Explanatory Note

(This note is not part of the Regulations)

These Regulations amend the Misuse of Drugs Regulations 2001 (S.I. 2001/3998) (“the 2001 Regulations”).

Regulation 2 sets out the commencement arrangements for these Regulations.

Regulation 4 inserts a number of new definitions into regulation 2(1) of the 2001 Regulations.

Regulation 5 amends regulation 15 of the 2001 Regulations in respect of private prescriptions issued for human use containing controlled drugs specified in Schedules 1, 2 or 3 to the 2001 Regulations. These prescriptions must be written on a prescription form issued for the purposes of private prescribing by a Primary Care Trust in England, a Local Health Board in Wales or a Health Board in Scotland, and must specify the prescriber identification number of the person issuing it. An exception is, however, created where the issuer of the prescription believes on reasonable grounds that a private prescription is to be supplied by a pharmacist in a hospital: in that case the prescription does not need to be written on on a prescription form issued for the purposes of private prescribing by a Primary Care Trust in England, a Local Health Board in Wales or a Health Board in Scotland. “Prescriber identification number” and “private prescribing” are two of the new defined terms in the 2001 Regulations.

Regulation 6 amends regulation 16 of the 2001 Regulations. It changes the maximum validity period under regulation 16 of the 2001 Regulations for a prescription containing a controlled drug specified in Schedules 1 to 4 to the 2001 Regulations from 13 weeks to 28 days. This will mean that a controlled drug specified in Schedules 1 to 4 to the 2001 Regulations may not be supplied on a prescription (subject to regulation 16(4) of the 2001 Regulations) more than 28 days after the appropriate date as defined in new regulation 16(7) of the 2001 Regulations.

Regulation 6 also amends regulation 16 of the 2001 Regulations to provide exceptions to the requirement under regulation 16(1)(a) of the 2001 Regulations that a person shall not supply a drug specified in Schedules 1, 2 or 3 (except temazepam) to the 2001 Regulations on prescription unless the prescription complies with regulation 15 of the 2001 Regulations.

Regulation 6 also introduces provisions relating to the identification of persons collecting prescriptions for controlled drugs in Schedule 2 to the 2001. Regulations 7 and 10 make consequential changes to the recording requirements and Controlled Drugs Register respectively.

Regulations 8, 9 and 11 make minor amendments to the 2001 Regulations and regulations 12 and 13 contain transitional provisions.