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Explanatory Note

(This note is not part of the Regulations)

Regulation 2(2) to (11) amends the Misuse of Drugs Regulations 2001 (“the 2001 Regulations”) to make provision for supplementary prescribers (a first level nurse, pharmacist or registered midwife who satisfies certain conditions). Regulation 2(2) inserts a definition of “clinical management plan” and “supplementary prescriber” and provides that the term “prescription” includes a prescription issued by a supplementary prescriber for the medical treatment of a single individual. Regulation 2(3) enables a person who possesses a controlled drug set out in Schedules 2 to 5 to the 2001 Regulations, having been supplied them by a supplementary prescriber, to return them to certain persons for destruction. Regulation 2(4) provides that a supplementary prescriber who is acting under and in accordance with the terms of a clinical management plan may supply certain articles used for administering or preparing controlled drugs. Regulation 2(5) permits supplementary prescribers who are acting under and in accordance with the terms of a clinical management plan to administer those controlled drugs set out in Schedules 2, 3 and 4 to the 2001 Regulations and permits any person to administer such drugs to a patient in accordance with the directions of a supplementary prescriber acting under and in accordance with the terms of a clinical management plan. Regulation 2(6) and (7) permits supplementary prescribers who are acting under and in accordance with the terms of a clinical management plan, subject to certain exceptions, to supply those controlled drugs set out in Schedules 2 to 5 to the 2001 Regulations. Regulation 2(8) provides that persons can, in certain circumstances, possess those controlled drugs set out in Schedules 2 and 3 and Part 1 of Schedule 4 to the 2001 Regulations for administration for medical, dental or veterinary purposes in accordance with the directions of a supplementary prescriber acting under and in accordance with the terms of a clinical management plan. Regulation 2(8) also makes a number of consequential amendments. Regulation 2(9) provides that a supplier of a controlled drug must, before delivering those drugs to a supplementary prescriber, obtain certain information from the supplementary prescriber. Regulation 2(10) provides that the requirement in regulation 18 of the 2001 Regulations regarding the use of marked bottles, packages or other containers does not apply to the supply of controlled drugs by or on prescription of a supplementary prescriber. Regulation 2(11) requires supplementary prescribers to provide certain information regarding controlled drugs on demand.