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Report

After Heparin
Protecting Consumers from the Risks of Substandard and Counterfeit Drugs


Quick Summary

This report provides an overview of the complex pharmaceutical supply chain from manufacturing through distribution of the finished drug, and advances proposed policy solutions to help reduce the risks of counterfeit, adulterated and substandard drugs.

Read two fact sheets describing the heparin adulteration and other examples of breaches to the U.S. drug supply.

View an interactive graphic presenting an overview of today's globalized pharmaceutical supply chain and its vulnerabilities.

After Heparin
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Contact

Linda Paris, Tel: 202-540-6354

Report Project

Drug Safety Project

Report Topics

Drug Manufacturing and Distribution, Drug Safety

Policy Recommendations: Pharmaceutical Distribution

One concern expressed by pharmacy groups in particular was data security within a track-and-trace system. The representative from the National Association of Chain Drug Stores also noted that pharmacy inventory information has a proprietary value, which retailers worry could be threatened under a national system that permits others to access such data. This representative suggested that pilot projects could provide an early sense of how data would move between groups, and said that if track-and-trace were put in place, peer-to-peer authentication may be most appropriate. In this scenario, participants would only check a product with their immediate trading partner rather than providing visibility all the way back to the manufacturer. One wholesaler representative preferred a de-identified system, in which users could query the system with a given serial number and receive a green or red light to signal acceptable or not acceptable without revealing company information.

Finally, several participants expressed concern about the costs of implementing a stronger, more uniform system, particularly representatives from small pharmacies, who cautioned that some don't even have Internet access, so technology would need to be made accessible and cost effective for these stakeholders.

A. Improve drug distribution security through a federal serialization and verification system

  1. Require each drug package to bear a unique serial number. Drugs should be serialized at the level of the smallest container from which a drug may be repackaged or dispensed (also called a "unit"). Repackagers should be required to re-serialize product and link new serial numbers to original serial numbers.
  2. Create a uniform federal system for verification of distribution transaction history. Requiring verification of a drug's transaction history—as well as the systems necessary to support that verification—will enable responsible purchasing and provide an important tool to regulators investigating issues of counterfeiting, diversion and theft. 
    a. The system must apply to all entities involved in distribution. Requiring all manufacturers, wholesalers and pharmacies to participate in a federal pedigree system through a new federal law or revisions to existing law will ensure that bad actors have no clear regulatory exception to abuse.
    b. Regulators must be able to access full transaction histories for any drug when needed.
    c. Strong consideration should be given to implementation of an entirely electronic system, wherein serial numbers are embedded into electronic tags that may be scanned by each entity to authenticate the transaction history of a product.
    d. If the system requires the passage of a more traditional "pedigree" document, these documents should be electronic to better protect against falsification.

B. Strengthen wholesaler regulation and oversight

  1. Improve standards for wholesaler licensure and oversight. Federal guidance on minimum standards for wholesaler licensure should be strengthened to include a requirement for pre-licensure warehouse inspections, whether by federal or state officials, and for periodic inspections thereafter. Standards should also include required background checks for individuals in charge of wholesale operations prior to licensure. These principles are also included in the robust requirements for wholesaler licensure set forth in the NABP model rules. In the absence of stronger federal requirements, states should independently strengthen wholesaler licensure requirements where necessary to conform to these principles.549
  2. Require distributors and pharmacies to alert the FDA of any suspected product adulteration, counterfeiting, diversion or theft. Distributors and pharmacies should also report to the FDA any case in which they are unable to validate the transaction history of a drug. As with manufacturers, distributors are not required to report this information to the FDA; any sharing is done on a voluntary basis. FDA access to this information must be the priority when there is a public health risk of exposure to a potentially harmful product. 

 

Table of Contents
 

Date added:
Jul 12, 2011
Contact:
Linda Paris, Tel: 202-540-6354
Project:
Drug Safety Project
Topics:
Drug Manufacturing and Distribution, Drug Safety
Related Experts:
Allan Coukell, Gabrielle Cosel
References:
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References:

