the prescription only medicines (human use) order 1997

Status: This is the original version (as it was originally made).

STATUTORY INSTRUMENTS

1997 No. 1830

MEDICINES

The Prescription Only Medicines (Human Use) Order 1997

Made - - - - 25th July 1997

Laid before Parliament 28th July 1997

Coming into force - - 18th August 1997

The Secretary of State concerned with health in England, the Secretaries of State concerned withhealth and with agriculture in Wales and in Scotland respectively, the Minister of Agriculture,Fisheries and Food, the Department of Health and Social Services for Northern Ireland and theDepartment of Agriculture for Northern Ireland, acting jointly, in exercise of powers conferred onthem by sections 58(1), (4) and (5), 59(1) and 129(4) of the Medicines Act 1968(1) or, as the case maybe, those conferred by the said provisions and now vested in them(2), and of all other powers enablingthem in that behalf, after consulting such organisations as appear to them to be representative ofinterests likely to be substantially affected by this Order, pursuant to section 129(6) of that Act,and after consulting and taking into account the advice of the Medicines Commission pursuant tosections 58(6) and 129(7) of that Act, hereby make the following Order:

Citation, commencement and interpretation

1.—(1) This Order may be cited as the Prescription Only Medicines (Human Use) Order 1997and shall come into force on 18th August 1997.

(2) In this Order, unless the context otherwise requires–“the Act” means the Medicines Act 1968;“aerosol” means a product which is dispersed from its container by a propellent gas or liquid;“appropriate nurse practitioner” means–(a) a person who–

(i) is registered in Part 1 or 12 of the Register maintained by the United KingdomCentral Council for Nursing, Midwifery and Health Visiting under section 10 of

(1) 1968 c. 67. Section 58 has been amended by the Prescription by Nurses Etc. Act 1992 (c. 28), section 1. The expression “theappropriate Ministers” is defined in section 1(2) of the Medicines Act 1968.

(2) In the case of the Secretaries of State concerned with health in England and in Wales by virtue of article 2(2) of, andSchedule 1 to, the Transfer of Functions (Wales) Order 1969 (S.I. 1969/388); in the case of the Secretary of State concernedwith Agriculture in Wales by virtue of article 2(3) of, and Schedule 1 to, the Transfer of Functions (Wales) (No. 1) Order1978 (S.I. 1978/272) and in the case of the Northern Ireland Departments by virtue of section 40 of, and Schedule 5 to, theNorthern Ireland Constitution Act 1973 (c. 36) and section 1(3) of, and paragraph 2(1)(b) of Schedule 1 to, the NorthernIreland Act 1974 (c. 28).

http://www.legislation.gov.uk/id/ukpga/1968/67


http://www.legislation.gov.uk/id/uksi/1969/388




Document Generated: 2021-04-22Status: This is the original version (as it was originally made).

the Nurses, Midwives and Health Visitors Act 1979(3) (referred to below in thisdefinition as “the professional register”), and

(ii) has a district nursing qualification additionally recorded in the professional registerunder rule 11 of the Nurses, Midwives and Health Visitors Rules 1983(4); or

(b) a person who is registered in Part 11 of the professional register as a health visitor;against whose name (in each case) is recorded in the professional register an annotationsignifying that he is qualified to order drugs, medicines and appliances for patients;“controlled drug” has the meaning assigned to it by section 2 of the Misuse of Drugs Act1971(5);“cyanogenetic substances” means preparations which–(a) are presented for sale or supply under the name of, or as containing, amygdalin, laetrile

or vitamin B17, or(b) contain more than 0.1 per cent by weight of any substance having the formula

either α-Cyanobenzyl-6-O-β-d-glucopyranosyl-β-d-glucopyranoside or α-Cyanobenzyl-β-d-glucopy ranosiduronic acid;

“dosage unit” means–(a) where a 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 article, or(b) where a medicinal product is not in any such form, the unit of measurement which is

used as the unit by reference to which the dose of the medicinal product is measured;“external use” means application to the skin, hair, teeth, mucosa of the mouth, throat, nose, ear,eye, vagina or anal canal when a local action only is intended and extensive systemic absorptionis unlikely to occur; and references to medicinal products for external use shall be readaccordingly except that such references shall not include throat sprays, throat pastilles, throatlozenges, throat tablets, nasal drops, nasal sprays, nasal inhalations or teething preparations;“health prescription” means a prescription issued by a doctor, dentist or nurse prescriber underor by virtue of–(a) in England and Wales, the National Health Service Act 1977(6),(b) in Scotland, the National Health Service (Scotland) Act 1978(7), and(c) in Northern Ireland, the Health and Personal Social Services (Northern Ireland) Order

1972(8);“inhaler” does not include an aerosol;“master” has the same meaning as in section 313(1) of the Merchant Shipping Act 1995(9);“maximum daily dose” or “MDD” means the maximum quantity of a substance contained inthe amount of a medicinal product which it is recommended should be taken or administeredin a period of 24 hours;“maximum dose” or “MD” means the maximum quantity of a substance contained in theamount of a medicinal product which it is recommended should be taken or administered atany one time;“maximum strength” means–

(3) 1979 c. 36; the Parts of the professional register were determined by S.I. 1983/667, amended by S.I. 1989/104 and 1989/1455.(4) Approved by S.I. 1983/873, to which there are amendments not relevant to this Order.(5) 1971 c. 38.(6) 1977 c. 49.(7) 1978 c. 29.(8) S.I. 1972/1265 (N.I. 14).(9) 1995 c. 21.

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http://www.legislation.gov.uk/id/nisi/1972/1265



(a) the maximum quantity of a substance by weight or volume contained in a dosage unitof a medicinal product;

(b) the maximum percentage of a substance contained in a medicinal product calculated inany of the following ways–(i) weight in weight,(ii) weight in volume,(iii) volume in weight, or(iv) volume in volume,and if the maximum percentage calculated in those ways differs, the higher or highestsuch percentage;

“medicinal product” includes any article or substance in respect of which section 58 of the Acthas effect by virtue of an order made under section 104 of the Act, but does not include–(a) a medicinal product which is a veterinary drug as defined in section 132(1) of the Act or(b) an article or substance in respect of which section 58 has such effect where that article

or substance is only to be administered to animals;“the Misuse of Drugs Regulations” means, in relation to England, Wales and Scotland, theMisuse of Drugs Regulations 1985(10) and in relation to Northern Ireland, the Misuse of Drugs(Northern Ireland) Regulations 1986(11);“occupational health scheme” means a scheme in which a person, in the course of a businesscarried on by him, provides facilities for his employees for the treatment or prevention ofdisease;“offshore installation” means an offshore installation within the meaning of the MineralWorkings (Offshore Installations) Act 1971(12) which is within–(a) tidal waters and parts of the sea in or adjacent to the United Kingdom up to the seaward

limits of territorial waters;(b) waters in any area designated under section 1(7) of the Continental Shelf Act 1964(13);“operator”, in relation to an aircraft, means the person for the time being having themanagement of the aircraft;“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 aclass specified in article 3 of this Order;“prolonged release” in relation to a medicinal product means a formulation of that productwhich–(a) is used to reduce the rate at which the active ingredient in that product is released after

administration, and(b) is sold or supplied as a prolonged, controlled or sustained release medicinal product;“registered midwife” means a person who is registered in Part 10 of the Register maintainedby the United Kingdom Central Council for Nursing, Midwifery and Health Visiting undersection 10 of the Nurses, Midwives and Health Visitors Act 1979;

(10) S.I. 1985/2066.(11) SR 1986 No. 52.(12) 1971 c. 61; section 1 was substituted by section 24 of the Oil and Gas (Enterprise) Act 1982 (c. 23).(13) 1964 c. 29.

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“registered nurse” means a person who is registered in the Register maintained by the UnitedKingdom Central Council for Nursing, Midwifery and Health Visiting under section 10 of theNurses, Midwives and Health Visitors Act 1979;“registered ophthalmic optician” means a person who is registered in either of the Registers ofophthalmic opticians maintained under section 7(a) of the Opticians Act 1989(14);“repeatable prescription” means a prescription which contains a direction that it may bedispensed more than once;“sell” means sell by retail as defined in section 131 of the Act and “sale” has a correspondingmeaning;“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 andmaintained under section 2(1) of the Professions Supplementary to Medicine Act 1960(15) bythe Chiropodists Board;“supply” means supply in circumstances corresponding to retail sale as defined in section 131of the Act;“unit preparation” means a preparation, including a mother tincture, prepared by a processof 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, whereapplicable, by impregnating tablets, granules, powders or other inert substances.

(3) For the purposes of this Order, the equivalence of a substance to a reference material shall bedetermined by calculating the amount of that reference material which is contained in that substanceeither by weight or, where the amount of the reference material is specified in terms of internationalunits of activity, those units.

(4) In this Order, unless the context otherwise requires, a reference–(a) to a numbered section is to the section of the Act which bears that number,(b) to a numbered article or Schedule is to the article of, or Schedule to, this Order which

bears that number,(c) in an article or in a Part of a Schedule to a numbered paragraph is to the paragraph of that

article or Part of that Schedule which bears that number, and(d) in a paragraph to a lettered sub-paragraph is to the sub-paragraph of that paragraph which

bears that letter.(5) In Schedules 1 to 3–

(a) entries specified in columns 2 to 5 relate to the substances listed in column 1 against whichthey appear and where, in relation to a particular substance listed in column 1, an entry incolumns 2 to 5 bears a number or letter it relates only to such entries in the other of thosecolumns as bear the same number or letter;

(b) the following abbreviations are used:“g” for gram,“iu” for international unit of activity,“mcg” for microgram,“mg” for milligram,“ml” for millilitre.

(14) 1989 c. 44.(15) 1960 c. 66.

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(6) In Schedule 3, the abbreviation “NPF” means the Nurse Prescribers' Formulary Appendix inthe British National Formulary.

Appropriate practitioners

2. For the purposes of section 58 (medicinal products on prescription only), the following shallbe appropriate practitioners–

(a) in relation to the descriptions and classes of medicinal products specified in article 3,doctors, dentists, veterinary surgeons and veterinary practitioners;

(b) in relation to the descriptions and classes of medicinal products specified in Schedule 3,appropriate nurse practitioners.

Medicinal products on prescription only

3. Subject to article 6, the following descriptions and classes of medicinal products are specifiedfor the purposes of section 58, namely–

(a) medicinal products consisting of or containing a substance listed in column 1 ofSchedule 1;

(b) medicinal products that are controlled drugs;(c) medicinal products that are for parenteral administration, other than preparations of insulin

for parenteral administration;(d) cyanogenetic substances, other than preparations for external use;(e) medicinal products that on administration emit radiation, or contain or generate any

substance which emits radiation, in order that radiation may be used;(f) medicinal products for human use which are classified as subject to medical prescription

in marketing authorizations granted under Council Regulation 2309/93(16);(g) medicinal products–

(i) which are not of a description and do not fall within a class specified insubparagraphs (a) to (f),

(ii) which are of a description in respect of which the conditions specified insection 59(1) are satisfied, and

(iii) in respect of which a product licence or marketing authorization has been grantedwhich contains a provision to the effect that the method of sale or supply of themedicinal product is to be only in accordance with a prescription given by anappropriate practitioner.

Duration of special provisions in relation to new medicinal products

4. The duration specified for the purposes of section 59(2)(a) (duration of restrictions for certainnew products) shall be a period of 5 years.

Exempt medicinal products

5.—(1) A medicinal product shall be exempt from the restrictions imposed by section 58(2)(a)(restrictions on sale or supply) if it, or a substance in it, is listed in column 1 of Schedule 1 and there–

(a) is an entry in column 2, 3, 4 or 5 of that Schedule which contains a condition and thatcondition is satisfied in accordance with the following provisions of this article; or

(16) OJ No. L214, 24.8.93, p. 1.5


(b) there is more than one such condition which applies where that substance is used in thatproduct and each of those conditions is so satisfied.

(2) Where a maximum strength is specified in column 2 in relation to a substance, a medicinalproduct which consists of or contains that substance satisfies the condition where the maximumstrength of that substance in that medicinal product, or where specified in that column the maximumstrength of a medicinal product which contains that substance, does not exceed that specifiedmaximum or, where the medicinal product consists of more than one of the substances sodiumfluoride, sodium monofluorophosphate or stannous fluoride combined in a dentifrice, where themaximum strength of that combination of substances in a product does not exceed the equivalentof 0.15 per cent of fluorine.

