§356c. Discontinuance or interruption in the production of life-saving drugs — Inbound Citations

Code of Federal Regulations Citations

Cited by 2 regulations in the Code of Federal Regulations.

• 21 C.F.R. § 314.81(b)(3)(iii) — Other postmarketing reports.

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  (iii) (a) An applicant of a prescription drug product must notify FDA in writing of a permanent discontinuance of manufacture of the drug product or an interruption in manufacturing of the drug product that is likely to lead to a meaningful disruption in supply of that drug in the United States if:

  (1) The drug product is life supporting, life sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition, including any such drug used in emergency medical care or during surgery; and

  (2) The drug product is not a radiopharmaceutical drug product.

  (b) Notifications required by paragraph (b)(3)(iii)(a) of this section must be submitted to FDA electronically in a format that FDA can process, review, and archive:

  (1) At least 6 months prior to the date of the permanent discontinuance or interruption in manufacturing; or

  (2) If 6 months' advance notice is not possible because the permanent discontinuance or interruption in manufacturing was not reasonably anticipated 6 months in advance, as soon as practicable thereafter, but in no case later than 5 business days after the permanent discontinuance or interruption in manufacturing occurs.

  (c) Notifications required by paragraph (b)(3)(iii)(a) of this section must include the following information:

  (1) The name of the drug subject to the notification, including the NDC for such drug;

  (2) The name of the applicant;

  (3) Whether the notification relates to a permanent discontinuance of the drug or an interruption in manufacturing of the drug;

  (4) A description of the reason for the permanent discontinuance or interruption in manufacturing; and

  (5) The estimated duration of the interruption in manufacturing.

  (d)(1) FDA will maintain a publicly available list of drugs that are determined by FDA to be in shortage. This drug shortages list will include the following information:

  (i) The names and NDC(s) for such drugs;

  (ii) The name of each applicant for such drugs;

  (iii) The reason for the shortage, as determined by FDA from the following categories: Requirements related to complying with good manufacturing practices; regulatory delay; shortage of an active ingredient; shortage of an inactive ingredient component; discontinuation of the manufacture of the drug; delay in shipping of the drug; demand increase for the drug; or other reason; and

  (iv) The estimated duration of the shortage.

  (2) FDA may choose not to make information collected to implement this paragraph available on the drug shortages list or available under section 506C(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c(c)) if FDA 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 the drug to patients). FDA will also not provide information on the public drug shortages list or under section 506C(c) of the Federal Food, Drug, and Cosmetic Act that is protected by 18 U.S.C. 1905 or 5 U.S.C. 552(b)(4), including trade secrets and commercial or financial information that is considered confidential or privileged under § 20.61 of this chapter.

  (e) If an applicant fails to submit a notification as required under paragraph (b)(3)(iii)(a) of this section and in accordance with paragraph (b)(3)(iii)(b) of this section, FDA will issue a letter to the applicant informing it of such failure.

  (1) Not later than 30 calendar days after the issuance of such a letter, the applicant must submit to FDA a written response setting forth the basis for noncompliance and providing the required notification under paragraph (b)(3)(iii)(a) of this section and including the information required under paragraph (b)(3)(iii)(c) of this section; and

  (2) Not later than 45 calendar days after the issuance of a letter under paragraph (b)(3)(iii)(e) of this section, FDA will make the letter and the applicant's response to the letter public, unless, after review of the applicant's response, FDA determines that the applicant had a reasonable basis for not notifying FDA as required under paragraph (b)(3)(iii)(a) of this section.

  (f) The following definitions of terms apply to paragraph (b)(3)(iii) of this section:

  Drug shortage or shortage means a period of time when the demand or projected demand for the drug within the United States exceeds the supply of the drug.

  Intended for use in the prevention or treatment of a debilitating disease or condition means a drug product intended for use in the prevention or treatment of a disease or condition associated with mortality or morbidity that has a substantial impact on day-to-day functioning.

  Life supporting or life sustaining means a drug product that is essential to, or that yields information that is essential to, the restoration or continuation of a bodily function important to the continuation of human life.

  Meaningful disruption means a change in production that is reasonably likely to lead to a reduction in the supply of a drug by a manufacturer that is more than negligible and affects the ability of the manufacturer to fill orders or meet expected demand for its product, and does not include interruptions in manufacturing due to matters such as routine maintenance or insignificant changes in manufacturing so long as the manufacturer expects to resume operations in a short period of time.

• 21 C.F.R. § 600.82(d)(2) — Notification of a permanent discontinuance or an interruption in manufacturing.

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  (2) FDA may choose not to make information collected to implement this paragraph available on the biological product shortages list or available under section 506C(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c(c)) if FDA 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 the biological product to patients). FDA will also not provide information on the public shortages list or under section 506C(c) of the Federal Food, Drug, and Cosmetic Act that is protected by 18 U.S.C. 1905 or 5 U.S.C. 552(b)(4), including trade secrets and commercial or financial information that is considered confidential or privileged under § 20.61 of this chapter.

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

• 21 U.S.C. § 356c–1(c)

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  (c) In this section, the term “drug shortage” or “shortage” has the meaning given such term in section 356c 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.

Citations to §356c(a)

• 21 U.S.C. § 356c–1(a)(1)

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  (1) specifies the number of manufacturers that submitted a notification to the Secretary under section 356c(a) of this title during such calendar year;

• 21 U.S.C. § 356d(b)

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  (b) The Secretary shall ensure that, prior to any enforcement action or issuance of a warning letter that the Secretary determines could reasonably be anticipated to lead to a meaningful disruption in the supply in the United States of a drug described under section 356c(a) of this title, there is communication with the appropriate office of the Food and Drug Administration with expertise regarding drug shortages regarding whether the action or letter could cause, or exacerbate, a shortage of the drug.

• 21 U.S.C. § 356d(c)

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  (c) If the Secretary determines, after the communication described in subsection (b), that an enforcement action or a warning letter could reasonably cause or exacerbate a shortage of a drug described under section 356c(a) of this title, then the Secretary shall evaluate the risks associated with the impact of such shortage upon patients and those risks associated with the violation involved before taking such action or issuing such letter, unless there is imminent risk of serious adverse health consequences or death to humans.

Citations to §356c(c)

• 21 U.S.C. § 356e(c)(3)

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  (3) The 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).

Citations to §356c(f)

• 21 U.S.C. § 356c–1(a)(8)

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  (8) lists the names of manufacturers that were issued letters under section 356c(f) of this title; and

Citations to §356c(g)(1)

• 21 U.S.C. § 356c–1(a)(5)(B)(i)

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  (i) the number of applications and supplements for which the Secretary expedited review under section 356c(g)(1) of this title during such calendar year; and

Citations to §356c(g)(2)

• 21 U.S.C. § 356c–1(a)(5)(B)(ii)

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  (ii) the number of establishment inspections or reinspections that the Secretary expedited under section 356c(g)(2) of this title during such calendar year;