Misuse of Drugs (Coronavirus) (Amendments relating to the supply of controlled drugs during a pandemic etc) Regulations 2020 - in force 30 April 2020

30 April 2020

These Regulations amend the Misuse of Drugs Regulations 2001 ('the 2001 Regulations').

Section 5 of the Misuse of Drugs Act 1971 places a general restriction on possessing controlled drugs, subject to exceptions in regulations. In the case of drugs supplied by pharmacists, drugs specified in Schedules 2 to Part 1 of Schedule 4 to the 2001 Regulations presuppose the existence of directions of a person lawfully entitled to prescribe the drug.

In a pandemic situation, the Secretary of State may make an announcement permitting pharmacists without prescribing rights to issue the necessary directions themselves in relation to NHS supplies, in two circumstances. Both of these relate to easements from the normal restrictions on supplies of prescription only medicines in the Human Medicines Regulations 2012 – and both relate to continuity of treatment:

The first easement relates to a pharmacist's ability, in a pandemic situation, to supply, at registered pharmacy premises, prescription only drugs previously supplied to a patient on prescription.
The second easement relates to supplies under a serious shortage protocol, where to help manage a serious shortage (not necessarily in a pandemic situation), a pharmacist at a registered pharmacy may, under a Secretary of State protocol, reduce the amount to be supplied to a patient or substitute a different product (for example, a different pharmaceutical form of the drug that was prescribed).

Regulation 4 inserts a new regulation 10A into the 2001 Regulations to enable these easements to apply, in a pandemic situation, to drugs specified in Schedule 2 to Part 1 of Schedule 4, in the case of NHS supplies. The announcement may only permit this utilisation for up to three months, but that period may be extended for further periods of up to three months.

The 2001 Regulations contain restrictions on the form of prescriptions of Schedule 2 and 3 drugs, which include, in the case of drugs intended to be supplied by instalments, requiring the prescriber to specify the intervals between the supply of the instalments. Regulation 5 amends regulation 15 of the 2001 Regulations to enable, in a pandemic situation, the Secretary of State to make an announcement that would permit pharmacists to change the intervals for Schedule 2 and 3 drugs with the agreement of the prescriber or their appointed representative, where these are supplied under NHS arrangements.

Regulation 3 also makes a consequential amendment to regulation 2 of the 2001 Regulations (interpretation).

Back to News