To satisfy the inspection requirement under subsection (b)(6), the Federal or State licensing authority may conduct the inspection or may accept an inspection by the State in which the facility is located, or by a third-party accreditation or inspection service approved by the Secretary or the State licensing such wholesale distributor.
21 U.S. Code § 360eee–2 - National standards for prescription drug wholesale distributors
(a) In general
(b) ContentFor the purpose of ensuring uniformity with respect to standards set forth in this section, the standards established under subsection (a) shall apply to all State and Federal licenses described under section 353(e)(1) of this title and shall include standards for the following:
The storage and handling of prescription drugs, including facility requirements.
(3) The furnishing of a bond or other equivalent means of security, as follows:
For purposes of clause (i), the State or other applicable authority may accept a surety bond in the amount of $25,000 if the annual gross receipts of the previous tax year for the wholesaler is $10,000,000 or less.
Mandatory background checks and fingerprinting of facility managers or designated representatives.
(d) Prohibited personsThe standards established under subsection (a) shall include requirements to prohibit a person from receiving or maintaining licensure for wholesale distribution if the person—
has engaged in a pattern of violating the requirements of this section, or State requirements for licensure, that presents a threat of serious adverse health consequences or death to humans.
(e) RequirementsThe Secretary, in promulgating any regulation pursuant to this section, shall, notwithstanding section 553 of title 5—
The following state regulations pages link to this page.