21 U.S. Code § 360eee–2 - National standards for prescription drug wholesale distributors
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(a) In general
For 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:
(3) The furnishing of a bond or other equivalent means of security, as follows:
(i) For the issuance or renewal of a wholesale distributor license, an applicant that is not a government owned and operated wholesale distributor shall submit a surety bond of $100,000 or other equivalent means of security acceptable to the State.
(4) Mandatory background checks and fingerprinting of facility managers or designated representatives.
(6) The mandatory physical inspection of any facility to be used in wholesale distribution within a reasonable time frame from the initial application of the facility and to be conducted by the licensing authority or by the State, consistent with subsection (c).
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.
(d) Prohibited persons
The standards established under subsection (a) shall include requirements to prohibit a person from receiving or maintaining licensure for wholesale distribution if the person—
(1) has been convicted of any felony for conduct relating to wholesale distribution, any felony violation of subsection (i) or (k) ofsection 331 of this title, or any felony violation of section 1365 of title 18 relating to product tampering; or
The Secretary, in promulgating any regulation pursuant to this section, shall, notwithstanding section 553 of title 5—
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