1 U.S. Centers for Disease Control and Prevention. Acute Allergic-Type Reactions among Patients Undergoing Hemodialysis—Multiple States, 2007–2008. Morbidity and Mortality Weekly Report, February 1, 2008 / 57 (Early Release); 1–2. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm57e201a1.htm. Accessed May 3, 2011.
 2 Blossom, David B., Alexander J. Kallen, et al. Outbreak of Adverse Reactions Associated with Contaminated Heparin. N Engl J Med, December 18, 2008, 359:2674–84.
 3 Parkinson, Robert L., Chief Executive Officer, Baxter International. Testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, U.S. House of Representatives. April 29, 2008.
 4 Kishimoto, Takashi Kei, Karthik Viswanathan, et al. Contaminated Heparin Associated with Adverse Clinical Events and Activation of the Contact System. N Engl J Med, June 5, 2008, 358:2457–67.
 5 Usdin, Steve. The Heparin Story. International Journal of Risk & Safety in Medicine, Vol. 21, 2009, 99–103.
 6 U.S. Government Accountability Office (October 2010). U.S. Food and Drug Administration: Response to Heparin Contamination Helped Protect Public Health; Controls That Were Needed for Working with External Entities Were Recently Added (Publication No. GAO-11-95).
 7 Autor, Deborah M. Director, CDER Office of Compliance. U.S. Food and Drug Administration. "Globalization: Challenges and Recent Case Studies." Presentation at DCAT Week, March 18, 2009.
 8 U.S. Government Accountability Office (September 2010). Drug Safety: FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed. Appendix 1: Comments from the Department of Health and Human Services (Publication No. GAO-10-961).
 9 Hamburg, Margaret. Commissioner, U.S. Food and Drug Administration. Testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, U.S. House of Representatives. April 13, 2011. http://republicans.energycommerce.house.gov/Media/file/Hearings/Oversight/041311/Hamburg.pdf. Accessed April 27, 2011.
 10 U.S. Government Accountability Office (March 1998). Food and Drug Administration: Improvements Needed in the Foreign Drug Inspection Program (Publication No. GAO/HEHS-98-21).
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 12 Rosa, Carmelo. Acting Chief, International Compliance Branch, Division of Manufacturing & Product Quality Office of Compliance, Center for Drug Evaluation & Research, U.S. Food and Drug Administration. "Catching Up to 21st-Century Challenges: FDA's Supplier Quality and Compliance Outlook." Presentation at FDA News 2nd Annual Supplier Quality Management Congress. Bethesda, Md., August 18–20, 2010.
 13 U.S. Government Accountability Office (September 2010). Drug Safety: FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed. (Publication No. GAO-10-961).
 14 Thompson, Cheryl A. Counterfeit Drugs Arise from Various Sources; Wholesalers Blamed for Promoting Drug Diversion. Am J Health-Syst Pharm, Vol. 60, August 1, 2003.
 15 Young, Donna. Counterfeit Drug Lawsuit Points Finger at Wholesaler, Pharmacy. Am J Health-Syst Pharm, Vol. 61, October 1, 2004.
 16 Fagan, Kevin. Testimony before the Subcommittee on Criminal Justice, Drug Policy, and Human Resources, Committee on Oversight and Government Reform U.S. House of Representatives. Hearing on "Sick Crime: Counterfeit Drugs in the United States," November 1, 2005.
 17 U.S. Food and Drug Administration. Update to FDA Alert about Stolen Insulin. August 26, 2009. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm180320.htm. Accessed November 12, 2010.
 18 Rudolph, P.M. and I.B.G. Bernstein. Counterfeit Drugs. N Engl J Med, April 1, 2004, 350:1384–86.
 19 IMS Institute for Healthcare Informatics. The Use of Medicines in the United States: Review of 2010. April 2011. http://www.imshealth.com/deployedfiles/imshealth/Global/Content/IMS%20Institute/Static%20File/IHII_UseOfMed_report.pdf. Accessed May 2, 2011.
 20 Maybarduk, Peter. Access to Medicines Program Director, Public Citizen. Comments on the DG TAXUD consultation paper "Review of EU Legislation on Customs Enforcement of Intellectual Property Rights," May 25, 2010. http://www.citizen.org/documents/Public%20Citizen%20comments%20submitted%20to%20DG%20TAXUD%20on%201383.pdf. Accessed August 16, 2010.
 21 Health Action International, Oxfam International, and Knowledge Ecology International. Seizure of UNITAID/Clinton Foundation Antiretroviral Medicines by Dutch Customs Authorities "Unacceptable." Press release, March 6, 2009.
 22 International Medical Products Anti-Counterfeiting Taskforce, World Health Organization. "Counterfeit Drugs Kill!" Updated May 2008. Accessed April 12, 2011. http://www.who.int/impact/FinalBrochureWHA2008a.pdf.
 23 21 USC §333 (a)(2).
 24 Van Trieste, Martin. Chair, Rx 360. Call to Action & Global Perspective. Presentation at 2010 PDA/FDA Pharmaceutical Supply Chain Workshop. Bethesda, Md. April 26–28, 2010.
 25 U.S. Drug Enforcement Administration. Federal Trafficking Penalties. http://www.justice.gov/dea/agency/penalties.htm. Accessed February 14, 2011.
 26 Siak, Nadine Leavitt. United States Intensifies Fight against Counterfeit Drugs: Tougher Trademark Laws Considered, Say Justice Officials. USINFO. December 1, 2006. http://www.america.gov/st/washfile-english/2006/December/20061201120711LNkaiS0.2569086.html. Accessed May 3, 2010.
 27 U.S. Food and Drug Administration. Strategic Priorities 2011–2015: Responding to the Public Health Challenges of the 21st Century. http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM252092.pdf. Accessed May 2, 2011.
 28 U.S. Food and Drug Administration. Protecting Patients: FY 2011 Congressional Justification with summary table. http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM205622.pdf. Accessed May 2, 2011.
 29 Ibid.
 30 U.S. Government Accountability Office (September 2010). Drug Safety: FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed. (Publication No. GAO-10-961).
 31 U.S. Food and Drug Administration. Strategic Priorities 2011–2015: Responding to the Public Health Challenges of the 21st Century. http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM252092.pdf. Accessed May 2, 2011.
 32 21 CFR §210.3.
 33 21 CFR §207.3.
 34 U.S. Food and Drug Administration Compliance Program Guidance Manual Program 7356.002f: Chapter 56—Drug Quality Assurance. Subject: Active Pharmaceutical Ingredient (API) Process Inspection. Implementation Date: February 13, 2006; Completion Date: February 12, 2008. http://www.fda.gov/downloads/ICECI/ComplianceManuals/ComplianceProgramManual/ucm125420.pdf. Accessed October 13, 2010.
 35 U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Guidance for Industry: Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.August 2001.
 36 U.S. Food and Drug Administration Compliance Program Guidance Manual Program 7356.002f: Chapter 56—Drug Quality Assurance. Subject: Active Pharmaceutical Ingredient (API) Process Inspection. Implementation Date: February 13, 2006; Completion Date: February 12, 2008. http://www.fda.gov/downloads/ICECI/ComplianceManuals/ComplianceProgramManual/ucm125420.pdf. Accessed October 13, 2010.
 37 U.S. Centers for Disease Control and Prevention. Acute Allergic-Type Reactions among Patients Undergoing Hemodialysis—Multiple States, 2007–2008. Morbidity and Mortality Weekly Report, February 1, 2008 / 57 (Early Release); 1–2. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm57e201a1.htm. Accessed May 3, 2011.
 38 Blossom, David B., Alexander J. Kallen, et al. Outbreak of Adverse Reactions Associated with Contaminated Heparin. N Engl J Med, December 18, 2008, 359:2674–84.
 39 Parkinson, Robert L., Chief Executive Officer, Baxter International. Testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, U.S. House of Representatives. April 29, 2008.
 40 Kishimoto, Takashi Kei, Viswanathan, Karthik, et al. Contaminated Heparin Associated with Adverse Clinical Events and Activation of the Contact System. N Engl J Med, June 5, 2008, 358: 2457–67.
 41 McMahon, Ann W. et al. Description of Hypersensitivity Adverse Events following Administration of Heparin That Was Potentially Contaminated with Oversulfated Chondroitin Sulfate in Early 2008. Pharmacoepidemiology and Drug Safety, 2010, 19:921–933.
 42 Ibid.
 43 U.S. Government Accountability Office (October 2010). U.S. Food and Drug Administration: Response to Heparin Contamination Helped Protect Public Health; Controls That Were Needed for Working with External Entities Were Recently Added (Publication No. GAO-11-95).
 44 Blossom, David B., Alexander J. Kallen, et al. Outbreak of Adverse Reactions Associated with Contaminated Heparin. N Engl J Med, December 18, 2008, 359:2674–84.
 45 Usdin, Steve. The Heparin Story. International Journal of Risk & Safety in Medicine, Vol. 21, 2009, 99–103.
 46 McMahon, Ann W. et al. Description of Hypersensitivity Adverse Events following Administration of Heparin That Was Potentially Contaminated with Oversulfated Chondroitin Sulfate in Early 2008. Pharmacoepidemiology and Drug Safety, 2010, 19:921–933.
