Marking of bottles and other containersU.K.
18.—(1) Subject to paragraph (2), no person shall supply a controlled drug otherwise than in a bottle, package or other container which is plainly marked—
(a)in the case of a controlled drug other than a preparation, with the amount of the drug contained therein;
(b)in the case of a controlled drug which is a preparation—
(i)made up into tablets, capsules or other dosage units, with the amount of each component (being a controlled drug) of the preparation in each dosage unit and the number of dosage units in the bottle, package or other container;
(ii)not made up as aforesaid, with the total amount of the preparation in the bottle, package or other container and the percentage of each of its components which is a controlled drug.
(2) Nothing in this regulation shall have effect in relation to—
(a)the drugs specified in Schedules 4 and 5 or poppy-straw;
(b)any drug specified in Schedule 3 contained in or comprising a preparation which—
(i)is required for use as a buffering agent in chemical analysis;
(ii)has present in it both a substance specified in paragraph 1 or 2 of that Schedule and a salt of that substance; and
(iii)is premixed in a kit;
(c)any exempt product;
[F1(d)the supply of a controlled drug by or on the prescription of a practitioner, a supplementary prescriber, a nurse independent prescriber or a pharmacist independent prescriber;]
(e)the supply of a controlled drug for administration in a clinical trial or a medicinal test on animals.
[F2(3) In this regulation—
“clinical trial” has the same meaning as in the Medicines for Human Use (Clinical Trials) Regulations 2003;
“medicinal test on animals” has the same meaning as in the Medicines Act 1968.]
Textual Amendments
F1Reg. 18(2)(d) substituted (23.4.2012) by The Misuse of Drugs (Amendment No.2) (England, Wales and Scotland) Regulations 2012 (S.I. 2012/973), regs. 1(1), 13
F2Reg. 18(3) substituted (1.5.2004) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg. 1, Sch. 10 Pt. 2 para. 16