The Prescription Only Medicines (Human Use) Order 1997

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 with health 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 the Department of Agriculture for Northern Ireland, acting jointly, in exercise of powers conferred on them by sections 58(1), (4) and (5), 59(1) and 129(4) of the Medicines Act 1968(1) or, as the case may be, those conferred by the said provisions and now vested in them(2), and of all other powers enabling them in that behalf, after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by this Order, pursuant to section 129(6) of that Act, and after consulting and taking into account the advice of the Medicines Commission pursuant to sections 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 1997 and 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 Kingdom Central Council for Nursing, Midwifery and Health Visiting under section 10 of the Nurses, Midwives and Health Visitors Act 1979(3) (referred to below in this definition as “the professional register”), and

(ii)

has a district nursing qualification additionally recorded in the professional register under 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 annotation signifying 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 Act 1971(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 absorption is unlikely to occur; and references to medicinal products for external use shall be read accordingly except that such references shall not include throat sprays, throat pastilles, throat lozenges, throat tablets, nasal drops, nasal sprays, nasal inhalations or teething preparations;

“health prescription” means a prescription issued by a doctor, dentist or nurse prescriber under or 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 in the amount of a medicinal product which it is recommended should be taken or administered in a period of 24 hours;

“maximum dose” or “MD” means the maximum quantity of a substance contained in the amount of a medicinal product which it is recommended should be taken or administered at any one time;

“maximum strength” means–

(a)

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

(b)

the maximum percentage of a substance contained in a medicinal product calculated in any 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 highest such percentage;

“medicinal product” includes any article or substance in respect of which section 58 of the Act has 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, the Misuse 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 business carried on by him, provides facilities for his employees for the treatment or prevention of disease;

“offshore installation” means an offshore installation within the meaning of the Mineral Workings (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 the management 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 a class specified in article 3 of this Order;

“prolonged release” in relation to a medicinal product means a formulation of that product which–

(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 maintained by the United Kingdom Central Council for Nursing, Midwifery and Health Visiting under section 10 of the Nurses, Midwives and Health Visitors Act 1979;

“registered nurse” means a person who is registered in the Register maintained by the United Kingdom Central Council for Nursing, Midwifery and Health Visiting under section 10 of the Nurses, Midwives and Health Visitors Act 1979;

“registered ophthalmic optician” means a person who is registered in either of the Registers of ophthalmic opticians maintained under section 7(a) of the Opticians Act 1989(14);

“repeatable prescription” means a prescription which contains a direction that it may be dispensed more than once;

“sell” means sell by retail as defined in section 131 of the Act and “sale” has a corresponding meaning;

“soap” means any compound of a fatty acid with an alkali or amine;

“state registered chiropodist” means a person who is registered in the Register established and maintained under section 2(1) of the Professions Supplementary to Medicine Act 1960(15) by the Chiropodists Board;

“supply” means supply in circumstances corresponding to retail sale as defined in section 131 of the Act;

“unit preparation” means a preparation, including a mother tincture, prepared by a process of solution, extraction or trituration with a view to being diluted tenfold or one hundredfold, either once or repeatedly, in an inert diluent, and then used either in this diluted form or, where applicable, by impregnating tablets, granules, powders or other inert substances.

(3) For the purposes of this Order, the equivalence of a substance to a reference material shall be determined by calculating the amount of that reference material which is contained in that substance either by weight or, where the amount of the reference material is specified in terms of international units 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 which they appear and where, in relation to a particular substance listed in column 1, an entry in columns 2 to 5 bears a number or letter it relates only to such entries in the other of those columns as bear the same number or letter;

(b) the following abbreviations are used:

• “g” for gram,

• “iu” for international unit of activity,

• “mcg” for microgram,

• “mg” for milligram,

• “ml” for millilitre.

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

Appropriate practitioners

2.  For the purposes of section 58 (medicinal products on prescription only), the following shall be 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 specified for the purposes of section 58, namely–

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

(b) medicinal products that are controlled drugs;

(c) medicinal products that are for parenteral administrationF1 ...;

(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 in subparagraphs (a) to (f),

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

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

Textual Amendments

F1 Words in art. 3(c) omitted (13.8.1998) by The Prescription Only Medicines (Human Use) Amendment Order 1998 (S.I. 1998/108), arts. 1, 2

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 certain new 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 that condition is satisfied in accordance with the following provisions of this article; or

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

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

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

(4) Where a use is specified in column 3 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition in respect of use where it is sold or supplied 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 medicinal product which consists of or contains that substance satisfies the condition where it is sold or supplied in that pharmaceutical form.

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

(8) A medicinal product which contains more than one of the substances–

• Atropine

• Atropine Methobromide

• Atropine Methonitrate

• Atropine Oxide Hydrochloride

• Atropine Sulphate

• Hyoscine

• Hyoscine Butylbromide

• Hyoscine Hydrobromide

• Hyoscine Methobromide

• Hyoscine Methonitrate

• Hyoscyamine

• Hyoscyamine Hydrobromide

• Hyoscyamine Sulphate,

satisfies the condition only where it is sold or supplied for use at a maximum daily dose which does not exceed 1 milligram in total of the alkaloids derived from belladonna, hyoscyamus, stramonium or other solanaceous plant which are contained in that medicinal product.

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

(10) Where a maximum quantity is specified in column 5 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition where it, or where so specified in that column, the medicinal product which contains that substance is sold or supplied in a 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 reference to the column bearing that number in Schedule 1.

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

6.—(1) A medicinal product shall not be a prescription only medicine by reason that it is a controlled 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 Order and no other controlled drug;

(b) contains that substance at a strength that does not exceed the maximum strength specified in 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 that Schedule.

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

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

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

• Adrenaline Injection 1 in 1000 (1 mg in 1 ml)

• Atropine Sulphate Injection

• Chlorpheniramine Injection

• Cobalt Edetate Injection

• Dextrose Injection Strong B.P.C.

• Diphenhydramine Injection

• Glucagon Injection

• Hydrocortisone Injection

• Mepyramine Injection

• Promethazine Hydrochloride Injection

• Snake Venom Antiserum

• Sodium Nitrite Injection

• Sodium Thiosulphate Injection

• Sterile 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 not apply to the sale or supply of a prescription only medicine by a person lawfully conducting a retail pharmacy 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 by reason of an emergency is unable to furnish a prescription immediately;

(b) that the doctor has undertaken to furnish the person lawfully conducting a retail pharmacy business 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 directions of the doctor requesting it;

(d) subject to paragraph (5), that the prescription only medicine is not a controlled drug specified 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 or Supply) (Miscellaneous Provisions) Regulations 1980(18) within the time specified in that regulation stating the particulars required under paragraph 1 of Schedule 2 to those Regulations.

(3) The restrictions imposed by section 58(2)(a) shall not apply to the sale or supply of a prescription only medicine by a person lawfully conducting a retail pharmacy business where the conditions 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 and has satisfied himself–

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

(ii) that treatment with the prescription only medicine requested has on a previous occasion 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 person to 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 [F2 a preparation of insulin,] an aerosol for the relief of asthma, an ointment or cream, and has been made up for sale in a container elsewhere than at the place of sale or supply, the smallest pack that the pharmacist has available for sale or supply may be sold or supplied,

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

(iii) is an antibiotic for oral administration in liquid form, the smallest quantity that will provide 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 contain a substance specified in Schedule 4 to this Order and is not a controlled drug specified in Schedule 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 regulation stating 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, the pharmaceutical 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 prescription only medicine consists of or contains phenobarbitone or phenobarbitone sodium (but no other substance specified in Schedule 4 to this Order or Schedule 1, 2 or 3 to the Misuse of Drugs Regulations) and is sold or supplied for use in the treatment of epilepsy.

Textual Amendments

F2 Words in art. 8(4)(b)(i) inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 2

Exemption for non-parenteral administration to human beings

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

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 parenteral administration and which consists of or contains, any of the substances listed in column 1 of Schedule 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 the person selling, supplying or administering the medicinal product has been requested by or on behalf of a particular person and in that person’s presence to use his own judgment as to the treatment required; or

(b) each such unit preparation has been diluted to at least one part in a million million (6c).

Exemptions for certain persons

11.—(1) The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply–

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

(b) to the supply by a person listed in column 1 of Part II of Schedule 5 of the prescription only medicines listed in relation to that person in column 2 of that Part where the conditions specified 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 apply to the administration by a person listed in column 1 of Part III of Schedule 5 of the prescription only medicines for parenteral administration listed in relation to that person in column 2 of that Part where 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 apply to the sale or supply of any prescription only medicine in the course of the business of a hospital where the prescription only medicine is sold or supplied in accordance with the written directions of a doctor or dentist notwithstanding that those directions do not satisfy the conditions specified in 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 apply to the sale or supply of a prescription only medicine by a person who, having exercised all due diligence, believes on reasonable grounds that the product sold or supplied is not a prescription only medicine.

Exemption in the case of a forged prescription

14.  The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply to the sale or supply of a prescription only medicine by a pharmacist in accordance with a forged prescription where the pharmacist, having exercised all due diligence, believes on reasonable grounds that the prescription is genuine.

Prescriptions

15.—(1) For the purposes of section 58(2)(a) a prescription only medicine shall not be taken to be sold or supplied in accordance with a prescription given by an appropriate practitioner unless the conditions specified in paragraph (2) are fulfilled.

(2) The conditions referred to in paragraph (1) are that the prescription–

(a) shall be signed in ink with his own name by the 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 in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations, in which case it may be written by 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 veterinary practitioner,

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

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

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

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

(3) The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply to a sale or supply of a prescription only medicine which is not in accordance with a prescription given by an appropriate practitioner by reason only that a condition specified in paragraph (2) is not satisfied where the person selling or supplying the prescription only medicine, having exercised all due diligence, believes on reasonable grounds that that condition is satisfied in relation to that sale 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 not be dispensed; and

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

and, for the purposes of sub-paragraphs (d) and (e) of that paragraph, where a health prescription bears both the date on which it was signed and a date indicated as being that before which it shall not 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

Baroness Jay

Minister of State,

Department of Health

Win Griffiths

Parliamentary Under Secretary of State, Welsh Office

Sam Galbraith

Parliamentary Under Secretary of State, The Scottish Office

Jeff Rooker

Minister of State, Ministry of Agriculture, Fisheries and Food

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

D. C. Gowdy

Permanent Secretary

Sealed with the Official Seal of the Department of Agriculture for Northern Ireland on 18th July 1997.

