Pharmacists Ask FDA For Biosimilar Substitution Power

Law360, Washington (June 1, 2012, 4:56 PM EDT) -- Three pharmacy trade groups pushed the U.S. Food and Drug Administration to allow pharmacists to substitute biosimilars for their biologic counterparts without physician approval, saying substitution standards don't need another step before patients receive medication, in a letter made public Thursday.

The letter, signed by the American Pharmacists Association, National Association of Chain Drug Stores and National Community Pharmacists Association, requested additional guidance on the agency's standards for substituting the drugs, saying pharmacists need more information, but shouldn't require physician oversight when dispensing drugs to patients....
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