Under FDCA labeling laws, what must appear on a drug label?

Under FDCA labeling laws, what must appear on a drug label?

• A. The drug's active ingredient
• B. The expiration date
• C. The name of the manufacturer and any address associated with the company
• D. The country of origin

Answer: (C)

Labels must include the name and address of the manufacturer, packer, or distributor. This requirement from FDCA labeling laws ensures clear identification of the product’s source and provides a direct contact point for accountability, safety communications, and recalls. While other details like expiration date or country of origin are important in many contexts, the explicit FDCA requirement being tested is the presence of the manufacturer's name and address on the label.

Labels must include the name and address of the manufacturer, packer, or distributor. This requirement from FDCA labeling laws ensures clear identification of the product’s source and provides a direct contact point for accountability, safety communications, and recalls. While other details like expiration date or country of origin are important in many contexts, the explicit FDCA requirement being tested is the presence of the manufacturer's name and address on the label.