P. Small

Permanent Secretary

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

SCHEDULE 1 SUBSTANCES WHICH IF INCLUDED IN MEDICINAL PRODUCTS MAKE THOSE PRODUCTS 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 of prescription only medicines
Column 1	Column 2	Column 3	Column 4		Column 5
Substance	Maximum strength	Route of administration, use or pharmaceutical form	Treatment limitations		Maximum quantity
Acarbose
Acebutolol Hydrochloride
Acemetacin
Acetarsol
Acetazolamide
Acetazolamide Sodium
Acetohexamide
Acetylcholine Chloride	0.2 per cent	External
Acetylcysteine
Acipimox
Aciclovir	5.0 per cent	External			Container or package containing not more than 2g of medicinal product
		For treatment of herpes simplex virus infections of the lips and face (Herpes labialis)
Acitretin
Aclarubicin Hydrochloride
Aconite	1.3 per cent	External
Acrivastine			24 mg (MDD)		Container or package containing not more than 240mg of Acrivastine
Acrosoxacin
Actinomycin C
Actinomycin D
Adenosine
Adrenaline		(1) By inhaler
		(2) External
Adrenaline Acid Tartrate		(1) By inhaler
		(2) External
Adrenaline Hydrochloride		(1) By inhaler
		(2) External
Adrenocortical Extract
Albendazole
Alclofenac
Alclometasone Dipropionate
Alcuronium Chloride
Aldesleukin
Aldosterone
Alfacalcidol
Alfuzosin Hydrochloride
Allergen Extracts
Allopurinol
Allyloestrenol
[F3 Aloxiprin	(1) 620 mg	(1) Non-effervescent tablets and capsules			(1) The quantity sold or supplied in one container or package shall not exceed 32
					The quantity of non-effervescent tablets, capsules or a combination of both sold or supplied to a person at any one time shall not exceed 100
		(2) All preparations other than non-effervescent tablets or capsules]
Alphadolone Acetate
Alphaxalone
Alprenolol
Alprenolol Hydrochloride
Alprostadil
Alseroxylon
Amantadine Hydrochloride
Ambenonium Chloride
Ambutonium Bromide
Amcinonide
Ametazole Hydrochloride
Amethocaine		Non-ophthalmic use
Amethocaine Gentisate		Non-ophthalmic use
Amethocaine Hydrochloride		Non-ophthalmic use
Amikacin Sulphate
Amiloride Hydrochloride
Aminocaproic Acid
Aminoglutethimide
Aminopterin Sodium
Amiodarone Hydrochloride
Amiphenazole Hydrochloride
Amitriptyline
Amitriptyline Embonate
Amitriptyline Hydrochloride
Amlodipine Besylate
Ammonium Bromide
Amodiaquine Hydrochloride
Amorolfine Hydrochloride
Amoxapine
Amoxycillin
Amoxycillin Sodium
Amoxycillin Trihydrate
Amphomycin Calcium
Amphotericin
Ampicillin
Ampicillin Sodium
Ampicillin Trihydrate
Amsacrine
Amygdalin
Amyl Nitrite
Amylocaine Hydrochloride		Non-ophthalmic use
Ancrod
Androsterone
Angiotensin Amide
Anistreplase
Anterior Pituitary Extract
Antimony Barium Tartrate
Antimony Dimercaptosuccinate
Antimony Lithium Thiomalate
Antimony Pentasulphide
Antimony Potassium Tartrate
Antimony Sodium Tartrate
Antimony Sodium Thioglycollate
Antimony Sulphate
Antimony Trichloride
Antimony Trioxide
Antimony Trisulphide
Apiol
Apomorphine
Apomorphine Hydrochloride
Aprotinin
Arecoline Hydrobromide
Argipressin
Aristolochia
Aristolochia Clematitis
Aristolochia Contorta
Aristolochia Debelis
Aristolochia Fang-chi
Aristolochia Manshuriensis
Aristolochia Serpentaria
Arsenic
Arsenic Triiodide
Arsenic Trioxide
Arsphenamine
[F4 Aspirin	[F5 (1) 75mg]	[F5 (1) Non-effervescent tablets and capsules]			[F5 (1) The quantity sold or supplied in one container or package shall not exceed 100 The quantity of non-effervescent tablets, capsules or a combination of both sold or supplied to a person at any one time shall not exceed 100]
	[F6 [F7 (2)] 500 mg]	[F7 (2)] Non-effervescent tablets and capsules			[F7 (2)] The quantity sold or supplied in one container or package shall not exceed 32
		[F7 (3)] All preparations other than non-effervescent tablets or capsules			The quantity of non-effervescent tablets, capsules or a combination of both sold or supplied to a person at any one time shall not exceed 100]
Astemizole		F8 . . .	F8 . . .		F8 . . .
		F8 . . .
		F8 . . .
Atenolol
Atracurium Besylate
Atropine		(1) Internal
		(a) by inhaler
		(b) otherwise than by inhaler	(b) 300mcg (MD)
			1mg (MDD)
		(2) External (except ophthalmic)
Atropine Methobromide		(1) Internal
		(a) by inhaler
		(b) otherwise than by inhaler	(b) 400mcg (MD)
			1.3mg (MDD)
		(2) External (except ophthalmic)
Atropine Methonitrate		Internal
		(a) by inhaler
		(b) otherwise than by inhaler	(b) 400mcg (MD)
			1.3mg (MDD)
Atropine Oxide Hydrochloride		(1) Internal
		(a) by inhaler
		(b) otherwise than by inhaler	(b) 360mcg (MD)
			1.2mg (MDD) 3
		(2) External (except ophthalmic)
Atropine Sulphate		(1) Internal
		(a) by inhaler
		(b) otherwise than by inhaler	(b) 360mcg (MD)
			1.2mg (MDD)
		(2) External (except ophthalmic)
Auranofin
Azapropazone
Azathioprine
Azathioprine Sodium
Azelaic Acid
Azelastine Hydrochloride		For nasal administration	140mcg per nostril (MD)		Container or package containing not more than 5,040mcg of Azelastine Hydrochloride
		For the treatment of seasonal allergic rhinitis	280mcg per nostril (MDD)
		For use in adults and children not less than 12 years
		As a non-aerosol, aqueous form
Azidocillin Potassium
Azithromycin
Azlocillin Sodium
Aztreonam
Bacampicillin Hydrochloride
Bacitracin
Bacitracin Methylene Disalicylate
Bacitracin Zinc
Baclofen
Bambuterol Hydrochloride
Barium Carbonate
Barium Chloride
Barium Sulphide
Beclamide
Beclomethasone
Beclomethasone Dipropionate		For nasal administration (non-aerosol)	100mcg per nostril (MD)		Container or package containing not more than [F9 20,000 mcg] of Beclomethasone Dipropionate
		For the prevention and treatment of allergic rhinitis	200 mcg per nostril (MDD)[F10 For a maximum period of 3 months]
		[F11 For use in persons aged 18 years and over]
Belladonna Herb		(1) Internal	(1) 1mg of the alkaloids (MDD)
		(2) External
Belladonna Root		(1) Internal	(1) 1mg of the alkaloids (MDD)
		(2) External
Bemegride
Bemegride Sodium
Benapryzine Hydrochloride
Bendrofluazide
Benethamine Penicillin
Benoxaprofen
Benperidol
Benserazide Hydrochloride
Bentiromide
Benzathine Penicillin
Benzbromarone
Benzhexol Hydrochloride
Benzilonium Bromide
Benzocaine		Any use except ophthalmic use
Benzoctamine Hydrochloride
Benzoyl Peroxide	10.0 per cent	External
N-Benzoyl Sulphanilamide
Benzquinamide
Benzquinamide Hydrochloride
Benzthiazide
Benztropine Mesylate
Benzylpenicillin Calcium
Benzylpenicillin Potassium
Benzylpenicillin Sodium
Beractant
Betahistine Hydrochloride
Betamethasone
Betamethasone Adamantoate
Betamethasone Benzoate
Betamethasone Dipropionate
Betamethasone Sodium Phosphate
Betamethasone Valerate
Betaxolol Hydrochloride
Bethanechol Chloride
Bethanidine Sulphate
Bezafibrate
Biperiden Hydrochloride
Biperiden Lactate
Bismuth Glycollylarsanilate
Bisoprolol Fumarate
Bleomycin
Bleomycin Sulphate
Bretylium Tosylate
Bromhexine Hydrochloride
Bromocriptine Mesylate
Bromperidol
Bromvaletone
Brotizolam
Budesonide		For nasal administration	200mcg per nostril (MD)		Container or package containing not more than 10mg of Budesonide
		For the prevention or treatment of seasonal allergic rhinitis	[F10 For a maximum period of 3 months]
		200 mcg per nostril (MDD)
		[F11 For use in persons aged 18 years and over]
		As a non-aerosol, aqueous form
Bufexamac
Bumetanide
Buphenine Hydrochloride			6mg (MD)
			18mg (MDD)
Bupivacaine		Any use except ophthalmic use
Bupivacaine Hydrochloride		Any use except ophthalmic use
Buserelin Acetate
Buspirone Hydrochloride
Busulphan
Butacaine Sulphate		Any use except ophthalmic use
Butorphanol Tartrate
Butriptyline Hydrochloride
Calcipotriol
Calcitonin
Calcitriol
Calcium Amphomycin
Calcium Benzamidosalicylate
Calcium Bromide
Calcium Bromidolactobionate
Calcium Carbimide
Calcium Folinate
Calcium Metrizoate
Calcium Sulphaloxate
[F12 Candesartan Cilexetil]
Candicidin
Canrenoic Acid
Cantharidin	0.01 per cent	External
Capreomycin Sulphate
Captopril
Carbachol
Carbamazepine
Carbaryl
Carbenicillin Sodium
Carbenoxolone Sodium		(1) Pellet	(1) 5mg (MD)
			25mg (MDD)
	(2) 2.0 per cent	(2) Gel
	(3) 1.0 per cent	(3) Granules for mouthwash in adults and children not less than 12 years	(3) 20mg (MD)		(3) Container or package containing not more than [F13 560mg] of Carbenoxolone Sodium
			80mg (MDD)
Carbidopa
Carbimazole
Carbocisteine
Carbon Tetrachloride
Carboplatin
Carboprost Trometamol
Carbuterol Hydrochloride
Carfecillin Sodium
Carindacillin Sodium
Carisoprodol
Carmustine
Carperidine
Carteolol Hydrochloride
Cefaclor
Cefadroxil
Cefazedone Sodium
Cefixime
Cefodizime Sodium
Cefotaxime Sodium
Cefoxitin Sodium
Cefpodoxime Proxetil
Cefsulodin Sodium
Ceftazidime
Ceftizoxime Sodium
Ceftriaxone Sodium
Cefuroxime Axetil
Cefuroxime Sodium
Celiprolol Hydrochloride
Cephalexin
Cephalexin Sodium
Cephaloridine
Cephalothin Sodium
Cephamandole Nafate
Cephazolin Sodium
Cephradine
Cerium Oxalate
Cerivastatin
Ceruletide Diethylamine
Cetirizine Hydrochloride			10mg (MDD)		Container or package containing not more than 100mg of Cetirizine Hydrochloride
Chenodeoxycholic Acid
Chloral Hydrate		External
Chlorambucil
Chloramphenicol
Chloramphenicol Cinnamate
Chloramphenicol Palmitate
Chloramphenicol Sodium Succinate
Chlorhexadol
Chlormadinone Acetate
Chlormerodrin
Chlormethiazole
Chlormethiazole Edisylate
Chlormezanone
Chloroform(20)	(1) 5.0 per cent	(1) Internal
		(2) External
Chloroquine Phosphate		Prophylaxis of malaria
Chloroquine Sulphate		Prophylaxis of malaria
Chlorothiazide
Chlorotrianisene
Chlorphenoxamine Hydrochloride
Chlorpromazine
Chlorpromazine Embonate
Chlorpromazine Hydrochloride
Chlorpropamide
Chlorprothixene
Chlorprothixene Hydrochloride
Chlortetracycline
Chlortetracycline Calcium
Chlortetracycline Hydrochloride
Chlorthalidone
Chlorzoxazone
Cholestyramine
Ciclacillin
Ciclobendazole
Cilastatin Sodium
Cilazapril
