high managerial agent

Defined in 1 place of the United States Code.

For purposes of section 335a of this title, the term "high managerial agent"—

Source

1994–2023 21 U.S.C. § 321Food and Drugs · Definitions; generally · for the purposes of this chapter

For purposes of section 335a of this title, the term “high managerial agent”—

(1) means—

(A) an officer or director of a corporation or an association,

(B) a partner of a partnership, or

(C) any employee or other agent of a corporation, association, or partnership,

(2) includes persons having management responsibility for—

(A) submissions to the Food and Drug Administration regarding the development or approval of any drug product,

(B) production, quality assurance, or quality control of any drug product, or

(C) research and development of any drug product.

Source

2013–present 21 U.S.C. § 321Food and Drugs · Definitions; generally · for the purposes of this chapter