U.S. FDA May Relieve Rules For Prescription-Drug

FDAWashington: The FDA may set up a “behind the counter” system letting more drugs, which presently need a recommendation to be sold without one.

In a perceive set to be released in today’s Federal Register, the agency declared a Nov. 14 hearing to explore "the public health benefit of drugs being available without a prescription but only after intervention by a pharmacist."

Such involvement could need a pharmacist to ensure a patient fulfills certain measures to obtain a particular drug and to teach the patient how to accurately use it.

Presently, the majority of drugs are sold either with a direction or otc in retail stores and drugstores. The group has carved out some elisions, comprising limiting distribution of Barr Pharmaceuticals Inc. "Plan B" emergency- birth control pill to pharmacies, which decided to keep it behind the counter and to require women to show a photo identification to confirm they are age 18 or older.

A few groups that have called for a behind-the-counter position for drugs have said it might permit certain drugs sold with a recommendation to be securely sold without one.

In 2005, an FDA board of outside medical specialists froze off a bid by Merck & Co. and Johnson & Johnson to sell Mevacor, a cholesterol-lowering drug, without a recommendation.

Various board members stated that the FDA should think setting up a behind-the-counter scheme, which would let users to buy Mevacor from chemists much like the British are permitted to pay for Merck's Zocor, another cholesterol-lowering drug. Most panel members said that, if such a system existed in the U.S., they would have voted to allow Mevacor to be sold without a prescription.

The FDA mentioned that other countries with behind-the-counter grade comprise Australia, Canada, New Zealand, Denmark, Germany, Italy, the Netherlands, Sweden and Switzerland.

Together with a Nov. 14 meeting to seek public comments on the issue, the FDA told that it is also looking for written or electronic comments on the issue until Nov. 28.

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