Cimetidine		(a) For the short-term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion and hyperacidity and for the prophylaxis of meal-induced heartburn	(a) 200mg (MD)
			800mg (MDD)
			For a maximum period of 14 days
		(b) For the prophylactic management of nocturnal heartburn by a single dose taken at night	(b) 100mg (MD) to be taken as a single dose at night
			For a maximum period of 14 days
Cimetidine Hydrochloride
Cinchocaine	3.0 per cent	Non-ophthalmic use
Cinchocaine Hydrochloride	Equivalent of 3.0 per cent of Cinchocaine	Non-ophthalmic use
Cinchophen
Cinoxacin
Ciprofibrate
Ciprofloxacin
Ciprofloxacin Hydrochloride
Cisapride
Cisplatin
Clarithromycin
Clavulanic Acid
Clidinium Bromide
Clindamycin
Clindamycin Hydrochloride
Clindamycin Palmitate Hydrochloride
Clindamycin Phosphate
Clioquinol		(1) External (other than treatment of mouth ulcers)
	(2) 35mg	(2) Treatment of mouth ulcers	(2) 350mg (MDD)
Clobetasol Propionate
Clobetasone Butyrate
Clofazimine
Clofibrate
Clomiphene Citrate
Clomipramine
Clomipramine Hydrochloride
Clomocycline
Clomocycline Sodium
Clonidine
Clonidine Hydrochloride
Clopamide
Clopenthixol Decanoate
Clopenthixol Hydrochloride
Clorexolone
Clotrimazole		External but in the case of vaginal use only external use for the treatment of vaginal candidiasis
Cloxacillin Benzathine
Cloxacillin Sodium
Clozapine
Cocculus Indicus
Co-dergocrine Mesylate
Colaspase
Colchicine
Colestipol Hydrochloride
Colfosceril Palmitate
Colistin Sulphate
Colistin Sulphomethate
Colistin Sulphomethate Sodium
Coniine
Conium Leaf	7.0 per cent	External
Corticotrophin
Cortisone
Cortisone Acetate
Co-tetroxazine
Co-trimoxazole
Cropropamide
Crotethamide
Croton Oil
Croton Seed
Curare
Cyclofenil
Cyclopenthiazide
Cyclopentolate Hydrochloride
Cyclophosphamide
Cycloserine
Cyclosporin
Cyclothiazide
Cyproterone Acetate
Cytarabine
Cytarabine Hydrochloride
Dacarbazine
Dalteparin Sodium
Danazol
Danthron
Dantrolene Sodium
Dapsone
Dapsone Ethane Ortho Sulphonate
Daunorubicin Hydrochloride
Deanol Bitartrate			26mg (MDD)
Debrisoquine Sulphate
Demecarium Bromide
Demeclocycline
Demeclocycline Calcium
Demeclocycline Hydrochloride
Deoxycortone Acetate
Deoxycortone Pivalate
Deptropine Citrate
Dequalinium Chloride	(1) 0.25mg	(1) Internal: throat lozenges or throat pastilles
	(2) 1.0 per cent	(2) External: paint
Deserpidine
Desferrioxamine Mesylate
Desflurane
Desipramine Hydrochloride
Deslanoside
Desmopressin
Desmopressin Acetate
Desogestrel
Desonide
Desoxymethasone
Dexamethasone
Dexamethasone Acetate
Dexamethasone Isonicotinate
Dexamethasone Phenylpropionate
Dexamethasone Pivalate
Dexamethasone Sodium Metasulphobenzoate
Dexamethasone Sodium Phosphate
Dexamethasone Troxundate
Dexfenfluramine Hydrochloride
Dextromethorphan Hydrobromide		Internal	(a) In the case of a prolonged release preparation: equivalent of 30mg of Dextromethorphan (MD)
			equivalent of 75mg of Dextromethorphan (MDD)
			(b) in any other case: equivalent of 15mg of Dextromethorphan (MD)
			equivalent of 75mg of Dextromethorphan (MDD)
Dextrothyroxine Sodium
Diazoxide
Dibenzepin Hydrochloride
Dichloralphenazone
Dichlorphenamide
Diclofenac Diethylammonium	1.16 per cent	External	For maximum period of 7 days		Container or package containing not more than 30g of medicinal product
		For local symptomatic relief of pain and inflammation in trauma of the tendons, ligaments, muscles and joints and in localised forms of soft tissue rheumatism
		For use in adults and children not less than 12 years
Diclofenac Potassium
Diclofenac Sodium
Dicyclomine Hydrochloride			10mg (MD)
			60mg (MDD)
Dienoestrol
Diethanolamine Fusidate
Diflucortolone Valerate
Diflunisal
Digitalin
Digitalis Leaf
Digitalis Prepared
Digitoxin
Digoxin
Dihydralazine Sulphate
Dihydroergotamine Mesylate
Dihydrostreptomycin
Dihydrostreptomycin Sulphate
Diloxanide Furoate
Diltiazem Hydrochloride
Dimercaprol
Dimethisoquin Hydrochloride		Non-ophthalmic use
Dimethisterone
Dimethothiazine Mesylate
Dimethyl Sulphoxide
Dimethyltubocurarine Bromide
Dimethyltubocurarine Chloride
Dimethyltubocurarine Iodide
Dinoprost
Dinoprost Trometamol
Dinoprostone
[F3 Diphenhydramine Hydrochloride	All preparations except liquid-filled capsules]
Dipivefrin Hydrochloride
Dipyridamole
Disodium Etidronate
Disodium Pamidronate
Disopyramide
Disopyramide Phosphate
Distigmine Bromide
Disulfiram
Dithranol	1.0 per cent
Dobutamine Hydrochloride
Domperidone
Domperidone Maleate		[F14 For the relief of post-prandial symptoms of excessive fullness, nausea, epigastric bloating and belching, occasionally accompanied by epigastric discomfort and heartburn,]	[F15 10 mg of Domperidone as Domperidone Maleate (MD)]		[F14 Container or package containing not more than 100mg of Domperidone as Domperidone Maleate;]
			[F15 40 mg of Domperidone as Domperidone Maleate (MDD)]
Dopamine Hydrochloride
Dopexamine Hydrochloride
Dothiepin
Dothiepin Hydrochloride
Doxapram Hydrochloride
Doxazosin Mesylate
Doxepin Hydrochloride
Doxorubicin
Doxorubicin Hydrochloride
Doxycycline
Doxycycline Calcium Chelate
Doxycycline Hydrochloride
Droperidol
Dydrogesterone
Dyflos
Econazole		External but in the case of vaginal use only external use for the treatment of vaginal candidiasis
Econazole Nitrate		External but in the case of vaginal use only external use for the treatment of vaginal candidiasis
Ecothiopate Iodide
Edrophonium Chloride
Eflornithine Hydrochloride
Embutramide
Emepronium Bromide
Emetine	1.0 per cent
Emetine Bismuth Iodide
Emetine Hydrochloride	Equivalent of 1.0 per cent of Emetine
Enalapril Maleate
Encephalitis Virus, Tick-borne, Cent Eur
Enoxacin
Enoxaparin Sodium
Enoximone
Ephedrine		(1) Internal (other than nasal sprays or nasal drops)	(1) 30mg (MD)
			60mg (MDD)
	(2) 2.0 per cent	(2) Nasal sprays or nasal drops
		(3) External
Ephedrine Hydrochloride		(1) Internal (other than nasal sprays or nasal drops)	(1) Equivalent of 30mg of Ephedrine (MD)
			Equivalent of 60mg of Ephedrine (MDD)
	(2) Equivalent of 2.0 per cent of Ephedrine	(2) Nasal sprays or nasal drops
		(3) External
Ephedrine Sulphate		(1) Internal (other than nasal sprays or nasal drops)	(1) Equivalent of 30mg of Ephedrine (MD)
			Equivalent of 60mg of Ephedrine (MDD)
	(2) Equivalent of 2.0 per cent of Ephedrine	(2) Nasal sprays or nasal drops
		(3) External
Epicillin
Epirubicin
Epirubicin Hydrochloride
Epithiazide
Epoetin Alfa
Epoetin Beta
Epoprostenol Sodium
Ergometrine Maleate
Ergometrine Tartrate
Ergot, Prepared
Ergotamine Tartrate
Erythromycin
Erythromycin Estolate
Erythromycin Ethylcarbonate
Erythromycin Ethyl Succinate
Erythromycin Lactobionate
Erythromycin Phosphate
Erythromycin Stearate
Erythromycin Thiocyanate
Esmolol Hydrochloride
Estramustine Phosphate
[F16 Estramustine Sodium Phosphate]
Etafedrine Hydrochloride
Ethacrynic Acid
Ethambutol Hydrochloride
Ethamivan
Ethamsylate
Ethiazide
Ethinyl Androstenediol
Ethinyloestradiol
Ethionamide
Ethisterone
Ethoglucid
Ethoheptazine Citrate
Ethopropazine Hydrochloride
Ethosuximide
Ethotoin
Ethyl Biscoumacetate
Ethynodiol Diacetate
Etodolac
Etomidate
Etomidate Hydrochloride
Etoposide
Etretinate
Famciclovir
Famotidine		For the short-term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion and hyperacidity, and prevention of these symptoms when associated with food and drink, including nocturnal symptoms	10mg (MD)
			20mg (MDD)
			For maximum period of 14 days
Fazadinium Bromide
Felbinac	3.17 per cent	External	For maximum period of 7 days		Container or package containing not more than 30g of medicinal product
		[F17 For the relief of rheumatic pain, pain of non-serious arthritic conditions and soft tissue injuries such as sprains, strains and contusions]
		For use in adults and children not less than 12 years
Felodipine
Felypressin
Fenbufen
Fenclofenac
Fenfluramine Hydrochloride
Fenofibrate
Fenoprofen
Fenoprofen Calcium
Fenoterol Hydrobromide
Fenticonazole Nitrate
Feprazone
Ferrous Arsenate
Filgrastim
Finasteride
Flavoxate Hydrochloride
Flecainide Acetate
Flosequinan
Fluanisone
Flubendazole
Fluclorolone Acetonide
Flucloxacillin Magnesium
Flucloxacillin Sodium
Fluconazole		For oral administration for the treatment of vaginal candidiasis in persons aged not less than 16 but less than 60 years	150mg (MD)		Container or package containing not more than 150mg of Fluconazole
Flucytosine
Fludrocortisone Acetate
Flufenamic Acid
Flumazenil
Flumethasone
Flumethasone Pivalate
Flunisolide	0.025 per cent	(a) For the prevention and treatment of seasonal allergic rhinitis, including hay fever	(a) 50mcg per nostril (MD)		(a) Container or package containing not more than 6,000mcg of Flunisolide
			100mcg per nostril (MDD)
		[F18 For use in persons aged 18 years and over]	[F19 For a maximum period of 3 months]
		In the form of a non-pressurised nasal spray
		F20 ...	F20 ...		F20 ...
			F20 . . .
		F20 . . .
		F20 . . .
Fluocinolone Acetonide
Fluocinonide
Fluocortin Butyl
Fluocortolone
Fluocortolone Hexanoate
Fluocortolone Pivalate
Fluorescein Dilaurate
Fluorometholone
Fluorouracil
Fluorouracil Trometamol
Fluoxetine Hydrochloride
Flupenthixol Decanoate
Flupenthixol Hydrochloride
Fluperolone Acetate
Fluphenazine Decanoate
Fluphenazine Enanthate
Fluphenazine Hydrochloride
Fluprednidene Acetate
Fluprednisolone
Fluprostenol Sodium
Flurandrenolone
Flurbiprofen
Flurbiprofen Sodium
Fluspirilene
Flutamide
Fluticasone Propionate
Fluvastatin Sodium
Fluvoxamine Maleate
Folic Acic			500mcg (MDD)
Formestane
Formocortal
Foscarnet Sodium
Fosfestrol Sodium
Fosfomycin Trometamol
Fosinopril Sodium
Framycetin Sulphate
Frusemide
Furazolidone
Fusafungine
Fusidic Acid
Gabapentin
Gadoteridol
Gallamine Triethiodide
Ganciclovir
Ganciclovir Sodium
Gelsemine	0.1 per cent
Gelsemium			25mg (MD)
			75mg (MDD)
Gemeprost
