Medicines (Prescription Only) Order 1977
| Jurisdiction | UK Non-devolved |
| Citation | SI 1977/2127 |
1977 No. 2127
MEDICINES
The Medicines (Prescription Only) Order 197720thDecember 1977
5thJanuary 1978
1stFebruary 1978
The Secretaries of State respectively concerned with health in England and in Wales, the Secretary of State concerned with health and with agriculture hi Scotland, the Minister of Agriculture, Fisheries and Food, the Department of Health and Social Services for Northern Ireland and the Department of Agriculture for Northern Ireland, acting jointly, in exercise of powers conferred by sections 58(1) and (4), 59(1), 62 and 129(4) of the Medicines Act 1968(a) and now vested in them(b) and of all other powers enabling them in that behalf, after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by the following order, and after consulting and taking into account the advice of the Medicines Commission, hereby make the following order:—
Citation, commencement and interpretation
1.—(1) This order may be cited as the Medicines (Prescription Only) Order 1977 and shall come into operation on 1st February 1978.
(2) In this order, unless the context otherwise requires—
"the Act" means the Medicines Act 1968;
"bank holiday" means a bank holiday under the Banking and Financial Dealings Act 1971(c);
"controlled drug" has the meaning assigned to it by section 2 of the Misuse of Drugs Act 1971(d);
"dosage unit" means—
(a) where the medicinal product is in the form of a tablet or capsule or is an article in some other similar pharmaceutical form, that tablet, capsule or other similar article, or
(b) where the medicinal product is not in the form as aforesaid, that quantity of the medicinal product which is used as the unit by reference to which the dose of the medicinal product is measured;
"external use" means—
(a) 1968 c. 67.
(b) In the case of the Secretaries of State concerned with health in England and in Wales by virtue of Article 2(2) of, and Schedule 1 to, the Transfer of Functions (Wales) Order 1969 (S.I. 1969/388 (1969 I, p. 1070)) and in the case of the Northern Ireland Departments by virtue of section 40 of, and Schedule 5 to, the Northern Ireland Constitution Act 1973 (c. 36), and section 1(3) of, and paragraph 2(1)(fc) of Schedule 1 to, the Northern Ireland Act 1974 (c. 28).
(c) 1971 c. 80.
(d) 1971 c. 38.
(a) in relation to medicinal products for use by being administered to human beings, application to the skin, teeth, mucosa of the mouth, throat, nose, ear, eye, vagina or anal canal,
(b) in relation to veterinary drugs, application to the skin, hair, fur, feathers, scales, hoof, horn, ear, eye, mouth or mucosa of the throat or prepuce,
in either case when a local action only is necessary and extensive systemic absorption is unlikely to occur and references to "medicinal products for external use" shall be read accordingly except that in relation to paragraph (a) above the references shall not include throat sprays, throat pastilles, throat lozenges, throat tablets, nasal drops, nasal sprays, nasal inhalations or teething preparations;
"master" has the same meaning as in the Merchant Shipping Act 1894(a);
"maximum daily dose" or "MDD" means the maximum quantity of the substance contained in the amount of the medicinal product for internal use which it is recommended should be taken or administered in any period of 24 hours;
"maximum dose" or "MD" means the maximum quantity of the substance contained in the amount of the medicinal product for internal use which it is recommended should be taken or administered at any one time;
"maximum strength" means either, or if so specified both, of the following—
(a) the maximum quantity of the substance by weight or volume contained in a dosage unit of the medicinal product, or
(b) the maximum percentage of the substance contained in a medicinal product calculated in terms of weight in weight (w/w), weight in volume (w/v), volume in weight (v/w) or volume hi volume (v/v), as appropriate;
"parenteral administration" means administration by breach of the skin or mucous membrane;
"prescription only medicine" means a medicinal product of a description or falling within a class specified in Article 3 of this order;
"registered ophthalmic optician" means a person who is registered in either of the registers of ophthalmic opticians established and maintained under section 2(a) of the Opticians Act 1958(b);
"repeat prescription" means a prescription which contains a direction that it may be dispensed a stated number of times;
"sell" means sell by retail as defined in section 131 of the Act and "sale" has a corresponding meaning;
"soap" means any compound of a fatty acid with an alkali or amine;
"state registered chiropodist" means a person who is registered in the register established and maintained under section 2(1) of the Professions Supplementary to Medicine Act 1960(c) by the Chiropodists Board;
"supply" means supply in circumstances corresponding to retail sale as denned in section 131 of the Act;
"unit preparation" means a preparation, including a mother tincture, prepared by a process of solution, extraction or trituration with a view to being further diluted tenfold, or serially in multiple powers of ten,
(a) 1894 c. 60.