 47 Barton, Senator Joe. Ranking Member, Committee on Energy and Commerce, and Michael Burgess, Ranking Member, Subcommittee on Oversight and Investigations, Committee on Energy and Commerce. U.S. House of Representatives. Letter to Margaret A. Hamburg, Commissioner, U.S. Food and Drug Administration. July 29, 2010.
 48 Usdin, Steve. The Heparin Story. International Journal of Risk & Safety in Medicine, Vol. 21, 2009, 99–103.
 49 Parkinson, Robert L., Chief Executive Officer, Baxter International. Testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, U.S. House of Representatives. April 29, 2008.
 50 Gardiner, Erin. Director, Corporate Communications, Baxter International Inc. Direct communication, February 19, 2010.
 51 Fairclough, Gordon. Where a Drug Begins. Interactive Slideshow. Wall Street Journal Online. http://online.wsj.com/article/SB120352438415380201.html. Accessed February 21, 2011.
 52 Usdin, Steve. The Heparin Story. International Journal of Risk & Safety in Medicine, Vol. 21, 2009, 99–103.
 53 Parkinson, Robert L., Chief Executive Officer, Baxter International. Testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, U.S. House of Representatives. April 29, 2008.
 54 Gardiner, Erin. Director, Corporate Communications, Baxter International Inc. Direct communication, February 19, 2010.
 55 Parkinson, Robert L., Chief Executive Officer, Baxter International. Testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, U.S. House of Representatives. April 29, 2008.
 56 U.S. Government Accountability Office (October 2010). U.S. Food and Drug Administration: Response to Heparin Contamination Helped Protect Public Health; Controls That Were Needed for Working with External Entities Were Recently Added (Publication No. GAO-11-95).
 57 Bogdanich, Walt. Japan: Heparin Recalled as Precaution. New York Times, March 11, 2008. http://query.nytimes.com/gst/fullpage.html?res=9B02E1DD1F3AF932A25750C0A96E9C8B63. Accessed August 20, 2010.
 58 Schwartzkopff, Frances. Sweden Pulls Contaminated Sanofi Heparin Batches (Update3). Bloomberg. April 24, 2008. http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aj.u8ersCaQc&refer=europe. Accessed August 20, 2010.
 59 Swissmedic. Swissmedic Recalls Heparin Products in Switzerland. March 20, 2008. http://www.swissmedic.ch/aktuell/00003/00564/index.html?lang=en Accessed August 20, 2010.
 60 Australian Government, Department of Health and Ageing, Therapeutic Goods Administration. Heparin products: Urgent safety advisory. April 7, 2008. http://www.tga.gov.au/safety/alerts-medicine-heparin-080320.htm. Accessed March 29, 2011.
 61 Usdin, Steve. The Heparin Story. International Journal of Risk & Safety in Medicine, Vol. 21, 2009, 99–103.
 62 U.S. Government Accountability Office (October 2010). U.S. Food and Drug Administration: Response to Heparin Contamination Helped Protect Public Health; Controls That Were Needed for Working with External Entities Were Recently Added (Publication No. GAO-11-95).
 63 Usdin, Steve. The Heparin Story. International Journal of Risk & Safety in Medicine, Vol. 21, 2009, 99–103.
 64 Villax, Guy. Member of the Board and Head of Globalization Task-Force, European Fine Chemicals Group. "Business of Counterfeit Heparin and its Implications." Presentation at the 3rd EFCG Pharma Business Conference. May 29, 2008. Lisbon, Portugal.
 65 Usdin, Steve. The Heparin Story. International Journal of Risk & Safety in Medicine, Vol. 21, 2009, 99–103.
 66 Ibid.
 67 Parkinson, Robert L., Chief Executive Officer, Baxter International. Testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, U.S. House of Representatives. April 29, 2008.
 68 Usdin, Steve. The Heparin Story. International Journal of Risk & Safety in Medicine, Vol. 21, 2009, 99–103.
 69 Williams, Roger. Chief Executive Officer, U.S. Pharmacopoeia. "Economically Motivated Adulteration." Presentation at U.S. Food and Drug Administration Public Meeting on Economically Motivated Adulteration. May 1, 2009.
 70 Usdin, Steve. The Heparin Story. International Journal of Risk & Safety in Medicine, Vol. 21, 2009, 99–103.
 71 Gardiner, Erin. Director, Corporate Communications, Baxter International Inc. Direct communication, February 19, 2010.
 72 Usdin, Steve. The Heparin Story. International Journal of Risk & Safety in Medicine, Vol. 21, 2009, 99–103.
 73 Williams, Roger. Chief Executive Officer, United States Pharmacopoeia. Direct communication, July 27, 2010.
 74 Parkinson, Robert L., Chief Executive Officer, Baxter International. Testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, U.S. House of Representatives. April 29, 2008.
 75 Ibid.
 76 U.S. Food and Drug Administration, Division of Manufacturing and Product Quality Office of Compliance Center for Drug Evaluation and Research. Warning Letter (WL: 320-08-01) to Dr. Yan Wang, PhD., General Manager, Changzhou SPL Company, Ltd (a/k/a "Kaipu"). April 21, 2008.
 77 Ibid.
 78 Gardiner, Erin. Director, Corporate Communications, Baxter International Inc. Direct communication, February 25, 2011.
 79 U.S. Government Accountability Office (October 2010). U.S. Food and Drug Administration: Response to Heparin Contamination Helped Protect Public Health; Controls That Were Needed for Working with External Entities Were Recently Added (Publication No. GAO-11-95).
 80 Ibid.
 81 Ibid.
 82 Hepeng, Jia. Regulators Scramble to Tighten Loopholes after Heparin Debacle. Nature Biotechnology, May 2008, Vol. 26, No 5.
 83 Ireland, J. FDA letter to Representative Barton. June 16, 2010. http://republicans.energycommerce.house.gov/Media/file/News/061610_FDA_Response_Heparin.pdf. Accessed February 17, 2011.
 84 U.S. Food and Drug Administration, Minneapolis District Office. Form FDA 483 Inspectional Observations. To David G. Strunce, President and CEO, Scientific Protein Laboratories LLC, September 3, 2010. http://www.fda.gov/downloads/AboutFDA/CentersOffices/ORA/ORAElectronicReadingRoom/UCM230120.pdf. Accessed November 11, 2010.
 85 Ibid.
 86 Usdin, Steve. The Heparin Story. International Journal of Risk & Safety in Medicine, Vol. 21, 2009, 99–103.
 87 Gardiner, Erin. Director, Corporate Communications, Baxter International Inc. Direct communication, February 19, 2010.
 88 Villax, Guy. Board Member of the European Fine Chemicals Group and Rx-360; CEO, Hovione. Direct communication, February 22, 2010.
 89 Wu, Huifang. Orientbit Technology Co., Ltd. Direct communication, August 24, 2010.
 90 Gardiner, Erin. Director, Corporate Communications, Baxter International Inc. Direct communication, February 19, 2010.
 91 Gardiner, Erin. Director, Corporate Communications, Baxter International Inc. Direct communication, October 22, 2010.
 92 Hamburg, Margaret A., MD. Commissioner of Food and Drugs, U.S. Food and Drug Administration. "FDA and the American Public: The Safety of Foods and Medical Products in the Global Age." Remarks of Margaret A. Hamburg, MD., at Center for Strategic and International Studies. February 4, 2010. http://www.fda.gov/NewsEvents/Speeches/ucm199926.htm Accessed October 22, 2010.
 93 Autor, Deborah M., Director, CDER Office of Compliance. U.S. Food and Drug Administration. "Globalization: Challenges and Recent Case Studies." Presentation at DCAT Week, March 18, 2009.
 94 U.S. Government Accountability Office (November 2007). Drug Safety: Preliminary Findings Suggest Weakness in FDA's Program for Inspecting Foreign Drug Manufacturers (Publication No. GAO-08-224T).
 95 U.S. Government Accountability Office (September 2010). Drug Safety: FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed (Publication No. GAO-10-961).
 96 Autor, Deborah M., Director, CDER Office of Compliance. U.S. Food and Drug Administration. "Globalization: Challenges and Recent Case Studies." Presentation at DCAT Week, March 18, 2009.
 97 Hamburg, Margaret. Commissioner, U.S. Food and Drug Administration. Testimony before the House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations. April 13, 2011. http://republicans.energycommerce.house.gov/Media/file/Hearings/Oversight/041311/Hamburg.pdf. Accessed April 27, 2011.
 98 Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration. Direct communication, June 13, 2011.
 99 _Gren, Jeffrey. Director, Office of Health and Consumer Goods, U.S. Department of Commerce. "The Impact of the Globalization of the Pharmaceutical Industry on the Counterfeit and Substandard Medicines Problem" Presentation at RX-360 Meeting, June 5, 2009, Washington, D.C.
 100 Axendia Report. Achieving Global Supply Chain Visibility, Control & Collaboration in Life Sciences: "Regulatory Necessity; Business Imperative." October 2010.
 101 Shahani, Shalini. "Contract Pharmaceutical Manufacturing, Research and Packaging." BCC Research, Wellesley, Mass. October 2009.