Gemfibrozil
Gentamicin
Gentamicin Sulphate
Gestodene
Gestrinone
Gestronol
Gestronol Hexanoate
Glibenclamide
Glibornuride
Gliclazide
Glipizide
Gliquidone
Glisoxepide
Glucagon
Glycopyrronium Bromide			1mg (MD)
			2mg (MDD)
Glymidine
Gonadorelin
Goserelin Acetate
Gramicidin	0.2 per cent	External
Granisetron Hydrochloride
Griseofulvin
Growth Hormone
Guanethidine Monosulphate
Guanfacine Hydrochloride
Guanoclor Sulphate
Guanoxan Sulphate
Halcinonide
Halofantrine Hydrochloride
Haloperidol
Haloperidol Decanoate
Heparin		External
Heparin Calcium		External
Heparin Sodium
Hexachlorophane		External
	(a) 2.0 per cent	(a) Soaps
	(b) 0.1 per cent	(b) Aerosols
	(c) 0.75 per cent	(c) preparations other than soaps and aerosols
Hexamine Phenylcinchoninate
Hexobarbitone
Hexobarbitone Sodium
Hexoestrol
Hexoestrol Dipropionate
L-Histidine Hydrochloride		Dietary supplementation
Homatropine		(1) Internal	(1) 0.15mg (MD)
			0.45mg (MDD)
		(2) External (except ophthalmic)
Homatropine Hydrobromide			0.2mg (MD)
			0.6mg (MDD)
Homatropine Methylbromide			2mg (MD)
			6mg (MDD)
Hydralazine Hydrochloride
Hydrargaphen		Local application to skin
Hydrobromic Acid
Hydrochlorothiazide
Hydrocortisone	[F21 (1) 0.5 per cent]	[F21 (1) External (a) For use in combination with Nystatin of maximum strength 3.0 per cent for intertrigo (b) For use in adults and children not less than 10 years]			[F21 (1) Container or package containing not more than 15g of medicinal product]
	[F22 (2)] 1.0 per cent	[F22 (2)] External (a) For use either alone or in conjunction with Crotamiton in irritant dermatitis, contact allergic dermatitis, insect bite reactions, mild to moderate eczema, and either in combination with Clotrimazole [F23 or Miconazole Nitrate] for athlete’s foot and candidal intertrigo or in combination with lignocaine for anal and perianal itch associated with haemorrhoids (b) For use in adults and children not less than 10 years (c) Cream ointment or spray			[F22 (2)] Container or package containing not more than 15g of medicinal product (cream or ointment) or 30ml (spray)
Hydrocortisone Acetate	Equivalent to 1.0 per cent Hydrocortisone	External
		For use in irritant dermatitis, contact allergic dermatitis, insect bite reactions, mild to moderate eczema, and in combination with one or more of the following: Benzyl Benzoate, Bismuth Oxide, Bismuth Subgallate, Peru Balsam, Pramoxine Hydrochloride, Zinc Oxide, for haemorrhoids			Container or package containing not more than 15g of medicinal product
					In the case of suppositories, container or package containing no more than 12
		For use in adults and children not less than 10 years
		Cream, ointment or suppositories
Hydrocortisone Butyrate
Hydrocortisone Caprylate
Hydrocortisone Hydrogen Succinate
Hydrocortisone Sodium Phosphate
Hydrocortisone Sodium Succinate	Equivalent to 2.5mg Hydrocortisone	External			Container or package containing not more than equivalent to 50mg of Hydrocortisone
		For aphthous ulceration of the mouth for adults and children not less than 12 years
		In the form of pellets
[F3 Hydrocyanic Acid]
Hydroflumethiazide
Hydroxychloroquine Sulphate		Prophylaxis of malaria
Hydroxyprogesterone
Hydroxyprogesterone Enanthate
Hydroxyprogesterone Hexanoate
Hydroxyurea
Hydroxyzine Embonate
Hydroxyzine Hydrochloride		(a) For the management of pruritis associated with acute or chronic urticaria or atopic dermatitis or contact dermatitis, in adults and in children not less than 12 years	(a) 25mg (MD)		(a) Container or package containing not more than 750mg of Hydroxyzine Hydrochloride
			75mg (MDD)
		(b) For the management of pruritis associated with acute or chronic urticaria or atopic dermatitis or contact dermatitis, in children not less than 6 years but less than 12 years	(b) 25 mg (MD)		(b) Container or package containing not more than 750mg of Hydroxyzine Hydrochloride
			50mg (MDD)
Hyoscine	(1) 0.15 per cent	(1) Internal
		(2) External (except ophthalmic)
Hyoscine Butylbromide		(1) Internal
		(a) by inhaler
		(b) otherwise than by inhaler	(b) 20mg (MD)		(b) Container or package containing not more than 240mg of Hyoscine Butylbromide
			80mg (MDD)
		(2) External
Hyoscine Hydrobromide		(1) Internal
		(a) by inhaler
		(b) otherwise than by inhaler	(b) 300mcg (MD)
			900mcg (MDD)
		(2) External (except ophthalmic)
Hyoscine Methobromide		(1) Internal
		(a) by inhaler
		(b) otherwise than by inhaler	(b) 2.5mg (MD)
			7.5mg (MDD)
		(2) External
Hyoscine Methonitrate		(1) Internal
		(a) by inhaler
		(b) otherwise than by inhaler	(b) 2.5mg (MD)
			7.5mg (MDD)
		(2) External
Hyoscyamine		(1) Internal
		(a) by inhaler
		(b) otherwise than by inhaler	(b) 300mcg (MD)
			1mg (MDD)
		(2) External
Hyoscyamine Hydrobromide		(1) Internal
		(a) by inhaler
		(b) otherwise than by inhaler	(b) Equivalent of 300mcg of Hyoscyamine (MD)
			Equivalent of 1mg of Hyoscyamine (MDD)
		(2) External
Hyoscyamine Sulphate		(1) Internal
		(a) by inhaler
		(b) otherwise than by inhaler	(b) Equivalent of 300mcg of Hyoscyamine (MD)
			Equivalent of 1mg of Hyoscyamine (MDD)
		(2) External
Ibuprofen		Rheumatic and muscular pain, pain of non-serious arthritic conditions, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza
		(1) Internal	(1)(a) In the case of a prolonged release preparation 600mg (MD)
			1,200mg (MDD)
			(b) in any other case 400mg (MD)
			1,200mg (MDD)
	(2) 5.0 per cent	(2) External
[F3 Ibuprofen Lysine		Rheumatic and muscular pain, pain of non-serious arthritic conditions, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza	(a) in the case of a prolonged release preparation 600 mg (MD) 1,200 mg (MDD)
		Internal	(b) in any other case 400 mg (MD) 1,200 mg (MDD)]
Idarubicin Hydrochloride
Idoxuridine
Ifosfamide
Ignatius Bean
Imipenem Hydrochloride
Imipramine
Imipramine Hydrochloride
Imipramine Ion Exchange Resin Bound Salt or Complex
Indapamide Hemihydrate
Indomethacin
Indomethacin Sodium
Indoprofen
Indoramin Hydrochloride
Inosine Pranobex
[F24 Insulin]
Iodamide
Iodamide Meglumine
Iodamide Sodium
Iohexol
Iomeprol
Iopamidol
Iopentol
Iothalamic Acid
Ioversol
Ioxaglic Acid
Ipratropium Bromide
Iprindole Hydrochloride
Iproniazid Phosphate
Isoaminile
Isoaminile Citrate
Isocarboxazid
Isoconazole Nitrate		External but in the case of vaginal use only external use for the treatment of vaginal candidiasis
Isoetharine
Isoetharine Hydrochloride
Isoetharine Mesylate
Isoniazid
Isoprenaline Hydrochloride
Isoprenaline Sulphate
Isopropamide Iodide			Equivalent of 2.5mg of Isopropamide ion (MD)
			Equivalent of 5.0mg of Isopropamide ion (MDD)
Isotretinoin
Isradipine
Itraconazole
Jaborandi		External
Kanamycin Acid Sulphate
Kanamycin Sulphate
Ketamine Hydrochloride
Ketoconazole	2.0 per cent	[F25 (a)] [F26 External]	[F25 (a)] Maximum frequency of application of once every 3 days		[F25 (a)] Container or package containing not more than 120ml of medicinal product and containing not more than 2,400mg of Ketoconazole
		For the prevention and treatment of dandruff and seborrhoeic dermatitis of the scalp
		In the form of a shampoo
		[F27 (b) For the treatment of the following mycotic infections of the skin: tinea pedis, tinea cruris and candidal intertrigo]
Ketoprofen	2.5 per cent	External	For maximum period of 7 days		Container or package containing not more than 30g of medicinal product
		For rheumatic and muscular pain in adults and children not less than 12
Ketorolac Trometamol
Ketotifen Fumarate
Labetalol Hydrocholoride
Lachesine Chloride
Lacidipine
Lamotrigine
Lanatoside C
Lanatoside Complex A, B and C
Latamoxef Disodium
Levallorphan Tartrate
Levobunolol Hydrochloride
[F3 Levocabastine Hydrochloride	Equivalent of 0.05 per cent Levocabastine	(1) Nasal sprays			(1) Container or package containing not more than 10 ml of medicinal product
		For the symptomatic treatment of seasonal allergic rhinitis
		(2) Aqueous eye drops			(2) Container or package containing not more than 4 ml of medicinal product]
		For the symptomatic treatment of seasonal allergic conjunctivitis
Levodopa
Levonorgestrel
Lidoflazine
Lignocaine		Non-ophthalmic use
Lignocaine Hydrochloride		Non-ophthalmic use
Lincomycin
Lincomycin Hydrochloride
Liothyronine Sodium
Lisinopril
Lithium Carbonate			Equivalent of 5mg of Lithium (MD)
			Equivalent of 15mg of Lithium (MDD)
Lithium Citrate
Lithium Succinate
Lithium Sulphate			Equivalent of 5mg of Lithium (MD)
			Equivalent of 15mg of Lithium (MDD)
Lobeline		(1) Internal	(1) 3mg (MD)
			9mg (MDD)
		(2) External
Lobeline Hydrochloride		(1) Internal	(1) Equivalent of 3mg of Lobeline (MD)
			Equivalent of 9mg of Lobeline (MDD)
		(2) External
Lobeline Sulphate		(1) Internal	(1) Equivalent of 3mg of Lobeline (MD)
			Equivalent of 9mg of Lobeline (MDD)
		(2) External
Lodoxamide Trometamol
Lofepramine
Lofepramine Hydrochloride
Lofexidine Hydrochloride
Lomefloxacin Hydrochloride
Lomustine
Loperamide Hydrochloride		Treatment of acute diarrhoea
Loratidine			10mg (MDD)		Container or package containing not more than 100mg of Loratidine
[F12 Lornoxicam]
[F12 Losartan Potassium]
Loxapine Succinate
Lung Surfactant Porcine
Luteinising Hormone
Lymecycline
Lynoestrenol
Lypressin
Lysuride Maleate
Mafenide
Mafenide Acetate
Mafenide Hydrochloride
Mafenide Propionate	5.0 per cent	Eye drops
Magnesium Fluoride
Magnesium Metrizoate
Mandragora Autumnalis
Mannomustine Hydrochloride
Maprotiline Hydrochloride
Mebanazine
Mebendazole		For oral use in the treatment of enterobiasis in adults and in children not less than 2 years	100mg (MD)		Container or package containing not more than 800mg of Mebendazole
Mebeverine Hydrochloride		[F28 (a) For the symptomatic relief of irritable bowel syndrome	[F28 (a) 135 mg (MD) 405 mg (MDD)]
