21 C.F.R. § 516.12

Purpose.

Last amended: 2016Year: 2026Length: 32 wordsOfficial source

Cite as 21 C.F.R. § 516.12 (2026)

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.
21 C.F.R. § 516.12: Purpose. | Justis AI