MEDICINES Title, commencement, interpretation and revocation 1 1 This Order may be cited as the Medicines (Veterinary Drugs) (Prescription Only) Order 1991 and shall come into force on 8th July 1991. 2 In this Order, unless the context otherwise requires,— a “ the Act ” means the Medicines Act 1968; “controlled drug” has the meaning assigned to it by section 2 of the Misuse of Drugs Act 1971 ; “dosage unit” means— where a veterinary drug is in the form of a tablet or capsule or is an article in some other similar pharmaceutical form, that tablet, capsule or other article, or where a veterinary drug is not in any such form, that quantity of the drug which is used as the unit by reference to which the dose is measured; “external use” means application to the skin, hair, fur, feathers, scales, hoof, horn, ear, eye, mouth or mucosa of the throat or prepuce, when a local action only is intended and extensive systemic absorption is unlikely to occur; “intermediate feed” means a medicated feeding stuff sold, supplied or imported for use wholly or mainly as an ingredient in the preparation of a substance which is to be fed to one or more animals for a medicinal purpose or for purposes that include that purpose, with or without further processing; “The Misuse of Drugs Regulations ” means, in relation to England. Wales and Scotland the Misuse of Drugs Regulations 1985 and, in relation to Northern Ireland, the Misuse of Drugs (Northern Ireland) Regulations 1986 ; “parenteral administration” means administration to an animal by breach of the skin or mucous membrane; “perscription only medicine” means a medicinal product of a description or falling within a class specified in article 3 and, for the purposes of this Order, does not include “intermediate feed”; “repeatable prescription” means a prescription which contains a direction that it may be dispensed more than once; “sell” means sell by retail as defined in section 131 and “sale” has a corresponding meaning; “soap” means any compound of a fatty acid with an alkali or amine; “strength”, and “maximum strength” mean, in the case of a substance listed in column 1 of Schedule 1 in relation to which there is an entry in column 2, or listed or mentioned in column 1 or 3 of Schedule 2 or column 2 of Part I of Schedule 3, the strength or, as the case may be, maximum strength of the substance in a veterinary drug expressed in the terms of— the quantity of the substance, by weight or volume, and a strength so expressed shall be taken to relate to the quantity contained in a dosage unit of the drug, or the quantity of the substance as a percentage of the drug calculated in terms of weight in weight (w/w), weight in volume (w/v), volume in weight (v/w), or volume in volume (v/v), or an equivalent strength of some other substance and, for this purpose “equivalent” means a strength corresponding to the active moiety of that other substance; “supply” means supply in circumstances corresponding to retail sale as defined in section 131; “unit preparation” means a preparation, including a mother tincture, prepared by a process of solution, extraction or trituration with a view to being diluted tenfold or one hundredfold, either once or repeatedly, 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 animals; “the Veterinary Drugs Exemption Order ” means the Medicines (Veterinary Drugs) (Pharmacy and Merchants' List) ( No. 2) Order 1989 ; and b a reference— i to a numbered section is to the section of the Act which bears that number, ii to a numbered article or Schedule is to the article of, or Schedule to, this Order which bears that number, iii in an article or in a Part of a Schedule to a numbered paragraph is to the paragraph of that article or that Part of that Schedule which bears that number, and iv in a paragraph to a lettered sub-paragraph is to the sub-paragraph of that paragraph which bears that letter. 3 In Schedule 1— a entries specified in columns 2 and 3 relate to the substances listed in column 1 against which they appear and where, in relation to a particular substance listed in column 1, an entry in column 2 or 3 bears a number or letter it relates only to such entries in the other of those columns as bear the same number or letter; b the following abbreviations are used: “ kg ” for kilogram “mg” for milligram “ppm” for parts per million. 4 The Medicines (Veterinary Drugs) (Prescription Only) Order 1989 is hereby revoked. Appropriate practitioners 2 For the purposes of section 58 (medicinal products on prescription only) 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 that section in article 3. Medicinal products on prescription only 3 1 There are hereby specified descriptions and classes of medicinal products for the purposes of section 58, namely— a subject to article 4(1) and (2) veterinary drugs consisting of or containing a substance listed in column 1 of Schedule 1; b veterinary drugs that are controlled drugs; c subject to article 4(2), veterinary drugs for parenteral administration whether or not they fall within sub-paragraph (a) or (b); d veterinary drugs— i which are not of a description and do not fall within a class specified in any of sub-paragraphs (a), (b) or (c); ii which are of a description in respect of which the conditions specified in section 59(1) are fulfilled, and iii in respect of which a product licence is granted after the date of coming into force of this Order containing a provision to the effect that the method of sale or supply of the veterinary drug is to be only in accordance with a prescription given by an appropriate practitioner; e medicinal products which are veterinary drugs by reason of their having been sold or supplied for administration to animals and which, prior to such sale or supply, were prescription only medicines as defined in article 1(2) of the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Order 1983 . 2 For the purposes of section 59(2)(a) (duration of restrictions for certain new products) the duration shall be a period of five years. Medicinal products that are not prescription only 4 1 Notwithstanding article 3(1)(a), a veterinary drug in respect of which there has been granted a product licence shall not be a prescription only medicine by reason that it consists of or contains a particular substance listed in column 1 of Schedule 1 where— a in relation to that substance there is an entry in one or more of columns 2 and 3; b the strength in the drug of that substance does not exceed the maximum strength, if any, specified in column 2; and c the veterinary drug is sold or supplied— i if a pharmaceutical form or a route of administration is specified in column 3, in such pharmaceutical form, and for administration only by such route, as may be so specified, and ii if a use is specified in column 3, in a container or package labelled to show a use so specified to which the veterinary drug is to be put but no use not so specified. 