		(b) For uses other than the symptomatic relief of irritable bowel syndrome]	[F28 (b) 100 mg (MD) 300 mg (MDD)]
Mebeverine Pamoate
Mebhydrolin
Mebhydrolin Napadisylate
Mecamylamine Hydrochloride
Mecillinam
Meclofenoxate Hydrochloride
Medigoxin
Medrogestone
Medroxyprogesterone Acetate
Mefenamic Acid
Mefloquine Hydrochloride
Mefruside
Megestrol
Megestrol Acetate
Meglumine Gadopentetate
Meglumine Iodoxamate
Meglumine Ioglycamate
Meglumine Iothalamate
Meglumine Iotroxate
Meglumine Ioxaglate
Melphalan
Melphalan Hydrochloride
Menotrophin
Mepenzolate Bromide			25mg (MD)
			75mg (MDD)
Mephenesin
Mephenesin Carbamate
Mepivacaine Hydrochloride		Any use except ophthalmic use
Meptazinol Hydrochloride
Mequitazine
Mercaptopurine
Mersalyl
Mersalyl Acid
Mesalazine
Mesna
Mestranol
Metaraminol Tartrate
Metergoline
Metformin Hydrochloride
Methacycline
Methacycline Calcium
Methacycline Hydrochloride
Methallenoestril
Methicillin Sodium
Methixene
Methixene Hydrochloride
Methocarbamol
Methocidin		Throat lozenges and throat pastilles
Methohexitone Sodium
Methoin
Methoserpidine
Methotrexate
Methotrexate Sodium
Methotrimeprazine
Methotrimeprazine Hydrochloride
Methotrimeprazine Maleate
Methoxamine Hydrochloride	0.25 per cent	Nasal sprays or nasal drops not containing liquid paraffin as a vehicle
Methsuximide
Methyclothiazide
Methyldopa
Methyldopate Hydrochloride
Methylephedrine Hydrochloride			30mg (MD)
			60mg (MDD)
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Sodium Succinate
Methylthiouracil
Methysergide Maleate
Metipranolol
Metirosine
Metoclopramide Hydrochloride
Metolazone
Metoprolol Fumarate
Metoprolol Succinate
Metoprolol Tartrate
Metronidazole
Metronidazole Benzoate
Metyrapone
Mexiletine Hydrochloride
Mezlocillin Sodium
Mianserin Hydrochloride
Miconazole		External but in the case of vaginal use only external use for the treatment of vaginal candidiasis
Miconazole Nitrate		External but in the case of vaginal use only external use for the treatment of vaginal candidiasis
Mifepristone
Miglitol
Milrinone
Milrinone Lactate
Minocycline
Minocycline Hydrochloride
Minoxidil	[F29 (1) 2.0 per cent]	[F29 (1) External
	[F29 (2) 5.0 per cent	(2) External use for the treatment of alopecia androgenetica, in men aged 18 to 65 (but not in women);]
Misoprostol
Mitobronitol
Mitomycin
Mitozantrone Hydrochloride
Mivacurium Chloride
[F16 Mizolastine]
Moclobemide
Molgramostim
Molindone Hydrochloride
Mometasone Furoate
Moracizine Hydrochloride
Morazone Hydrochloride
Mupirocin
Mupirocin Calcium
Mustine Hydrochloride
Nabilone
Nabumetone
Nadolol
Nafarelin Acetate
Naftidrofuryl Oxalate
Naftifine Hydrochloride
Nalbuphine Hydrochloride
Nalidixic Acid
Nalorphine Hydrobromide
Naloxone Hydrochloride
Naltrexone Hydrochloride
Naphazoline Hydrochloride	(1) 0.05 per cent	(1) Nasal sprays or nasal drops not containing liquid paraffin as a vehicle
	(2) 0.015 per cent	(2) Eye drops
Naphazoline Nitrate	0.05 per cent	Nasal sprays or nasal drops not containing liquid paraffin as a vehicle
Naproxen
Naproxen Sodium
Natamycin
[F12 Nebivolol Hydrochloride]
Nedocromil Sodium	[F30 2.0 per cent]	[F30 For the prevention, relief and treatment of seasonal and perennial allergic conjunctivitis]			[F30 Container or package containing not more than 3 ml of medicinal product]
Nefazodone Hydrochloride
Nefopam Hydrochloride
Neomycin
Neomycin Oleate
Neomycin Palmitate
Neomycin Sulphate
Neomycin Undecanoate
Neostigmine Bromide
Neostigmine Methylsulphate
Netilmicin Sulphate
Nicardipine Hydrochloride
Nicergoline
[F16 Niceritrol]
Nicotinic Acid		Any use, except for the treatment of hyperlipidaemia	600mg (MDD)
Nicoumalone
Nifedipine
Nifenazone
Nikethamide
[F3 Nilutamide]
Nimodipine
Niridazole
[F12 Nisoldipine]
Nitrendipine
Nitrofurantoin
Nitrofurazone
Nizatidine		For the prevention [F31 and treatment] of the symptoms of food-related heartburn [F31 and meal-induced indigestion]	75mg (MD)
			[F32 150mg (MDD)]
			[F33 For a maximum period of 14 days]
		For use in adults and children not less than 16 years
Nomifensine Maleate
Noradrenaline
Noradrenaline Acid Tartrate
Norethisterone
Norethisterone Acetate
Norethisterone Enanthate
Norethynodrel
Norfloxacin
Norgestimate
Norgestrel
Nortriptyline Hydrochloride
Noscapine
Noscapine Hydrochloride
Novobiocin Calcium
Novobiocin Sodium
Nux Vomica Seed
Nystatin	[F34 3.0 per cent]	[F34 External			[F34 Container or package containing not more than 15g of medicinal product]
		For use in combination with Hydrocortisone of maximum strength 0.5 per cent for intertrigo
		For use in adults and children not less than 10 years]
Octacosactrin
Octreotide
Oestradiol
Oestradiol Benzoate
Oestradiol Cypionate
Oestradiol Dipropionate
Oestradiol Diundecanoate
Oestradiol Enanthate
Oestradiol Phenylpropionate
Oestradiol Undecanoate
Oestradiol Valerate
Oestriol
Oestriol Succinate
Oestrogenic Substances Conjugated
Oestrone
Ofloxacin
Olsalazine Sodium
Omeprazole
Ondansetron Hydrochloride
Orciprenaline Sulphate
Orphenadrine Citrate
Orphenadrine Hydrochloride
Ouabain
Ovarian Gland Dried
Oxamniquine
Oxantel Embonate
Oxaprozin
Oxatomide
Oxedrine Tartrate
Oxethazaine			10mg (MD)		Container or package containing not more than 400mg of Oxethazaine
			30mg (MDD)
Oxitropium Bromide
Oxolinic Acid
Oxpentifylline
Oxprenolol Hydrochloride
Oxybuprocaine Hydrochloride		Non-ophthalmic use
Oxybutynin Hydrochloride
Oxypertine
Oxypertine Hydrochloride
Oxyphenbutazone
Oxyphencyclimine Hydrochloride
Oxyphenonium Bromide			5mg (MD)
			15mg (MDD)
Oxytetracycline
Oxytetracycline Calcium
Oxytetracycline Dihydrate
Oxytetracycline Hydrochloride
Oxytocin, natural
Oxytocin, synthetic
Pancreatin	(1) 21,000 European Pharmacopoeia units of lipase per capsule	(1) capsules
	(2) 25,000 European Pharmacopoeia units of lipase per gram	(2) powder
Pancuronium Bromide
Papaverine		(1) By inhaler
		(2) Otherwise than by inhaler	(2) 50mg (MD)
			150mg (MDD)
Papaverine Hydrochloride		(1) By inhaler
		(2) Otherwise than by inhaler	(2) Equivalent of 50mg of Papaverine (MD)
			Equivalent of 150mg of Papaverine (MDD)
[F4 Paracetamol	(1) 120 mg	(1) Non-effervescent tablets and capsules for use in children aged less than 12 years			(1) The quantity sold or supplied in one container or package shall not exceed 32 The quantity of non-effervescent tablets, capsules or a combination of both sold or supplied to a person at any one time shall not exceed 100
	(2) 500 mg	(2) Non-effervescent tablets and capsules for use in adults and children not less than 12 years
		(3) All preparations other than non-effervescent tablets and capsules			(2) The quantity sold or supplied in one container or package shall not exceed 32 The quantity of non-effervescent tablets, capsules or a combination of both sold or supplied to a person at any one time shall not exceed 100]
Paraldehyde
Paramethadione
Paramethasone Acetate
Parathyroid Gland
Pargyline Hydrochloride
Paroxetine Hydrochloride
Pecilocin
Penamecillin
Penbutolol Sulphate
Penicillamine
Penicillamine Hydrochloride
Pentamidine Isethionate
Penthienate Bromide			5mg (MD)
			15mg (MDD)
Pentolinium Tartrate
Perfluamine
Pergolide Mesylate
Perhexiline Maleate
Pericyazine
Perindopril
Perindopril Erbumine
Perphenazine
Phenacetin	0.1 per cent
Phenazone		External
Phenazone Salicylate
Phenbutrazate Hydrochloride
Phenelzine Sulphate
Phenethicillin Potassium
Phenformin Hydrochloride
Phenglutarimide Hydrochloride
Phenindione
[F35 Phenolphthalein.]
Phenoxybenzamine Hydrochloride
Phenoxymethylpenicillin
Phenoxymethylpenicillin Calcium
Phenoxymethylpenicillin Potassium
Phenprocoumon
Phensuximide
Phentolamine Hydrochloride
Phentolamine Mesylate
Phenylbutazone
Phenylbutazone Sodium
Phenylpropanolamine Hydrochloride		Internal
		(1) all preparations except prolonged release capsules, nasal sprays and nasal drops	(1) 25mg (MD)
			100mg (MDD)
		(2) prolonged release capsules	(2) 50mg (MD)
			100mg (MDD)
	(3) 2.0 per cent	(3) nasal sprays and nasal drops
Phenytoin
Phenytoin Sodium
Phthalylsulphathiazole
Physostigmine
Physostigmine Aminoxide Salicylate
Physostigmine Salicylate
Physostigmine Sulphate
[F3 Phytomenadione		Any use except the prevention or treatment of haemorrhagic disorders]
Picrotoxin
Pilocarpine
Pilocarpine Hydrochloride
Pilocarpine Nitrate
Pimozide
Pindolol
Pipenzolate Bromide			5mg (MD)
			15mg (MDD)
Piperacillin Sodium
Piperazine Oestrone Sulphate
Piperidolate Hydrochloride			50mg (MD)
			150mg (MDD)
Pipothiazine Palmitate
Piracetam
Pirbuterol Acetate
Pirbuterol Hydrochloride
[F36 Pirenzepine Dihydrochloride Monohydrate]
Pirenzepine Hydrochloride
Piretanide
Piroxicam	0.5 per cent	External	For maximum period of 7 days		Container or package containing not more than 30g of medicinal product
		For the relief of rheumatic pain, pain of non-serious arthritic conditions and muscular aches, pains and swellings such as strains, sprains and sports injuries
		For use in adults and children not less than 12 years
[F16 Piroxicam Beta-cyclodextrin]
Pituitary Gland (Whole Dried)		By inhaler
Pituitary Powdered (Posterior Lobe)		By inhaler
Pivampicillin
Pivampicillin Hydrochloride
Pivmecillinam
Pivmecillinam Hydrochloride
Pizotifen
Pizotifen Malate
Plicamycin
Podophyllotoxin
Podophyllum
Podophyllum Indian
Podophyllum Resin	20.0 per cent	External
		Ointment or impregnated plaster
Poldine Methylsulphate			2mg (MD)
			6mg (MDD)
Polidexide
Polyestradiol Phosphate
Polymyxin B Sulphate
Polythiazide
Poppy Capsule
Potassium Arsenite	0.0127 per cent
Potassium Bromide
Potassium Canrenoate
Potassium Clavulanate
Potassium Perchlorate
Practolol
Pralidoxime Chloride
Pralidoxime Iodide
Pralidoxime Mesylate
Pravastatin Sodium
Prazosin Hydrochloride
Prednisolone
Prednisolone Acetate
Prednisolone Butylacetate
Prednisolone Hexanoate
Prednisolone Metasulphobenzoate