(3) Where a route of administration is specified in column 3 in relation to a substance, a medicinalproduct which consists of or contains that substance satisfies the condition where it is sold or suppliedfor administration only by that route.

(4) Where a use is specified in column 3 in relation to a substance, a medicinal product whichconsists of or contains that substance satisfies the condition in respect of use where it is sold orsupplied only for use–

(a) where a purpose for which it may be used is so specified, for that purpose;(b) where the class of persons in whom it may be used is so specified, in persons of that class.

(5) Where a pharmaceutical form is specified in column 3 in relation to a substance, a medicinalproduct which consists of or contains that substance satisfies the condition where it is sold or suppliedin that pharmaceutical form.

(6) Where a maximum dose is specified in column 4 in relation to a substance, a medicinal productwhich consists of or contains that substance satisfies the condition where it is sold or supplied foruse at a maximum dose which does not exceed that specified maximum dose.

(7) Subject to paragraph (8), where a maximum daily dose is specified in column 4 in relation toa substance, a medicinal product which consists of or contains that substance satisfies the conditionwhere it is sold or supplied for use at a maximum daily dose which does not exceed that specifiedmaximum daily dose.

(8) A medicinal product which contains more than one of the substances–AtropineAtropine MethobromideAtropine MethonitrateAtropine Oxide HydrochlorideAtropine SulphateHyoscineHyoscine ButylbromideHyoscine HydrobromideHyoscine MethobromideHyoscine MethonitrateHyoscyamineHyoscyamine HydrobromideHyoscyamine Sulphate,

satisfies the condition only where it is sold or supplied for use at a maximum daily dose which doesnot exceed 1 milligram in total of the alkaloids derived from belladonna, hyoscyamus, stramoniumor other solanaceous plant which are contained in that medicinal product.

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(9) Where a maximum period of use or a maximum frequency of use is specified in column 4in relation to a substance, a medicinal product which consists of or contains that substance satisfiesthe condition where it is sold or supplied for use for a maximum period or frequency, as the casemay be, which does not exceed the maximum period of use or the maximum frequency of use whichis so specified.

(10) Where a maximum quantity is specified in column 5 in relation to a substance, a medicinalproduct which consists of or contains that substance satisfies the condition where it, or where sospecified in that column, the medicinal product which contains that substance is sold or supplied ina quantity which does not exceed that specified maximum quantity.

(11) In paragraphs (2) to (7) and (9) and (10) a reference to a numbered column is a referenceto the column bearing that number in Schedule 1.

Circumstances in which controlled drugs and medicinal products authorized by theEuropean Community are not prescription only medicines

6.—(1) A medicinal product shall not be a prescription only medicine by reason that it is acontrolled drug listed in Schedule 2 to the Misuse of Drugs Act 1971 where, it–

(a) contains not more than one of the substances listed in column 1 of Schedule 2 to this Orderand no other controlled drug;

(b) contains that substance at a strength that does not exceed the maximum strength specifiedin column 2 of that Schedule; and

(c) is sold or supplied–(i) in such pharmaceutical form as may be specified in column 3 of that Schedule, and

(ii) for use at a maximum dose which does not exceed that specified in column 4 of thatSchedule.

(2) A medicinal product for human use in respect of which a marketing authorization has beengranted under Council Regulation 2309/93/EEC(17) shall not be a prescription only medicine wherethat authorization does not classify the medicinal product as subject to medical prescription.

Exemption for parenteral administration in an emergency to human beings of certainprescription only medicines

7. The restriction imposed by section 58(2)(b) (restriction on administration) shall not applyto the administration to human beings of any of the following medicinal products for parenteraladministration–

Adrenaline Injection 1 in 1000 (1 mg in 1 ml)Atropine Sulphate InjectionChlorpheniramine InjectionCobalt Edetate InjectionDextrose Injection Strong B.P.C.Diphenhydramine InjectionGlucagon InjectionHydrocortisone InjectionMepyramine InjectionPromethazine Hydrochloride Injection

(17) OJ No. L214, 24.8.93, p. 1.7


Snake Venom AntiserumSodium Nitrite InjectionSodium Thiosulphate InjectionSterile Pralidoxime

where the administration is for the purpose of saving life in an emergency.

Exemptions for emergency sale or supply

8.—(1) The restrictions imposed by section 58(2)(a) (restriction on sale and supply) shall notapply to the sale or supply of a prescription only medicine by a person lawfully conducting a retailpharmacy business where the conditions specified in paragraph (2) are satisfied.

(2) The conditions referred to in paragraph (1) are–(a) that the pharmacist by or under whose supervision the prescription only medicine is to be

sold or supplied is satisfied that the sale or supply has been requested by a doctor who byreason of an emergency is unable to furnish a prescription immediately;

(b) that the doctor has undertaken to furnish the person lawfully conducting a retail pharmacybusiness with a prescription within 72 hours of the sale or supply;

(c) that the prescription only medicine is sold or supplied in accordance with the directionsof the doctor requesting it;

(d) subject to paragraph (5), that the prescription only medicine is not a controlled drugspecified in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations;

(e) that an entry is made in the record kept under regulation 6 of the Medicines (Sale orSupply) (Miscellaneous Provisions) Regulations 1980(18) within the time specified inthat regulation stating the particulars required under paragraph 1 of Schedule 2 to thoseRegulations.

(3) The restrictions imposed by section 58(2)(a) shall not apply to the sale or supply of aprescription only medicine by a person lawfully conducting a retail pharmacy business where theconditions specified in paragraph (4) are satisfied.

(4) The conditions referred to in paragraph (3) are–(a) that the pharmacist by or under whose supervision the prescription only medicine is to be

sold or supplied has interviewed the person requesting a prescription only medicine andhas satisfied himself–

(i) that there is an immediate need for the prescription only medicine requested tobe sold or supplied and that it is impracticable in the circumstances to obtain aprescription without undue delay,

(ii) that treatment with the prescription only medicine requested has on a previousoccasion been prescribed by a doctor for the person requesting it, and

(iii) as to the dose which in the circumstances it would be appropriate for that personto take;

(b) that no greater quantity of the prescription only medicine than will provide 5 days'treatment is sold or supplied except that where the prescription only medicine–

(i) is an aerosol for the relief of asthma, an ointment or cream, and has been made upfor sale in a container elsewhere than at the place of sale or supply, the smallest packthat the pharmacist has available for sale or supply may be sold or supplied,

(18) S.I. 1980/1923, amended by S.I. 1997/1831.8




(ii) is an oral contraceptive, a quantity sufficient for a full treatment cycle may be soldor supplied,

(iii) is an antibiotic for oral administration in liquid form, the smallest quantity that willprovide a full course of treatment may be sold or supplied;

(c) subject to paragraph (5), that the prescription only medicine does not consist of or containa substance specified in Schedule 4 to this Order and is not a controlled drug specified inSchedule 1, 2 or 3 to the Misuse of Drugs Regulations;

(d) that an entry is made in the record kept under regulation 6 of the Medicines (Sale or Supply)(Miscellaneous Provisions) Regulations 1980 within the time specified in that regulationstating the particulars required under paragraph 3 of Schedule 2 to those Regulations;

(e) that the container or package of the prescription only medicine is labelled so as to show–(i) the date on which the prescription only medicine is sold or supplied,

(ii) the name, quantity and, except where it is apparent from the name, thepharmaceutical form and strength of the prescription only medicine,

(iii) the name of the person requesting the prescription only medicine,(iv) the name and address of the registered pharmacy from which the prescription only

medicine is sold or supplied, and(v) the words “Emergency Supply”.

(5) The conditions specified in paragraphs (2)(d) and (4)(c) shall not apply where the prescriptiononly medicine consists of or contains phenobarbitone or phenobarbitone sodium (but no othersubstance specified in Schedule 4 to this Order or Schedule 1, 2 or 3 to the Misuse of DrugsRegulations) and is sold or supplied for use in the treatment of epilepsy.

Exemption for non-parenteral administration to human beings

9. The restriction imposed by section 58(2)(b) (restriction on administration) shall not applyto the administration to human beings of a prescription only medicine which is not for parenteraladministration.

Exemption for medicinal products at high dilutions

10. The restrictions imposed by section 58(2) (restrictions on sale, supply and administration)shall not apply to the sale, supply or administration of a medicinal product which is not for parenteraladministration and which consists of or contains, any of the substances listed in column 1 ofSchedule 1 or 2, only one or more unit preparation of such substances, if–

(a) each such unit preparation has been diluted to at least one part in a million (6x), and theperson selling, supplying or administering the medicinal product has been requested byor on behalf of a particular person and in that person’s presence to use his own judgmentas 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

11.—(1) The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall notapply–

(a) to the sale or supply by a person listed in column 1 of Part I of Schedule 5 of the prescriptiononly medicines listed in relation to that person in column 2 of that Part where the conditionsspecified in the corresponding paragraphs in column 3 of that Part are satisfied;

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(b) to the supply by a person listed in column 1 of Part II of Schedule 5 of the prescription onlymedicines listed in relation to that person in column 2 of that Part where the conditionsspecified in the corresponding paragraphs in column 3 of that Part are satisfied.

(2) The restriction imposed by section 58(2)(b) (restriction on administration) shall not applyto the administration by a person listed in column 1 of Part III of Schedule 5 of the prescriptiononly medicines for parenteral administration listed in relation to that person in column 2 of that Partwhere the conditions specified in the corresponding paragraphs in column 3 of that Part are satisfied.

Exemption for sale or supply in hospitals

12. The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not applyto the sale or supply of any prescription only medicine in the course of the business of a hospitalwhere the prescription only medicine is sold or supplied in accordance with the written directionsof a doctor or dentist notwithstanding that those directions do not satisfy the conditions specifiedin article 15(2).

Exemption in cases involving another’s default

13. The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not applyto the sale or supply of a prescription only medicine by a person who, having exercised all duediligence, believes on reasonable grounds that the product sold or supplied is not a prescription onlymedicine.

Exemption in the case of a forged prescription

14. The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall notapply to the sale or supply of a prescription only medicine by a pharmacist in accordance with aforged prescription where the pharmacist, having exercised all due diligence, believes on reasonablegrounds that the prescription is genuine.

Prescriptions

15.—(1) For the purposes of section 58(2)(a) a prescription only medicine shall not be taken tobe sold or supplied in accordance with a prescription given by an appropriate practitioner unless theconditions 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 appropriate practitioner giving it;(b) shall, without prejudice to sub-paragraph (a), be written in ink or otherwise so as to be

indelible, unless it is a health prescription which is not for a controlled drug specified inSchedule 1, 2 or 3 to the Misuse of Drugs Regulations, in which case it may be writtenby means of carbon paper or similar material;

(c) shall contain the following particulars–(i) the address of the appropriate practitioner giving it,

(ii) the appropriate date,(iii) such particulars as indicate whether the appropriate practitioner giving it is a doctor,

a dentist, an appropriate nurse practitioner, a veterinary surgeon or a veterinarypractitioner,

(iv) where the appropriate practitioner giving it is a doctor, dentist or appropriate nursepractitioner, the name, address and the age, if under 12, of the person for whosetreatment it is given, and

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(v) where the appropriate practitioner giving it is a veterinary surgeon or a veterinarypractitioner, the name and address of the person to whom the prescription onlymedicine is to be delivered and a declaration by the veterinary surgeon or veterinarypractitioner giving it that the prescription only medicine is prescribed for an animalor herd under his care;

(d) shall not be dispensed after the end of the period of 6 months from the appropriate date,unless it is a repeatable prescription in which case it shall not be dispensed for the first timeafter the end of that period nor otherwise than in accordance with the directions containedin the repeatable prescription;

(e) in the case of a repeatable prescription which does not specify the number of times it maybe dispensed, shall not be dispensed on more than two occasions unless it is a prescriptionfor an oral contraceptive in which case it may be dispensed 6 times before the end of theperiod of 6 months from the appropriate date.

(3) The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not applyto a sale or supply of a prescription only medicine which is not in accordance with a prescriptiongiven by an appropriate practitioner by reason only that a condition specified in paragraph (2) isnot satisfied where the person selling or supplying the prescription only medicine, having exercisedall due diligence, believes on reasonable grounds that that condition is satisfied in relation to thatsale or supply.

