U.S. Code
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Title 21
» Chapter CHAPTER 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter SUBCHAPTER V— DRUGS AND DEVICES › Part Part A— Drugs and Devices
21 U.S.C. § 356e
Drug shortage list
(a) EstablishmentThe Secretary shall maintain an up-to-date list of drugs that are determined by the Secretary to be in shortage in the United States.
(b) ContentsFor each drug on such list, the Secretary shall include the following information:(1) The name of the drug in shortage, including the National Drug Code number for such drug.(2) The name of each manufacturer of such drug.(3) The reason for the shortage, as determined by the Secretary, selecting from the following categories:(A) Requirements related to complying with good manufacturing practices.(B) Regulatory delay.(C) Shortage of an active ingredient.(D) Shortage of an inactive ingredient component.(E) Discontinuance of the manufacture of the drug.(F) Delay in shipping of the drug.(G) Demand increase for the drug.(4) The estimated duration of the shortage as determined by the Secretary.(c) Public availability(1) In generalSubject to paragraphs (2) and (3), the Secretary shall make the information in such list publicly available.
(2) Trade secrets and confidential informationNothing in this section alters or amends section 1905 of title 18 or section 552(b)(4) of title 5.
(3) Public health exceptionThe Secretary may choose not to make information collected under this section publicly available under paragraph (1) or section 356c(c) of this title if the Secretary determines that disclosure of such information would adversely affect the public health (such as by increasing the possibility of hoarding or other disruption of the availability of drug products to patients).
(d) Interagency notificationNot later than 180 days after March 27, 2020, and every 90 days thereafter, the Secretary shall transmit a report regarding the drugs of the current drug shortage list under this section to the Administrator of the Centers for Medicare & Medicaid Services.
(June 25, 1938, ch. 675, § 506E, as added Pub. L. 112–144, title X, § 1004, July 9, 2012, 126 Stat. 1104; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(G), Dec. 13, 2016, 130 Stat. 1153; Pub. L. 116–136, div. A, title III, § 3112(c), Mar. 27, 2020, 134 Stat. 362.)Editorial NotesAmendments2020—Subsec. (d). Pub. L. 116–136 added subsec. (d).
2016—Subsec. (b)(3)(E). Pub. L. 114–255, which directed substitution of “discontinuance” for “discontinuation”, was executed by substituting “Discontinuance” for “Discontinuation” to reflect the probable intent of Congress.
Statutory Notes and Related SubsidiariesEffective Date of 2020 AmendmentAmendment by Pub. L. 116–136 effective 180 days after Mar. 27, 2020, see section 3112(g) of Pub. L. 116–136, set out as a note under section 356c of this title.
Notes of Decisions
Athenex Pharma Solutions, LLC v. Azar, II (D.D.C. 2019).
“The drug shortage list predates the DQSA, and its requirements are codified in 21 U.S.C. § 356e. That provision directs the Secretary to maintain a list of drugs that are in short supply in the United States for various listed reasons, including regulatory delay, shortage of an…”
Novo Nordisk Inc. v. Brooksville Pharm. Inc. (M.D. Fla. 2025).
“168-2 ¶ 13; see 21 U.S.C. § 356e(a). Because Ozempic and Wegovy were on the FDA’s drug “shortage list,” the FDA did not consider these drugs to be “commercially available,” and therefore, the limitations on compounding “inordinate amounts” of “essentially copies of a…”
— 21 U.S.C. § 356e(a) — 1 case
Novo Nordisk Inc. v. Brooksville Pharm. Inc. (M.D. Fla. 2025).
“168-2 ¶ 13; see 21 U.S.C. § 356e(a). Because Ozempic and Wegovy were on the FDA’s drug “shortage list,” the FDA did not consider these drugs to be “commercially available,” and therefore, the limitations on compounding “inordinate amounts” of “essentially copies of a…”
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