The Pharmaceutical Journal
Vol 279 No 7467 p221
1 September 2007

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Pseudoephedrine products remain OTC, but with new pack size limits

Products containing pseudoephedrine and ephedrine will remain available over the counter, the Medicines and Healthcare products Regulatory Agency has decided. However, pack sizes will be restricted to 720mg and sales limited to one pack per customer, to be carried out by a pharmacist.

The recommendations come in response to a public consultation which the MHRA launched because of concerns over the potential use of decongestant products containing pseudoephedrine and ephedrine in the illegal manufacture of methylamphetamine (crystal meth).

The MHRA says that unless the risk of misuse of these products is contained by these new measures, their legal status should be changed in 2009 from pharmacy-only to prescription-only medicines.

In a joint statement from the Royal Pharmaceutical Society, the National Pharmacy Association, the Company Chemists’ Association and the Association of Independent Multiple Pharmacies, the announcement was welcomed as an opportunity for pharmacy to demonstrate it can confidently manage supply of these products.

“Allowing pharmacists and support staff to continue to manage the supply of pseudo-ephedrine- and ephedrine-containing medicines is good news for consumers and provides a clear signal of faith in the pharmacy profession.”

The Society says it will be giving urgent consideration to the issue of personal sales by a pharmacist. It also plans to liaise with other national pharmacy bodies to consider pharmacy recording of sales and a requirement for customer identity to be checked.

Colette McCreedy, director of pharmacy practice at the NPA, commented: “I think this is an example of how effective pharmacy bodies and industry can be when we work together. We have spoken with one determined voice, with a real strength of feeling and the case we made was compelling.”

Sheila Kelly, executive director of the Proprietary Association of Great Britain, said she has no doubt that the co-ordinated work by pharmacy bodies and industry had made the difference to the MHRA’s thinking.

“Although the Commission on Human Medicines has said its preferred option was to reclassify these products as prescription-only medicines, we had always treated the situation as if all the options were still on the table,” she said.