1987 No. 674

MEDICINES

The Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Amendment Order 1987

Made

Laid before Parliament

Coming into force

The Secretary of State concerned with health in England, the Secretaries of State respectively concerned with health and with agriculture in Wales and in Scotland, the Minister of Agriculture, Fisheries and Food, the Department of Health and Social Services for Northern Ireland and the Department of Agriculture for Northern Ireland, acting jointly, in exercise of powers conferred by sections 58(1), (4) and (5) and 129(4) of the Medicines Act 19681 and now vested in them2 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, interpretation and commencement1

This Order, which may be cited as the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Amendment Order 1987, amends the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Order 19833 (hereinafter referred to as “the principal Order”) and shall come into force on 30th April 1987.

Amendment of articles 1, 6 and 12 of the principal Order2

1

In article 1(2) of the principal Order (interpretation) for the definition of “the Misuse of Drugs Regulations” there is substituted the following definition:

  • “the Misuse of Drugs Regulations” means, in relation to England, Wales and Scotland, the Misuse of Drugs Regulations 19854 and, in relation to Northern Ireland, the Misuse of Drugs (Northern Ireland) Regulations 19865;

2

In article 6(2)(d), (4)(c) and (5) of the principal Order (which refers to emergency sale or supply by a retail pharmacist) and in article 12(2)(b) of the principal Order (conditions relating to prescriptions), for the words, “Schedule 2, 3 or 4 to the Misuse of Drugs Regulations” there are substituted the words, “Schedule 1, 2 or 3 to the Misuse of Drugs Regulations”.

Amendment of articles 3 and 4 of, and Schedule 1 to, the principal Order3

1

In article 3(1)(a) of the principal Order (medicinal products on prescription only), after the words “subject to article 4(1)” there are inserted the words “and (1A), and Part IV of Schedule 1”.

2

In article 4 of the principal Order (medicinal products that are not prescription only), after paragraph (1) there is inserted the following paragraph—

1A

Notwithstanding article 3(1)(a), medicinal products specified in Part IV of Schedule 1 shall not be prescription only medicines.

3

In Part I of Schedule 1 to the principal Order (which lists substances which render a medicinal product a prescription only medicine except in circumstances also listed)—

a

there are inserted in column 1, at the appropriate point in the alphabetical order of the substances listed, the substances specified in column 1 of Schedule 1 to this Order and in columns 2 and 3, so as to appear against the particular substance to which it relates, there is inserted as the case may be any entry appearing in columns 2 and 3 of Schedule 1 to this Order against that substance;

b

there are deleted from column 1 the substances specified in Schedule 2 to this Order;

c

for the entry in columns 2 and 3 relating to the substance Podophyllum Resin listed in column 1 there is substituted the entry relating to that substance set out in columns 2 and 3 of Schedule 3 to this Order;

d

i

in the footnote to the column 4 entries relating to the substances Atropine, Atropine Methobromide, Atropine Methonitrate, Atropine Oxide Hydrochloride, Atropine Sulphate, Hyoscine Butylbromide, Hyoscine Hydrobromide, Hyoscine Methobromide, Hyoscine Methonitrate, Hyoscyamine, Hyoscyamine Hydrobromide and Hyoscyamine Sulphate, after the words, “Subject to” there are inserted the words, “paragraph 1 of”; and

ii

in column 2 opposite each of the substances Sodium Fluoride, Sodium Monofluorophosphate and Stannous Fluoride there is inserted “(b)” and at the foot of each page where such an insertion is made there are inserted the words, “(b) Subject to paragraph 2 of the note at the end of Part I of Schedule 1.”; and

iii

after the word “Note:” where it appears at the end of that Part there is inserted the number “1.” and after the entry for the Note numbered 1. there is inserted the following new paragraph:

2

In relation to a medicinal product which contains more than one of the substances Sodium Fluoride, Sodium Monofluorophosphate and Stannous Fluoride combined in a dentifrice, the maximum strength of the combination for the purposes of column 2 shall not exceed 0.15 per cent calculated as Fluorine.