 102 Ibid.
 103 Associated Press Financial Wire, Pfizer Considers Outsourcing Up to 30 Percent of Manufacturing, Much of It to Asia. November 30, 2007.
 104 Barnes, Kristy. GSK to Strip Down through Outsourcing and Offshoring. Drugresearcher.com, October 26, 2007. http://www.drugresearcher.com/Research-management/GSK-to-strip-down-through-outsourcing-and-offshoring. Accessed May 3, 2010.
 105 Jack, Andrew. Outsourcing Tonic for Supply Chain. Financial Times, April 16, 2008. http://www.ft.com/cms/s/0/478054bc-0b4c-11dd-8ccf-0000779fd2ac.html#axzz1BVZg4xat. Accessed January 19, 2011.
 106 Shahani, Shalini. "Contract Pharmaceutical Manufacturing, Research and Packaging." BCC Research, Wellesley, Mass. October 2009.
 107 Ibid.
 108 Source of original data: United States Census Bureau, Foreign Trade Division.
 109 Ibid.
 110 Ibid.
 111 NSD Bio Group. "Potential Health & Safety Impacts from Pharmaceuticals and Supplements Containing Chinese-Sourced Raw Ingredients." Prepared for the United States China Economic and Security Review Commission. April 2010. http://www.uscc.gov/researchpapers/2010/NSD_BIO_Pharma_Report--Revised_FINAL_for_PDF--14_%20April_2010.pdf. Accessed April 14, 2010.
 112 Ibid.
 113 Kennedy, Robert. Manager, Industry Research, Thomson Reuters API Intelligence. "Can China retain its API sourcing appeal?" Scrip100, December 9, 2009. http://thomsonreuters.com/content/science/pdf/ls/hub/can_China_retain_api_sourcing_appeal.pdf. Accessed January 19, 2011.
 114 Source of original data: United States Census Bureau, Foreign Trade Division.
 115 NSD Bio Group. "Potential Health & Safety Impacts from Pharmaceuticals and Supplements Containing Chinese-Sourced Raw Ingredients." Prepared for the United States China Economic and Security Review Commission. April 2010. http://www.uscc.gov/researchpapers/2010/NSD_BIO_Pharma_Report--Revised_FINAL_for_PDF--14_%20April_2010.pdf. Accessed April 14, 2010.
 116 Ibid.
 117 Ibid.
 118 U.S. Government Accountability Office (September 2010). Drug Safety: FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed (Publication No. GAO-10-961).
 119 U.S. Government Accountability Office (November 2007). Drug Safety: Preliminary Findings Suggest Weakness in FDA's Program for Inspecting Foreign Drug Manufacturers (Publication No. GAO-08-224T).
 120 Greene, William. "The Emergence of India's Pharmaceutical Industry and Implications for the U.S. Generic Drug Market." Office of Economics Working Paper, U.S. International Trade Commission. May 2007. http://www.usitc.gov/publications/332/working_papers/EC200705A.pdf. Accessed August 25, 2010.
 121 Hoffman, Jean. Generics Growth in the USA and the EU: The Role of India. Journal of Generic Medicines, October 2005, Vol. 3, No 1.
 122 Source of original data: United States Census Bureau, Foreign Trade Division.
 123 Greene, William. "The Emergence of India's Pharmaceutical Industry and Implications for the U.S. Generic Drug Market." Office of Economics Working Paper, U.S. International Trade Commission. May 2007. http://www.usitc.gov/publications/332/working_papers/EC200705A.pdf. Accessed August 25, 2010.
 124 KPMG International. Pharmaceuticals: "The Indian Pharmaceutical Industry: Collaboration for Growth." 2006. http://www.in.kpmg.com/pdf/Indian%20pharma%20outlook.pdf. Accessed August 25, 2010.
 125 Woodcock, Janet, MD. Director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration. "CDER Workload and Resources." Presentation at Stakeholder Meeting on Prescription Drug User Fee Act (PDUFA) Reauthorization. August 5, 2010.
 126 Pharmaceuticals Export Promotion Council (Pharmexcil). Compilation & Analysis of USFDA DMFs database; summary highlights. http://pharmexcil.org/index.php?option=com_content&view=article&id=1201:Compilation%20&%20Analysis%20of%20USFDA%20DMFs%20database&catid=17:pharmexcil-news. Accessed November 11, 2010.
 127 Source of original data: United States Census Bureau, Foreign Trade Division.
 128 Ibid.
 129 Crosse, Marcia. GAO. "Medical Devices: Challenges for FDA in Conducting Manufacturer Inspections." Testimony before the Subcommittee on Oversight and Investigation, Committee on Energy and Commerce, U.S. House of Representatives. January 29, 2008.
 130 Ibid.
 131 Devices and Diagnostics Letter. Outsourcing Lowers Device Firms' Costs, Provides Access to Technology. December 5, 2005, Vol. 32, No. 48.
 132 The Silver Sheet. Device Recalls Reach New High in 2006 as FDA Works on Postmarket Issues. February 15, 2007. Accessed January 5, 2009.
 133 Burns, Melissa B. FDA, Center for Devices and Radiological Health, Office of Compliance. "Supplier Controls: the FDA Regulations." Presentation at AdvaMed/MTLI, October 5, 2009.
 134 Crosse, Marcia. GAO. "Medical Devices: Challenges for FDA in Conducting Manufacturer Inspections." Testimony before the Subcommittee on Oversight and Investigation, Committee on Energy and Commerce, U.S. House of Representatives. January 29, 2008.
 135 Ibid.
 136 Crosse, Marcia. GAO. "Medical Devices: Shortcomings in FDA's Premarket Review, Postmarket Surveillance, and Inspections of Device Manufacturing Establishments." Testimony before the Subcommittee on Health, Committee on Energy and Commerce, U.S. House of Representatives. June 18, 2009.
 137 Ministry of Health and Family Welfare, Government of India. Report of the Expert Committee on a Comprehensive Examination of Drug Regulatory Issues, Including the Problem of Spurious Drugs. November 2003. http://cdsco.nic.in/html/Final%20Report%20mashelkar.pdf. Accessed January 10, 2011.
 138 Tomlinson, R. China Cracks Down on Counterfeit Medicines. Br Med J, March 1999, 318:624.
 139 Sampath, Padmashree Gehl. Economic Aspects of Access to Medicines after 2005: Product Patent Protection and Emerging Firm—Strategies in the Indian Pharmaceutical Industry. United Nations University-Institute for New Technologies (UNU-INTECH). http://www.who.int/intellectualproperty/studies/PadmashreeSampathFinal.pdf. Accessed May 3, 2011.
 140 Kennedy, Robert. Manager, Industry Research, Thomson Reuters API Intelligence. "For How Long Will the Chinese API Sourcing Market Retain Its Appeal?" Presentation at API Global Sourcing Strategies 2009. Berlin, Germany, June 29, 2009.
 141 Kennedy, Robert. Manager, Industry Research, Thomson Reuters API Intelligence. "Can China retain its API sourcing appeal?" Scrip100, December 9, 2009. http://thomsonreuters.com/content/science/pdf/ls/hub/can_China_retain_api_sourcing_appeal.pdf. Accessed January 19, 2011.
 142 Chervenak, Matthew. China: Moving towards Innovation in Pharma. Drug Discovery Today, September 1, 2005, Volume 10, Issue 17:1127–1130.
 143 Jialing, Dai and Cox, Bowman. China Releases New Drug GMPs; Domestic Consolidation Expected. The Gold Sheet, February 2011, Vol. 45, No. 2.
 144 Ibid.
 145 Villax, Guy. Board Member of the European Fine Chemicals Group and Rx-360; CEO, Hovione. Direct communication. February 22, 2010.
 146 André, Philippe. Director, Qualiau Pharmaceutical Auditing Co., Ltd.; Associate Professor, School of Pharmaceutical Science and Technology, Tianjin University. Direct communication, March 8, 2010.
 147 India Business Insight. India in Pursuit of Setting Up Quality Manufacturing Facilities (About 2,000–4,000 Pharma Units in India to be Closed Down for Not Complying with Revised Schedule M GMP Norms). October 27, 2005.
 148 Daily International Pharma Alert. Swift Compliance with India's Manufacturing Rules Urged. Col. 2, No. 123. June 24, 2005.
 149 India Business Insight. NPC Finds 40 Percent SSI Units Shut Due to Enforcement of GMP Norms (Schedule M Norms were Implemented in 2005 to Improve Quality of Drugs and Encourage R&D in the Pharma Sector). July 24, 2008.
 150 U.S. Food and Drug Administration. Warning Letter (WL: 320-11-003) to Mr. Arjun S. Handa, Chief Executive Officer & Managing Director, Claris Lifesciences Limited, Chacharwadi—Vasana. November 1, 2010. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm233010.htm. Accessed November 14, 2010.
 151 U.S. Food and Drug Administration. FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India. FDA News Release, September 16, 2008. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116949.htm. Accessed February 17, 2010.
 152 U.S. Food and Drug Administration. Warning Letter (WL: 320-11-003) to Mr. Arjun S. Handa, Chief Executive Officer & Managing Director, Claris Lifesciences Limited, Chacharwadi—Vasana. November 1, 2010. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm233010.htm. Accessed November 14, 2010.
 153 U.S. Food and Drug Administration. Memorandum to Mr. Malvinder Mohan Singh, CEO & Managing Director, Ranbaxy Laboratories Limited. February 25, 2009.
 154 Ministry of Health and Family Welfare, Government of India. Report of the Expert Committee on a Comprehensive Examination of Drug Regulatory Issues, Including the Problem of Spurious Drugs. November 2003. http://cdsco.nic.in/html/Final%20Report%20mashelkar.pdf. Accessed January 10, 2011.
