A to the POM order to make changes to the list of medicines which may be prescribed by extended formulary nurse prescribers.

Article 7 amends Schedule 5 to the POM Order (exemptions from restrictions on supply or administration of prescription only medicines), to provide that, in addition to those medicines which may be sold or supplied in the course of their professional practice by all optometrists, certain other medicines may be sold or supplied by a registered pharmacist to an “additional supply optometrist”, and that those medicines may be sold or supplied by an additional supply optometrist in the course of that person’s professional practice and in an emergency. It also amends Schedule 5 to provide that water for injection may be supplied in the course of a lawful drug treatment service.

Part 4 amends the Medicines (Pharmacy and General Sale— Exemption) Order 1980 (“ the Pharmacy and General Sale Order”) which provides for exemptions from sections 52 and 53 of the Medicines Act 1968 (restrictions on the sale or supply of medicinal products). Article 8 amends article 1 of the Pharmacy and General Sale Order to extend the definition of “supplementary prescriber” to include certain optometrists and to make certain other related amendments to the definitions in that Order.

Article 9 amends Schedule 1 to the Pharmacy and General Sale Order to provide that, in addition to those medicines which may be sold or supplied by all registered optometrists, certain additional medicines may be sold or supplied by “additional supply optometrists”. Article 9 also provides that the term “registered opthalmic optician”, which is used in Schedule 1 is replaced with the term “registered optometrist”. It also amends Schedule 1 to provide that water for injection may be supplied in the course of a lawful drug treatment service.

A Regulatory Impact Assessment in relation to this Order has been placed in the libraries of both Houses of Parliament and copies may be obtained from the Department of Health, Medicines and Healthcare products Regulatory Agency, Information Centre, Room 10–202 Market Towers, 1 Nine Elms Lane, London SW8 5NQ.