§ 9211 Biologics Production Compliance

• •You can't make biologics (like vaccines or medical treatments from living things) unless the federal government says it's okay.
• •This law makes sure only approved people or companies make these special medicines.
• •If you try to make biologics without permission, you're breaking the law.

A small lab starts making and selling their own version of a flu vaccine without asking the government first.

This is against the law because they didn’t get permission from the federal government to make the vaccine. They could get in big trouble for doing this.