Record-keeping requirements in respect of drugs in Schedules 1 and 219.
(1)
Subject to paragraph (3) and regulation 21, every person authorised by or under regulation 5 or 8 to supply any drug specified in Schedule 1 or 2 shall comply with the following requirements, that is to say—
(a)
he shall, in accordance with the provisions of this regulation and of regulation 20, keep a register and shall enter therein in chronological sequence F1subject to subparagraph (f), using the headings specified in subparagraphs (d) and (e), particulars of every quantity of a drug specified in Schedule 1 or 2 obtained by him and of every quantity of such a drug supplied (whether by way of administration or otherwise) by him whether to persons within or outside Great Britain;
(b)
he shall use a separate register or separate part of the register for entries made in respect of each class of drugs, and each of the drugs specified in paragraphs 1 and 3 of Schedule 1 and paragraphs 1, 3 and 6 of Schedule 2 together with its salts and any preparation or other product containing it or any of its salts shall be treated as a separate class, so however that any stereoisomeric form of a drug or its salts shall be classed with that drug.
F2(d)
The headings in respect of entries made for drugs obtained are—
(i)
Date supply received;
(ii)
Name and address from whom received;
(iii)
Quantity received.
(e)
The headings in respect of entries made for drugs supplied are—
(i)
Date supplied;
(ii)
Name/Address of person or firm supplied;
(iii)
Details of authority to possess – prescriber or licence holder’s details;
(iv)
Quantity supplied;
(v)
Person collecting Schedule 2 controlled drug (patient/ patient’s rep/ healthcare professional) and if healthcare professional, name and address;
(vi)
Was proof of identity requested of patient/ patient’s rep (Yes/No);
(vii)
Was proof of identity of person collecting provided (Yes/No).
(f)
The headings at subparagraph (e)(v) to (vii) apply only in respect of drugs specified in Schedule 2.
F3(2)
Entries made in respect of drugs obtained and drugs supplied may be made on the same page or on separate pages in the register.
F4(2A)
Subject to regulation 20(e), nothing in F5paragraph (1) shall prevent the use of a register to record additional information to that required or allowed under those provisions.
(3)
The foregoing provisions of this regulation shall not have effect in relation to—
(a)
in the case of a drug supplied to him for the purpose of destruction in pursuance of regulation 6(2) or (3), a practitioner or pharmacist;
(b)
a person licensed under regulation 5 to supply any drug, where the licence so directs; or
F6(c)
the senior registered nurse, acting senior registered nurse or registered midwife, for the time being in charge of a ward, theatre or other department in a hospital, care home or prison.