(4) In paragraph (2) “the appropriate date” means–(a) in the case of a health prescription, the date on which it was signed by the appropriate

practitioner giving it or a date indicated by him as being the date before which it shall notbe dispensed; and

(b) in every other case, the date on which the prescription was signed by the appropriatepractitioner giving it;

and, for the purposes of sub-paragraphs (d) and (e) of that paragraph, where a health prescriptionbears both the date on which it was signed and a date indicated as being that before which it shallnot be dispensed, the appropriate date is the later of those dates.

Revocations

16.—(1) The Orders specified in Schedule 6 are revoked.(2) In the Medicines (Prescription Only, Pharmacy and General Sale) Amendment Order

1989(19) articles 2 to 6 and Schedules 1 and 2 are revoked.

Signed by authority of the Secretary of State for Health

21st July 1997

Baroness JayMinister of State,

Department of Health

(19) S.I. 1989/1852.11



25th July 1997

Win GriffithsParliamentary Under Secretary of State, Welsh

Office

23rd July 1997

Sam GalbraithParliamentary Under Secretary of State, The

Scottish Office

25th July 1997

Jeff RookerMinister of State, Ministry of Agriculture,

Fisheries and Food

Sealed with the Official Seal of the Department of Health and Social Services for Northern Irelandon 22nd July 1997.

D. C. GowdyPermanent Secretary

Sealed with the Official Seal of the Department of Agriculture for Northern Ireland on 18th July1997.

P. SmallPermanent Secretary

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SCHEDULE 1 Articles 3(a), 5(1) and 10

SUBSTANCES WHICH IF INCLUDED IN MEDICINAL PRODUCTS MAKE THOSEPRODUCTS PRESCRIPTION ONLY MEDICINES AND EXEMP TIONS FROM

RESTRICTIONS ON THE SALE AND SUPPLY OF PRESCRIPTION ONLY MEDICINES

Exemptions from the restrictions on the sale and supply ofprescription only medicines

Column 1 Column 2 Column 3 Column 4 Column 5Substance Maximum

strengthRoute ofadministration,use orpharmaceuticalform

Treatmentlimitations

Maximumquantity

Acarbose

AcebutololHydrochloride

Acemetacin

Acetarsol

Acetazolamide

AcetazolamideSodium

Acetohexamide

AcetylcholineChloride

0.2 per cent External

Acetylcysteine

Acipimox

ExternalAciclovir 5.0 per cent

For treatmentof herpessimplex virusinfections ofthe lips andface (Herpeslabialis)

Containeror packagecontaining notmore than 2gof medicinalproduct

Acitretin

AclarubicinHydrochloride

Aconite 1.3 per cent External

Acrivastine 24 mg (MDD) Containeror packagecontainingnot more than240mg ofAcrivastine

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Maximumquantity

Acrosoxacin

ActinomycinC

ActinomycinD

Adenosine

(1) By inhalerAdrenaline

(2) External

(1) By inhalerAdrenalineAcid Tartrate

(2) External

(1 )By inhalerAdrenalineHydrochloride

(2) External

AdrenocorticalExtract

Albendazole

Alclofenac

AlclometasoneDipropionate

AlcuroniumChloride

Aldesleukin

Aldosterone

Alfacalcidol

AlfuzosinHydrochloride

AllergenExtracts

Allopurinol

Allyloestrenol

AlphadoloneAcetate

Alphaxalone

14






Maximumquantity

Alprenolol

AlprenololHydrochloride

Alprostadil

Alseroxylon

AmantadineHydrochloride

AmbenoniumChloride

AmbutoniumBromide

Amcinonide

AmetazoleHydrochloride

Amethocaine Non-ophthalmicuse

AmethocaineGentisate

Non-ophthalmicuse

AmethocaineHydrochloride

Non-ophthalmicuse

AmikacinSulphate

AmilorideHydrochloride

AminocaproicAcid

Aminoglutethimide

AminopterinSodium

AmiodaroneHydrochloride

15






Maximumquantity

AmiphenazoleHydrochloride

Amitriptyline

AmitriptylineEmbonate

AmitriptylineHydrochloride

AmlodipineBesylate

AmmoniumBromide

AmodiaquineHydrochloride

AmorolfineHydrochloride

Amoxapine

Amoxycillin

AmoxycillinSodium

AmoxycillinTrihydrate

AmphomycinCalcium

Amphotericin

Ampicillin

AmpicillinSodium

AmpicillinTrihydrate

Amsacrine

Amygdalin

Amyl Nitrite

16






Maximumquantity

AmylocaineHydrochloride

Non-ophthalmicuse

Ancrod

Androsterone

AngiotensinAmide

Anistreplase

AnteriorPituitaryExtract

AntimonyBariumTartrate

AntimonyDimercaptosuccinate

AntimonyLithiumThiomalate

AntimonyPentasulphide

AntimonyPotassiumTartrate

AntimonySodiumTartrate

AntimonySodiumThioglycollate

AntimonySulphate

AntimonyTrichloride

AntimonyTrioxide

17






Maximumquantity

AntimonyTrisulphide

Apiol

Apomorphine

ApomorphineHydrochloride

Aprotinin

ArecolineHydrobromide

Argipressin

Aristolochia

AristolochiaClematitis

AristolochiaContorta

AristolochiaDebelis

AristolochiaFang-chi

AristolochiaManshuriensis

AristolochiaSerpentaria

Arsenic

ArsenicTriiodide

ArsenicTrioxide

Arsphenamine

OralAstemizole

For treatmentof hayfeverin adults andchildren not

10mg (MDD) Containeror packagecontainingnot more than100mg ofAstemizole

18






Maximumquantity

less than 12years

Not aprolongedreleasepreparation

Atenolol

AtracuriumBesylate

(1) Internal

(a) by inhaler

(b) otherwisethan by inhaler

(b) 300mcg(MD)

1mg (MDD)

Atropine

(2) External(exceptophthalmic)

(1) Internal

(a) by inhaler


(b) 400mcg(MD)

1.3mg (MDD)

AtropineMethobromide


Internal

(a) by inhaler


(b) 400mcg(MD)

AtropineMethonitrate

1.3mg (MDD)

(1) Internal

(a) by inhaler

AtropineOxideHydrochloride


(b) 360mcg(MD)

19






Maximumquantity

1.2mg (MDD)3


(1) Internal

(a) by inhaler


(b) 360mcg(MD)

1.2mg (MDD)

AtropineSulphate


Auranofin

Azapropazone

Azathioprine

AzathioprineSodium

Azelaic Acid

For nasaladministration

140mcg pernostril (MD)

For thetreatmentof seasonalallergicrhinitis

280mcg pernostril (MDD)

For use inadults andchildren notless than 12years

AzelastineHydrochloride

As a non-aerosol,aqueous form

Containeror packagecontainingnot more than5,040mcg ofAzelastineHydrochloride

AzidocillinPotassium

20






Maximumquantity

Azithromycin

AzlocillinSodium

Aztreonam

BacampicillinHydrochloride

Bacitracin

BacitracinMethyleneDisalicylate

BacitracinZinc

Baclofen

BambuterolHydrochloride

BariumCarbonate

BariumChloride

BariumSulphide

Beclamide

Beclomethasone

For nasaladministration(non-aerosol)



BeclomethasoneDipropionate

For thepreventionand treatmentof allergicrhinitis

Containeror packagecontainingnot more than5,600mcg ofBeclomethasoneDipropionate

For use inadults andchildren not

21






Maximumquantity

less than 12years

(1) Internal (1) 1mg ofthe alkaloids(MDD)

BelladonnaHerb

(2) External

(1) Internal (1) 1mg ofthe alkaloids(MDD)

BelladonnaRoot

(2) External

Bemegride

BemegrideSodium

BenapryzineHydrochloride

Bendrofluazide

BenethaminePenicillin

Benoxaprofen

Benperidol

BenserazideHydrochloride

Bentiromide

BenzathinePenicillin

Benzbromarone

BenzhexolHydrochloride

BenziloniumBromide

Benzocaine Any useexceptophthalmicuse

22






Maximumquantity

BenzoctamineHydrochloride

BenzoylPeroxide

10.0 per cent External

N-BenzoylSulphanilamide

Benzquinamide

BenzquinamideHydrochloride

Benzthiazide

BenztropineMesylate

BenzylpenicillinCalcium

BenzylpenicillinPotassium

BenzylpenicillinSodium

Beractant

BetahistineHydrochloride

Betamethasone

BetamethasoneAdamantoate

BetamethasoneBenzoate

BetamethasoneDipropionate

BetamethasoneSodiumPhosphate

BetamethasoneValerate

BetaxololHydrochloride

23






Maximumquantity

BethanecholChloride

BethanidineSulphate

Bezafibrate

BiperidenHydrochloride

BiperidenLactate

BismuthGlycollylarsanilate

BisoprololFumarate

Bleomycin

BleomycinSulphate

BretyliumTosylate

BromhexineHydrochloride

BromocriptineMesylate

Bromperidol

Bromvaletone

Brotizolam

For nasaladministration


For thepreventionor treatmentof seasonalallergicrhinitis


Budesonide

For use inadults and inchildren not

Containeror packagecontainingnot morethan 10mg ofBudesonide

24






Maximumquantity

less than 12years

As a non-aerosol,aqueous form

Bufexamac

Bumetanide

6mg (MD)BuphenineHydrochloride

18mg (MDD)

Bupivacaine Any useexceptophthalmicuse

BupivacaineHydrochloride

Any useexceptophthalmicuse

BuserelinAcetate

BuspironeHydrochloride

Busulphan

ButacaineSulphate


ButorphanolTartrate

ButriptylineHydrochloride

Calcipotriol

Calcitonin

Calcitriol

CalciumAmphomycin

25






Maximumquantity

CalciumBenzamidosalicylate

CalciumBromide

CalciumBromidolactobionate

CalciumCarbimide

CalciumFolinate

CalciumMetrizoate

CalciumSulphaloxate

Candicidin

CanrenoicAcid

Cantharidin 0.01 per cent External

CapreomycinSulphate

Captopril

Carbachol

Carbamazepine

Carbaryl

CarbenicillinSodium

(1) 5mg (MD) (1) Pellet

25mg (MDD)

(2) 2.0 percent

(2) Gel

(3) 20mg(MD)

CarbenoxoloneSodium

(3) 1.0 percent

(3)Granules formouthwashin adults andchildren not

80mg (MDD)

(3) Containeror packagecontainingnot more than506mg of

26






Maximumquantity

less than 12years

CarbenoxoloneSodium

Carbidopa

Carbimazole

Carbocisteine

CarbonTetrachloride

Carboplatin

CarboprostTrometamol

CarbuterolHydrochloride

CarfecillinSodium

CarindacillinSodium

Carisoprodol

Carmustine

Carperidine

CarteololHydrochloride

Cefaclor

Cefadroxil

CefazedoneSodium

Cefixime

CefodizimeSodium

CefotaximeSodium

CefoxitinSodium

CefpodoximeProxetil

27






Maximumquantity

CefsulodinSodium

Ceftazidime

CeftizoximeSodium

CeftriaxoneSodium

CefuroximeAxetil

CefuroximeSodium

CeliprololHydrochloride

Cephalexin

CephalexinSodium

Cephaloridine

CephalothinSodium

CephamandoleNafate

CephazolinSodium

Cephradine

CeriumOxalate

Cerivastatin

CeruletideDiethylamine

CetirizineHydrochloride

10mg (MDD) Containeror packagecontainingnot more than100mg ofCetirizineHydrochloride

28






Maximumquantity

ChenodeoxycholicAcid

ChloralHydrate

External

Chlorambucil

Chloramphenicol

ChloramphenicolCinnamate

ChloramphenicolPalmitate

ChloramphenicolSodiumSuccinate

Chlorhexadol

ChlormadinoneAcetate

Chlormerodrin

Chlormethiazole

ChlormethiazoleEdisylate

Chlormezanone

(1) 5.0 percent

(1) InternalChloroform(20)

(2) External

ChloroquinePhosphate

Prophylaxis ofmalaria

ChloroquineSulphate


Chlorothiazide

Chlorotrianisene

ChlorphenoxamineHydrochloride

(20) SeeS.I. 1979/382 amended by S.I. 1980/263 and S.I. 1989/1124.29









Maximumquantity

Chlorpromazine

ChlorpromazineEmbonate

ChlorpromazineHydrochloride

Chlorpropamide

Chlorprothixene

ChlorprothixeneHydrochloride

Chlortetracycline

ChlortetracyclineCalcium

ChlortetracyclineHydrochloride

Chlorthalidone

Chlorzoxazone

Cholestyramine

Ciclacillin

Ciclobendazole

CilastatinSodium

Cilazapril

(a) 200mg(MD)

