Iowa Admin. Code r. 657-17.7

Current through Register Vol. 47, No. 5, September 4, 2024

Rule 657-17.7 - Compliance with federal and state laws

A wholesale distributor is responsible for complying with all applicable federal and state laws, including those not specifically identified in this chapter.

(1) A licensed wholesale distributor shall meet the requirements set forth in the Drug Supply Chain Security Act, including but not limited to:

a.21 U.S.C. § 360ee e-1, relating to product tracing, product identifiers, authorized trading partners, suspect products, and illegitimate products;

b.21 U.S.C. § 360ee e-2, relating to national standards for drug wholesale distributors; and

c. Any regulations promulgated thereunder.

(2) A licensed wholesale distributor shall permit agents of the board to enter and inspect the facility for compliance with federal and state laws. A licensed wholesale distributor shall cooperate with other regulatory or law enforcement officials with jurisdiction over the facility.

Iowa Admin. Code r. 657-17.7

Amended by IAB December 19, 2018/Volume XLI, Number 13, effective 1/23/2019