 155 State Food and Drug Administration, China. Article 3, Regulations on Pharmaceutical Processing for Export (trial version). Released July 29, 2003. Cited in "Potential Health & Safety Impacts from Pharmaceuticals and Supplements Containing Chinese-Sourced Raw Ingredients." Prepared for the United States China Economic and Security Review Commission by NSD Bio Group. April 2010. http://www.uscc.gov/researchpapers/2010/NSD_BIO_Pharma_Report--Revised_FINAL_for_PDF--14_%20April_2010.pdf. Accessed April 14, 2010.
 156 Ibid.
 157 Bruttin, Frances and Doug Dean. "Managing the Cost of Compliance in Pharmaceutical Operations." IBM Business Consulting Services, April 2004.
 158 The Congressional Budget Office, United States Congress. How Increased Competition from Generic Drugs Has Affected Prices and Returns in the Pharmaceutical Industry. July 1998. http://www.cbo.gov/ftpdocs/6xx/doc655/pharm.pdf. Accessed August 25, 2010.
 159 NSD Bio Group. "Potential Health & Safety Impacts from Pharmaceuticals and Supplements Containing Chinese-Sourced Raw Ingredients." Prepared for the United States China Economic and Security Review Commission. April 2010. http://www.uscc.gov/researchpapers/2010/NSD_BIO_Pharma_Report--Revised_FINAL_for_PDF--14_%20April_2010.pdf. Accessed April 14, 2010.
 160 Greene, William. "The Emergence of India's Pharmaceutical Industry and Implications for the U.S. Generic Drug Market." Office of Economics Working Paper, U.S. International Trade Commission. May 2007. http://www.usitc.gov/publications/332/working_papers/EC200705A.pdf. Accessed August 25, 2010.
 161 Hoffman, Jean. Generics Growth in the USA and the EU: The Role of India. Journal of Generic Medicines, October 2005, Vol. 3, No 1.
 162 Greene, William. "The Emergence of India's Pharmaceutical Industry and Implications for the U.S. Generic Drug Market." Office of Economics Working Paper, U.S. International Trade Commission. May 2007. http://www.usitc.gov/publications/332/working_papers/EC200705A.pdf. Accessed August 25, 2010.
 163 U.S. Food and Drug Administration. FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India. FDA News Release, September 16, 2008. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116949.htm. Accessed February 17, 2010.
 164 Blum, Justin. US Approves Ranbaxy Drugs Despite Questions. Bloomberg. August 13, 2008. http://www.livemint.com/articles/2008/08/13223620/US-approves-Ranbaxy-drugs-desp.html. Accessed May 3, 2010.
 165 FDA Media Briefing on Ranbaxy Labs. September 17, 2008. Moderator: Rita Chappelle. http://www.fda.gov/downloads/NewsEvents/Newsroom/MediaTranscripts/ucm121266.pdf. Accessed August 19, 2010.
 166 U.S. Food and Drug Administration. Memorandum to Mr. Malvinder Mohan Singh, CEO & Managing Director, Ranbaxy Laboratories Limited. February 25, 2009.
 167 Ibid.
 168 Ibid.
 169 U.S. Food and Drug Administration, Division of Manufacturing and Product Quality, International Compliance Team. Inspections, Compliance, Enforcement, and Criminal Investigations. Warning Letter (WL: 320-08-03) to Mr. Malvinder Singh, CEO & Managing Director, Ranbaxy Laboratories Limited. September 16, 2008.
 170 Ibid.
 171 United States District Court for the District of Maryland (Southern Division). Motion to Enforce Subpoenas and Points and Authorities. United States of America, petitioner, v. Ranbaxy, Inc., and Parexel Consulting, respondents. July 3, 2008.
 172 FDA Media Briefing on Ranbaxy Labs. September 17, 2008. Moderator: Rita Chappelle. http://www.fda.gov/downloads/NewsEvents/Newsroom/MediaTranscripts/ucm121266.pdf. Accessed August 19, 2010.
 173 U.S. Food and Drug Administration, Division of Manufacturing and Product Quality, Office of Compliance. Inspections, Compliance, Enforcement, and Criminal Investigations. Warning Letter (WL: 320-06-03) to Mr. Ramesh Parekh, Vice President, Manufacturing, Ranbaxy Laboratories Limited. June 15, 2006.
 174 FDA Media Briefing on Ranbaxy Labs. September 17, 2008. Moderator: Rita Chappelle. http://www.fda.gov/downloads/NewsEvents/Newsroom/MediaTranscripts/ucm121266.pdf. Accessed August 19, 2010.
 175 Ibid.
 176 U.S. Food and Drug Administration. FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India. FDA News Release, September 16, 2008. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116949.htm. Accessed February 17, 2010.
 177 U.S. Food and Drug Administration. List of Drugs Manufactured at the Dewas and Paonta Sahib Facilities of Ranbaxy Laboratories, Ltd. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/ucm118441.htm. Accessed February 17, 2010.
 178 U.S. Food and Drug Administration. FDA Takes New Regulatory Action Against Ranbaxy's Paonta Sahib Plant in India. FDA News Release, February 25, 2009. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149532.htm. Accessed February 17, 2010.
 179 U.S. Food and Drug Administration, New York District. Warning Letter (NYK: 2010-07) to Robert Patton, Vice President, General Manager, Ohm Laboratories, Inc. December 21, 2009. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm204903.htm. Accessed November 11, 2010.
 180 FDA Media Briefing on Ranbaxy Labs. September 17, 2008. Moderator: Rita Chappelle. http://www.fda.gov/downloads/NewsEvents/Newsroom/MediaTranscripts/ucm121266.pdf. Accessed August 19, 2010.
 181 Bate, Roger. "Good Move on Bad Drugs: The Ranbaxy Scandal." American Enterprise Institute for Public Policy Research. Articles and Commentary. October 3, 2008. http://www.aei.org/article/28726. Accessed August 20, 2010.
 182 Srinivasan, V. Srini, Vice President, Verification Program, United States Pharmacopoeia. Direct communication, September 10, 2009.
 183 U.S. Food and Drug Administration Consumer Health Information. "FDA beyond Our Borders." http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/ucm103044.pdf Accessed June 18, 2010.
 184 U.S. Food and Drug Administration. FDA Public Health Alert: Healthcare Professionals Warned Not to Use Certain Intravenous Metronidazole, Ondansetron, and Ciprofloxacin Due to Potential Contamination. Updated June 1, 2010. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm214035.htm Accessed June 3, 2010.
 185 Ibid.
 186 Chambers, Rick. "Pfizer Initiates a Nationwide Voluntary Recall of All Lots of Metronidazole Injection, Ciprofloxacin Injection, and Ondansetron Injection Bags Made by Claris Lifesciences Due to Non-Sterility." Pfizer Inc. June 3, 2010. http://www.fda.gov/Safety/Recalls/ucm214848.htm. Accessed June 11, 2010.
 187 U.S. Food and Drug Administration. Warning Letter (WL: 320-11-003) to Mr. Arjun S. Handa, Chief Executive Officer & Managing Director, Claris Lifesciences Limited, Chacharwadi—Vasana. November 1, 2010. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm233010.htm. Accessed November 14, 2010.
 188 U.S. Food and Drug Administration. Warning Letter (WL: 320-10-01) to Mr. Tao Chen, General Manager, XiAn Libang Pharmaceutical Co., Ltd. Shaanxi, China. January 28, 2010. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm200384.htm. Accessed January 11, 2011.
 189 Ibid.
 190 European Commission. Annex I: Scientific Conclusions and Ground for Amendments of the Marketing Authorisation and Recall of Batches Presented by the European Medicines Agency. Annex to multiple Commission Decisions of 29.3.2010: suspending the marketing and withdrawing, under Article 20 of Regulation (EC) No 726/2004 of the European Parliament and of the Council, certain batches of [multiple Clopidogrel products], a medicinal product for human use. http://ec.europa.eu/health/documents/community-register/2010/2010032978389/anx_78389_en.pdf. Accessed August 25, 2010.
 191 U.S. Food and Drug Administration. Memorandum to Mr. Malvinder Mohan Singh, CEO & Managing Director, Ranbaxy Laboratories Limited. February 25, 2009.
 192 André, Philippe. Director, Qualiau Pharmaceutical Auditing Co., Ltd.; Associate Professor, School of Pharmaceutical Science and Technology, Tianjin University. "API Manufacturing Situation in China." Presentation to European Fine Chemicals Group, May 13, 2009.
 193 Usdin, Steve. The Heparin Story. International Journal of Risk & Safety in Medicine, Vol. 21, 2009, 99–103.
 194 Parkinson, Robert L., Chief Executive Officer, Baxter International. Testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, U.S. House of Representatives. April 29, 2008.
 195 U.S. Food and Drug Administration, Division of Manufacturing and Product Quality, International Compliance Team. Inspections, Compliance, Enforcement, and Criminal Investigations. Warning Letter (WL: 320-09-01) to Dr. Mao Jian Yi, General Manager, Shanghai No. 1 Biochemical & Pharmaceutical Co. Ltd. April 14, 2009.
 196 Ibid.
 197 Ibid.
 198 Kishimoto, Takashi Kei, Viswanathan, Karthik, et al. Contaminated Heparin Associated with Adverse Clinical Events and Activation of the Contact System. N Engl J Med, June 5, 2008, 358: 2457–67.
