Prominence of Name of Distributor of Biological Products

Samenvatting

The Food and Drug Administration (FDA) is proposing to amend the labeling regulations to remove the requirement that the manufacturer's name be more prominent than the distributor and to permit the names of distributors to be prominently displayed on biological product container labels, package labels, and labeling. This proposed change in the 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 with the corresponding labeling regulations applicable to drugs approved under the Federal Food Drug and Cosmetic Act (the act). FDA is considering further revisions to the labeling requirements.