21 CFR 516.12

§ 516.12 Purpose.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 516.12, § 516.12 Purpose, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86998
Permanent ID: ys:prov:86998@1
SHA-256: c4956a1de64e002a484b528225b9fb0737b2abc3c447aa421e69372c1891ccd4

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Full text

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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.