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Drug Product Formulation Changes (Resolution No. 97-05-01)
Resolution No. 97-05-01
Title: Drug Product Formulation Changes
Action: Passed
Whereas, the Food and Drug Administration (FDA) regulates the manufacture of drugs and the boards of pharmacy regulate the practice of pharmacy; and
Whereas, the boards of pharmacy are dedicated to the elimination of medication errors; and
Whereas, the regulations addressing changes in formulation for drug products allow products with different active ingredients to retain the same brand name; and
Whereas, this situation could result in medication errors and threaten the health of patients;
THEREFORE BE IT RESOLVED that NABP work with the Food and Drug Administration (FDA), the Pharmaceutical Research and Manufacturers of America (PhRMA), the Consumer Healthcare Products Association (CHPA), and the US Pharmacopeia (USP) to prevent the practice of using the same brand name for products in which the active ingredient(s) was changed unless a notice is provided from the manufacturer directly to the patient that the formulation has been altered.
(Resolution passed at NABP’s 97th Annual Meeting, Seattle, WA)