 199 André, Philippe. Director, Qualiau Pharmaceutical Auditing Co., Ltd.; Associate Professor, School of Pharmaceutical Science and Technology, Tianjin University. "Supervision of Chinese-Made Drug Substances." Presentation at Pew Health Group Conference "After Heparin: A Roundtable on Ensuring the Safety of the U.S. Drug Supply." March 14, 2011. http://prescriptionproject.org/assets/pdfs/Andre.pdf. Accessed May 13, 2011.
 200 André, Philippe. Director, Qualiau Pharmaceutical Auditing Co., Ltd.; Associate Professor, School of Pharmaceutical Science and Technology, Tianjin University. "API Manufacturing Situation in China." Presentation to European Fine Chemicals Group, May 13, 2009.
 201 Ibid.
 202 Henkel, John. Probe Proves Effective against Antibiotic Smuggling Scheme. FDA Consumer. January–February 1998. http://permanent.access.gpo.gov/lps1609/www.fda.gov/fdac/departs/1998/198_irs.html. Accessed February 21, 2010.
 203 Thompson, Cheryl A. FDA Admits to Lacking Control over Counterfeit Drug Imports. Health-System Pharmacists News, American Society of Health-System Pharmacists. June 9, 2000. http://www.ajhp.org/content/57/14/1296.citation. Accessed February 21, 2010.
 204 Ibid.
 205 Henkel, John. Probe Proves Effective against Antibiotic Smuggling Scheme. FDA Consumer. January–February 1998. http://permanent.access.gpo.gov/lps1609/www.fda.gov/fdac/departs/1998/198_irs.html. Accessed February 21, 2010.
 206 Ibid.
 207 U.S. Department of Justice. "New Jersey Drug Firm and Owner Sentenced and Fined in Illegal Pharmaceutical and Money Laundering Scheme." Press release. Thursday, April 10, 1997.
 208 Thompson, Cheryl A. FDA Admits to Lacking Control over Counterfeit Drug Imports. Health-System Pharmacists News, American Society of Health-System Pharmacists. June 9, 2000. http://www.ajhp.org/content/57/14/1296.citation. Accessed February 21, 2010.
 209 U.S. Centers for Disease Control and Prevention. "Endotoxin-Like Reactions Associated with Intravenous Gentamicin—California, 1998." Morbidity and Mortality Weekly Report, October 23, 1998, 47(41):877–880.
 210 Ibid.
 211 Thompson, Cheryl A. FDA Admits to Lacking Control over Counterfeit Drug Imports. Health-System Pharmacists News, American Society of Health-System Pharmacists. June 9, 2000. http://www.ajhp.org/content/57/14/1296.citation. Accessed February 21, 2010.
 212 Wienen, Frank, Ralph Deubner, and Ulrike Holzgrabe. Composition and Impurity Profile of Multisource Raw Material of Gentamicin—a Comparison. Pharmeuropa, April 2003, Vol. 15, No. 2.
 213 Lewis, Carol. FDA Investigators' Reports—January–February 2002. FDA Consumer Magazine. January 4, 2002.
 214 U.S. Food and Drug Administration. The Enforcement Story, Fiscal Year 2001. Chapter 6: Office of Criminal Investigation. http://www.fda.gov/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/ucm106657.htm. Accessed August 22, 2010.
 215 Ibid.
 216 Lewis, Carol. FDA Investigators' Reports—January–February 2002. FDA Consumer Magazine. January 4, 2002.
 217 Ibid.
 218 U.S. Food and Drug Administration. The Enforcement Story, Fiscal Year 2005. Chapter 6: Office of Criminal Investigations. March 2006. http://www.fda.gov/downloads/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/UCM091079.pdf. Accessed August 22, 2010.
 219 U.S. Food and Drug Administration. The Enforcement Story, Fiscal Year 2001. Chapter 6: Office of Criminal Investigation. http://www.fda.gov/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/ucm106657.htm Accessed August 22, 2010.
 220 Ibid.
 221 Ibid.
 222 Ibid.
 223 U.S. Food and Drug Administration. The Enforcement Story, Fiscal Year 2005. Chapter 6: Office of Criminal Investigations. March 2006. http://www.fda.gov/downloads/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/UCM091079.pdf. Accessed August 22, 2010.
 224 U.S. Food and Drug Administration. The Enforcement Story, Fiscal Year 2001. Chapter 6: Office of Criminal Investigation. http://www.fda.gov/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/ucm106657.htm Accessed August 22, 2010.
 225 Lewis, Carol. FDA Investigators' Reports—January–February 2002. FDA Consumer Magazine. January 4, 2002.
 226 Ibid.
 227 21 USC §331(j).
 228 Rentz, E.D., L. Lewis, et al. Outbreak of Acute Renal Failure in Panama in 2006: a Case-Control Study. Bull World Health Organ 2008; 86:749–756.
 229 Ibid.
 230 Schep, L.J., R.J. Slaughter, et al. Diethylene Glycol Poisoning. Clinical Toxicology. 2009. Vol. 47 No. 6.
 231 Rentz, E.D., L. Lewis, et al. Outbreak of Acute Renal Failure in Panama in 2006: a Case-Control Study. Bull World Health Organ, 2008, 86:749–756.
 232 Rivera-Martinez, Edwin. Chief, Manufacturing Assessment and Preapproval Compliance Branch, Division of Manufacturing & Product Quality, Office of Compliance, Center for Drug Evaluation & Research, U.S. Food and Drug Administration. "Ensuring the Integrity of the Pharmaceutical Ingredient Supply Chain." Presentation at the 2008 PDA/FDA Pharmaceutical Ingredient Supply Chain Conference, San Diego, Calif. December 1, 2008.
 233 Schier, J.G., C.S. Rubin, et al. Medication-associated Diethylene Glycol Mass Poisoning: A Review and Discussion on the Origin of Contamination. Journal of Public Health Policy. 2009. Vol. 30, No. 2.
 234 Rivera-Martinez, Edwin. Chief, Manufacturing Assessment and Preapproval Compliance Branch, Division of Manufacturing & Product Quality, Office of Compliance, Center for Drug Evaluation & Research, U.S. Food and Drug Administration. "Ensuring the Integrity of the Pharmaceutical Ingredient Supply Chain." Presentation at the 2008 PDA/FDA Pharmaceutical Ingredient Supply Chain Conference, San Diego, Calif. December 1, 2008.
 235 Schier, J.G., C.S. Rubin, et al. Medication-associated Diethylene Glycol Mass Poisoning: A Review and Discussion on the Origin of Contamination. Journal of Public Health Policy. 2009. Vol. 30, No. 2.
 236 Rentz, E.D., L. Lewis, et al. Outbreak of Acute Renal Failure in Panama in 2006: a Case-Control Study. Bull World Health Organ, 2008, 86:749–756.
 237 Ballentine, Carol. Taste of Raspberries, Taste of Death. The 1937 Elixir Sulfanilamide Incident. FDA Consumer, June 1981. http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/SulfanilamideDisaster/default.htm Accessed October 15, 2010.
 238 Schep, L.J., R.J. Slaughter, et al. Diethylene Glycol Poisoning. Clinical Toxicology. 2009. Vol. 47 No. 6.
 239 Ibid.
 240 Bogdanich, Walt, and Jake Hooker. From China to Panama, a Trail of Poisoned Medicine. New York Times. May 6, 2007. http://www.nytimes.com/2007/05/06/world/americas/06poison.html?pagewanted=1. Accessed February 1, 2010.
 241 O'Brien K.L., J.D. Selanikio, et al. Epidemic of Pediatric Deaths from Acute Renal Failure Caused by Diethylene Glycol Poisoning. Acute Renal Failure Investigation Team. JAMA 1998; 279:1175–1180.
 242 Junod, Suzanne White. Diethylene Glycol Deaths in Haiti. Public Health Reports, January–February 2000, Vol. 115, No. 1.
 243 Singh, J., A.K. Dutta, et al. Diethylene Glycol Poisoning in Gurgaon, India, 1998. Bull World Health Organ, 2001, 79:88–95.
 244 U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry: Testing of Glycerin for Diethylene Glycol. May 2007.
 245 United States Pharmacopoeia. Revision Bulletin Glycerin Monograph. May 1, 2009. http://www.usp.org/USPNF/notices/glycerinMonographAnnouncement.html. Accessed August 27, 2010.
 246 Shahani, Shalini. "Contract Pharmaceutical Manufacturing, Research and Packaging." BCC Research, Wellesley, Mass. October 2009.
 247 Axendia Report. Achieving Global Supply Chain Visibility, Control & Collaboration in Life Sciences: 'Regulatory Necessity; Business Imperative." October 2010.
 248 Trautman, Kimberly. Medical Device Quality Systems Expert, Office of Compliance, Center for Devices and Radiological Health, U.S. Food and Drug Administration. "Supplier Controls–the FDA Medical Device Requirements." Presentation at FDA News Supplier Quality Management Congress, Arlington, Va., August 19–21, 2009.
 249 Ely, Cynthia. Supplier Quality Management Specialist, Amgen. Presentation at FDA News Supplier Management Congress, Arlington, Va., August 19–21, 2009.
 250 Niedelman, Steven. Senior Consultant, Crowell & Moring (and former director of ORA, FDA). Direct communication, November 16, 2009.
 251 U.S. Food and Drug Administration. Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations. September 2006. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070337.pdf. Accessed December 8, 2010.
 252 Rosa, Carmelo, Acting Chief, International Compliance Branch, Division of Manufacturing & Product Quality Office of Compliance, Center for Drug Evaluation & Research, U.S. Food and Drug Administration. "Catching Up to 21st-Century Challenges: FDA's Supplier Quality and Compliance Outlook." Presentation at FDA News 2nd Annual Supplier Quality Management Congress. Bethesda, Md., August 18–20, 2010.
