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ASHP Policy Position 0719

FDA AUTHORITY TO PROHIBIT REUSE OF BRAND NAMES

Status: Current

To advocate for Food and Drug Administration authority to prohibit reuse of brand names of prescription and nonprescription drugs when any active component of the product is changed or after any other changes are made in the product that may affect its safe use. 

This policy was reviewed in 2022 by the Council on Public Policy and was found to still be appropriate.

This policy position supersedes ASHP policy position 0613.

Rationale

To avoid patient safety risks and provider error, FDA should not reuse brand names for drugs. In particular, recent examples of the reuse of product names or minor changes to product names in the nonprescription category (e.g., Zantac 360, Dramamine Drug-Free) have resulted in patient and provider confusion.