These Regulations amend the Misuse of Drugs Regulations 2001 (the “2001 Regulations”) to allow a nurse independent prescriber and a pharmacist independent prescriber (defined in regulation 2(1) of the 2001 Regulations, as amended by regulation 3(b)) to prescribe, possess, supply, offer to supply, administer and give directions for the administration of any controlled drug specified in Schedules 2 to 5 of the 2001 Regulations, but not in relation to cocaine, diamorphine or dipipanone as regards persons addicted to these drugs otherwise than for the purpose of treating organic disease or injury suffered by such persons. The amendments also allow a nurse independent prescriber and a pharmacist independent prescriber to supply certain articles for administering or preparing controlled drugs.

Regulation 8(1)(c) and (d) of the 2001 Regulations (inserted by regulation 9(a)) provides for specified persons to compound any drug specified in Schedule 2 or 5 to the 2001 Regulations for the purposes of administration of that drug in accordance with regulation 7 of the 2001 Regulations, and regulation 9(1)(d) and (e) of the 2001 Regulations (inserted by regulation 10(a)) provides for such compounding in relation to any drug specified in Schedule 3 or 4. Regulation 10(1)(e) of the 2001 Regulations (substituted by regulation 11(b)) allows a person specified in regulations 8(7), 8(8)(a), 9(7) or 9(8) to have in her possession any drug specified in those regulations in accordance with conditions specified in those regulations.

Regulation 12 includes a nurse independent prescriber and a pharmacist independent prescriber within the list of persons in regulation 14(4) of the 2001 Regulations in relation to documentation to be obtained by the supplier of a controlled drug in the circumstances set out in regulation 14. Regulation 13 amends regulation 18 of the 2001 Regulations to the effect that the requirement in regulation 18(1) concerning marking of bottles and other containers does not apply in relation to the supply of a controlled drug by or on the prescription of a nurse independent prescriber or a pharmacist independent prescriber. Regulation 14 amends regulation 26 of the 2001 Regulations to include a nurse independent prescriber within the list of persons in regulation 26(2) in relation to the furnishing of information with respect to controlled drugs.

Regulation 4(a) amends regulation 4(2) of the 2001 Regulations to provide that the application of the provisions referred to in regulation 4(2) are excluded only where a person himself carries out the importation or exportation of the drug specified in Part II of Schedule 4 to the 2001 Regulations. The requirement for such a drug to be contained in a medicinal product is omitted from regulation 4(2) of the 2001 Regulations, as amended by regulation 4(a), and regulations 4(b), 10(a) and (e) and 11(a) make similar amendments. The definition of ‘medicinal product’ is omitted from regulation 2(1) of the 2001 Regulations, as amended by regulation 3(a).