Prednisolone Metasulphobenzoate Sodium
Prednisolone Pivalate
Prednisolone Sodium Phosphate
Prednisolone Steaglate
Prednisone
Prednisone Acetate
Prenalterol Hydrochloride
Prenylamine Lactate
Prilocaine Hydrochloride		Non-ophthalmic use
Primidone
Probenecid
Probucol
Procainamide Hydrochloride
Procaine Hydrochloride		Non-ophthalmic use
Procaine Penicillin
Procarbazine Hydrochloride
Prochlorperazine
Prochlorperazine Edisylate
Prochlorperazine Maleate
Prochlorperazine Mesylate
Procyclidine Hydrochloride
Progesterone
Prolactin
Proligestone
Prolintane Hydrochloride
Promazine Embonate
Promazine Hydrochloride
Propafenone
Propafenone Hydrochloride
Propanidid
Propantheline Bromide			15mg (MD)
			45mg (MDD)
[F12 Propiverine Hydrochloride]
Propofol
Propranolol Hydrochloride
Propylthiouracil
Proquazone
Protamine Sulphate
Prothionamide
Protirelin
Protriptyline Hydrochloride
Proxymetacaine Hydrochloride		Non-ophthalmic use
Pseudoephedrine Hydrochloride		Internal	(a) In the case of a prolonged release preparation
			120mg (MD)
			240mg (MDD)
			(b) in any other case 60mg (MD)
			240mg (MDD)
Pseudoephedrine Sulphate			60mg (MD)
			180mg (MDD)
Pyrantel Embonate		(a) For the treatment of enterobiosis, in adults and children not less than 12 years	(a) 750mg MDD (as a single dose)		(a) Container or package containing not more than 750mg of Pyrantel Embonate
		(b) For the treatment of enterobiosis, in children less than 12 years but not less than 6 years	(b) 500mg MDD (as a single dose)		(b) Container or package containing not more than 750mg of Pyrantel Embonate
		(c) For the treatment of enterobiosis in children less than 6 years but not less than 2 years	(c) 250mg MDD (as a single dose)		(c) Container or package containing not more than 750mg of Pyrantel Embonate
Pyrantel Tartrate
Pyrazinamide
Pyridostigmine Bromide
Pyrimethamine
[F12 Quetiapine Fumarate]
Quinapril
[F36 Quinapril Hydrochloride]
Quinestradol
Quinestrol
Quinethazone
Quinidine
Quinidine Bisulphate
Quinidine Polygalacturonate
Quinidine Sulphate
Quinine			100mg (MD)
			300mg (MDD)
Quinine Bisulphate			Equivalent of 100mg of Quinine (MD)
			Equivalent of 300mg of Quinine (MDD)
Quinine Cinchophen			Equivalent of 100mg of Quinine (MD)
			Equivalent of 300mg of Quinine (MDD)
Quinine Dihydrochloride			Equivalent of 100mg of Quinine (MD)
			Equivalent of 300mg of Quinine (MDD)
Quinine Ethyl Carbonate			Equivalent of 100mg of Quinine (MD)
			Equivalent of 300mg of Quinine (MDD)
Quinine Glycerophosphate			Equivalent of 100mg of Quinine (MD)
			Equivalent of 300mg of Quinine (MDD)
Quinine Hydrobromide			Equivalent of 100mg of Quinine (MD)
			Equivalent of 300mg of Quinine (MDD)
Quinine Hydrochloride			Equivalent of 100mg of Quinine (MD)
			Equivalent of 300mg of Quinine (MDD)
Quinine Iodobismuthate			Equivalent of 100mg of Quinine (MD)
			Equivalent of 300mg of Quinine (MDD)
Quinine Phosphate			Equivalent of 100mg of Quinine (MD)
			Equivalent of 300mg of Quinine (MDD)
Quinine Salicylate			Equivalent of 100mg of Quinine (MD)
			Equivalent of 300mg of Quinine (MDD)
Quinine Sulphate			Equivalent of 100mg of Quinine (MD)
			Equivalent of 300mg of Quinine (MDD)
Quinine Tannate			Equivalent of 100mg of Quinine (MD)
			Equivalent of 300mg of Quinine (MDD)
Quinine in combination with Urea Hydrochloride
Ramipril
Ranitidine Hydrochloride		For the short term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion and hyperacidity [F37 or the prevention of these symptoms when associated with consuming food and drink]	Equivalent to 75mg of Ranitidine (MD)
			Equivalent to 300mg of Ranitidine (MDD)
			For a maximum period of 14 days
Rauwolfia Serpentina
Rauwolfia Vomitoria
Razoxane
Remoxipride Hydrochloride
Reproterol Hydrochloride
Rescinnamine
Reserpine
Rifabutin
Rifampicin
Rifampicin Sodium
Rifamycin
Rimiterol Hydrobromide
Risperidone
Ritodrine Hydrochloride
Rolitetracycline Nitrate
Sabadilla
Salbutamol
Salbutamol Sulphate
Salcatonin
Salcatonin Acetate
Salmefamol
Salmeterol Xinafoate
Salsalate
Saralasin Acetate
Selegiline Hydrochloride
Semisodium Valproate
Serum Gonadotrophin
Silver Sulphadiazine
Simvastatin
Sissomicin
Sissomicin Sulphate
Snake Venoms
Sodium Acetrizoate
Sodium Aminosalicylate
Sodium Antimonylgluconate
Sodium Arsanilate
Sodium Arsenate
Sodium Arsenite	0.013 per cent
Sodium Bromide
Sodium Clodronate
Sodium Cromoglycate		(a) For nasal admistration
	(b) 2.0 per cent	(b) For the treatment of acute seasonal allergic conjunctivitis [F38 or perennial allergic conjunctivitis]			(b) Container or package containing not more than 10ml of medicinal product
		In the form of aqueous eye drops
	(c) 4.0 per cent	(c) For the treatment of acute seasonal allergic conjunctivitis			(c) Container or package containing not more than 5g of medicinal product
		In the form of an eye ointment
Sodium Ethacrynate
Sodium Fluoride	(1) 0.33 per cent	(1) Dentifrices
		(2) Other preparations for use in the prevention of dental caries
		In the form of
		(a) tablets or drops	(a) 2.2 mg (MDD)
	(b) 0.2 per cent	(b) mouth rinses other than those for daily use
	(c) 0.05 per cent	(c) mouth rinses for daily use
Sodium Fusidate
Sodium Metrizoate
Sodium Monofluorophosphate	1.14 per cent	Dentrifrice
Sodium Oxidronate
Sodium Stibogluconate
Sodium Valproate
Somatorelin Acetate
Sotalol Hydrochloride
Spectinomycin
Spectinomycin Hydrochloride
Spiramycin
Spiramycin Adipate
Spironolactone
Stannous Fluoride	0.62 per cent	Dentifrice
Stilboestrol
Stilboestrol Dipropionate
Streptodornase		External
Streptokinase		External
Streptomycin
Streptomycin Sulphate
Strychnine
Strychnine Arsenate
Strychnine Hydrochloride
[F3 Strychnine Nitrate]
Styramate
Succinylsulphathiazole
Sucralfate
Sulbactam Sodium
Sulbenicillin
Sulbenicillin Sodium
Sulconazole Nitrate		External (except vaginal)
[F3 Sulfabenzamide]
Sulfacytine
Sulfadoxine
Sulfamerazine
Sulfamerazine Sodium
Sulfametopyrazine
Sulfamonomethoxine
Sulindac
Sulphacetamide
Sulphacetamide Sodium
Sulphadiazine
Sulphadiazine Sodium
Sulphadimethoxine
Sulphadimidine
Sulphadimidine Sodium
Sulphafurazole
Sulphafurazole Diethanolamine
Sulphaguanidine
Sulphaloxic Acid
Sulphamethizole
Sulphamethoxazole
Sulphamethoxydiazine
Sulphamethoxypyridazine
Sulphamethoxypyridazine Sodium
Sulphamoxole
Sulphanilamide
Sulphaphenazole
Sulphapyridine
Sulphapyridine Sodium
Sulphasalazine
Sulphathiazole
Sulphathiazole Sodium
Sulphaurea
Sulphinpyrazone
Sulpiride
Sultamicillin
Sultamicillin Tosylate
Sulthiame
Sumatriptan Succinate
Suprofen
Suxamethonium Bromide
Suxamethonium Chloride
Suxethonium Bromide
[F12 Tacalcitol Monohydrate]
Tacrine Hydrochloride
Talampicillin
Talampicillin Hydrochloride
Talampicillin Napsylate
Tamoxifen
Tamoxifen Citrate
Tazobactam Sodium
Teicoplanin
Temocillin Sodium
Tenoxicam
Terazosin Hydrochloride
Terbinafine
Terbutaline
Terbutaline Sulphate
Terfenadine			F39 . . .		F39 ...
Terlipressin
Terodiline Hydrochloride
Tetrabenazine
Tetracosactrin
Tetracosactrin Acetate
Tetracycline
Tetracycline Hydrochloride
Tetracycline Phosphate Complex
Tetroxoprim
Thallium Acetate
Thallous Chloride
Thiabendazole
Thiambutosine
Thiethylperazine Malate
Thiethylperazine Maleate
Thiocarlide
Thioguanine
Thiopentone Sodium
Thiopropazate Hydrochloride
Thioproperazine Mesylate
Thioridazine
Thioridazine Hydrochloride
Thiosinamine
Thiotepa
Thiothixene
Thiouracil
Thymoxamine Hydrochloride
Thyroid
Thyrotrophin
Thyroxine Sodium
Tiamulin Fumarate
Tiaprofenic Acid
Tibolone
Ticarcillin Sodium
Tigloidine Hydrobromide
Timolol Maleate
Tinidazole
Tinzaparin
Tioconazole	(1) 2.0 per cent	(1) External (except vaginal)
		(2) Vaginal for treatment of vaginal candidiasis
Tobramycin
Tobramycin Sulphate
Tocainide Hydrochloride
Tofenacin Hydrochloride
Tolazamide
Tolazoline Hydrochloride		External
Tolbutamide
Tolbutamide Sodium
Tolfenamic Acid
Tolmetin Sodium
[F16 Torasemide]
Tramadol Hydrochloride
Trandolapril
Tranexamic Acid
Tranylcypromine Sulphate
Trazodone Hydrochloride
Treosulfan
Tretinoin
Triamcinolone
Triamcinolone Acetonide	0.1 per cent	For the treatment of common mouth ulcers			Container or package containing not more than 5g of medicinal product
Triamcinolone Diacetate
Triamcinolone Hexacetonide
Triamterene
Tribavirin
Triclofos Sodium
Trientine Dihydrochloride
Trifluoperazine
Trifluoperazine Hydrochloride
Trifluperidol
Trifluperidol Hydrochloride
Trilostane
Trimeprazine
Trimeprazine Tartrate
Trimetaphan Camsylate
Trimetazidine
Trimetazidine Hydrochloride
Trimethoprim
Trimipramine Maleate
Trimipramine Mesylate
Tropicamide
Tropisetron Hydrochloride
Troxidone
L-Tryptophan		(1) Oral
		Dietary supplementation
		(2) External
Tubocurarine Chloride
Tulobuterol
Tulobuterol Hydrochloride
Tyrothricin		Throat lozenges or throat pastilles
Uramustine
Urea Stibamine
Urethane
Uridine 5'-triphosphate
Urofollitrophin
Urokinase
Ursodeoxychoic Acid
Vaccine: Bacillus Salmonella Typhi
Vaccine: Poliomyelitis (Oral)
Valproic Acid
Vancomycin Hydrochloride
Vasopressin
Vasopressin Tannate
Vecuronium Bromide
Verapamil Hydrochloride
Veratrine
Veratrum, Green
Veratrum, White
Vidarabine
Vigabatrin
Viloxazine Hydrochloride
Vinblastine Sulphate
Vincristine Sulphate
Vindesine Sulphate
Viomycin Pantothenate
Viomycin Sulphate
Vitamin A		(1) Internal	(1) 7,500iu (2,250mcg Retinol equivalent) (MDD)
		(2) External
Vitamin A Acetate		(1) Internal	(1) Equivalent to 7,500iu Vitamin A (2,250mcg Retinol equivalent) (MDD)
		(2) External
Vitamin A Palmitate		(1) Internal	(1) Equivalent to 7,500iu Vitamin A (2,250mcg Retinol equivalent) (MDD)
		(2) External
Warfarin
Warfarin Sodium
Xamoterol Fumarate
Xipamide
Yohimbine Hydrochloride
Zidovudine
Zimeldine Hydrochloride
Zolpidem Tartrate
Zomepirac Sodium
Zopiclone
Zuclopenthixol Acetate
Zuclopenthixol Decanoate
Zuclopenthixol Hydrochloride]