4

In Part III of Schedule 1 to the principal Order (medicinal products, specified by name and product licence number, which are prescription only medicines) there is deleted the entry “Debrisan 0009/0021”.

5

After Part III of Schedule 1 to the principal Order there is added Part IV as set out in Schedule 4 to this Order.

Amendment of Schedule 2 to the principal Order4

From Schedule 2 to the principal Order (substances not to be contained in a prescription only medicine sold or supplied under the exemption conferred by article 6(3) of the principal Order), there are deleted the substances Phentermine Hydrochloride and Phentermine Resin Complex.

Signed by authority of the Secretary of State for Social Services.

Tony NewtonMinister of State,Department of Health and Social Security
Nicholas EdwardsSecretary of State for Wales
Malcolm RifkindSecretary of State for Scotland

In witness whereof the official seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 1st April 1987.

Michael JoplingMinister of Agriculture, Fisheries and Food

Sealed with the official seal of the Department of Health and Social Services for Northern Ireland this 3rd day of April 1987.

Maurice N. HayesPermanent Secretary

Sealed with the official seal of the Department of Agriculture for Northern Ireland this 6th day of April 1987.

W. H. JackPermanent Secretary

SCHEDULE 1ENTRIES INSERTED IN PART I OF SCHEDULE 1 TO THE PRINCIPAL ORDER6

Article 3(3)(a)

CIRCUMSTANCES EXCLUDING MEDICINAL PRODUCTS FROM THE CLASS OF PRESCRIPTION ONLY MEDICINES

Column 1

Column 2

Column 3

Column 4

Substance

Maximum strength

Use, pharmaceutical form or route of administration

Maximum dose and maximum daily dose

Amsacrine

Betamethasone Dipropionate

Bromperidol

Ceftazidime

Ceftizoxime Sodium

Dipivefrin Hydrochloride

Enalapril Maleate

Epirubicin

Fluvoxamine Maleate

Gemfibrozil

Iohexol

Lachesine Chloride

Lithium Citrate

Lofepramine Hydrochloride

Meglumine Ioxaglate

Metronidazole Benzoate

Minoxidil

Mitozantrone Hydrochloride

Nicergoline

Plicamycin

Saralasin Acetate

Sulconazole Nitrate

External (except vaginal use)

Suprofen

Tetroxoprim

Tioconazole

2.0 per cent

External (except vaginal use)

Tobramycin

Vecuronium Bromide

SCHEDULE 2SUBSTANCES DELETED FROM PART I OF SCHEDULE 1 TO THE PRINCIPAL ORDER

Article 3(3)(b)

  • Alprazolam

  • Bromazepam

  • Chlordiazepoxide

  • Clobazam

  • Clonazepam

  • Dextropropoxyphene Hydrochloride

  • Dextropropoxyphene Napsylate

  • Diazepam

  • Ethchlorvynol

  • Flunitrazepam

  • Flurazepam Hydrochloride

  • Flurazepam Monohydrochloride

  • Glutethimide

  • Ketazolam

  • Loprazolam Mesylate

  • Lorazepam

  • Lormetazepam

  • Mazindol

  • Medazepam

  • Meprobamate

  • Methyprylone

  • Mithramycin

  • Nitrazepam

  • Oxazepam

  • Pentazocine Hydrochloride

  • Pentazocine Lactate

  • Phentermine Hydrochloride

  • Phentermine Resin Complex

  • Prazepam

  • Sutoprofen

  • Temazepam

  • Triazolam

SCHEDULE 3ENTRY SUBSTITUTED IN COLUMNS 2 AND 3 OF PART I OF SCHEDULE 1 TO THE PRINCIPAL ORDER7

Article 3(3)(c)

CIRCUMSTANCES EXCLUDING MEDICINAL PRODUCTS FROM THE CLASS OF PRESCRIPTION ONLY MEDICINES

Column 1

Column 2

Column 3

Column 4

Substance

Maximum strength

Use, pharmaceutical form or route of administration

Maximum dose and maximum daily dose

Podophyllum Resin

2.0 per cent

External: ointment or impregnated plaster

SCHEDULE 4ADDITION OF PART IV OF SCHEDULE 1 TO THE PRINCIPAL ORDER

Article 3(5)