 253 Rothman, Barry. Division of Manufacturing & Product Quality, Office of Compliance, Center for Drug Evaluation & Research, U.S. Food and Drug Administration. "Pharmaceutical Ingredient Supply Chains." Presentation at FDA News Supplier Management Congress, Arlington, Va., August 19–21, 2009.
 254 Rivera-Martinez, Edwin. Chief, Manufacturing Assessment and Preapproval Compliance Branch, Division of Manufacturing & Product Quality, Office of Compliance, Center for Drug Evaluation & Research, U.S. Food and Drug Administration. "Ensuring the Integrity of the Pharmaceutical Ingredient Supply Chain." Presentation at the 2008 PDA/FDA Pharmaceutical Ingredient Supply Chain Conference, San Diego, Calif. December 1, 2008.
 255 Ibid.
 256 Hasselbalch, Brian. Division of Manufacturing and Product Quality, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration "Public Health Challenges for the Quality of Human Drugs" Presentation at FDA/Xavier University Global Outsourcing Conference, June 14–16, 2010.
 257 Cox, Bowman. FDA Warns More Contract Manufacturers. The Gold Sheet, July 2010, Vol. 44, No.7.
 258 21 CFR §211.84 (d)(2).
 259 Rentz, E.D., L. Lewis, et al. Outbreak of Acute Renal Failure in Panama in 2006: a Case-Control Study. Bull World Health Organ 2008; 86:749–756.
 260 Rivera-Martinez, Edwin. Chief, Manufacturing Assessment and Preapproval Compliance Branch, Division of Manufacturing & Product Quality, Office of Compliance, Center for Drug Evaluation & Research, U.S. Food and Drug Administration. "Ensuring the Integrity of the Pharmaceutical Ingredient Supply Chain." Presentation at the 2008 PDA/FDA Pharmaceutical Ingredient Supply Chain Conference, San Diego, Calif. December 1, 2008.
 261 Ibid.
 262 21 CFR §314.70.
 263 U.S. Food and Drug Administration. Guidance for Industry: Changes to an Approved NDA or ANDA. April 2004. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm077097.pdf. Accessed November 11, 2010.
 264 Gardiner, Erin. Director, Corporate Communications, Baxter International Inc. Direct communication, February 25, 2011.
 265 U.S. Food and Drug Administration, Office of Compliance, Center for Drug Evaluation and Research. Warning Letter (WL: 320-11-0) to Mr. Kartikeya Sarabhai, Chairman, Synbiotics Limited c/o Ambalal Sarabhai Enterprises. Ahmadabad, India. December 16, 2010. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm237767.htm. Accessed January 20, 2011.
 266 http://www.rx-360.com.
 267 Bloom, Michael, Assistant Director for Policy & Coordination, Bureau of Competition, United States of America Federal Trade Commission. Letter to Ms. Joanne Lewers, Drinker Biddle & Reath LLP. September 15, 2010.
 268 19 USC §1304.
 269 19 CFR §134.1(d).
 270 21 CFR §201.1 (a).
 271 21 USC §351 (a)(2)(B).
 272 21 USC §374.
 273 Rothman, Barry. Division of Manufacturing & Product Quality, Office of Compliance, Center for Drug Evaluation & Research,  "Pharmaceutical Ingredient Supply Chains." Presentation at FDA News Supplier Management Congress, Arlington, Va., August 19–21, 2009.
 274 Drug Industry Daily. FDA to Revise GMPs for Components to Protect Supply Chain. April 28, 2010, Vol. 7, No. 83.
 275 21 CFR §210/211, applies to the manufacture, processing, packaging, and holding of drug products.
 276 World Health Organization Quality Assurance guidelines. http://www.who.int/medicines/areas/quality_safety/quality_assurance/en/. Accessed October 15, 2010.
 277 U.S. Food and Drug Administration. Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations. September 2006. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070337.pdf. Accessed December 8, 2010.
 278 Hasselbalch, Brian. Division of Manufacturing and Product Quality, Office of Compliance, Center for Drug Evaluation and Research, "Public Health Challenges for the Quality of Human Drugs." Presentation at FDA/Xavier University Global Outsourcing Conference, June 14–16, 2010.
 279 Cox, Bowman. FDA Looks to Expand Drug GMPs Farther Up the Pharmaceutical Supply Chain. The Gold Sheet, October 1, 2009.
 280 21 CFR §820.
 281 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline Q10: Pharmaceutical Quality System. Current Step 4 version. June 4, 2008. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q10/Step4/Q10_Guideline.pdf. Accessed January 27, 2011.
 282 21 CFR §820.50.
 283 Guidance for Industry: Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. September 2001. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm129098.pdf. Accessed January 27, 2011.
 284 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline Q9: Quality Risk Management. Current Step 4 version. November 9, 2005. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Step4/Q9_Guideline.pdf. Accessed January 27, 2011.
 285 Cox, Bowman. Record Drug Recall Totals for 2009 Resulted from GMP Breakdowns. The Gold Sheet, May 2010, Vol. 44, No. 5.
 286 Ibid.
 287 Eglovitch, Joanne S. Enforcement on Steroids: FDA Delivers Twice the Drug GMP Warning Letters. The Gold Sheet, April 2010, Vol. 44, No. 4.
 288 Sharfstein, Joshua. Deputy Commissioner, U.S. Food and Drug Administration. Testimony before the Committee on Oversight and Government Reform, U.S. House of Representatives. Hearing on Johnson & Johnson's Recall of Children's Tylenol and Other Children's Medicines. May 27, 2010.
 289 U.S. Food and Drug Administration. Form FDA 483 Inspectional Observations. To Hakan Erdemir, Vice President of Operations, McNeil Consumer Healthcare, Division of McNeil-PPC, Inc. April 30, 2010. http://www.fda.gov/downloads/AboutFDA/CentersOffices/ORA/ORAElectronicReadingRoom/UCM210772.pdf. Accessed May 26, 2010.
 290 U.S. Food and Drug Administration, Detroit District Office. Warning Letter (WL: 2010-DT-11) to Mr. Joseph C. Papa, President and Chief Executive Officer, L. Perrigo Company. April 29, 2010. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm213166.htm. Accessed November 11, 2010.
 291 Ibid.
 292 U.S. Food and Drug Administration. "L. Perrigo Co." http://www.fda.gov/AboutFDA/CentersOffices/ORA/ORAElectronicReadingRoom/ucm214720.htm. Accessed November 11, 2010.
 293 U.S. Food and Drug Administration. "Acetaminophen 500 mg Caplets by Perrigo Company." November 9, 2006. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150409.htm. Accessed November 11, 2010.
 294 United States Department of Justice, Office of Public Affairs. GlaxoSmithKline to Plead Guilty & Pay $750 Million to Resolve Criminal and Civil Liability Regarding Manufacturing Deficiencies at Puerto Rico Plant. Press Release. Tuesday, October 26, 2010. http://www.justice.gov/opa/pr/2010/October/10-civ-1205.html. Accessed November 14, 2010.
 295 Riley, Karen. Genzyme Corp. Signs Consent Decree to Correct Violations at Allston, Mass., Manufacturing Plant and Give Up $175 Million in Profits. May 24, 2010. U.S. Food and Drug Administration. Electronic. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm213212.htm Accessed June 22, 2010.
 296 Cox, Bowman. Record Drug Recall Totals for 2009 Resulted from GMP Breakdowns. The Gold Sheet, May 2010, Vol. 44, No. 5.
 297 Eglovitch, Joanne S. Enforcement on Steroids: FDA Delivers Twice the Drug GMP Warning Letters. The Gold Sheet, April 2010, Vol. 44, No. 4.
 298 21 CFR §211.165.
 299 21 CFR §211.84; 21 CFR §211.110; 21 CFR §211.165.
 300 21 CFR §314.50(d)(1) and 314.94(a)(9)(i).
 301 Williams, Roger L. Official USP Reference Standards: Metrology concepts, overview, and scientific issues and opportunities. Journal of Pharmaceutical and Biomedical Analysis. January 23, 2006, Vol. 40, No.1.
 302  21 USC §351 (b).
 303  21 USC §355.
 304  21 USC §351 (a)(1).
 305 U.S. Food and Drug Administration, U.S. Customhouse, Philadelphia, PA. Form FDA 483, Inspectional Observations. To Hakan Erdemir, Vice President of Operations, McNeil Consumer Healthcare, Division of McNeil-PPC, Inc.  April 30, 2010. http://www.fda.gov/downloads/AboutFDA/CentersOffices/ORA/ORAElectronicReadingRoom/UCM210772.pdf. Accessed May 26, 2010.
 306 U.S. Food and Drug Administration. Memorandum to Mr. Malvinder Mohan Singh, CEO & Managing Director, Ranbaxy Laboratories Limited. February 25, 2009.
 307 European Commission. Annex I: Scientific Conclusions and Ground for Amendments of the Marketing Authorisation and Recall of Batches Presented by the European Medicines Agency. Annex to multiple Commission Decisions of 29.3.2010: suspending the marketing and withdrawing, under Article 20 of Regulation (EC) No 726/2004 of the European Parliament and of the Council, certain batches of [multiple Clopidogrel products], a medicinal product for human use. http://ec.europa.eu/health/documents/community-register/2010/2010032978389/anx_78389_en.pdf. Accessed August 25, 2010.
