121 STAT. 962
PUBLIC LAW 110–85—SEPT. 27, 2007 ‘‘(A) has been approved under subsection (c); and ‘‘(B) is marketed, sold, or distributed directly or indirectly to retail class of trade under a different labeling, packaging (other than repackaging as the listed drug in blister packs, unit doses, or similar packaging for use in institutions), product code, labeler code, trade name, or trade mark than the listed drug.’’.
SEC. 921. ADVERSE DRUG REACTION REPORTS AND POSTMARKET SAFETY.
Subsection (k) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), as amended by section 905, is amended by adding at the end the following: ‘‘(5) The Secretary shall— ‘‘(A) conduct regular, bi-weekly screening of the Adverse Event Reporting System database and post a quarterly report on the Adverse Event Reporting System Web site of any new safety information or potential signal of a serious risk identified by Adverse Event Reporting System within the last quarter; ‘‘(B) report to Congress not later than 2 year after the date of the enactment of the Food and Drug Administration Amendments Act of 2007 on procedures and processes of the Food and Drug Administration for addressing ongoing post market safety issues identified by the Office of Surveillance and Epidemiology and how recommendations of the Office of Surveillance and Epidemiology are handled within the agency; and ‘‘(C) on an annual basis, review the entire backlog of postmarket safety commitments to determine which commitments require revision or should be eliminated, report to the Congress on these determinations, and assign start dates and estimated completion dates for such commitments.’’.
TITLE X—FOOD SAFETY 21 USC 2101.
SEC. 1001. FINDINGS.
dkrause on GSDDPC44 with PUBLAW
Congress finds that— (1) the safety and integrity of the United States food supply are vital to public health, to public confidence in the food supply, and to the success of the food sector of the Nation’s economy; (2) illnesses and deaths of individuals and companion animals caused by contaminated food— (A) have contributed to a loss of public confidence in food safety; and (B) have caused significant economic losses to manufacturers and producers not responsible for contaminated food items; (3) the task of preserving the safety of the food supply of the United States faces tremendous pressures with regard to— (A) emerging pathogens and other contaminants and the ability to detect all forms of contamination;
VerDate Aug 31 2005
13:52 Jan 23, 2009
Jkt 059194
PO 00001
Frm 00960
Fmt 6580
Sfmt 6581
M:\STATUTES\2007\59194PT1.001
APPS10
PsN: 59194PT1
�
