Pharmacies May Tread On FDA Turf With HRTs

Law360 (January 9, 2008, 12:00 AM EST) -- Warning letters recently sent by the Food and Drug Administration to pharmacies, alleging they made misleading claims about their bioidentical hormone replacement therapies, have set off a debate concerning where the FDA's authority ends and whether compounding pharmacies should be more closely regulated.

Compounding pharmacies have traditionally tweaked and altered prescription drugs for patients who, for instance, are allergic to certain substances. But as these pharmacies started altering hormone replacement therapies, substituting synthetic FDA-approved hormones with the unapproved hormone estriol, opponents cried out for more regulation....
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