§ 356e. Drug shortage list

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 1938

   Food and Drug Administration Safety and Innovation Act

   Pub. L. 112–144 title X § 1004 · 126 Stat. 993

   Enacted · 21 U.S.C. § 356e

   June 25, 1938, ch. 675, § 506E, as added Pub. L. 112–144, title X, § 1004, July 9, 2012, 126 Stat. 1104

   Source evidence

   Code source credit
   June 25, 1938, ch. 675, § 506E, as added Pub. L. 112–144, title X, § 1004, July 9, 2012, 126 Stat. 1104

   Enacted provision · exact public law section
   SEC. 1004. DRUG SHORTAGE LIST.   Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after section 506D, as added by section 1003 of this Act, the following: “SEC. 506E. DRUG SHORTAGE LIST. “(a) Establishment.— The 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) Contents.— For 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) Discontinuation 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 general.— Subject to paragraphs (2) and (3), the Secretary shall make the information in such list publicly available. “(2) Trade secrets and confidential information.— Nothing in this section alters or amends section 1905 of title 18, United States Code, or section 552(b)(4) of title 5 of such Code. “(3) Public health exception.— The Secretary may choose not to make information collected under this section publicly available under paragraph (1) or section 506C(c) 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).” .

2. 2016

   21st Century Cures Act

   Pub. L. 114–255 div. A title III § 3101(a)(2)(G) · 130 Stat. 1033

   1. Substituted · 21 U.S.C. § 356e(b)(3)(E)

      Pub. L. 114–255, which directed substitution of “discontinuance” for “discontinuation” to reflect the probable intent of Congress

   2. Substituted · 21 U.S.C. § 356e(b)(3)(E)

      Pub. L. 114–255, which directed substitution of “Discontinuance” for “Discontinuation” to reflect the probable intent of Congress

   Source evidence

   Code amendment note
   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.

   Enacted provision · exact public law section
   (G) Drug shortage list.— Section 506E(b)(3)(E) (21 U.S.C. 356e(b)(3)(E)) is amended by striking “discontinuation” and inserting “discontinuance”.

3. 2020

   Coronavirus Aid, Relief, and Economic Security Act

   Pub. L. 116–136 div. A title III § 3112(c) · 134 Stat. 281

   Added · 21 U.S.C. § 356e(d)

   Pub. L. 116–136 added subsec. (d)

   Source evidence

   Code amendment note
   Subsec. (d). Pub. L. 116–136 added subsec. (d).

   Enacted provision · exact public law section
   (c) Annual Notification.— Section 506E of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356e) is amended by adding at the end the following: “(d) Interagency Notification.— Not later than 180 days after the date of enactment of this subsection, 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.” .

   Effective date note
   Amendment 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.

4 of 4 references resolved to an enrolled provision