Medicines, Ethics and Practice: a guide for pharmacists

September 2003 amendments

In the first issue of each month The Journal updates the guidance on the legal status of medicines published in the 27th (July 2003) edition of 'Medicines, ethics and practice: A guide for pharmacists'.

The amendments are given in bold type when added to the list and repeated each month in light type. A product's legal status can be obtained by consulting first the latest amendment list and then the guide. The abbreviations used in the list are explained in the key to annotations in the body of the guide (p27 and p73).

Human medicines

Users of the guide should note that changes to the reclassification procedure for medicines mean that the legal status of a product now becomes part of its marketing authorisation rather than being determined by the active substance listed in secondary legislation. Because a change of legal status will be conferred only on products that are the subject of an application for reclassification, users of the guide should refer to the entry for the specific proprietary product and not rely only on the entry for the active substance. Since the POM Order remains in force, entries for active substances will remain in the guidance but will include cross references wherever proprietary products have been reclassified.

Further guidance or clarification on the status of individual products can be obtained from manufacturers or from the Medicines and Healthcare products Regulatory Agency (tel 020 7273 0523; e-mail info@mhra.gsi.gov.uk).

Alka Rapid crystals GSL

Alomide Allergy ophthalmic solution P

Anthisan Bite and Sting cream GSL

Anthisan Plus spray entry should read: Anthisan Plus spray GSL

4-Androstene-3,17-dione CD anab POM 5-Androstene-3,17-diol CD anab POM

Beclometasone/ Beclomethasone dipropionate entry — replace “P” at end of entry with “please refer to proprietary names for classification granted under the marketing authorisation (see Beconase products)

Beconase Allergy nasal spray entry should read: Beconase Allergy nasal spray P

Beconase Hayfever nasal spray entry should read: Beconase Hayfever nasal spray GSL

Canesten AF Once Daily P

Canesten Complete P

Dihydroetorpine CD POM

FemTab POM

FemTab Sequi POM

FemTab Continuous POM

Fuzeon injection POM

Gammahydroxy-butyrate [GHB] CD benz POM

4-Hydroxy-n-butyric acid CD benz POM

Ketoconazole entry — replace “P” at end of entry with “please refer to proprietary names for classification granted under the marketing authorisation (see Nizoral products)

Metvix cream POM

Minoxidil entry — delete first “P” and replace “P” at end of entry with “please refer to proprietary names for classification granted under the marketing authorisation (see Regaine products)

Modisal preparations entry should read: Modisal XL tablets P

Monit tablets entry should read: Monit tablets P

Monit SR tablets entry should read: Monit SR tablets P

Monit XL tablets P

Motilium preparations entry should read: Motilium suppositories POM

Motilium suspension POM

Motilium tablets POM

Motilium 10 tablets P

Nicotinell TTS entry should read: Nicotinell TTS GSL

Nizoral (Johnson & Johnson MSD) Anti Dandruff shampoo GSL

19-Nor-4-androstene-3,17-dione CD anab POM

19-Nor-5-androstene-3,17-diol CD anab POM

Olmetec tablets POM

Regaine topical solution entry should read: Regaine Regular Strength topical solution GSL

Remifentanil CD POM

Salicylic acid entry — delete maximum strengths in sections 2 (corn plasters) and 10 (wart plasters)

Stilnoct tablets entry should read: Stilnoct tablets CD benz POM

Testogel gel CD anab POM

Ultiva injection entry should read: Ultiva injection CD POM

Zolpidem tartrate entry should read: Zolpidem tartrate CD benz POM