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.
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.
(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 or section
552(b)(4) of title
(3) Public health exception
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).
The table below lists the classification updates, since Jan. 3, 2012, for this section. Updates to a broader range of sections may be found at the update page for containing chapter, title, etc.
The most recent Classification Table update that we have noticed was Tuesday, August 13, 2013
An empty table indicates that we see no relevant changes listed in the classification tables. If you suspect that our system may be missing something, please double-check with the Office of the Law Revision Counsel.