800mg(MDD)

Cimetidine (a) For theshort-termsymptomaticrelief ofheartburn,dyspepsia,indigestion,acidindigestionandhyperacidityand for theprophylaxis of

For amaximumperiod of 14days

30






Maximumquantity

meal-inducedheartburn

(b) 100mg(MD) to betaken as asingle dose atnight

(b) For theprophylacticmanagementof nocturnalheartburn bya single dosetaken at night For a

maximumperiod of 14days

CimetidineHydrochloride

Cinchocaine 3.0 per cent Non-ophthalmicuse

CinchocaineHydrochloride

Equivalent of3.0 per cent ofCinchocaine

Non-ophthalmicuse

Cinchophen

Cinoxacin

Ciprofibrate

Ciprofloxacin

CiprofloxacinHydrochloride

Cisapride

Cisplatin

Clarithromycin

ClavulanicAcid

ClidiniumBromide

Clindamycin

ClindamycinHydrochloride

31






Maximumquantity

ClindamycinPalmitateHydrochloride

ClindamycinPhosphate

(1) External(other thantreatment ofmouth ulcers)

Clioquinol

(2) 35mg (2) Treatmentof mouthulcers

(2) 350mg(MDD)

ClobetasolPropionate

ClobetasoneButyrate

Clofazimine

Clofibrate

ClomipheneCitrate

Clomipramine

ClomipramineHydrochloride

Clomocycline

ClomocyclineSodium

Clonidine

ClonidineHydrochloride

Clopamide

ClopenthixolDecanoate

ClopenthixolHydrochloride

Clorexolone

32






Maximumquantity

Clotrimazole External butin the case ofvaginal useonly externaluse for thetreatmentof vaginalcandidiasis

CloxacillinBenzathine

CloxacillinSodium

Clozapine

CocculusIndicus

Co-dergocrineMesylate

Colaspase

Colchicine

ColestipolHydrochloride

ColfoscerilPalmitate

ColistinSulphate

ColistinSulphomethate

ColistinSulphomethateSodium

Coniine

Conium Leaf 7.0 per cent External

Corticotrophin

Cortisone

CortisoneAcetate

33






Maximumquantity

Co-tetroxazine

Co-trimoxazole

Cropropamide

Crotethamide

Croton Oil

Croton Seed

Curare

Cyclofenil

Cyclopenthiazide

CyclopentolateHydrochloride

Cyclophosphamide

Cycloserine

Cyclosporin

Cyclothiazide

CyproteroneAcetate

Cytarabine

CytarabineHydrochloride

Dacarbazine

DalteparinSodium

Danazol

Danthron

DantroleneSodium

Dapsone

DapsoneEthane OrthoSulphonate

34






Maximumquantity

DaunorubicinHydrochloride

DeanolBitartrate

26mg (MDD)

DebrisoquineSulphate

DemecariumBromide

Demeclocycline

DemeclocyclineCalcium

DemeclocyclineHydrochloride

DeoxycortoneAcetate

DeoxycortonePivalate

DeptropineCitrate

(1) 0.25mg (1) Internal:throatlozenges orthroat pastilles

DequaliniumChloride

(2) 1.0 percent

(2) External:paint

Deserpidine

DesferrioxamineMesylate

Desflurane

DesipramineHydrochloride

Deslanoside

Desmopressin

DesmopressinAcetate

35






Maximumquantity

Desogestrel

Desonide

Desoxymethasone

Dexamethasone

DexamethasoneAcetate

DexamethasoneIsonicotinate

DexamethasonePhenylpropionate

DexamethasonePivalate

DexamethasoneSodiumMetasulphobenzoate

DexamethasoneSodiumPhosphate

DexamethasoneTroxundate

DexfenfluramineHydrochloride

(a) In the caseof a prolongedreleasepreparation:equivalentof 30mg ofDextromethorphan(MD)

equivalentof 75mg ofDextromethorphan(MDD)

DextromethorphanHydrobromide

Internal

(b) in anyother case:equivalent

36






Maximumquantity

of 15mg ofDextromethorphan(MD)

equivalentof 75mg ofDextromethorphan(MDD)

DextrothyroxineSodium

Diazoxide

DibenzepinHydrochloride

Dichloralphenazone

Dichlorphenamide

External

For localsymptomaticrelief ofpain andinflammationin trauma ofthe tendons,ligaments,muscles andjoints andin localisedforms ofsoft tissuerheumatism

DiclofenacDiethylammonium

1.16 per cent


For maximumperiod of 7days


DiclofenacPotassium

DiclofenacSodium

37






Maximumquantity

10mg (MD)DicyclomineHydrochloride

60mg (MDD)

Dienoestrol

DiethanolamineFusidate

DiflucortoloneValerate

Diflunisal

Digitalin

Digitalis Leaf

DigitalisPrepared

Digitoxin

Digoxin

DihydralazineSulphate

DihydroergotamineMesylate

Dihydrostreptomycin

DihydrostreptomycinSulphate

DiloxanideFuroate

DiltiazemHydrochloride

Dimercaprol

DimethisoquinHydrochloride

Non-ophthalmicuse

Dimethisterone

DimethothiazineMesylate

DimethylSulphoxide

38






Maximumquantity

DimethyltubocurarineBromide

DimethyltubocurarineChloride

DimethyltubocurarineIodide

Dinoprost

DinoprostTrometamol

Dinoprostone

DipivefrinHydrochloride

Dipyridamole

DisodiumEtidronate

DisodiumPamidronate

Disopyramide

DisopyramidePhosphate

DistigmineBromide

Disulfiram

Dithranol 1.0 per cent

DobutamineHydrochloride

Domperidone

DomperidoneMaleate

DopamineHydrochloride

DopexamineHydrochloride

Dothiepin

39






Maximumquantity

DothiepinHydrochloride

DoxapramHydrochloride

DoxazosinMesylate

DoxepinHydrochloride

Doxorubicin

DoxorubicinHydrochloride

Doxycycline

DoxycyclineCalciumChelate

DoxycyclineHydrochloride

Droperidol

Dydrogesterone

Dyflos

Econazole External butin the case ofvaginal useonly externaluse for thetreatmentof vaginalcandidiasis

EconazoleNitrate

External butin the case ofvaginal useonly externaluse for thetreatmentof vaginalcandidiasis

40






Maximumquantity

EcothiopateIodide

EdrophoniumChloride

EflornithineHydrochloride

Embutramide

EmeproniumBromide

Emetine 1.0 per cent

EmetineBismuthIodide

EmetineHydrochloride

Equivalent of1.0 per cent ofEmetine

EnalaprilMaleate

EncephalitisVirus, Tick-borne, CentEur

Enoxacin

EnoxaparinSodium

Enoximone

(1) Internal(other thannasal sprays ornasal drops)

(1) 30mg(MD)

60mg (MDD)

(2) 2.0 percent

(2) Nasalsprays or nasaldrops

Ephedrine

(3) External

41






Maximumquantity

(1) Equivalentof 30mg ofEphedrine(MD)


Equivalentof 60mg ofEphedrine(MDD)

(2) Equivalentof 2.0 per centof Ephedrine


EphedrineHydrochloride

(3) External


(1) Equivalentof 30mg ofEphedrine(MD)

Equivalentof 60mg ofEphedrine(MDD)

(2) Equivalentof 2.0 per centof Ephedrine


EphedrineSulphate

(3) External

Epicillin

Epirubicin

EpirubicinHydrochloride

Epithiazide

Epoetin Alfa

Epoetin Beta

EpoprostenolSodium

ErgometrineMaleate

42






Maximumquantity

ErgometrineTartrate

Ergot,Prepared

ErgotamineTartrate

Erythromycin

ErythromycinEstolate

ErythromycinEthylcarbonate

ErythromycinEthylSuccinate

ErythromycinLactobionate

ErythromycinPhosphate

ErythromycinStearate

ErythromycinThiocyanate

EsmololHydrochloride

EstramustinePhosphate

EtafedrineHydrochloride

EthacrynicAcid

EthambutolHydrochloride

Ethamivan

Ethamsylate

Ethiazide

43






Maximumquantity

EthinylAndrostenediol

Ethinyloestradiol

Ethionamide

Ethisterone

Ethoglucid

EthoheptazineCitrate

EthopropazineHydrochloride

Ethosuximide

Ethotoin

EthylBiscoumacetate

EthynodiolDiacetate

Etodolac

Etomidate

EtomidateHydrochloride

Etoposide

Etretinate

Famciclovir

10mg (MD)

20mg (MDD)

Famotidine For theshort-termsymptomaticrelief ofheartburn,dyspepsia,indigestion,acidindigestionandhyperacidity,and preventionof these


44






Maximumquantity

symptomswhenassociatedwith foodand drink,includingnocturnalsymptoms

FazadiniumBromide

External

For the reliefof symptomsassociatedwith softtissue injurysuch asstrains, sprainsand contusions

Felbinac 3.17 per cent




Felodipine

Felypressin

Fenbufen

Fenclofenac

FenfluramineHydrochloride

Fenofibrate

Fenoprofen

FenoprofenCalcium

FenoterolHydrobromide

45






Maximumquantity

FenticonazoleNitrate

Feprazone

FerrousArsenate

Filgrastim

Finasteride

FlavoxateHydrochloride

FlecainideAcetate

Flosequinan

Fluanisone

Flubendazole

FlucloroloneAcetonide

FlucloxacillinMagnesium

FlucloxacillinSodium

Fluconazole For oraladministrationfor thetreatmentof vaginalcandidiasis inpersons agednot less than16 but lessthan 60 years

150mg (MD) Containeror packagecontainingnot more than150mg ofFluconazole

Flucytosine

FludrocortisoneAcetate

FlufenamicAcid

Flumazenil 46






Maximumquantity

Flumethasone

FlumethasonePivalate

(a) 50mcg pernostril (MD)

(a) For thepreventionand treatmentof seasonalallergicrhinitis,including hayfever



In the formof a non-pressurisednasal spray

(a) Containeror packagecontainingnot more than6,000mcg ofFlunisolide

(b) 25mcg pernostril (MD)

(b) For thepreventionand treatmentof seasonalallergicrhinitisincluding hayfever


(b) Containeror packagecontainingnot more than6,000mcg ofFlunisolide

For use inchildren notless than 12years but lessthan 16 years

Flunisolide 0.025 per cent

In the formof a non-pressurisednasal spray

FluocinoloneAcetonide

Fluocinonide 47






Maximumquantity

FluocortinButyl

Fluocortolone

FluocortoloneHexanoate

FluocortolonePivalate

FluoresceinDilaurate

Fluorometholone

Fluorouracil

FluorouracilTrometamol

FluoxetineHydrochloride

FlupenthixolDecanoate

FlupenthixolHydrochloride

FluperoloneAcetate

FluphenazineDecanoate

FluphenazineEnanthate

FluphenazineHydrochloride

FluprednideneAcetate

Fluprednisolone

FluprostenolSodium

Flurandrenolone

Flurbiprofen

48






Maximumquantity

FlurbiprofenSodium

Fluspirilene

Flutamide

FluticasonePropionate

FluvastatinSodium

FluvoxamineMaleate

Folic Acic 500mcg(MDD)

Formestane

Formocortal

FoscarnetSodium

FosfestrolSodium

FosfomycinTrometamol

FosinoprilSodium

FramycetinSulphate

Frusemide

Furazolidone

Fusafungine

Fusidic Acid

Gabapentin

Gadoteridol

GallamineTriethiodide

Ganciclovir

49






Maximumquantity

GanciclovirSodium

Gelsemine 0.1 per cent

25mg (MD)Gelsemium

75mg (MDD)

Gemeprost

Gemfibrozil

Gentamicin

GentamicinSulphate

Gestodene

Gestrinone

Gestronol

GestronolHexanoate

Glibenclamide

Glibornuride

Gliclazide

Glipizide

Gliquidone

Glisoxepide

Glucagon

1mg (MD)GlycopyrroniumBromide

2mg (MDD)