(b) 1958 c. 32.
(c) 1960 c. 66.
in an inert diluent, and then used either in this diluted form or, where applicable, by impregnating tablets, granules, powders or other inert substances for the purpose of being administered to human beings;
and other expressions have the same meanings as in the Act.
(3) Except in so far as the context otherwise requires, any reference in this order to any enactment, order or regulations shall be construed as a reference to that enactment or order or those regulations, as the case may be, as amended extended or re-enacted by any other enactment, order or regulations.
(4) The rules for the construction of Acts of Parliament contained in the Interpretation Act 1889(a) shall apply for the purposes of the interpretation of this order as they apply for the purposes of the interpretation of an Act of Parliament.
Appropriate practitioners
2. For the purposes of section 58 of the Act (medicinal products on prescription only), doctors, dentists, veterinary surgeons and veterinary practitioners shall be appropriate practitioners in relation to all the descriptions and classes of medicinal products specified for the purposes of the said section 58 in Article 3 of this order.
Medicinal products on prescription only
3.—(1) There are hereby specified descriptions and classes of medicinal products for the purposes of section 58 of the Act, namely—
(a) subject to the provisions of Article 4(1) and (3) of this order, medicinal products consisting of or containing one or more substances listed in column 1 of Part I of Schedule 1 to this order;
(b) subject to the provisions of Article 4(2) of, and Part II of Schedule 1 to, this order, medicinal products consisting of or containing one or more of the substances specified in Schedule 2 to the Misuse of Drugs Act 1971;
(c) medicinal products specified in Part III of Schedule 1 to this order;
(d) subject to the provisions of Articles 4(3) and (4) and 5 of this order, medicinal products that are for parenteral administration whether or not they fall within (a) or (6) above.
(2) There is also hereby specified for the purposes of section 58 of the Act as that section has effect by virtue of section 59 of the Act (new medicinal products), the following class of medicinal products, namely, medicinal products—
(a) which are not of a description and do not fall within a class specified in paragraph (1) above, and
(b) in respect of which a product licence is granted containing a provision to the effect that the method of sale or supply of the medicinal product in question is to be only in accordance with a prescription given by an appropriate practitioner.
(3) For the purposes of section 59(2)(a) of the Act the duration shall be a period of three years.
(a) 1889 c. 63.
Medicinal products that are not prescription only
4.—(1) Notwithstanding the provisions of Article 3(1)(a) of this order, medicinal products consisting of or containing one or more of the substances listed hi column 1 of Part I of Schedule 1 to this order shall not be prescription only medicines where there is in relation to each of such substances an entry in one or more of columns 2, 3 or 4 of the said Part I if the maximum strength of each such substance in the medicinal product does not exceed the maximum strength as may be specified in the said column 2 and if the medicinal product in question is sold, supplied or administered—
(a) for the purpose or in the pharmaceutical form or for use by the route of administration as may be specified in the said column 3, and
(b) in or from containers or packages labelled to show doses not exceeding the maximum dose and the maximum daily dose as may be specified in the said column 4.
(2) Notwithstanding the provisions of Article 3(1)(i) of this order, medicinal products consisting of or containing, in combination with one or more other substances, not more than one of the substances specified in Schedule 2 to the Misuse of Drugs Act 1971 shall not be prescription only medicines when the said substance so specified is also listed in column 1 of Part II of Schedule 1 to this order and the maximum strength of that substance in the medicinal product does not exceed the maximum strength as may be specified in column 2 of the said Part II in relation to the said substance and the medicinal product in question—
(a) does not contain a substance listed in column 1 of Part I of the said Schedule except in the circumstances specified in paragraph (1) of this Article, and
(b) is sold, supplied or administered—
(i) in the pharmaceutical form as may be specified in column 3 of the said Part II in relation to the said substance, and
(ii) in or from containers or packages labelled to show doses not...
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