FDA limits the distribution of certain cough medicines

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BANGKOK, 10 July 2012  – The Food and Drug Administration (FDA) has reported on the progress of its recently issued restriction on the sale of cough medicine containing Diphenhydramine, Promethazine, and Dextromethorphan.

In light of recent reports on cough syrup abuse, the FDA has placed restrictions on the supply and distribution of over-the-counter cough syrups containing the three active ingredients. No more than 300 bottles of such cough syrups are to be distributed to each pharmacy per month and only 3 bottles can be sold at a time to each buyer.

Following the announcement, the agency dispatched mobile inspection units to the Southern region, where a widespread misuse of cough medicine was reported. The mobile teams found that a number of pharmacies in the area have repeatedly sold the cough medicine over the legal limit and have often prescribed off-label drugs to customers.

The FDA has instructed the provincial health offices to revoke the offending pharmacies’ licenses, to regulate against the dispensing of a large amount of cough syrups while no pharmacist is on duty, and to promote the use of medical inventory.

The FDA has also urged all pharmacies in the South to exercise additional caution when prescribing medicines containing Diphenhydramine, Promethazine, and Dextromethorphan due to potential health risks associated with the use of these medication.

Any violations of the FDA’s restrictions by medical personnel are punishable by law and will be forwarded to the Pharmacy Council for further review.