21 U.S. Code § 356c–1 - Annual reporting on drug shortages

Status message

There is 1 Update Pending. Select the tab below to view.
(a) Annual reports to Congress
Not later than the end of calendar year 2013, and not later than the end of each calendar year thereafter, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on drug shortages that—
(1) specifies the number of manufacturers that submitted a notification to the Secretary under section 356c (a) of this title during such calendar year;
(2) describes the communication between the field investigators of the Food and Drug Administration and the staff of the Center for Drug Evaluation and Research’s Office of Compliance and Drug Shortage Program, including the Food and Drug Administration’s procedures for enabling and ensuring such communication;
(3)
(A) lists the major actions taken by the Secretary to prevent or mitigate the drug shortages described in paragraph (7);
(B) in the list under subparagraph (A), includes—
(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
(ii) the number of establishment inspections or reinspections that the Secretary expedited under section 356c (g)(2) of this title during such calendar year;
(4) describes the coordination between the Food and Drug Administration and the Drug Enforcement Administration on efforts to prevent or alleviate drug shortages;
(5) identifies the number of and describes the instances in which the Food and Drug Administration exercised regulatory flexibility and discretion to prevent or alleviate a drug shortage;
(6) lists the names of manufacturers that were issued letters under section 356c (f) of this title; and
(7) specifies the number of drug shortages occurring during such calendar year, as identified by the Secretary.
(b) Trend analysis
The Secretary is authorized to retain a third party to conduct a study, if the Secretary believes such a study would help clarify the causes, trends, or solutions related to drug shortages.
(c) Definition
In this section, the term “drug shortage” or “shortage” has the meaning given such term in section 356c of this title.

Source

(June 25, 1938, ch. 675, § 506C–1, as added Pub. L. 112–144, title X, § 1002,July 9, 2012, 126 Stat. 1102.)

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.

21 USCDescription of ChangeSession YearPublic LawStatutes at Large
§ 356c-1new2012112-144 [Sec.] 1002 "506C-1"126 Stat. 1102

 

LII has no control over and does not endorse any external Internet site that contains links to or references LII.