PART IVname and product licence number of medicinal products that are not prescription only medicines

  • Anflam Cream 0142/0190

  • Anflam Ointment 0142/0191

  • Beechams Hydrocortisone Cream 0079/0203

  • Cortaid Cream 1% 0032/0126

  • Cortaid Ointment 1% 0032/0127

  • Corteze Cream 0001/0107

  • Cortiderm 2855/0010

  • Cortovate Hydrocortisone Cream 1% 0039/0198

  • Cortril Topical Ointment 1% (non-greasy) 0057/0251

  • CP Hydrocortisone Cream 0.5% 4543/0238

  • CP Hydrocortisone Cream 1% 4543/0239

  • CP Hydrocortisone Ointment 0.5% 4543/0236

  • CP Hydrocortisone Ointment 1% 4543/0237

  • Dermacort Hydrocortisone Cream 0129/0076

  • Efcortelan P Cream 1% 0004/0327

  • Efcortelan P Ointment 1% 0004/0326

  • Femafen 0188/0071

  • Hc45 Hydrocortisone Cream 0327/0039

  • Kerfoot Hydrocortisone Cream 1% 0058/0092

  • Lanacort Cream 3157/0008

  • Lanacort Ointment 3157/0011

  • Medicort Cream 3920/0010

  • Oriel Capsules 0073/0023

  • Pharmacort Cream 0.5% 0011/0077

  • Proflex Sustained Relief Capsules 0001/0109

  • Suspren 0188/0072

  • Timocort Hydrocortisone Cream 0044/0090

  • Wasp-Eze Hydrocortisone Cream 0232/0058

  • Wasp-Eze Hydrocortisone Ointment 0232/0059

  • Zenoxone Cream 0181/0033

  • Zenoxone Ointment 0181/0032

(This note is not part of the Order)

This Order further amends the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Order 1983 (the principal Order) which specifies descriptions and classes of prescription only medicines, that is to say 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.

The amendments made by this Order are as follows:

Article 2 amends the definition of the “Misuse of Drugs Regulations” in the principal Order and makes consequential amendments to the references to those Regulations in articles 6 and 12 of the principal Order.

Article 3 amends articles 3 and 4 of, and Schedule 1 to, the principal Order.

Article 3(1) and (2) makes provision whereby certain topical Hydrocortisone preparations and certain sustained release preparations of Ibuprofen shall not be prescription only medicines notwithstanding that they would otherwise be so by reason that they consist of or contain a substance specified in Part I of Schedule 1 to the principal Order. Such products are specified by name and product licence number in a new Part IV of Schedule 1 to the principal Order which is added by Article 3(5) of this Order.

Article 3(3) amends Part I of Schedule 1 to the principal Order. Article 3(3)(a) adds to the list of prescription only medicines those substances which are set out in Schedule 1 to this Order. Article 3(3)(b) deletes from that list those substances which are set out in Schedule 2 to this Order although such substances remain subject to the provisions of the principal Order by reason either of their being controlled drugs or because they have been relisted in Part I of Schedule 1 to the principal Order under a new approved name. Article 3(3)(c) substitutes a new entry in the list relating to the substance Podophyllum Resin. Article 3(3)(d) makes provision for the circumstances in which a medicinal product containing more than one of the substances Sodium Fluoride, Sodium Monofluorophosphate and Stannous Fluoride combined in a dentifrice shall be a prescription only medicine.

Article 3(4) amends Part III of Schedule 1 to the principal Order (medicinal products, specified by name and product licence number, which are prescription only medicines) by deletion of the entry “Debrisan 0009/0021”.

Article 4 amends Schedule 2 to the principal Order (substances not to be contained in a prescription only medicine sold or supplied under the exemption conferred by article 6(3) of the principal Order, which relates to emergency sale or supply by a retail pharmacist), by deleting certain substances which nonetheless remain excluded from the exemption conferred by article 6(3) by reason of their being controlled drugs.