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

(a) The Secretary must create licensing standards for prescription drug wholesale distributors within 2 years of November 27, 2013. These standards cover issuing, revoking, and renewing licenses. (b) These standards must be the same nationwide, covering both state and federal licenses. They must cover how drugs are stored and handled. They must require records of drug distribution. They must require a security bond, generally $100,000, or $25,000 for smaller wholesalers with yearly sales of $10 million or less. A bond from one state can satisfy another state's requirement. They must require background checks and fingerprinting for facility managers. They must set qualifications for key staff. They must require physical inspection of facilities within a reasonable time. And they must bar certain people from getting a license. (c) To meet the inspection requirement, the licensing authority may inspect the facility itself. Or it may accept an inspection done by the state where the facility is located. It may also accept one from an approved third-party inspection service. (d) A person is barred from getting a license if they have a felony conviction for wholesale distribution, certain felony drug violations, or product tampering. A person is also barred for a pattern of violations that seriously threatens human health or life. (e) When writing these regulations, the Secretary must skip the usual shortcut rulemaking process in section 553 of title 5. Instead, the Secretary must publish the proposed rule and allow at least 60 days for public comments. The final rule must take effect 2 years after it is published.

The record. According to the source credit, this section was added to the Federal Food, Drug, and Cosmetic Act (originally enacted June 25, 1938, ch. 675) by Public Law 113–54, title II, § 204(a)(5), on November 27, 2013, and is codified as section 583 of that Act. The source credit reflects only this single addition, with no subsequent amendments noted. Historical context. Public Law 113–54 is commonly known as the Drug Quality and Security Act of 2013. This law is generally understood to have been enacted in response to public health incidents involving contaminated and compounded drugs, as well as broader concerns about the integrity and traceability of the pharmaceutical supply chain. The Act's title II, sometimes referred to by the short title Drug Supply Chain Security Act, is commonly described as establishing a national system for tracing prescription drugs as they move through the supply chain and for licensing wholesale distributors and third-party logistics providers, in part to address inconsistencies among state licensing regimes and to reduce the risk of counterfeit or diverted drugs entering commerce. Beyond this general understanding of the enacting act's purpose, the record does not establish the specific legislative reasoning behind the particular standards set out in this section—such as the bonding amounts or background-check requirements. Any more detailed account of why Congress chose these specific provisions would go beyond what is documented here.