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After Heparin: - The Pew Charitable Trusts

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REFERENCES<br />

219<br />

U.S. Food and Drug Administration. <strong>The</strong> Enforcement Story, Fiscal Year 2001. Chapter 6: Office of Criminal Investigation.<br />

http://www.fda.gov/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/ucm106657.htm Accessed<br />

August 22, 2010.<br />

220<br />

Ibid.<br />

221<br />

Ibid.<br />

222<br />

Ibid.<br />

223<br />

U.S. Food and Drug Administration. <strong>The</strong> Enforcement Story, Fiscal Year 2005. Chapter 6: Office of Criminal Investigations.<br />

March 2006. http://www.fda.gov/downloads/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/<br />

UCM091079.pdf. Accessed August 22, 2010.<br />

224<br />

U.S. Food and Drug Administration. <strong>The</strong> Enforcement Story, Fiscal Year 2001. Chapter 6: Office of Criminal Investigation.<br />

http://www.fda.gov/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/ucm106657.htm Accessed<br />

August 22, 2010.<br />

225<br />

Lewis, Carol. FDA Investigators’ Reports—January–February 2002. FDA Consumer Magazine. January 4, 2002.<br />

226<br />

Ibid.<br />

227<br />

21 USC §331(j).<br />

228<br />

Rentz, E.D., L. Lewis, et al. Outbreak of Acute Renal Failure in Panama in 2006: a Case-Control Study. Bull World Health<br />

Organ 2008; 86:749–756.<br />

229<br />

Ibid.<br />

230<br />

Schep, L.J., R.J. Slaughter, et al. Diethylene Glycol Poisoning. Clinical Toxicology. 2009. Vol. 47 No. 6.<br />

231<br />

Rentz, E.D., L. Lewis, et al. Outbreak of Acute Renal Failure in Panama in 2006: a Case-Control Study. Bull World Health<br />

Organ, 2008, 86:749–756.<br />

232<br />

Rivera-Martinez, Edwin. Chief, Manufacturing Assessment and Preapproval Compliance Branch, Division of Manufacturing<br />

& Product Quality, Office of Compliance, Center for Drug Evaluation & Research, U.S. Food and Drug Administration.<br />

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Ingredient Supply Chain Conference, San Diego, Calif. December 1, 2008.<br />

233<br />

Schier, J.G., C.S. Rubin, et al. Medication-associated Diethylene Glycol Mass Poisoning: A Review and Discussion on the<br />

Origin of Contamination. Journal of Public Health Policy. 2009. Vol. 30, No. 2.<br />

234<br />

Rivera-Martinez, Edwin. Chief, Manufacturing Assessment and Preapproval Compliance Branch, Division of Manufacturing<br />

& Product Quality, Office of Compliance, Center for Drug Evaluation & Research, U.S. Food and Drug Administration.<br />

“Ensuring the Integrity of the Pharmaceutical Ingredient Supply Chain.” Presentation at the 2008 PDA/FDA Pharmaceutical<br />

Ingredient Supply Chain Conference, San Diego, Calif. December 1, 2008.<br />

235<br />

Schier, J.G., C.S. Rubin, et al. Medication-associated Diethylene Glycol Mass Poisoning: A Review and Discussion on the<br />

Origin of Contamination. Journal of Public Health Policy. 2009. Vol. 30, No. 2.<br />

236<br />

Rentz, E.D., L. Lewis, et al. Outbreak of Acute Renal Failure in Panama in 2006: a Case-Control Study. Bull World Health<br />

Organ, 2008, 86:749–756.<br />

237<br />

Ballentine, Carol. Taste of Raspberries, Taste of Death. <strong>The</strong> 1937 Elixir Sulfanilamide Incident. FDA Consumer, June 1981.<br />

http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/SulfanilamideDisaster/default.htm Accessed<br />

October 15, 2010.<br />

238<br />

Schep, L.J., R.J. Slaughter, et al. Diethylene Glycol Poisoning. Clinical Toxicology. 2009. Vol. 47 No. 6.<br />

239<br />

Ibid.<br />

240<br />

Bogdanich, Walt, and Jake Hooker. From China to Panama, a Trail of Poisoned Medicine. New York Times. May 6, 2007.<br />

http://www.nytimes.com/2007/05/06/world/americas/06poison.html?pagewanted=1. Accessed February 1, 2010.<br />

241<br />

O’Brien K.L., J.D. Selanikio, et al. Epidemic of Pediatric Deaths from Acute Renal Failure Caused by Diethylene Glycol<br />

Poisoning. Acute Renal Failure Investigation Team. JAMA 1998; 279:1175–1180.<br />

242<br />

Junod, Suzanne White. Diethylene Glycol Deaths in Haiti. Public Health Reports, January–February 2000, Vol. 115, No. 1.<br />

243<br />

Singh, J., A.K. Dutta, et al. Diethylene Glycol Poisoning in Gurgaon, India, 1998. Bull World Health Organ, 2001, 79:88–95.<br />

<strong>After</strong> <strong>Heparin</strong>: PRotecting Consumers from the Risks of Substandard and Counterfeit Drugs 89

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