Textual Amendments

F3 Words in Sch. 1 inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), art. 1(1), Sch.

F4 Words in Sch. 1 inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment Order 1997 (S.I. 1997/2044), art. 1(1), Sch. 1

F5 Words in Sch. 1 inserted (22.4.1999) by The Prescription Only Medicines (Human Use) Amendment Order 1999 (S.I. 1999/1044), arts. 1(1), 2(a)

F6 Words in Sch. 1 substituted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(a)

F7 Sch. 1: entries renumbered (22.4.1999) by The Prescription Only Medicines (Human Use) Amendment Order 1999 (S.I. 1999/1044), arts. 1(1), 2(a)

F8 Words in Sch. 1 omitted (16.9.1998) by virtue of The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(b)

F9 Word in Sch. 1 substituted (22.4.1999) by The Prescription Only Medicines (Human Use) Amendment Order 1999 (S.I. 1999/1044), arts. 1(1), 2(b)

F10 Words in Sch. 1 inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(c)(ii)

F11 Words in Sch. 1 substituted (16.9.1998) by virtue ofThe Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(c)(i)

F12 Words in Sch. 1 inserted (22.4.1999) by The Prescription Only Medicines (Human Use) Amendment Order 1999 (S.I. 1999/1044), arts. 1(1), 2(e)

F13 Word in Sch. 1 substituted (16.9.1997) by The Prescription Only Medicines (Human Use) Amendment Order 1997 (S.I. 1997/2044), arts. 1(1), 2(a)

F14 Words in Sch. 1 inserted (1.6.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 1998 (S.I. 1998/1178), arts. 1(1), 2(a)

F15 Words in Sch. 1 substituted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(d)

F16 Words in Sch. 1 inserted (13.2.1998) by The Prescription Only Medicines (Human Use) Amendment Order 1998 (S.I. 1998/108), arts. 1, 3(e)(i)

F17 Words in Sch. 1 substituted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(e)

F18 Words in Sch. 1 substituted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(f)(i)

F19 Words in Sch. 1 inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(f)(ii)

F20 Words in Sch. 1 omitted (16.9.1998) by virtue of The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(f)(iii)

F21 Words in Sch. 1 inserted (22.4.1999) by The Prescription Only Medicines (Human Use) Amendment Order 1999 (S.I. 1999/1044), arts. 1(1), 2(c)

F22 Sch. 1: entries renumbered (22.4.1999) by The Prescription Only Medicines (Human Use) Amendment Order 1999 (S.I. 1999/1044), arts. 1(1), 2(c)

F23 Words in Sch. 1 inserted (13.2.1998) by The Prescription Only Medicines (Human Use) Amendment Order 1998 (S.I. 1998/108), arts. 1, 3(a)

F24 Word in Sch. 1 inserted (13.8.1998) by The Prescription Only Medicines (Human Use) Amendment Order 1998 (S.I. 1998/108), arts. 1, 3(e)(ii)

F25 Word in Sch. 1 inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(g)(ii)

F26 Words in Sch. 1 inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(g)(i)

F27 Words in Sch. 1 inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(g)(iii)

F28 Words in Sch. 1 substituted (13.2.1998) by The Prescription Only Medicines (Human Use) Amendment Order 1998 (S.I. 1998/108), arts. 1, 3(b)

F29 Words in Sch. 1 substituted (1.6.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 1998 (S.I. 1998/1178), arts. 1(1), 2(b)

F30 Words in Sch. 1 inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 3(h)

F31 Words in Sch. 1 inserted (1.6.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 1998 (S.I. 1998/1178), arts. 1(1), 2(c)(i)

F32 Words in Sch. 1 inserted (1.6.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 1998 (S.I. 1998/1178), arts. 1(1), 2(c)(ii)

F33 Words in Sch. 1 substituted (1.6.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 1998 (S.I. 1998/1178), arts. 1(1), 2(c)(iii)

F34 Words in Sch. 1 inserted (22.4.1999) by The Prescription Only Medicines (Human Use) Amendment Order 1999 (S.I. 1999/1044), arts. 1(1), 2(d)

F35 Words in Sch. 1 inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 1998 (S.I. 1998/1178), arts. 1(1), 2(d)(ii)

F36 Words in Sch. 1 inserted (1.6.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 1998 (S.I. 1998/1178), arts. 1(1), 2(d)(i)

F37 Words in Sch. 1 added (13.2.1998) by The Prescription Only Medicines (Human Use) Amendment Order 1998 (S.I. 1998/108), arts. 1, 3(c)

F38 Words in Sch. 1 inserted (13.2.1998) by The Prescription Only Medicines (Human Use) Amendment Order 1998 (S.I. 1998/108), arts. 1, 3(d)

F39 Words in Sch. 1 omitted (16.9.1997) by virtue of The Prescription Only Medicines (Human Use) Amendment Order 1997 (S.I. 1997/2044), arts. 1(1), 2(b)

Articles 6(1) and 10

SCHEDULE 2

Column 1	Circumstances excluding medicinal products from the class of prescription only medicines
	Column 2	Column 3	Column 4
Substance	Maximum strength	Pharmaceutical Form	Maximum Dose
Codeine and its salts	Equivalent of 1.5 per cent of codeine monohydrate		Equivalent of 20 mg of codeine monohydrate
Dihydrocodeine and its salts	Equivalent of 1.5 per cent of dihydrocodeine		Equivalent of 10 mg of dihydrocodeine
Ethylmorphine andits salts	Equivalent of 0.2 per cent of ethylmorphine		Equivalent of 7.5 mg of ethylmorphine
Morphine and its salts	(1) Equivalent of 0.02 per cent anhydrous morphine	(1) Liquid	(1) Equivalent of 3 mg of anhydrous morphine
	(2) Equivalent of 0.04 per cent of anhydrous morphine; equivalent of 300 mcg of anhydrous morphine	(2) Solid	(2) Equivalent of 3 mg of anhydrous morphine
Medicinal Opium	(1) Equivalent of 0.02 per cent of anhydrous morphine	(1) Liquid	(1) Equivalent of 3 mg of anhydrous morphine
	(2) Equivalent of 0.04 per cent of anhydrous morphine	(2) Solid	(2) Equivalent of 3 mg of anhydrous morphine
Pholcodine and its salts	Equivalent of 1.5 per cent of pholcodine monohydrate		Equivalent of 20 mg of pholcodine monohydrate

Article 2(b)

SCHEDULE 3 DESCRIPTIONS AND CLASSES OF PRESCRIPTION ONLY MEDICINES IN RELATION TO WHICH APPROPRIATE NURSE PRACTITIONERS ARE APPROPRIATE PRACTITIONERS

• [F40 Co-danthramer Capsules NPF]

• [F40 Co-danthramer Capsules, Strong NPF]

• Co-danthramer-Oral Suspension NPF

• Co-danthramer-Oral Suspension Strong NPF

• Co-danthrusate Capsules

• [F40 Co-danthrusate Oral Suspension NPF]

• Mebendazole Tablets NPF

• Mebendazole Oral Suspension NPF

• Miconazole Oral Gel NPF

• Nystatin Oral Suspension

• Nystatin Pastilles NPF

• Streptokinase and Streptodornase Topical Powder NPF

Textual Amendments

F40 Words in Sch. 3 inserted (13.2.1998) by The Prescription Only Medicines (Human Use) Amendment Order 1998 (S.I. 1998/108), arts. 1, 4

Article 8(4)(c)

SCHEDULE 4 SUBSTANCES NOT TO BE CONTAINED IN A PRESCRIPTION ONLY MEDI CINE SOLD OR SUPPLIED UNDER THE EXEMPTION CONFERRED BY ARTICLE 8(3)

• Ammonium Bromide

• Calcium Bromide

• Calcium Bromidolactobionate

• Embutramide

• Fencamfamin Hydrochloride

• Fluanisone

• Hexobarbitone

• Hexobarbitone Sodium

• Hydrobromic Acid

• Meclofenoxate Hydrochloride

• Methohexitone Sodium

• Pemoline

• Piracetam

• Potassium Bromide

• Prolintane Hydrochloride

• Sodium Bromide

• Strychnine Hydrochloride

• Tacrine Hydrochloride

• Thiopentone Sodium

Article 11(1)(a)

SCHEDULE 5 EXEMPTION FOR CERTAIN PERSONS FROM SECTION 58(2) OF THE ACT

PART I EXEMPTION FROM RESTRICTIONS ON SALE OR SUPPLY

Column 1	Column 2	Column 3
Persons exempted	Prescription only medicines to which the exemption applies	Conditions
1. Persons selling or supplying prescription only medicines to universities, other institutions concerned with higher education or institutions concerned with research.	1. All prescription only medicines	1. The sale or supply shall be– (a) subject to the presentation of an order signed by the principal of the institution concerned with education or research or the appropriate head of department in charge of a specified course of research stating– (i) the name of the institution for which the prescription only medicine is required, (ii) the purpose for which the prescription only medicine is required, and (iii) the total quantity required, and (b) for the purposes of the education or research with which the institution is concerned.
2. Persons selling or supplying prescription only medicines to any of the following– (1) a public analyst appointed under section 27 of the Food Safety Act 1990(21) or article 36 of the Food (Northern Ireland) Order 1989(22), (2) an authorized officer within the meaning of section 5(6) of the Food Safety Act 1990, (3) a sampling officer within the meaning of article 38(1) of the Food (Northern Ireland) Order 1989, (4) a person duly authorized by an enforcement authority under sections 111 and 112, (5) a sampling officer within the meaning of Schedule 3 to the Act.	2. All prescription only medicines.	2. The sale or supply shall be subject to the presentation of an order signed by or on behalf of any person listed in column 1 of this paragraph stating the status of the person signing it and the amount of prescription only medicine required, and shall be only in connection with the exercise by those persons of their statutory functions.
3. Persons selling or supplying prescription only medicines to any person employed or engaged in connection with a scheme for testing the quality and checking the amount of the drugs and appliances supplied under the National Health Service Act 1977(23), the National Health Service (Scotland) Act 1978(24) and the Health and Personal Social Services (Northern Ireland) Order 1972(25), or under any subordinate legislation made under those Acts or that Order.	3. All prescription only medicines.	3. The sale or supply shall be– (a) subject to the presentation of an order signed by or on behalf of the person so employed or engaged stating the status of the person signing it and the amount of prescription only medicine required, and (b) for the purposes of a scheme referred to in column 1 in this paragraph.
4. Registered midwives.	4. Prescription only medicines containing any of the following substances– Chloral hydrate Ergometrine maleate Pentazocine hydrochloride [F41 Phytomenadione] Triclofos sodium.	4. The sale or supply shall be only in the course of their professional practice and in the case of Ergometrine maleate only when contained in a medicinal product which is not for parenteral administration.
5. Persons lawfully conducting a retail pharmacy business within the meaning of section 69.	5. Prescription only medicines which are not for parenteral administration and which– (a) are eyes drops and are prescription only medicines by reason only that they contain not more than 0.5 per cent Chloramphenicol, or (b) are eye ointments and are prescription only medicines by reason only that they contain not more than 1.0 per cent Chloramphenicol, or (c) are prescription only medicines by reason only that they contain any of the following substances: Atropine sulphate Bethanecol chloride Carbachol Cyclopentolate hydrochloride Homatropine hydrobromide Naphazoline hydrochloride Naphazoline nitrate Physostigmine salicylate Physostigmine sulphate Pilocarpine hydrochloride Pilocarpine nitrate Tropicamide.	5. The sale or supply shall be subject to the presentation of an order signed by a registered ophthalmic optician.
6. Registered ophthalmic opticians.	6. Prescription only medicines listed in column 2 of paragraph 5.	6. The sale or supply shall be only– (a) in the course of their professional practice and (b) in an emergency.
7. Persons selling or supplying prescription only medicines to the British Standards Institution.	7. All prescription only medicines.	7. The sale or supply shall be– (a) subject to the presentation of an order signed on behalf of the British Standards Institution stating the status of the person signing it and the amount of the prescription only medicine required, and (b) only for the purpose of testing containers of medicinal products or determining the standards for such containers.
8. Holders of marketing authorizations, product licences or manufacturer’s licences.	8. Prescription only medicines referred to in the authorizations or licences.	8. The sale or supply shall be only– (a) to a pharmacist, (b) so as to enable that pharmacist to prepare an entry relating to the prescription only medicine in question in a tablet or capsule identification guide or similar publication, and (c) of no greater quantity than is reasonably necessary for that purpose.
9. Pharmacists selling or supplying to persons to whom cyanide salts may be sold by virtue of section 3 (regulation of poisons) or section 4 (exclusion of sales by wholesale and certain other sales) of the Poisons Act 1972(26) or by virtue of article 5 (prohibitions and regulations with respect to sale of poisons) or article 6 (exemption with respect to certain sales) of the Poisons (Northern Ireland) Order 1976(27).	9. Amyl nitrite.	9. The sale or supply shall only be so far as is necessary to enable an antidote to be available to persons at risk of cyanide poisoning.
[F42 10.   State registered chiropodists who hold a certificate of competence in the use of the medicines specified in Column 2 issued by or with the approval of the Chiropodists Board.	10.   The following prescription only medicines— (a) Co-dydramol 10/500 tablets; (b) Amorolfine hydrochloride cream where the maximum strength of the Amorolfine in the cream does not exceed 0.25 per cent by weight in weight; (c) Amorolfine hydrochloride lacquer where the maximum strength of the Amorolfine in the lacquer does not exceed 5 per cent by weight in volume; and (d) Topical hydrocortisone where the maximum strength of the hydrocortisone in the medicinal product does not exceed 1 per cent by weight in weight.	10.   The sale or supply shall be only in the course of their professional practice and (a) in the case of Co-dydramol 10/500 tablets the quantity sold or supplied to a person at any one time shall not exceed the amount sufficient for 3 days' treatment to a maximum of 24 tablets.]

