21 U.S. Code § 360eee–2 - National standards for prescription drug wholesale distributors

(a) In general

The Secretary shall, not later than 2 years after November 27, 2013, establish by regulation standards for the licensing of persons under section 353(e)(1) of this title, including the revocation, reissuance, and renewal of such license.

(b) Content

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:

(1) The storage and handling of prescription drugs, including facility requirements.

(2) The establishment and maintenance of records of the distributions of such drugs.

(3) The furnishing of a bond or other equivalent means of security, as follows:

(A)

(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.

(ii) 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.

(B) If a wholesale distributor can provide evidence that it possesses the required bond in a State, the requirement for a bond in another State shall be waived.

(4) Mandatory background checks and fingerprinting of facility managers or designated representatives.

(5) The establishment and implementation of qualifications for key personnel.

(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).

(7) In accordance with subsection (d), the prohibition of certain persons from receiving or maintaining licensure for wholesale distribution.

(c) Inspections

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) of section 331 of this title, or any felony violation of section 1365 of title 18 relating to product tampering; or

(2) 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) Requirements

The Secretary, in promulgating any regulation pursuant to this section, shall, notwithstanding section 553 of title 5—

(1) issue a notice of proposed rulemaking that includes a copy of the proposed regulation;

(2) provide a period of not less than 60 days for comments on the proposed regulation; and

(3) provide that the final regulation take effect on the date that is 2 years after the date such final regulation is published.

(June 25, 1938, ch. 675, § 583, as added Pub. L. 113–54, title II, § 204(a)(5), Nov. 27, 2013, 127 Stat. 634.)

Statutory Notes and Related Subsidiaries

Effective Date

Section effective Jan. 1, 2015, see section 204(c) of Pub. L. 113–54, set out as an Effective Date of 2013 Amendment note under section 353 of this title.