h 12 58141 1244088000 false 1244088000 2726 173 111 400195

6/4/2009--Introduced.Tim Fagan's Law or the Counterfeit Drug Enforcement Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to establish a criminal fine and/or imprisonment for a person who: (1) knowingly causes a prescription drug to be adulterated, misbranded, or misrepresented as an approved prescription drug and sells or trades the drug; or (2) purchases or trades for such drug knowing or having reason to know that the drug was knowingly adulterated, misbranded, or misrepresented. Requires a manufacturer of a drug to notify the Secretary of Health and Human Services (HHS) within 48 hours after first receiving or becoming aware of information that reasonably suggests that such a violation may have occurred. Deems a drug to be misbranded if it is not manufactured in accordance with the use of technologies that the Secretary determines are technically feasible and will assist in preventing such violations. Requires the Secretary to establish alternative requirements to the extent that such requirements provide greater certainty on the chain of custody and are technically feasible. Increases funding for Food and Drug Administration (FDA) inspections, examinations, and investigations. Requires the Secretary to educate the public and health care professionals on counterfeit drugs. Directs the Secretary: (1) upon a finding of reasonable probability that a drug intended for human use would cause serious health consequences or death, to issue an order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the drug) to cease distribution of the drug and to notify and instruct health professionals to cease administering or prescribing the drug; and (2) amend the order to include a recall if necessary.

1244088000 2009-06-04 Fri Nov 13 20:50:41 -0600 2009 introduced 58141 'law':4 'tim':1 'fagan':2 74849 false short introduced 58141 'act':4 '2009':6 'drug':2 'enforc':3 'counterfeit':1 74848 false short introduced 58141 'act':9 'caus':23 'drug':6,21,43,49 'food':5 'know':22 'sale':16 'amend':2 'chain':38 'feder':4 'recal':46 'trade':18 'author':47 'cosmet':8 'crimin':12 'modifi':30 'purpos':53 'record':34 'regard':48 'requir':31 'adulter':26 'custodi':40 'increas':11 'penalti':13 'maintain':33 'misbrand':28 'establish':45 'prescript':20,42 'chain-of-custodi':37 74155 false official action 58141 1244088000 Thu Jun 04 00:00:00 -0500 2009 197559 Referred to the House Committee on Energy and Commerce. I000057 1958-05-30 4505 432 Cannon House Office Building http://www.house.gov/formisrael/contact.html 2 202-225-4669 Steve 'd':4 '-2':6 'ny':5 'rep':1 'steve':2,7,9 'israel':3,8,10 M 400195 Israel Steve_Israel J. Rep. Steve Israel [D, NY-2] 1868 N00013345 6812 Democrat 202-225-3335 Jewish NY Steve Israel 2.5 http://www.house.gov/israel/ RepSteveIsrael A000022 1942-11-19 4019 2243 Rayburn House Office Building http://www.house.gov/writerep 5 202-225-1589 Gary 'd':4 '-5':6 'ny':5 'rep':1 'gari':2,7,9 'ackerman':3,8,10 M 400003 Ackerman Gary_L._Ackerman L. Rep. Gary Ackerman [D, NY-5] 1770 N00001143 7519 Democrat 202-225-2601 Jewish NY Gary Ackerman 2.27272727272727 http://www.house.gov/ackerman/ action 58141 1244088000 Thu Jun 04 00:00:00 -0500 2009 197559 Referred to the House Committee on Energy and Commerce. introduced 58141 1244088000 Thu Jun 04 00:00:00 -0500 2009 197558