Glymidine

Gonadorelin

GoserelinAcetate

Gramicidin 0.2 per cent External

GranisetronHydrochloride

50






Maximumquantity

Griseofulvin

GrowthHormone

GuanethidineMonosulphate

GuanfacineHydrochloride

GuanoclorSulphate

GuanoxanSulphate

Halcinonide

HalofantrineHydrochloride

Haloperidol

HaloperidolDecanoate

Heparin External

HeparinCalcium

External

HeparinSodium

External

(a) 2.0 percent

(a) Soaps

(b) 0.1 percent

(b) Aerosols

Hexachlorophane

(c) 0.75 percent

(c)preparationsother thansoaps andaerosols

HexaminePhenylcinchoninate

Hexobarbitone

51






Maximumquantity

HexobarbitoneSodium

Hexoestrol

HexoestrolDipropionate

L-HistidineHydrochloride

Dietarysupplementation

(1) 0.15mg(MD)

(1) Internal

0.45mg(MDD)

Homatropine


0.2mg (MD)HomatropineHydrobromide

0.6mg (MDD)

2mg (MD)HomatropineMethylbromide

6mg (MDD)

HydralazineHydrochloride

Hydrargaphen Localapplication toskin

HydrobromicAcid

Hydrochlorothiazide

ExternalHydrocortisone 1.0 per cent

For use eitheralone or inconjunctionwithCrotamitonin irritantdermatitis,contactallergic

Containeror packagecontaining notmore than 15gof medicinalproduct(cream orointment) or30ml (spray)

52






Maximumquantity

dermatitis,insect bitereactions, mildto moderateeczema, andeither incombinationwithClotrimazolefor athlete’sfoot andcandidalintertrigo or incombinationwithlignocainefor anal andperianal itchassociatedwithhaemorrhoids


Creamointment orspray

External


HydrocortisoneAcetate

Equivalent to1.0 per centHydrocortisone For use

in irritantdermatitis,contactallergicdermatitis,insect bitereactions, mildto moderateeczema, and incombinationwith one ormore of the

In the case ofsuppositories,containeror packagecontaining nomore than 12

53






Maximumquantity

following:BenzylBenzoate,BismuthOxide,BismuthSubgallate,Peru Balsam,PramoxineHydrochloride,ZincOxide, forhaemorrhoids


Cream,ointment orsuppositories

HydrocortisoneButyrate

HydrocortisoneCaprylate

HydrocortisoneHydrogenSuccinate

HydrocortisoneSodiumPhosphate

ExternalHydrocortisoneSodiumSuccinate

Equivalentto 2.5mgHydrocortisone For aphthous

ulceration ofthe mouth foradults andchildren notless than 12years

Containeror packagecontainingnot more thanequivalentto 50mg ofHydrocortisone

54






Maximumquantity

In the form ofpellets

Hydroflumethiazide

HydroxychloroquineSulphate


Hydroxyprogesterone

HydroxyprogesteroneEnanthate

HydroxyprogesteroneHexanoate

Hydroxyurea

HydroxyzineEmbonate

(a) 25mg(MD)

(a) For themanagementof pruritisassociatedwith acuteor chronicurticariaor atopicdermatitisor contactdermatitis, inadults and inchildren notless than 12years

75mg (MDD)

(a) Containeror packagecontainingnot more than750mg ofHydroxyzineHydrochloride

(b) 25 mg(MD)

HydroxyzineHydrochloride

(b) For themanagementof pruritisassociatedwith acuteor chronicurticariaor atopicdermatitisor contactdermatitis, inchildren not

50mg (MDD)

(b) Containeror packagecontainingnot more than750mg ofHydroxyzineHydrochloride

55






Maximumquantity

less than 6years but lessthan 12 years

(1) 0.15 percent

(1) InternalHyoscine


(1) Internal

(a) by inhaler

(b) 20mg(MD)


80mg (MDD)

(b) Containeror packagecontainingnot morethan 240mgof HyoscineButylbromide

HyoscineButylbromide

(2) External

(1) Internal

(a) by inhaler

(b) 300mcg(MD)


900mcg(MDD)

HyoscineHydrobromide


(1) Internal

(a) by inhaler

(b) 2.5mg(MD)


7.5mg (MDD)

HyoscineMethobromide

(2) External

(1) InternalHyoscineMethonitrate

(a) by inhaler

56






Maximumquantity

(b) 2.5mg(MD)


7.5mg (MDD)

(2) External

(1) Internal

(a) by inhaler

(b) 300mcg(MD)


1mg (MDD)

Hyoscyamine

(2) External

(1) Internal

(a) by inhaler

(b) Equivalentof 300mcg ofHyoscyamine(MD)


Equivalentof 1mg ofHyoscyamine(MDD)

HyoscyamineHydrobromide

(2) External

(1) Internal

(a) by inhaler

(b) Equivalentof 300mcg ofHyoscyamine(MD)


Equivalentof 1mg ofHyoscyamine(MDD)

HyoscyamineSulphate

(2) External

Ibuprofen Rheumaticand muscularpain, pain of

57






Maximumquantity

non-seriousarthriticconditions,backache,neuralgia,migraine,headache,dental pain,dysmenorrhoea,feverishness,symptomsof colds andinfluenza

(1)(a) In thecase of aprolongedreleasepreparation600mg (MD)

1,200mg(MDD)

(b) in anyother case400mg (MD)

(1) Internal

1,200mg(MDD)

(2) 5.0 percent

(2) External

IdarubicinHydrochloride

Idoxuridine

Ifosfamide

Ignatius Bean

ImipenemHydrochloride

Imipramine

ImipramineHydrochloride

58






Maximumquantity

ImipramineIon ExchangeResin BoundSalt orComplex

IndapamideHemihydrate

Indomethacin

IndomethacinSodium

Indoprofen

IndoraminHydrochloride

InosinePranobex

Iodamide

IodamideMeglumine

IodamideSodium

Iohexol

Iomeprol

Iopamidol

Iopentol

IothalamicAcid

Ioversol

Ioxaglic Acid

IpratropiumBromide

IprindoleHydrochloride

IproniazidPhosphate

59






Maximumquantity

Isoaminile

IsoaminileCitrate

Isocarboxazid

IsoconazoleNitrate


Isoetharine

IsoetharineHydrochloride

IsoetharineMesylate

Isoniazid

IsoprenalineHydrochloride

IsoprenalineSulphate

Equivalentof 2.5mg ofIsopropamideion (MD)

IsopropamideIodide

Equivalentof 5.0mg ofIsopropamideion (MDD)

Isotretinoin

Isradipine

Itraconazole

Jaborandi External

KanamycinAcid Sulphate

60






Maximumquantity

KanamycinSulphate

KetamineHydrochloride

For theprevention andtreatment ofdandruff andseborrhoeicdermatitis ofthe scalp

Ketoconazole 2.0 per cent

In the form ofa shampoo

Maximumfrequency ofapplication ofonce every 3days

Containeror packagecontainingnot morethan 120mlof medicinalproduct andcontainingnot more than2,400mg ofKetoconazole

ExternalKetoprofen 2.5 per cent

For rheumaticand muscularpain in adultsand childrennot less than12



KetorolacTrometamol

KetotifenFumarate

LabetalolHydrocholoride

LachesineChloride

Lacidipine

Lamotrigine

Lanatoside C

LanatosideComplex A, Band C

LatamoxefDisodium

61






Maximumquantity

LevallorphanTartrate

LevobunololHydrochloride

Levodopa

Levonorgestrel

Lidoflazine

Lignocaine Non-ophthalmicuse

LignocaineHydrochloride

Non-ophthalmicuse

Lincomycin

LincomycinHydrochloride

LiothyronineSodium

Lisinopril

Equivalentof 5mg ofLithium (MD)

LithiumCarbonate

Equivalentof 15mgof Lithium(MDD)

LithiumCitrate

LithiumSuccinate

Equivalentof 5mg ofLithium (MD)

LithiumSulphate

Equivalentof 15mg

62






Maximumquantity

of Lithium(MDD)

(1) 3mg (MD)(1) Internal

9mg (MDD)

Lobeline

(2) External

(1) Equivalentof 3mg ofLobeline(MD)

(1) Internal

Equivalentof 9mg ofLobeline(MDD)

LobelineHydrochloride

(2) External

(1) Equivalentof 3mg ofLobeline(MD)

(1) Internal

Equivalentof 9mg ofLobeline(MDD)

LobelineSulphate

(2) External

LodoxamideTrometamol

Lofepramine

LofepramineHydrochloride

LofexidineHydrochloride

LomefloxacinHydrochloride

Lomustine

LoperamideHydrochloride

Treatmentof acutediarrhoea

63






Maximumquantity

Loratidine 10mg (MDD) Containeror packagecontainingnot more than100mg ofLoratidine

LoxapineSuccinate

LungSurfactantPorcine

LuteinisingHormone

Lymecycline

Lynoestrenol

Lypressin

LysurideMaleate

Mafenide

MafenideAcetate

MafenideHydrochloride

MafenidePropionate

5.0 per cent Eye drops

MagnesiumFluoride

MagnesiumMetrizoate

MandragoraAutumnalis

MannomustineHydrochloride

MaprotilineHydrochloride

Mebanazine 64






Maximumquantity

Mebendazole For oral use inthe treatmentof enterobiasisin adults andin childrennot less than 2years

100mg (MD) Containeror packagecontainingnot more than800mg ofMebendazole

135mg (MD)MebeverineHydrochloride

For thesymptomaticrelief ofirritable bowelsyndrome

405mg(MDD)

MebeverinePamoate

Mebhydrolin

MebhydrolinNapadisylate

MecamylamineHydrochloride

Mecillinam

MeclofenoxateHydrochloride

Medigoxin

Medrogestone

MedroxyprogesteroneAcetate

MefenamicAcid

MefloquineHydrochloride

Mefruside

Megestrol

MegestrolAcetate

MeglumineGadopentetate

65






Maximumquantity

MeglumineIodoxamate

MeglumineIoglycamate

MeglumineIothalamate

MeglumineIotroxate

MeglumineIoxaglate

Melphalan

MelphalanHydrochloride

Menotrophin

25mg (MD)MepenzolateBromide

75mg (MDD)

Mephenesin

MephenesinCarbamate

MepivacaineHydrochloride


MeptazinolHydrochloride

Mequitazine

Mercaptopurine

Mersalyl

Mersalyl Acid

Mesalazine

Mesna

Mestranol

MetaraminolTartrate

66






Maximumquantity

Metergoline

MetforminHydrochloride

Methacycline

MethacyclineCalcium

MethacyclineHydrochloride

Methallenoestril

MethicillinSodium

Methixene

MethixeneHydrochloride

Methocarbamol

Methocidin Throatlozenges andthroat pastilles

MethohexitoneSodium

Methoin

Methoserpidine

Methotrexate

MethotrexateSodium

Methotrimeprazine

MethotrimeprazineHydrochloride

MethotrimeprazineMaleate

MethoxamineHydrochloride

0.25 per cent Nasal spraysor nasal dropsnot containingliquid paraffinas a vehicle

67






Maximumquantity

Methsuximide

Methyclothiazide

Methyldopa

MethyldopateHydrochloride

30mg (MD)MethylephedrineHydrochloride

60mg (MDD)

Methylprednisolone

MethylprednisoloneAcetate

MethylprednisoloneSodiumSuccinate

Methylthiouracil

MethysergideMaleate

Metipranolol

Metirosine

MetoclopramideHydrochloride

Metolazone

MetoprololFumarate

MetoprololSuccinate

MetoprololTartrate

Metronidazole

MetronidazoleBenzoate

Metyrapone

MexiletineHydrochloride

68






Maximumquantity

MezlocillinSodium

MianserinHydrochloride

Miconazole External butin the case ofvaginal useonly externaluse for thetreatmentof vaginalcandidiasis

MiconazoleNitrate


Mifepristone

Miglitol

Milrinone

MilrinoneLactate

Minocycline

MinocyclineHydrochloride

Minoxidil 2.0 per cent External

Misoprostol

Mitobronitol

Mitomycin

MitozantroneHydrochloride

MivacuriumChloride

69






Maximumquantity

Moclobemide

Molgramostim

MolindoneHydrochloride

MometasoneFuroate

MoracizineHydrochloride

MorazoneHydrochloride

Mupirocin

MupirocinCalcium

MustineHydrochloride

Nabilone

Nabumetone

Nadolol

NafarelinAcetate

NaftidrofurylOxalate

NaftifineHydrochloride

NalbuphineHydrochloride

Nalidixic Acid

NalorphineHydrobromide

NaloxoneHydrochloride

NaltrexoneHydrochloride

70






Maximumquantity

(1) 0.05 percent

(1) Nasalsprays or nasaldrops notcontainingliquid paraffinas a vehicle

NaphazolineHydrochloride

(2) 0.015 percent

(2) Eye drops

NaphazolineNitrate

0.05 per cent Nasal spraysor nasal dropsnot containingliquid paraffinas a vehicle

Naproxen

NaproxenSodium

Natamycin

NedocromilSodium

NefazodoneHydrochloride

NefopamHydrochloride

Neomycin

NeomycinOleate

NeomycinPalmitate

NeomycinSulphate

NeomycinUndecanoate

NeostigmineBromide

NeostigmineMethylsulphate

71






Maximumquantity

NetilmicinSulphate

NicardipineHydrochloride

Nicergoline

Nicotinic Acid Any use,except for thetreatment ofhyperlipidaemia

600mg(MDD)

Nicoumalone

Nifedipine

Nifenazone

Nikethamide

Nimodipine

Niridazole

Nitrendipine

Nitrofurantoin

Nitrofurazone

75mg (MD)For theprevention ofthe symptomsof food-relatedheartburn

Maximum of 4such doses inany period of14 days

Nizatidine


NomifensineMaleate

Noradrenaline

NoradrenalineAcid Tartrate

Norethisterone

72






Maximumquantity

NorethisteroneAcetate

NorethisteroneEnanthate

Norethynodrel

Norfloxacin

Norgestimate

Norgestrel

NortriptylineHydrochloride

Noscapine

NoscapineHydrochloride

NovobiocinCalcium

NovobiocinSodium

Nux VomicaSeed

Nystatin

Octacosactrin

Octreotide

Oestradiol

OestradiolBenzoate

OestradiolCypionate

OestradiolDipropionate

OestradiolDiundecanoate

OestradiolEnanthate

73






Maximumquantity

OestradiolPhenylpropionate

OestradiolUndecanoate

OestradiolValerate

Oestriol

OestriolSuccinate

OestrogenicSubstancesConjugated

Oestrone

Ofloxacin

OlsalazineSodium

Omeprazole

OndansetronHydrochloride

OrciprenalineSulphate

OrphenadrineCitrate

OrphenadrineHydrochloride

Ouabain

Ovarian GlandDried

Oxamniquine

OxantelEmbonate

Oxaprozin

Oxatomide

74






Maximumquantity

OxedrineTartrate

10mg (MD)Oxethazaine

30mg (MDD)

Containeror packagecontainingnot more than400mg ofOxethazaine

OxitropiumBromide

Oxolinic Acid

Oxpentifylline

OxprenololHydrochloride

OxybuprocaineHydrochloride

Non-ophthalmicuse

OxybutyninHydrochloride

Oxypertine

OxypertineHydrochloride

Oxyphenbutazone

OxyphencyclimineHydrochloride

5mg (MD)OxyphenoniumBromide

15mg (MDD)

Oxytetracycline

OxytetracyclineCalcium

OxytetracyclineDihydrate

OxytetracyclineHydrochloride

75






Maximumquantity

Oxytocin,natural

Oxytocin,synthetic

(1) 21,000EuropeanPharmacopoeiaunits of lipaseper capsule

(1) capsulesPancreatin

(2) 25,000EuropeanPharmacopoeiaunits of lipaseper gram

(2) powder

PancuroniumBromide

(1) By inhaler

(2) 50mg(MD)

Papaverine

(2) Otherwisethan by inhaler

150mg(MDD)

(1) By inhaler

(2) Equivalentof 50mg ofPapaverine(MD)

PapaverineHydrochloride

(2) Otherwisethan by inhaler

Equivalentof 150mg ofPapaverine(MDD)

Paraldehyde

Paramethadione

ParamethasoneAcetate

ParathyroidGland

76






Maximumquantity

PargylineHydrochloride

ParoxetineHydrochloride

Pecilocin

Penamecillin

PenbutololSulphate

Penicillamine

PenicillamineHydrochloride

PentamidineIsethionate

5mg (MD)PenthienateBromide

15mg (MDD)

PentoliniumTartrate

Perfluamine

PergolideMesylate

PerhexilineMaleate

Pericyazine

Perindopril

PerindoprilErbumine

Perphenazine

Phenacetin 0.1 per cent

Phenazone External

PhenazoneSalicylate

PhenbutrazateHydrochloride

77






Maximumquantity

PhenelzineSulphate

PhenethicillinPotassium

PhenforminHydrochloride

PhenglutarimideHydrochloride

Phenindione

PhenoxybenzamineHydrochloride

Phenoxymethylpenicillin

PhenoxymethylpenicillinCalcium

PhenoxymethylpenicillinPotassium

Phenprocoumon

Phensuximide

PhentolamineHydrochloride

PhentolamineMesylate

Phenylbutazone

PhenylbutazoneSodium

Internal

(1) 25mg(MD)

PhenylpropanolamineHydrochloride

(1) allpreparationsexceptprolongedreleasecapsules, nasalsprays andnasal drops

100mg(MDD)

78






Maximumquantity

(2) 50mg(MD)

(2) prolongedreleasecapsules 100mg

(MDD)

(3) 2.0 percent

(3) nasalsprays andnasal drops

Phenytoin

PhenytoinSodium

Phthalylsulphathiazole

Physostigmine

PhysostigmineAminoxideSalicylate

PhysostigmineSalicylate

PhysostigmineSulphate

Picrotoxin

Pilocarpine

PilocarpineHydrochloride

PilocarpineNitrate

Pimozide

Pindolol

5mg (MD)PipenzolateBromide

15mg (MDD)

PiperacillinSodium

PiperazineOestroneSulphate

79






Maximumquantity

50mg (MD)PiperidolateHydrochloride

150mg(MDD)

PipothiazinePalmitate

Piracetam

PirbuterolAcetate

PirbuterolHydrochloride

PirenzepineHydrochloride

Piretanide

External

For the reliefof rheumaticpain, pain ofnon-seriousarthriticconditionsand muscularaches, painsand swellingssuch asstrains, sprainsand sportsinjuries

Piroxicam 0.5 per cent




PituitaryGland (WholeDried)

By inhaler

PituitaryPowdered

By inhaler

80






Maximumquantity

(PosteriorLobe)

Pivampicillin

PivampicillinHydrochloride

Pivmecillinam

PivmecillinamHydrochloride

Pizotifen

PizotifenMalate

Plicamycin

Podophyllotoxin

Podophyllum

PodophyllumIndian

ExternalPodophyllumResin

20.0 per cent

Ointment orimpregnatedplaster

2mg (MD)PoldineMethylsulphate

6mg (MDD)

Polidexide

PolyestradiolPhosphate

Polymyxin BSulphate

Polythiazide

PoppyCapsule

PotassiumArsenite

0.0127 percent

PotassiumBromide

81






Maximumquantity

PotassiumCanrenoate

PotassiumClavulanate

PotassiumPerchlorate

Practolol

PralidoximeChloride

PralidoximeIodide

PralidoximeMesylate

PravastatinSodium

PrazosinHydrochloride

Prednisolone

PrednisoloneAcetate

PrednisoloneButylacetate

PrednisoloneHexanoate

PrednisoloneMetasulphobenzoate

PrednisoloneMetasulphobenzoateSodium

PrednisolonePivalate

PrednisoloneSodiumPhosphate

PrednisoloneSteaglate

82






Maximumquantity

Prednisone

PrednisoneAcetate

PrenalterolHydrochloride

PrenylamineLactate

PrilocaineHydrochloride

Non-ophthalmicuse

Primidone

Probenecid

Probucol

ProcainamideHydrochloride

ProcaineHydrochloride

Non-ophthalmicuse

ProcainePenicillin

ProcarbazineHydrochloride

Prochlorperazine

ProchlorperazineEdisylate

ProchlorperazineMaleate

ProchlorperazineMesylate

ProcyclidineHydrochloride

Progesterone

Prolactin

Proligestone

83






Maximumquantity

ProlintaneHydrochloride

PromazineEmbonate

PromazineHydrochloride

Propafenone

PropafenoneHydrochloride

Propanidid

15mg (MD)PropanthelineBromide

45mg (MDD)

Propofol

PropranololHydrochloride

Propylthiouracil

Proquazone

ProtamineSulphate

Prothionamide

Protirelin

ProtriptylineHydrochloride

ProxymetacaineHydrochloride

Non-ophthalmicuse

(a) In the caseof a prolongedreleasepreparation

120mg (MD)

PseudoephedrineHydrochloride

Internal

240mg(MDD)

84






Maximumquantity

(b) in anyother case60mg (MD)

240mg(MDD)

60mg (MD)PseudoephedrineSulphate

180mg(MDD)

(a) For thetreatment ofenterobiosis,in adults andchildren notless than 12years

(a) 750mgMDD (as asingle dose)

(a) Containeror packagecontainingnot morethan 750mgof PyrantelEmbonate

(b) For thetreatment ofenterobiosis,in childrenless than 12years but notless than 6years

(b) 500mgMDD (as asingle dose)

(b) Containeror packagecontainingnot morethan 750mgof PyrantelEmbonate

PyrantelEmbonate

(c) For thetreatment ofenterobiosis inchildren lessthan 6 yearsbut not lessthan 2 years

(c) 250mgMDD (as asingle dose)

(c) Containeror packagecontainingnot morethan 750mgof PyrantelEmbonate

PyrantelTartrate

Pyrazinamide

PyridostigmineBromide

Pyrimethamine

Quinapril

Quinestradol

85






Maximumquantity

Quinestrol

Quinethazone

Quinidine

QuinidineBisulphate

QuinidinePolygalacturonate

QuinidineSulphate

100mg (MD)Quinine

300mg(MDD)

Equivalentof 100mg ofQuinine (MD)

QuinineBisulphate

Equivalentof 300mgof Quinine(MDD)


QuinineCinchophen



QuinineDihydrochloride


Quinine EthylCarbonate


86






Maximumquantity



QuinineGlycerophosphate



QuinineHydrobromide



QuinineHydrochloride



QuinineIodobismuthate



QuininePhosphate


87






Maximumquantity


QuinineSalicylate



QuinineSulphate



QuinineTannate


Quinine incombinationwith UreaHydrochloride

Ramipril

Equivalentto 75mg ofRanitidine(MD)

Equivalentto 300mg ofRanitidine(MDD)

RanitidineHydrochloride

For theshort termsymptomaticrelief ofheartburn,dyspepsia,indigestion,acidindigestionandhyperacidity

For amaximumperiod of 14days

88






Maximumquantity

RauwolfiaSerpentina

RauwolfiaVomitoria

Razoxane

RemoxiprideHydrochloride

ReproterolHydrochloride

Rescinnamine

Reserpine

Rifabutin

Rifampicin

RifampicinSodium

Rifamycin

RimiterolHydrobromide

Risperidone

RitodrineHydrochloride

RolitetracyclineNitrate

Sabadilla

Salbutamol

SalbutamolSulphate

Salcatonin

SalcatoninAcetate

Salmefamol

SalmeterolXinafoate

89






Maximumquantity

Salsalate

SaralasinAcetate

SelegilineHydrochloride

SemisodiumValproate

SerumGonadotrophin

SilverSulphadiazine

Simvastatin

Sissomicin

SissomicinSulphate

Snake Venoms

SodiumAcetrizoate

SodiumAminosalicylate

SodiumAntimonylgluconate

SodiumArsanilate

SodiumArsenate

SodiumArsenite

0.013 per cent

SodiumBromide

SodiumClodronate

SodiumCromoglycate

(a) For nasaladmistration

90






Maximumquantity

(b) For thetreatment ofacute seasonalallergicconjunctivitis

(b) 2.0 percent

In the form ofaqueous eyedrops

(b) Containeror packagecontainingnot morethan 10mlof medicinalproduct

(c) For thetreatment ofacute seasonalallergicconjunctivitis

(c) 4.0 percent

In the formof an eyeointment

(c) Containeror packagecontaining notmore than 5gof medicinalproduct

SodiumEthacrynate

(1) Dentifrices

(2) Otherpreparationsfor use in theprevention ofdental caries

In the form of

(1) 0.33 percent

(a) tablets ordrops

(a) 2.2 mg(MDD)

(b) 0.2 percent

(b) mouthrinses otherthan those fordaily use

SodiumFluoride

(c) 0.05 percent

(c) mouthrinses for dailyuse

SodiumFusidate

SodiumMetrizoate

91






Maximumquantity

SodiumMonofluorophosphate

1.14 per cent Dentrifrice

SodiumOxidronate

SodiumStibogluconate

SodiumValproate

SomatorelinAcetate

SotalolHydrochloride

Spectinomycin

SpectinomycinHydrochloride

Spiramycin

SpiramycinAdipate

Spironolactone

StannousFluoride

0.62 per cent Dentifrice

Stilboestrol

StilboestrolDipropionate

Streptodornase External

Streptokinase External

Streptomycin

StreptomycinSulphate

Strychnine

StrychnineArsenate

StrychnineHydrochloride

92






Maximumquantity

Styramate

Succinylsulphathiazole

Sucralfate

SulbactamSodium

Sulbenicillin

SulbenicillinSodium

SulconazoleNitrate

External(exceptvaginal)

Sulfacytine

Sulfadoxine

Sulfamerazine

SulfamerazineSodium

Sulfametopyrazine

Sulfamonomethoxine

Sulindac

Sulphacetamide

SulphacetamideSodium

Sulphadiazine

SulphadiazineSodium

Sulphadimethoxine

Sulphadimidine

SulphadimidineSodium

Sulphafurazole

SulphafurazoleDiethanolamine

Sulphaguanidine 93






Maximumquantity

SulphaloxicAcid

Sulphamethizole

Sulphamethoxazole

Sulphamethoxydiazine

Sulphamethoxypyridazine

SulphamethoxypyridazineSodium

Sulphamoxole

Sulphanilamide

Sulphaphenazole

Sulphapyridine

SulphapyridineSodium

Sulphasalazine

Sulphathiazole

SulphathiazoleSodium

Sulphaurea

Sulphinpyrazone

Sulpiride

Sultamicillin

SultamicillinTosylate

Sulthiame

SumatriptanSuccinate

Suprofen

SuxamethoniumBromide

SuxamethoniumChloride

94






Maximumquantity

SuxethoniumBromide

TacrineHydrochloride

Talampicillin

TalampicillinHydrochloride

TalampicillinNapsylate

Tamoxifen

TamoxifenCitrate

TazobactamSodium

Teicoplanin

TemocillinSodium

Tenoxicam

TerazosinHydrochloride

Terbinafine

Terbutaline

TerbutalineSulphate

Terfenadine 120mg(MDD)

Containeror packagecontainingno more than1,200mg ofTerfenadine

Terlipressin

TerodilineHydrochloride

Tetrabenazine

Tetracosactrin 95






Maximumquantity

TetracosactrinAcetate

Tetracycline

TetracyclineHydrochloride

TetracyclinePhosphateComplex

Tetroxoprim

ThalliumAcetate

ThallousChloride

Thiabendazole

Thiambutosine

ThiethylperazineMalate

ThiethylperazineMaleate

Thiocarlide

Thioguanine

ThiopentoneSodium

ThiopropazateHydrochloride

ThioproperazineMesylate

Thioridazine

ThioridazineHydrochloride

Thiosinamine

Thiotepa

Thiothixene

Thiouracil 96






Maximumquantity

ThymoxamineHydrochloride

Thyroid

Thyrotrophin

ThyroxineSodium

TiamulinFumarate

TiaprofenicAcid

Tibolone

TicarcillinSodium

TigloidineHydrobromide

TimololMaleate

Tinidazole

Tinzaparin

(1) External(exceptvaginal)

Tioconazole (1) 2.0 percent

(2) Vaginalfor treatmentof vaginalcandidiasis

Tobramycin

TobramycinSulphate

TocainideHydrochloride

TofenacinHydrochloride

Tolazamide

97






Maximumquantity

TolazolineHydrochloride

External

Tolbutamide

TolbutamideSodium

TolfenamicAcid

TolmetinSodium

TramadolHydrochloride

Trandolapril

TranexamicAcid

TranylcypromineSulphate

TrazodoneHydrochloride

Treosulfan

Tretinoin

Triamcinolone

TriamcinoloneAcetonide

0.1 per cent For thetreatmentof commonmouth ulcers


TriamcinoloneDiacetate

TriamcinoloneHexacetonide

Triamterene

Tribavirin

TriclofosSodium

98






Maximumquantity

TrientineDihydrochloride

Trifluoperazine

TrifluoperazineHydrochloride

Trifluperidol

TrifluperidolHydrochloride

Trilostane

Trimeprazine

TrimeprazineTartrate

TrimetaphanCamsylate

Trimetazidine

TrimetazidineHydrochloride

Trimethoprim

TrimipramineMaleate

TrimipramineMesylate

Tropicamide

TropisetronHydrochloride

Troxidone

(1) Oral

Dietarysupplementation

L-Tryptophan

(2) External

TubocurarineChloride

Tulobuterol

99






Maximumquantity

TulobuterolHydrochloride

Tyrothricin Throatlozenges orthroat pastilles

Uramustine

UreaStibamine

Urethane

Uridine 5'-triphosphate

Urofollitrophin

Urokinase

UrsodeoxychoicAcid

Vaccine:BacillusSalmonellaTyphi

Vaccine:Poliomyelitis(Oral)

Valproic Acid

VancomycinHydrochloride

Vasopressin

VasopressinTannate

VecuroniumBromide

VerapamilHydrochloride

Veratrine

Veratrum,Green

100






Maximumquantity

Veratrum,White

Vidarabine

Vigabatrin

ViloxazineHydrochloride

VinblastineSulphate

VincristineSulphate

VindesineSulphate

ViomycinPantothenate

ViomycinSulphate

(1) Internal (1) 7,500iu(2,250mcgRetinolequivalent)(MDD)

Vitamin A

(2) External

(1) Internal (1) Equivalentto 7,500iuVitamin A(2,250mcgRetinolequivalent)(MDD)

Vitamin AAcetate

(2) External

Vitamin APalmitate

(1) Internal (1) Equivalentto 7,500iuVitamin A(2,250mcgRetinolequivalent)(MDD)

101






Maximumquantity

(2) External

Warfarin

WarfarinSodium

XamoterolFumarate

Xipamide

YohimbineHydrochloride

Zidovudine

ZimeldineHydrochloride

ZolpidemTartrate

ZomepiracSodium

Zopiclone

ZuclopenthixolAcetate

ZuclopenthixolDecanoate

ZuclopenthixolHydrochloride

SCHEDULE 2 Articles 6(1) and 10

Circumstances excluding medicinal products from the class ofprescription only medicines

Column 1 Column 2 Column 3 Column 4Substance Maximum strength Pharmaceutical

FormMaximum Dose

Codeine and its salts Equivalent of 1.5per cent of codeinemonohydrate

Equivalent of 20 mg ofcodeine monohydrate

102


Circumstances excluding medicinal products from the class ofprescription only medicines

Column 1 Column 2 Column 3 Column 4Substance Maximum strength Pharmaceutical

FormMaximum Dose

Dihydrocodeine andits salts

Equivalent of 1.5 percent of dihydrocodeine

Equivalent of 10 mg ofdihydrocodeine

Ethylmorphine anditssalts

Equivalent of 0.2 percent of ethylmorphine

Equivalent of 7.5 mgof ethylmorphine

(1) Equivalent of 0.02per cent anhydrousmorphine

(1) Liquid (1) Equivalent of3 mg of anhydrousmorphine

Morphine and its salts

(2) Equivalent of0.04 per cent ofanhydrous morphine;equivalent of 300mcg of anhydrousmorphine

(2) Solid (2) Equivalent of3 mg of anhydrousmorphine

(1) Equivalent of 0.02per cent of anhydrousmorphine

(1) Liquid (1) Equivalent of3 mg of anhydrousmorphine

Medicinal Opium

(2) Equivalent of 0.04per cent of anhydrousmorphine

(2) Solid (2) Equivalent of3 mg of anhydrousmorphine

Pholcodine and itssalts

Equivalent of 1.5 percent of pholcodinemonohydrate

Equivalent of 20mg of pholcodinemonohydrate

SCHEDULE 3 Article 2(b)

DESCRIPTIONS AND CLASSES OF PRESCRIPTION ONLY MEDICINES IN RELATION TOWHICH APPROPRIATE NURSE PRACTITIONERS ARE APPROPRIATE PRACTITIONERS

Co-danthramer-Oral Suspension NPFCo-danthramer-Oral Suspension Strong NPFCo-danthrusate CapsulesMebendazole Tablets NPFMebendazole Oral Suspension NPFMiconazole Oral Gel NPFNystatin Oral SuspensionNystatin Pastilles NPFStreptokinase and Streptodornase Topical Powder NPF

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SCHEDULE 4 Article 8(4)(c)

SUBSTANCES NOT TO BE CONTAINED IN A PRESCRIPTION ONLY MEDI CINESOLD OR SUPPLIED UNDER THE EXEMPTION CONFERRED BY ARTICLE 8(3)Ammonium BromideCalcium BromideCalcium BromidolactobionateEmbutramideFencamfamin HydrochlorideFluanisoneHexobarbitoneHexobarbitone SodiumHydrobromic AcidMeclofenoxate HydrochlorideMethohexitone SodiumPemolinePiracetamPotassium BromideProlintane HydrochlorideSodium BromideStrychnine HydrochlorideTacrine HydrochlorideThiopentone Sodium

SCHEDULE 5 Article 11(1)(a)

EXEMPTION FOR CERTAIN PERSONS FROM SECTION 58(2) OF THE ACT

PART IEXEMPTION FROM RESTRICTIONS ON SALE OR SUPPLY

Column 1 Column 2 Column 3Persons exempted Prescription only medicines

to which the exemptionapplies

Conditions

1. Persons selling or supplyingprescription only medicines touniversities, other institutionsconcerned with highereducation or institutionsconcerned with research.

1. All prescription onlymedicines

1. The sale or supply shallbe–(a) subject to the

presentation ofan order signedby the principalof the institution

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Conditions

concerned witheducation orresearch or theappropriate headof departmentin charge of aspecified course ofresearch stating–(i) the name of

the institutionfor which theprescriptiononly medicineis required,

(ii) the purposefor which theprescriptiononly medicineis required,and

(iii) the totalquantityrequired, and

(b) for the purposesof the educationor researchwith which theinstitution isconcerned.

2. Persons selling orsupplying prescriptiononly medicines to any ofthe following–(1) a public analyst

appointed undersection 27 of theFood Safety Act1990(21) or article36 of the Food(Northern Ireland)Order 1989(22),

(2) an authorizedofficer withinthe meaning ofsection 5(6) of the

2. All prescription onlymedicines.

2. The sale or supply shall besubject to the presentation ofan order signed by or on behalfof any person listed in column1 of this paragraph stating thestatus of the person signing itand the amount of prescriptiononly medicine required, andshall be only in connectionwith the exercise by thosepersons of their statutoryfunctions.

(21) 1990 c. 16.(22) S.I. 1989/846 (N.I. 6).

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Conditions

Food Safety Act1990,

(3) a sampling officerwithin the meaningof article 38(1) ofthe Food (NorthernIreland) Order1989,

(4) a person dulyauthorized byan enforcementauthority undersections 111 and112,

(5) a sampling officerwithin the meaningof Schedule 3 to theAct.

3. Persons selling or supplyingprescription only medicinesto any person employed orengaged in connection with ascheme for testing the qualityand checking the amountof the drugs and appliancessupplied under the NationalHealth Service Act 1977(23),the National Health Service(Scotland) Act 1978(24) andthe Health and Personal SocialServices (Northern Ireland)Order 1972(25), or under anysubordinate legislation madeunder those Acts or that Order.



presentation of anorder signed by oron behalf of theperson so employedor engaged statingthe status of theperson signing itand the amount ofprescription onlymedicine required,and

(b) for the purposes ofa scheme referredto in column 1 inthis paragraph.

4. Registered midwives. 4. Prescription onlymedicines containingany of the followingsubstances–

Chloral hydrateErgometrinemaleate

4. The sale or supply shallbe only in the course of theirprofessional practice and in thecase of Ergometrine maleateonly when contained in amedicinal product which is notfor parenteral administration.

(23) 1977 c. 49.(24) 1978 c. 29.(25) S.I. 1972/1265 (N.I. 14).

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Conditions

PentazocinehydrochlorideTriclofos sodium.

