§ 111460 Export Drug Device Labeling

• •Drugs or medical devices made for export (selling to other countries) won’t be called 'misbranded' if they follow these rules.
• •They must match exactly what the foreign buyer asked for.
• •They must follow the laws of the country they’re being sent to.
• •The shipping box must clearly say it’s for export only.
• •If the same product is sold inside the U.S., these rules don’t apply—it must follow all U.S. labeling laws.

A U.S. company makes painkillers to sell to Canada.

The pills must match Canada’s order, follow Canada’s laws, and the shipping box must say 'For Export to Canada.' If the company tries to sell these same pills in a U.S. store, they must follow all U.S. labeling rules or they’ll be in trouble.