2015 US Code
Title 21 - Food and Drugs (Sections 1 - 2252)
Chapter 9 - Federal Food, Drug, and Cosmetic Act (Sections 301 - 399f)
Subchapter V - Drugs and Devices (Sections 351 - 360fff-7)
Part A - Drugs and Devices (Sections 351 - 360n-1)
Sec. 356e - Drug shortage list
| Publication Title | United States Code, 2012 Edition, Supplement 3, Title 21 - FOOD AND DRUGS |
| Category | Bills and Statutes |
| Collection | United States Code |
| SuDoc Class Number | Y 1.2/5: |
| Contained Within | Title 21 - FOOD AND DRUGS CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT SUBCHAPTER V - DRUGS AND DEVICES Part A - Drugs and Devices Sec. 356e - Drug shortage list |
| Contains | section 356e |
| Date | 2015 |
| Laws In Effect As Of Date | January 3, 2016 |
| Positive Law | No |
| Disposition | standard |
| Source Credit | June 25, 1938, ch. 675, §506E, as added Pub. L. 112-144, title X, §1004, July 9, 2012, 126 Stat. 1104. |
| Statutes at Large Reference | 126 Stat. 1104 |
| Public and Private Law | Public Law 112-144 |
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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) 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) 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 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).
(June 25, 1938, ch. 675, §506E, as added Pub. L. 112–144, title X, §1004, July 9, 2012, 126 Stat. 1104.)
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