21 U.S.C. § 356e — Drug shortage list

(a) The Secretary must keep an up-to-date list of drugs that the Secretary has decided are in shortage in the United States. (b) For each drug on the list, the Secretary must include several pieces of information. That includes the drug's name and its National Drug Code number, and the name of each company that makes it. It also includes the reason for the shortage, chosen from a set list. That list covers manufacturing-practice problems, regulatory delay, an ingredient shortage, stopped production, shipping delay, or higher demand. Finally, the Secretary must include how long the shortage is expected to last. (c) The Secretary must generally make this list public. This section does not change trade-secret or confidential-information laws found elsewhere. The Secretary may withhold information if releasing it would harm public health, such as by encouraging people to hoard the drug. (d) By September 23, 2020, and every 90 days after that, the Secretary must send a report on the current shortage list. That report goes to the head of the Centers for Medicare & Medicaid Services.

The record. The source credit indicates that this section derives from the Federal Food, Drug, and Cosmetic Act of June 25, 1938 (ch. 675), though the specific provision here—section 506E—was not part of the original 1938 enactment. It was added later by Public Law 112-144, title X, § 1004, enacted July 9, 2012. The section has since been amended twice: by Public Law 114-255 in December 2016, and by Public Law 116-136 in March 2020. The source credit does not elaborate on the substance of these amendments beyond citing their statutory location. Historical context. Public Law 112-144 is commonly known as the FDA Safety and Innovation Act of 2012. That act is generally understood to have addressed a period of increasing concern over drug shortages in the United States, particularly involving generic injectable and oncology drugs, and to have sought to improve transparency and early warning mechanisms for such shortages. The 2016 amendment corresponds to the 21st Century Cures Act, which made various technical and organizational changes to FDA-related provisions. The 2020 amendment falls within the CARES Act, enacted during the early response to the COVID-19 pandemic, a period marked by heightened attention to medical supply and drug shortages. Beyond this general background, the record does not establish the specific legislative reasoning behind the particular reporting and disclosure requirements set out in this section.