Regulations last checked for updates: Feb 16, 2025

Title 21 - Food and Drugs last revised: Feb 03, 2025
§ 516.12 - Purpose.

This subpart establishes standards and procedures for determining eligibility for designation and the associated incentives and benefits described in section 573 of the act, including a 7-year period of exclusive marketing rights.

source: 72 FR 41017, July 26, 2007, unless otherwise noted.
cite as: 21 CFR 516.12