Textual Amendments

F41 Word in Sch. 5 Pt. 1 para. 4 inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 4(a)

F42 Sch. 5 Pt. 1 para. 10 inserted (13.2.1998) by The Prescription Only Medicines (Human Use) Amendment Order 1998 (S.I. 1998/108), art. 1, Sch.

Article 11(1)(b)

PART II EXEMPTIONS FROM THE RESTRICTION ON SUPPLY

Column 1	Column 2	Column 3
Persons exempted	Prescription only medicines to which the exemption applies	Conditions
1. Royal National Lifeboat Institution and certified first aiders of the Institution.	1. All prescription only medicines.	1. The supply shall be only so far as is necessary for the the treatment of sick or injured persons in the exercise of the functions of the Institution.
2. The owner or the master of a ship which does not carry a doctor on board as part of her complement.	2. All prescription only medicines.	2. The supply shall be only so far as is necessary for the treatment of persons on the ship.
3. Persons authorized by licences granted under regulation 5 of the Misuse of Drugs Regulations to supply a controlled drug.	3. Such prescription only medicines, being controlled drugs, as are specified in the licence.	3. The supply shall be subject to such conditions and in such circumstances and to such an extent as may be specified in the licence.
4. Persons requiring prescription only medicines for the purpose of enabling them, in the course of any business carried on by them, to comply with any requirements made by or in pursuance of any enactment with respect to the medical treatment of their employees.	4. Such prescription only medicines as may be specified in the relevant enactment.	4. The supply shall be– (a) for the purpose of enabling them to comply with any requirements made by or in pursuance of any such enactment, and (b) subject to such conditions and in such circumstances as may be specified in the relevant enactment.
5. Persons operating an occupational health scheme.	5. Prescription only medicines sold or supplied to a person operating an occupational health scheme in response to an order in writing signed by a doctor or a registered nurse.	5. — (1) The supply shall be in the course of an occupational health scheme. (2) The individual supplying the prescription only medicine, if not a doctor, shall be a registered nurse acting in accordance with the written instructions of a doctor as to the circumstances in which prescription only medicines of the description in question are to be used in the course of the occupational health scheme.
6. The operator or commander of an aircraft.	6. Prescription only medicines which are not for parenteral administration and which have been sold or supplied to the operator or commander of the aircraft in response to an order in writing signed by a doctor.	6. The supply shall be only so far as is necessary for the immediate treatment of sick or injured persons on the aircraft and shall be in accordance with the written instructions of a doctor as to the circumstances in which prescription only medicines of the description in question are to be used on the aircraft.
7. Persons employed as qualified first-aid personnel on offshore installations.	7. All prescription only medicines.	7. The supply shall be only so far as is necessary for the treatment of persons on the installation.

Article 11(2)

PART III EXEMPTIONS FROM RESTRICTION ON ADMINISTRATION Column 1

Column 1	Column 2	Column 3
Persons exempted	Prescription only medicines to which the exemption applies	Conditions
1. State registered chiropodists who hold a certificate of competence in the use of analgesics issued by or with the approval of the Chiropodists Board.	1. Prescription only medicines for parenteral administration that contain,as the sole active ingredient, not more than one of the following substances– [F43 Bupivacaine hydrochloride Bupivacaine hydrochloride with adrenaline where the maximum strength of the adrenaline does not exceed 1 mg in 200 ml of bupivacaine hydrochloride Lignocaine hydrochloride Lignocaine hydrochloride with adrenaline where the maximum strength of the adrenaline does not exceed 1 mg in 200 ml of lignocaine hydrochloride [F44 Mepivacaine hydrochloride] Prilocaine hydrochloride.]	1. The administration shall be only in the course of their professional practice.
2. Registered midwives.	2. Prescription only medicines for parenteral administration containing any of the following substances but no other substance specified in column 1 of Schedule 1 to this Order– Ergometrine maleate Lignocaine Lignocaine hydrochloride Naloxone hydrochloride Oxytocins, natural and synthetic Pentazocine lactate Pethidine hydrochloride Phytomenadione Promazine hydrochloride.	2. The administration shall be only in the course of their professional practice and in the case of Promazine hydrochloride, Lignocaine and Lignocaine hydrochloride shall be only while attending on a woman in childbirth.
3. Persons who are authorized as members of a group by a group authority granted under regulations 8(3) or 9(3) of the Misuse of Drugs Regulations to supply a controlled drug by way of administration only.	3. Prescription only medicines that are specified in the group authority.	3. The administration shall be subject to such conditions and in such circumstances and to such extent as may be specified in the group authority.
4. The owner or master of a ship which does not carry a doctor on board as part of her complement.	4. All prescription only medicines that are for parenteral administration.	4. The administration shall be only so far as is necessary for the treatment of persons on the ship.
5. Persons operating an occupational health scheme.	5. Prescription only medicines for parenteral administration sold or supplied to the person operating an occupational health scheme in response to an order in writing signed by a doctor or a registered nurse.	5. — (1) The administration shall be in the course of an occupational health scheme. (2) The individual administering the prescription only medicine, if neither a doctor nor acting in accordance with the directions of a doctor, shall be a registered nurse acting in accordance with the written instructions of a doctor as to the circumstances in which prescription only medicines of the description in question are to be used in the course of the occupational health scheme.
6. The operator or commander of an aircraft.	6. Prescription only medicines for parenteral administration which have been sold or supplied to the operator or commander of the aircraft in response to an order in writing signed by a doctor.	6. The administration shall be only so far as is necessary for the immediate treatment of sick or injured persons on the aircraft and shall be in accordance with the written instructions of a doctor as to the circumstances in which prescription only medicines of the description in question are to be used on the aircraft.
7. Persons who are, and at 11th February 1982 were, persons customarily administering medicinal products to human beings by parenteral administration in the course of a business in the field of osteopathy, naturopathy, acupuncture or other similar field except chiropody.	7. Medicinal products that are prescription only medicines by reason only that they fall within the class specified in article 3(c) (products for parenteral administration).	7. The person administering the prescription only medicine shall have been requested by or on behalf of the person to whom it is administered and in that person’s presence to use his own judgement as to the treatment required.
8. Persons employed as qualified first-aid personnel on offshore installations.	8. All prescription only medicines that are for parenteral administration.	8. The administration shall be only so far as is necessary for the treatment of persons on the installation.
9. Persons who hold a certificate of proficiency in ambulance paramedic skills issued by, or with the approval of, the Secretary of State.	9. The following prescription only medicines for parenteral administration– (a) Diazepam 5 mg per ml emulsion for injection; (b) Succinylated Modified Fluid Gelatin 4 per cent intravenous infusion; (c) prescription only medicines containing one or more of the following substances, but no active ingredient– Adrenaline Acid Tartrate Anhydrous Glucose [F45 Bretylium Tosylate] Compound Sodium Lactate Intravenous Infusion (Hartmann’s Solution) Ergometrine Maleate Glucose Heparin Sodium Lignocaine Hydrochloride Nalbuphine Hydrochloride Naloxone Hydrochloride Polygeline Sodium Bicarbonate Sodium Chloride	9. The administration shall be only for the immediate, necessary treatment of sick or injured persons and in the case of a prescription only medicine containing Heparin Sodium shall be only for the purpose of cannula flushing.

Textual Amendments

F43 Words in Sch. 5 Pt. 3 substituted (13.2.1998) by The Prescription Only Medicines (Human Use) Amendment Order 1998 (S.I. 1998/108), arts. 1, 5(2)

F44 Words in Sch. 5 Pt. 3 para. 1 inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 4(b)

F45 Words in Sch. 5 Pt. 3 para. 9 inserted (1.6.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 1998 (S.I. 1998/1178), arts. 1(1), 3

Article 16(1)

SCHEDULE 6 ORDERS REVOKED

Column 1	Column 2
Orders	References
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Order 1983	S.I. 1983/1212
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1984	S.I. 1984/756
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1986	S.I. 1986/586
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1987	S.I. 1987/674
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1987	S.I. 1987/1250
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1988	S.I. 1988/2017
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1991	S.I. 1991/962
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1992	S.I. 1992/1534
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1992	S.I. 1992/2937
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1993	S.I. 1993/1890
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1993	S.I. 1993/3256
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1994	S.I. 1994/558
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1994	S.I. 1994/3016
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 3) Order 1994	S.I. 1994/3050
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1995	S.I. 1995/1384
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1995	S.I. 1995/3174
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment Order 1996	S.I. 1996/1514
The Medicines (Products other than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1996	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 1983 Order as amended”) are revoked by article 16 and Schedule 6.

This Order specifies the descriptions and classes of prescription only medicines (i.e. medicinal products which, subject to exemptions, may be sold or supplied by retail only in accordance with a prescription given by an appropriate practitioner and which may be administered only by or in accordance with the directions of such a practitioner). Many medicinal products are included in a class of such medicines by reason of the substances contained in them (seeSchedule 1) but others are included because of other criteria, such as their method of administration (seearticle 3). In many cases 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 authorizations have been granted by the European Community. They include as prescription only medicines those medicines in respect of which such an authorization has been granted which classifies a medicine as being subject to medical prescription (article 3(f)). They exclude from the class of prescription only medicines those medicines in respect of which such an authorization provides for supply which is not subject to medical prescription (article 6(3)).

The differences between this Order and the 1983 Order as amended are in the main technical changes concerning the location of provisions such as the division of material in Schedule 1 to the 1983 Order as amended between the new Schedules 1 and 2. But within the new Schedule 1 there are changes which relate to–

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

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

(c) the incorporation in that Schedule of provisions from article 4 of, and Part IV of Schedule 1 to, 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 form the criteria for exemptions from the sale or supply requirements of section 58(2) of the Medicines Act 1968 instead of the criteria for excluding medicinal products from the class of prescription only medicines (see alsoarticle 5);

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

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

(1)

1968 c. 67. Section 58 has been amended by the Prescription by Nurses Etc. Act 1992 (c. 28), section 1. The expression “the appropriate 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, and Schedule 1 to, the Transfer of Functions (Wales) Order 1969 (S.I. 1969/388); in the case of the Secretary of State concerned with Agriculture in Wales by virtue of article 2(3) of, and Schedule 1 to, the Transfer of Functions (Wales) (No. 1) Order 1978 (S.I. 1978/272) and in the case of the Northern Ireland Departments by virtue of section 40 of, and Schedule 5 to, the Northern Ireland Constitution Act 1973 (c. 36) and section 1(3) of, and paragraph 2(1)(b) of Schedule 1 to, the Northern Ireland Act 1974 (c. 28).

(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.

(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.

(14)

1989 c. 44.

(15)

1960 c. 66.

(16)

OJ No. L214, 24.8.93, p. 1.

(17)

OJ No. L214, 24.8.93, p. 1.

(18)

S.I. 1980/1923, amended by S.I. 1997/1831.

(19)

S.I. 1989/1852.

(20)

See S.I. 1979/382 amended by S.I. 1980/263 and S.I. 1989/1124.

(21)

1990 c. 16.

(22)

S.I. 1989/846 (N.I. 6).

(23)

1977 c. 49.

(24)

1978 c. 29.

(25)

S.I. 1972/1265 (N.I. 14).

(26)

1972 c. 66.

(27)

S.I. 1976/1214 (N.I. 23).