21 USC § 360bbb–7 - Notification | LII / Legal Information Institute

prev | next

This preliminary release may be subject to further revision before it is released again as a final version. As with other online versions of the Code, the U.S. Code Classification Tables should be consulted for the latest laws affecting the Code. Those using the USCPrelim should verify the text against the printed slip laws available from GPO (Government Printing Office), the laws as shown on THOMAS (a legislative service of the Library of Congress), and the final version of the Code when it becomes available.

Current through Pub. L. 112-173. (See Public Laws for the current Congress.)

(a) Notification to Secretary

With respect to a drug, the Secretary may require notification to the Secretary by a regulated person if the regulated person knows—

(1) that the use of such drug in the United States may result in serious injury or death;

(2) of a significant loss or known theft of such drug intended for use in the United States; or

(3) that—

(A) such drug has been or is being counterfeited; and

(B)

(i) the counterfeit product is in commerce in the United States or could be reasonably expected to be introduced into commerce in the United States; or

(ii) such drug has been or is being imported into the United States or may reasonably be expected to be offered for import into the United States.

(b) Manner of notification

Notification under this section shall be made in such manner and by such means as the Secretary may specify by regulation or guidance.

(c) Savings clause

Nothing in this section shall be construed as limiting any other authority of the Secretary to require notifications related to a drug under any other provision of this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.].

(d) Definition

In this section, the term “regulated person” means—

(1) a person who is required to register under section 360 or 381 (s) of this title;

(2) a wholesale distributor of a drug product; or

(3) any other person that distributes drugs except a person that distributes drugs exclusively for retail sale.

This preliminary release may be subject to further revision before it is released again as a final version. As with other online versions of the Code, the U.S. Code Classification Tables should be consulted for the latest laws affecting the Code. Those using the USCPrelim should verify the text against the printed slip laws available from GPO (Government Printing Office), the laws as shown on THOMAS (a legislative service of the Library of Congress), and the final version of the Code when it becomes available.

Current through Pub. L. 112-173. (See Public Laws for the current Congress.)

Source

(June 25, 1938, ch. 675, § 568, as added Pub. L. 112–144, title VII, § 715(b),July 9, 2012, 126 Stat. 1075.)

References in Text

The Public Health Service Act, referred to in subsec. (c), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§ 201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

Codification

Section is comprised of subsec. (b) ofsection 715 of Pub. L. 112–144. Subsec. (a) of such section amended section 331 of this title.

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 Wednesday, December 26, 2012

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.

How To Use

Multiple entries for a section are listed most recent first, within the section.

The Session Year indicates which session of Congress was responsible for the changes classified. The Congress number forms the first part of the Public Law number; each Congress has two sessions.

Abbreviations used in the Description of Change column:

An empty field implies a standard amendment.
"new" means a new section or new note, or all new text of an existing section or note.
"nt" means note.
"nt [tbl]" means note [table].
"prec" means preceding.
"fr" means a transfer from another section.
"to" means a transfer to another section.
"omitted" means the section is omitted.
"repealed" means the section is repealed.
"nt ed change" and "ed change" - See the Editorial Classification Change Table [pdf].

The Public Law field is linked to the development of the law in the Thomas system at the Library of Congress.

The Statutes at Large field is linked to the text of the law, in the context of its volume of the Statutes at Large, at the Government Printing Office. Please note that it takes a while for these pages to get posted, so for very recent legislation, you need to look at the "enrolled" version at the Thomas site.

The Statutes at Large references have been rendered in the format used as page numbers in the Public Law web pages to which we link, to facilitate copy-paste into browser "find on this (web) page" tools. We are still working on a more direct link facility.

For serious comparison work, we suggest copying all or a portion of the Public Law text into your favorite text editor, for convenient content traversal and window control.

Sections with change type "new" are a special case, still under development. All are now listed, at the title level only.

You will find that occassionally a specific update you notice in a Public Law listed in a classification table will already have made it into the Code. We assume this is an artifact of the LRC edit process. The LII does not edit the LRC content.

top

General Reference

Refer to the LRC (Law Revision Council) for explanations about the US Code from the folks who put it all together.

You can look for information about what it is and is not, which titles are positive law, the schedule of Supplements, etc. Under download you can find the source data we use here (GPO locator files), as well as, PDF files that look just like the paper books (these may be rather large).

Refer to the Thomas site for changes that have not yet made it into the classification tables.

21 USC	Description of Change	Session Year	Public Law	Statutes at Large
§ 360bbb-7	new	2012	112-144 [Sec.] 715(b) "568"	126 Stat. 1075

21 USC § 360bbb–7 - Notification

U.S. Code Toolbox

Law about... Articles from Wex

Find a Lawyer

Get Involved