(1)  A scheduled substance when –

(a) made up or compounded as a medicine by a pharmaceutical chemist acting in the lawful practice of his or her profession as such, or by an assistant under his or her direct personal supervision, on and in accordance with the prescription of a medical practitioner, dentist or veterinary surgeon or an authorised optometrist; or

(b) made up or compounded extemporaneously as a medicine by a pharmaceutical chemist so acting for a specific and individual case, if the medicine does not contain any restricted substance or narcotic substance; or

(c) made up or compounded as a medicine which is supplied –

(i) by a medical practitioner so acting for the purposes of medical treatment; or

(ii) by a dentist so acting for the purposes of dental treatment; or

(iii) by a veterinary surgeon so acting for the purposes of animal treatment; or

(iv) by an authorised optometrist so acting for the purposes of optometrical treatment –

is exempt from all other provisions of these regulations relating to labels if the container of the substance is labelled in accordance with subregulation (2) .

(2)  For the purposes of subregulation (1) , the container is to be labelled with –

(a) the words "Keep out of reach of children" in red on a white background; and

(b) the name of the patient or in the case of an animal the name of the owner of the animal; and

(c) the name and address of the seller; and

(d) such additional inscriptions as are required by subregulation (3) to be included.

(3)  For the purposes of subregulation (2)(d) , the labelling of the container of the medicine is to include additional inscriptions as follows:

(a) where the medicine is for external use – the word "Poison" , or the words "Caution – Not to be taken" or "Do not swallow" , in red;

(b) where the medicine is, or includes, a substance in relation to which, but for this regulation, the container would be required, under the provisions of the Uniform Standard having effect under regulation 79 , to be labelled with a warning relating to pregnancy or to the effect that that substance causes, or may cause, birth defects – that warning, together with any inscription required by that regulation to be prefixed to that warning, in the form specified in that regulation;

(c) where the medicine is for internal use and contains a substance specified in Appendix K to the Uniform Standard – a warning statement in the form, or to the effect, of warning statement 39 or warning statement 40 in Part 1 of Appendix F to the Uniform Standard;

(d) where the medicine is levocabastine, a warning statement in the form, or to the effect, of warning statement 62 in Part 1 of Appendix F to the Uniform Standard;

(e) where the medicine is acitretin, adapalene, bexarotene, bosentan, etretinate, isotretinoin, sitaxentan, thalidomide or tretinoin –

(i) for oral use, warning statements in the form, or to the effect, of warning statements 7, 62 and 76 in Part 1 of Appendix F to the Uniform Standard; or

(ii) for topical use, warning statements in the for, or to the effect, of warning statements 62 and 77 in Part 1 of Appendix F to the Uniform Standard;

(f) where the medicine is leflunomide, warning statements in the form, or to the effect, of warning statements 7, 62 and 87 in Part 1 of Appendix F to the Uniform Standard;

(g) where the medicine is misoprostol, a warning statement in the form, or to the effect, of warning statement 53 in Part 1 of Appendix F to the Uniform Standard;

(h) where the medicine is dienestrol, a warning statement in the form, or to the effect of, warning statement 67 in Part 1 of Appendix F to the Uniform Standard;

(i) where the medicine is for animal treatment – the words "For animal treatment only" ;

(j) where the medicine is dispensed in accordance with a prescription –

(i) the particulars set out in the prescription to be included on the label; and

(ii) the name of the substance shown in the prescription unless –

(A) otherwise directed in the prescription; or

(B) the substance is a medicine compounded extemporaneously in accordance with the formula set forth in the prescription;

(k) where the medicine is not dispensed in accordance with a prescription –

(i) adequate directions for its use specifically in the treatment of the patient or animal for whose treatment it was supplied; and

(ii) the name and strength of the scheduled substance.

(4)  A number or letter required on a label is to be –

(a) at least 1·5 mm high; and

(b) in clear and distinct contrast to the background.

(5)  The Secretary may approve a variation to the labelling requirements set out in this regulation subject to any condition he or she considers appropriate.