2 Notwithstanding article 3(1)(a) and (c), a veterinary drug for parenteral administration consisting of or containing a substance listed in column 1 of Schedule 2 shall not be a prescription only medicine where the strength of that substance does not exceed the maximum strength, if any, specified in column 2 and the veterinary drug in question is sold or supplied only for the purpose or in the circumstances specified in column 3. Exemption for medicinal products at high dilutions 5 The restrictions imposed by section 58(2) (restrictions on sale, supply and administration) shall not apply to the sale, supply or administration of a veterinary drug which is not for parenteral administration and which consists of or contains, of the substances listed in column 1 of Schedule 1, only one or more unit preparations of such substances, if— a each such unit preparation has been diluted to at least one part in a million (6x), and the person selling, supplying or administering the veterinary drug has been requested by or on behalf of a particular person and in that person’s presence to use his own judgment as to the treatment required, or b each such unit preparation has been diluted to at least one part in a million million (6c). Exemptions for certain persons 6 1 The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply— a to the sale or supply by a person listed in column 1 of Part I of Schedule 3, or b to the supply by a person listed in column 1 of Part II of Schedule 3, of the prescription only medicines listed in column 2 of Part I or Part II, as the case may be, of Schedule 3 in relation to that person if and so long as the conditions specified in the corresponding paragraphs in column 3 of Part I or Part II, as the case may be, of Schedule 3 are fulfilled. 2 The restriction imposed by section 58(2)(b) (restriction on administration) shall not apply to the administration by a person listed in column 1 of Part III of Schedule 3 of the prescription only medicines for parenteral administration listed in column 2 of that Part in relation to that person if and so long as the conditions specified in the corresponding paragraphs in column 3 of that Part are fulfilled. Exemption in cases involving another’s default 7 The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply to the sale or supply of a prescription only medicine by a person who, having exercised all due diligence, believes on reasonable grounds that the product sold or supplied is not a prescription only medicine, where it is due to the act or default of another person that the product is a product to which section 58(2)(a) applies. Prescriptions 8 1 For the purposes of section 58(2)(a) a prescription only medicine shall not be taken to be sold or supplied in accordance with a prescription given by an appropriate practitioner unless the conditions specified in paragraph (2) are fulfilled. 2 The conditions referred to in paragraph (1) are that the prescription— a shall be signed in ink with his own name by the veterinary surgeon or veterinary practitioner giving it; b shall, without prejudice to sub-paragraph (a), be written in ink or otherwise so as to be indelible; c shall contain the following particulars— i the address of the veterinary surgeon or veterinary practitioner giving it, ii the appropriate date, iii such particulars as indicate whether it is given by a veterinary surgeon or veterinary practitioner, and iv the name and address of the person to whom the prescription only medicine is to be delivered and a declaration by the veterinary surgeon or veterinary practitioner giving it that the prescription only medicine is prescribed for an animal or herd under his care; d shall not be dispensed after the end of the period of six months from the appropriate date, unless it is a repeatable prescription in which case it shall not be dispensed for the first time after the end of that period nor otherwise than in accordance with the direction contained in the repeatable prescription; e in the case of a repeatable prescription that does not specify the number of times it may be dispensed, shall not be dispensed on more than two occasions. 3 The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply to a sale or supply of a prescription only medicine which is not in accordence with a prescription given by an appropriate practicitioner by reason only that a condition specified in paragraph (2) is not fulfilled, where the person selling or supplying the prescription only medicine, having exercised all due diligence, believes on reasonable grounds that the condition is fulfilled in relation to that sale or supply. 4 In paragraph (2) “the appropriate date” means the date on which the prescription was signed by the veterinary surgeon or veterinary practitioner giving it. Defences 9 The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply to the sale or supply of a prescription only medicine by an appropriate practitioner in accordance with a forged prescription where the appropriate practitioner, having exercised all due diligence, believes on reasonable grounds that the prescription is genuine. Transitional provision 10 Where, immediately before the coming into force of this Order, the restrictions imposed by section 58 applied to the sale, supply or administration of a veterinary drug of a particular description by reason that the veterinary drug fell within the class specified in article 3(1)(e) (certain new products) of the Medicines (Veterinary Drugs) (Prescription Only) Order 1989 those restrictions shall continue to apply to veterinary drugs of that description as though article 3(1)(e) and (2) of that Order had remained in force. Virginia Bottomley Minister of State for Health 11th June 1991 Strathclyde Parliamentary Under Secretary of State, Scottish Office 11th June 1991 David Hunt Secretary of State for Wales 12th June 1991 In witness whereof the Official Seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 10th June 1991. John Selwyn Gummer Minister of Agriculture, Fisheries and Food Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland this 13th day of June 1991 F. A. Elliott Permanent Secretary Sealed with the Official Seal of the Department of Agriculture for Northern Ireland this 13th day of June 1991 W. J. Hodges Permanent Secretary