§356e. Drug shortage list — Inbound Citations

Citations to 21 U.S.C. § 356e as a whole

• 21 U.S.C. § 353b(a)(2)(A)(ii)

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  (ii) the drug compounded from such bulk drug substance appears on the drug shortage list in effect under section 356e of this title at the time of compounding, distribution, and dispensing;
• 21 U.S.C. § 353b(b)(1)(A)(ii)

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  (ii) shall indicate whether the outsourcing facility intends to compound a drug that appears on the list in effect under section 356e of this title during the subsequent calendar year.
• 21 U.S.C. § 353b(b)(4)(C)(v)

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  (v) Whether the outsourcing facility has registered under this paragraph as an entity that intends to compound a drug that appears on the list in effect under section 356e of this title.
• 21 U.S.C. § 353b(d)(2)(A)

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  (A) a drug that is identical or nearly identical to an approved drug, or a marketed drug not subject to section 353(b) of this title and not subject to approval in an application submitted under section 355 of this title, unless, in the case of an approved drug, the drug appears on the drug shortage list in effect under section 356e of this title at the time of compounding, distribution, and dispensing; or
• 21 U.S.C. § 355(j)(11)(A)(ii)

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  (ii) that has been included on the list under section 356e of this title.
• 21 U.S.C. § 355–2(a)(2)(B)

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  (B) does not include any drug or biological product that appears on the drug shortage list in effect under section 356e of this title, unless—

  (i) the drug or biological product has been on the drug shortage list in effect under such section 356e of this title continuously for more than 6 months; or

  (ii) the Secretary determines that inclusion of the drug or biological product as a covered product is likely to contribute to alleviating or preventing a shortage.
• 21 U.S.C. § 355–2(a)(2)(B)(i)

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  (i) the drug or biological product has been on the drug shortage list in effect under such section 356e of this title continuously for more than 6 months; or
• 21 U.S.C. § 356c(c)

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  (c) To the maximum extent practicable, the Secretary shall distribute, through such means as the Secretary deems appropriate, information on the discontinuance or interruption of the manufacture of the drugs described in subsection (a) to appropriate organizations, including physician, health provider, and patient organizations, as described in section 356e of this title.
• 21 U.S.C. § 356d(a)(1)(C)(i)(II)

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  (II) in examining the capability and capacity to supply products in shortage, the “qualified manufacturer” could have a site that manufactures a drug listed under section 356e of this title or have the capacity to produce drugs in response to a shortage within a rapid timeframe; and
• 21 U.S.C. § 356f(a)(3)(A)

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  (A) extend the supply of a drug in response to the placement of the drug on a drug shortage list under section 356e of this title; and
• 21 U.S.C. § 356f(b)(1)

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  (1) during any period in which the drug is listed on the drug shortage list under section 356e of this title; or
• 21 U.S.C. § 356l(b)(2)(B)

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  (B) a drug that is on the drug shortage list under section 356e of this title.
• 21 U.S.C. § 374(b)(2)

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  (2) In carrying out this subsection with respect to any establishment manufacturing a drug approved under subsection (c) or (j) of section 355 of this title for which a notification has been submitted in accordance with section 356c of this title is, or has been in the last 5 years, listed on the drug shortage list under section 356e of this title, or that is described in section 355(j)(11)(A) of this title, a copy of the report shall be sent promptly to the appropriate offices of the Food and Drug Administration with expertise regarding drug shortages.
• 21 U.S.C. § 381(d)(1)(B)

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  (B) Except as authorized by the Secretary in the case of a drug that appears on the drug shortage list under section 356e of this title or in the case of importation pursuant to section 384 of this title, no drug that is subject to section 353(b)(1) of this title may be imported into the United States for commercial use if such drug is manufactured outside the United States, unless the manufacturer has authorized the drug to be marketed in the United States and has caused the drug to be labeled to be marketed in the United States.
• 21 U.S.C. § 826(h)(2)(A)

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  (A) the request pertains to a controlled substance on the list of drugs in shortage maintained under section 356e of this title;
• 42 U.S.C. § 1395w–114b(b)(1)(C)(i)

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  (i) in the case of a part D rebatable drug that is described as currently in shortage on the shortage list in effect under section 356e of title 21 at any point during the applicable period;
• 42 U.S.C. § 1395w–3a(i)(3)(G)(i)

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  (i) in the case of a part B rebatable drug that is described as currently in shortage on the shortage list in effect under section 356e of title 21 at any point during the calendar quarter; or