5. Persons lawfully conductinga retail pharmacy businesswithin the meaning ofsection 69.

5. Prescription onlymedicines which arenot for parenteraladministration andwhich–(a) are eyes drops and

are prescriptiononly medicinesby reason onlythat they containnot more than0.5 per centChloramphenicol,or

(b) are eye ointmentsand are prescriptiononly medicinesby reason onlythat they containnot more than1.0 per centChloramphenicol,or

(c) are prescriptiononly medicines byreason only thatthey contain anyof the followingsubstances:

AtropinesulphateBethanecolchlorideCarbacholCyclopentolatehydrochlorideHomatropinehydrobromideNaphazolinehydrochlorideNaphazolinenitratePhysostigminesalicylate

5. The sale or supply shall besubject to the presentation ofan order signed by a registeredophthalmic optician.

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Conditions

PhysostigminesulphatePilocarpinehydrochloridePilocarpinenitrateTropicamide.

6. Registered ophthalmicopticians.

6. Prescription only medicineslisted in column 2 of paragraph5.

6. The sale or supply shallbe only–(a) in the course of

their professionalpractice and

(b) in an emergency.

7. Persons selling or supplyingprescription only medicinesto the British StandardsInstitution.



presentation ofan order signedon behalf of theBritish StandardsInstitution statingthe status of theperson signing itand the amount ofthe prescriptiononly medicinerequired, and

(b) only for thepurpose of testingcontainers ofmedicinal productsor determining thestandards for suchcontainers.

8. Holders of marketingauthorizations, productlicences or manufacturer’slicences.

8. Prescription only medicinesreferred to in the authorizationsor licences.

8. The sale or supply shallbe only–(a) to a pharmacist,(b) so as to enable

that pharmacistto prepare anentry relating tothe prescriptiononly medicinein question in atablet or capsuleidentification

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Conditions

guide or similarpublication, and

(c) of no greaterquantity thanis reasonablynecessary for thatpurpose.

9. Pharmacists selling orsupplying to persons towhom cyanide salts may besold by virtue of section 3(regulation of poisons) orsection 4 (exclusion of salesby wholesale and certainother sales) of the Poisons Act1972(26) or by virtue of article5 (prohibitions and regulationswith respect to sale of poisons)or article 6 (exemption withrespect to certain sales) of thePoisons (Northern Ireland)Order 1976(27).

9. Amyl nitrite. 9. The sale or supply shallonly be so far as is necessaryto enable an antidote to beavailable to persons at risk ofcyanide poisoning.

Article 11(1)(b)

PART IIEXEMPTIONS FROM THE RESTRICTION ON SUPPLY



Conditions

1. Royal National LifeboatInstitution and certified firstaiders of the Institution.


1. The supply shall be only sofar as is necessary for the thetreatment of sick or injuredpersons in the exercise of thefunctions of the Institution.

2. The owner or the master ofa ship which does not carry adoctor on board as part of hercomplement.


2. The supply shall be onlyso far as is necessary for thetreatment of persons on theship.

(26) 1972 c. 66.(27) S.I. 1976/1214 (N.I. 23).

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Conditions

3. Persons authorized bylicences granted underregulation 5 of the Misuse ofDrugs Regulations to supply acontrolled drug.

3. Such prescription onlymedicines, being controlleddrugs, as are specified in thelicence.

3. The supply shall be subjectto such conditions and in suchcircumstances and to such anextent as may be specified inthe licence.

4. Persons requiringprescription only medicinesfor the purpose of enablingthem, in the course of anybusiness carried on by them, tocomply with any requirementsmade by or in pursuance ofany enactment with respect tothe medical treatment of theiremployees.

4. Such prescription onlymedicines as may be specifiedin the relevant enactment.

4. The supply shall be–(a) for the purpose

of enabling themto comply withany requirementsmade by or inpursuance of anysuch enactment,and

(b) subject to suchconditions and insuch circumstancesas may be specifiedin the relevantenactment.

5. Persons operating anoccupational health scheme.

5. Prescription only medicinessold or supplied to a personoperating an occupationalhealth scheme in response toan order in writing signed by adoctor or a registered nurse.

5. —(1) The supply shall be

in the course of anoccupational healthscheme.

(2) The individualsupplying theprescription onlymedicine, if nota doctor, shallbe a registerednurse acting inaccordance with thewritten instructionsof a doctor as to thecircumstances inwhich prescriptiononly medicines ofthe description inquestion are to beused in the courseof the occupationalhealth scheme.

6. The operator or commanderof an aircraft.

6. Prescription only medicineswhich are not for parenteraladministration and which havebeen sold or supplied to the

6. The supply shall be onlyso far as is necessary for theimmediate treatment of sick orinjured persons on the aircraft

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Conditions

operator or commander of theaircraft in response to an orderin writing signed by a doctor.

and shall be in accordance withthe written instructions of adoctor as to the circumstancesin which prescription onlymedicines of the description inquestion are to be used on theaircraft.

7. Persons employed asqualified first-aid personnel onoffshore installations.


7. The supply shall be onlyso far as is necessary for thetreatment of persons on theinstallation.

Article 11(2)

PART IIIEXEMPTIONS FROM RESTRICTION ON ADMINISTRATION Column 1



Conditions

1. State registered chiropodistswho hold a certificate ofcompetence in the use ofanalgesics issued by orwith the approval of theChiropodists Board.

1. Prescription onlymedicines for parenteraladministration thatcontain,as the sole activeingredient, not more thanone of the followingsubstances–

BupivacainehydrochlorideLignocainehydrochloridePrilocainehydrochloride.

1. The administration shallbe only in the course of theirprofessional practice.

2. Registered midwives. 2. Prescription onlymedicines for parenteraladministration containingany of the followingsubstances but no othersubstance specified incolumn 1 of Schedule 1to this Order–

ErgometrinemaleateLignocaine

2. The administration shallbe only in the course of theirprofessional practice andin the case of Promazinehydrochloride, Lignocaine andLignocaine hydrochloride shallbe only while attending on awoman in childbirth.

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Conditions

LignocainehydrochlorideNaloxonehydrochlorideOxytocins, naturaland syntheticPentazocine lactatePethidinehydrochloridePhytomenadionePromazinehydrochloride.

3. Persons who are authorizedas members of a group by agroup authority granted underregulations 8(3) or 9(3) of theMisuse of Drugs Regulationsto supply a controlled drug byway of administration only.

3. Prescription only medicinesthat are specified in the groupauthority.

3. The administration shallbe subject to such conditionsand in such circumstancesand to such extent as maybe specified in the groupauthority.

4. The owner or master of aship which does not carry adoctor on board as part of hercomplement.

4. All prescription onlymedicines that are forparenteral administration.

4. The administration shall beonly so far as is necessary forthe treatment of persons on theship.

5. Persons operating anoccupational health scheme.

5. Prescription only medicinesfor parenteral administrationsold or supplied to the personoperating an occupationalhealth scheme in response toan order in writing signed by adoctor or a registered nurse.

5. —(1) The administration

shall be in thecourse of anoccupational healthscheme.

(2) The individualadministering theprescription onlymedicine, if neithera doctor nor actingin accordance withthe directions ofa doctor, shallbe a registerednurse acting inaccordance with thewritten instructionsof a doctor as to thecircumstances inwhich prescriptiononly medicines ofthe description inquestion are to be

112




Conditions

used in the courseof the occupationalhealth scheme.

6. The operator or commanderof an aircraft.

6. Prescription only medicinesfor parenteral administrationwhich have been sold orsupplied to the operator orcommander of the aircraft inresponse to an order in writingsigned by a doctor.

6. The administration shallbe only so far as is necessaryfor the immediate treatmentof sick or injured persons onthe aircraft and shall be inaccordance with the writteninstructions of a doctor as tothe circumstances in whichprescription only medicines ofthe description in question areto be used on the aircraft.

7. Persons who are, and at 11thFebruary 1982 were, personscustomarily administeringmedicinal products tohuman beings by parenteraladministration in the courseof a business in the fieldof osteopathy, naturopathy,acupuncture or other similarfield except chiropody.

7. Medicinal products that areprescription only medicinesby reason only that they fallwithin the class specifiedin article 3(c) (products forparenteral administration).

7. The person administeringthe prescription only medicineshall have been requested byor on behalf of the person towhom it is administered and inthat person’s presence to usehis own judgement as to thetreatment required.

8. Persons employed asqualified first-aid personnel onoffshore installations.

8. All prescription onlymedicines that are forparenteral administration.

8. The administration shall beonly so far as is necessary forthe treatment of persons on theinstallation.

9. Persons who hold acertificate of proficiency inambulance paramedic skillsissued by, or with the approvalof, the Secretary of State.

9. The followingprescription onlymedicines for parenteraladministration–(a) Diazepam 5 mg per

ml emulsion forinjection;

(b) SuccinylatedModified FluidGelatin 4 percent intravenousinfusion;

(c) prescriptiononly medicinescontaining oneor more ofthe followingsubstances, but noactive ingredient–

9. The administration shallbe only for the immediate,necessary treatment of sick orinjured persons and in the caseof a prescription only medicinecontaining Heparin Sodiumshall be only for the purpose ofcannula flushing.

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Conditions

AdrenalineAcid TartrateAnhydrousGlucoseCompoundSodiumLactateIntravenousInfusion(Hartmann’sSolution)ErgometrineMaleateGlucoseHeparinSodiumLignocaineHydrochlorideNalbuphineHydrochlorideNaloxoneHydrochloridePolygelineSodiumBicarbonateSodiumChloride

SCHEDULE 6 Article 16(1)

ORDERS REVOKED

Column 1 Column 2Orders References

The Medicines (Products other than VeterinaryDrugs) (Prescription Only) Order 1983

S.I. 1983/1212

The Medicines (Products other than VeterinaryDrugs) (Prescription Only) Amendment Order1984

S.I. 1984/756


S.I. 1986/586

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S.I. 1987/674

The Medicines (Products other than VeterinaryDrugs) (Prescription Only) Amendment (No. 2)Order 1987

S.I. 1987/1250


S.I. 1988/2017


S.I. 1991/962


S.I. 1992/1534


S.I. 1992/2937


S.I. 1993/1890


S.I. 1993/3256


S.I. 1994/558


S.I. 1994/3016


S.I. 1994/3050


S.I. 1995/1384


S.I. 1995/3174


S.I. 1996/1514

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S.I. 1996/3193

EXPLANATORY NOTE

(This note is not part of the Order)

This Order consolidates with amendments the Medicines (Products Other Than Veterinary Drugs)(Prescription Only) Order 1983 as amended. That Order and the Orders amending it (“the 1983Order as amended”) are revoked by article 16 and Schedule 6.This Order specifies the descriptions and classes of prescription only medicines (i.e. medicinalproducts which, subject to exemptions, may be sold or supplied by retail only in accordance witha prescription given by an appropriate practitioner and which may be administered only by or inaccordance with the directions of such a practitioner). Many medicinal products are included in aclass of such medicines by reason of the substances contained in them (seeSchedule 1) but othersare included because of other criteria, such as their method of administration (seearticle 3). In manycases the provisions of the Act apply subject to exemptions (seearticles 4 and 5 to 13 and Schedule 1).The principal amendments relate to those medicines in respect of which marketing authorizationshave been granted by the European Community. They include as prescription only medicines thosemedicines in respect of which such an authorization has been granted which classifies a medicine asbeing subject to medical prescription (article 3(f)). They exclude from the class of prescription onlymedicines those medicines in respect of which such an authorization provides for supply which isnot subject to medical prescription (article 6(3)).The differences between this Order and the 1983 Order as amended are in the main technical changesconcerning the location of provisions such as the division of material in Schedule 1 to the 1983Order as amended between the new Schedules 1 and 2. But within the new Schedule 1 there arechanges which relate to–

(a) the deletion from Column 1 of substances which are no longer used in those medicinalproducts which are on the market;

(b) the use of current names for the substances which are specified in that Column where theirnames have changed;

(c) the incorporation in that Schedule of provisions from article 4 of, and Part IV of Schedule 1to, the 1983 Order as amended so that they may be found more easily;

(d) a change in the legal base for the entries in Columns 2 to 4 so that those entries now formthe criteria for exemptions from the sale or supply requirements of section 58(2) of theMedicines Act 1968 instead of the criteria for excluding medicinal products from the classof prescription only medicines (see alsoarticle 5);

(e) the introduction of a fifth Column which specifies the maximum pack sizes to whichexemptions apply.

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As this order will impose no additional costs to business a compliance cost assessment has not beenprepared.

117

the prescription only medicines (human use) order 1997

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