The Pharmaceutical Journal
Vol 280 No 7484 p10
5/12 January 2008

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New pseudoephedrine sales restrictions confirmed

Tightened restrictions on counter sales of products that contain pseudoephedrine or ephedrine have been confirmed by the Medicines and Healthcare products Regulatory Agency.

From 1 April 2008, all packs of products that contain more than 720mg of pseudo-ephedrine or 180mg of ephedrine will be available only on prescription.

The change is being made because of reports that over-the-counter medicines containing these ingredients are being used as source materials for the illicit manufacture of methylamphetamine. This is now believed to have happened on four occasions in the UK.

The Commission on Human Medicines has also advised that the change should be accompanied by a sales restriction for the smaller packs of one pack per customer and that professional guidance should be produced about what constitutes a transaction.

An MHRA statement warned: “It is in the best interests of the pharmacy profession to ensure the controls are effective — any reduction in the level of control could potentially result in the reclassification of these medicines to prescription only.”

Rob Darracott, chief executive of the Company Chemists Association, said: “The decision to reclassify large packs of pseudoephedrine and ephedrine is a blow to pharmacy.

“When we lobbied effectively with the industry last year to retain these ingredients as P medicines, the introduction of smaller pack sizes was part of the package. But we had argued that with awareness of the issue, there was no need to legislate to make the supply of more than 720mg illegal. This was one pharmacy could manage.”

He conceded that the facts speak for themselves. “Four illicit labs have been found; and there is evidence that OTC medicines fuelled them. Pharmacy has nowhere to hide.”