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UK to Pull Pseudoephedrine

ease pseudoephedrine-based products nor have the new immediate release phenylephrine-based products become popular as replacements for pseudoephedrine."

Despite this, Pfizer, Johnson & Johnson, Wyeth and GlaxoSmithKline now all offer phenylephrine-based cold and flu remedies in addition to their pseudoephedrine products in an effort to maintain an OTC presence.

The MHRA's favoured course of action, based on recommendations from the Commission on Human Medicines (CHM), is to change the legal status of pseudoephedrine-/ephedrine-containing products to prescription-only by the end of the year. The pack reduction would restrict the maximum pack size to 720mg pseudoephedrine/ephedrine (12 x 60mg tablets or 24 x 30mg in a combination pack or equivalent in other formulations).

The plans also recommend strategies to maintain consumer access to alternative OTC treatments, such as those containing phenylephrine.

The MHRA notes that some manufacturers will need to consider reformulation to expand their product offering in the face of the proposed regulations, but claims that "planned changes over a transition period would…enable costs to be minimised as companies adjust their manufacturing schedules to reduce stock of [OTC] pseudoephedrine/ephedrine products…in order to avoid wastage of stock."

The restriction in pack size, which would completely remove large packs from the market, would also require repackaging schemes on the part of manufacturers. However, the MHRA maintains that interim measures would be agreed between marketing authorisation holders and the agency so that disruption is minimised; for example, the use of adhesive over-labels so as to avoid destroying existing stock.

By implementing the proposed regulations, the UK would be following in the footsteps of several other countries that have already restricted the sale of drugs containing pseudoephedrine in the face of the growing methylamp
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