Prominence of Name of Distributor of Biological Products

Resumo

The Food and Drug Administration (FDA) is amending the labeling regulations for biological products to remove the requirement that the manufacturer's name be more prominent than that of the distributor and to permit the names of distributors to be prominently displayed on biological product container labels, package labels, and labeling. This change in labeling requirements is intended to facilitate flexible manufacturing, packaging, distribution, and labeling arrangements, and to harmonize labeling regulations applicable to biologic products licensed under the Public Health Service Act (the PHS Act) with the corresponding labeling regulations for drugs approved under the Federal Food, Drug, and Cosmetic Act (the act).