 308 United States Pharmacopeial Convention. White Paper: USP's Role in Setting Enforceable Quality Standards for Medicines. Council of the Convention Section on the Quality of Manufactured Medicines. September 23, 2009.
 309 Williams, Roger. Chief Executive Officer, United States Pharmacopoeia. "Economically Motivated Adulteration." Presentation at U.S. Food and Drug Administration Public Meeting on Economically Motivated Adulteration. May 1, 2009.
 310 Ibid.
 311 United States Pharmacopeial Convention. White Paper: USP's Role in Setting Enforceable Quality Standards for Medicines. Council of the Convention Section on the Quality of Manufactured Medicines. September 23, 2009.
 312 Firschein, Ben. Director, Government Affairs, United States Pharmacopeial Convention. Direct Communication, September 15, 2010.
 313 U.S. Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research. Guidance for Industry: Q3A Impurities in New Drug Substances. June 2008. ICH Revision 2. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm127984.pdf. Accessed December 30, 2010.
 314 Ibid.
 315 Basu, Prabir. Executive Director, National Institute for Pharmaceutical Technology and Education. Direct communication, December 17, 2009.
 316 Lutter, Randall. Deputy Commissioner for Policy, U.S. Food and Drug Administration. "Addressing Challenges of Economically-Motivated Adulteration." Presentation at U.S. Food and Drug Administration Public Meeting on Economically Motivated Adulteration. College Park, Md., May 1, 2009. http://www.fda.gov/downloads/NewsEvents/MeetingsConferencesWorkshops/UCM163631.ppt. Accessed August 27, 2010.
 317 Van Trieste, Martin. Vice President Quality; Commercial Operations, Amgen. Presentation at U.S. Food and Drug Administration Public Meeting on Economically Motivated Adulteration. College Park, Md., May 1, 2009.
 318 Lutter, Randall. Deputy Commissioner for Policy, U.S. Food and Drug Administration. "Addressing Challenges of Economically-Motivated Adulteration." Presentation at U.S. Food and Drug Administration Public Meeting on Economically Motivated Adulteration. College Park, Md., May 1, 2009. http://www.fda.gov/downloads/NewsEvents/MeetingsConferencesWorkshops/UCM163631.ppt. Accessed August 27, 2010.
 319 Hamburg, Margaret. A, Commissioner, U.S. Food and Drug Administration. Keynote presentation at the Partnership for Safe Medicines Interchange 2010, October 8, 2010. http://safemeds.typepad.com/files/safe-medicines-speech_final.pdf. Accessed October 13, 2010.
 320 Basu, Prabir. Today's Hidden Crisis in Health Care: the State of Pharmaceutical Manufacturing. The PRM Report. September 2008, Vol. 3, No. 14. http://www.nipte.org/docs/RPM_REPORT.pdf. Accessed August 16, 2010.
 321 Winkle, Helen N. Director, Office of Pharmaceutical Science, Center for Drug Evaluation and Research, U.S. Food and Drug Administration. "Office of Pharmaceutical Science Program Updates." Presentation at Consumer Healthcare Products Association 39th Manufacturing Controls Seminar, New Brunswick, N.J., October 4, 2007. http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ucm103452.pdf. Accessed January 20, 2011.
 322 Williams, Roger. Chief Executive Officer, United States Pharmacopoeia. "Economically Motivated Adulteration." Presentation at U.S. Food and Drug Administration Public Meeting on Economically Motivated Adulteration. May 1, 2009.
 323 Rothman, Barry. Division of Manufacturing & Product Quality, Office of Compliance, Center for Drug Evaluation & Research, U.S. Food and Drug Administration. "Pharmaceutical Ingredient Supply Chains." Presentation at FDA News Supplier Management Congress, Arlington, Va., August 19–21, 2009.
 324 Provan, Laura. "US Pharmacopeia Announces Revised Heparin Monographs and Reference Standards." US Pharmacopeia. June 23, 2008. http://www.eurekalert.org/pub_releases/2008-06/up-upa062308.php. Accessed June 10, 2010.
 325 http://www.usp.org/hottopics/heparin.html.
 326 U.S. Food and Drug Administration. Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations. September 2006. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070337.pdf. Accessed December 8, 2010.
 327 U.S. Food and Drug Administration. FDA Fundamentals. http://www.fda.gov/AboutFDA/Transparency/Basics/ucm192695.htm. Accessed December 8, 2010.
 328 U.S. Food and Drug Administration, Science Board, Subcommittee on Science and Technology. "FDA Science and Mission at Risk." November 2007.
 329 Ibid.
 330 Subcommittee on Health, Committee on Energy and Commerce, U.S. House of Representatives. Hearing on "Drug Safety." March 10, 2010. Hearing transcript. http://democrats.energycommerce.house.gov/Press_ill/20100310/transcript.03.10.2010.he.pdf. Accessed August 5, 2010.
 331 Public Law 110-161—December 26, 2007. Consolidated Appropriations Act, 2008, http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ161.110.pdf. Accessed January 17, 2011.
 332 Public Law 111-8—March 11, 2009. Omnibus Appropriations Act, 2009, http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_public_laws&docid=f:publ008.111.pdf. Accessed January 17, 2011.
 333 Public Law 111-80—October 21, 2009. Agriculture, Rural Development, U.S. Food and Drug Administration, and Related Agencies Appropriations Act, 2010. http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_public_laws&docid=f:publ080.111.pdf. Accessed January 17, 2011.
 334 Public Law 112-10—April 15, 2011. Department of Defense and Full-Year Continuing Appropriations Act, 2011. http://www.gpo.gov/fdsys/pkg/PLAW-112pub110/pdf/PLAW-112pub110.pdf. Accessed May 3, 2011.
 335 Acheson, David. Associate Commissioner on Foods, U.S. Food and Drug Administration. "FDA Funding to Protect America's Food Supply." Testimony before the Committee on Appropriations, Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies. U.S. House of Representatives. 2008. http://www.hhs.gov/asl/testify/2008/09/t20080917a.html. Accessed May 2, 2011.
 336 Public Law 110–252—June 30, 2008. Supplemental Appropriations Act, 2008. http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ252.110.pdf. Accessed January 17, 2011.
 337 U.S. Government Accountability Office (November 2007). Drug Safety: Preliminary Findings Suggest Weakness in FDA's Program for Inspecting Foreign Drug Manufacturers (Publication No. GAO-08-224T).
 338 U.S. Government Accountability Office (September 2010). Drug Safety: FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed (Publication No. GAO-10-961).
 339 U.S. Government Accountability Office (November 2007). Drug Safety: Preliminary Findings Suggest Weakness in FDA's Program for Inspecting Foreign Drug Manufacturers (Publication No. GAO-08-224T).
 340 Public Law 110-161—December 26, 2007. Consolidated Appropriations Act, 2008, http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ161.110.pdf. Accessed January 17, 2011.
 341 Public Law 111-8—March 11, 2009. Omnibus Appropriations Act, 2009, http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_public_laws&docid=f:publ008.111.pdf. Accessed January 17, 2011.
 342 Public Law 111-80—October. 21, 2009. Agriculture, Rural Development, U.S. Food and Drug Administration, and Related Agencies Appropriations Act, 2010. http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_public_laws&docid=f:publ080.111.pdf. Accessed January 17, 2011.
 343 Public Law 112-10—April 15, 2011. Department of Defense and Full-Year Continuing Appropriations Act, 2011. http://www.gpo.gov/fdsys/pkg/PLAW-112pub110/pdf/PLAW-112pub110.pdf. Accessed May 3, 2011.
 344 21 USC §360 subsection (h).
 345 U.S. Government Accountability Office (November 2007). Drug Safety: Preliminary Findings Suggest Weakness in FDA's Program for Inspecting Foreign Drug Manufacturers (Publication No. GAO-08-224T).
 346 Henney, Jane E., M.D, Commissioner, U.S. Food and Drug Administration. "Counterfeit Bulk Drugs." Statement before the Subcommittee on Oversight and Investigations, Committee on Commerce, U.S. House of Representatives, October 3, 2000.
 347 U.S. Government Accountability Office (September 2010). Drug Safety: FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed (Publication No. GAO-10-961).
 348 U.S. Government Accountability Office (November 2007). Drug Safety: Preliminary Findings Suggest Weakness in FDA's Program for Inspecting Foreign Drug Manufacturers (Publication No. GAO-08-224T).
 349 U.S. Food and Drug Administration. FY 2004 PDUFA Financial Report Required by the Prescription Drug User Fee Act of 1992 As Amended by the U.S. Food and Drug Administration Modernization Act of 1997 and by the Prescription Drug User Fee Amendments of 2002. March 2005. http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/FinancialReports/PDUFA/UCM134318.pdf. Accessed August 16, 2010.
 350 U.S. Government Accountability Office (November 2007). Drug Safety: Preliminary Findings Suggest Weakness in FDA's Program for Inspecting Foreign Drug Manufacturers (Publication No. GAO-08-224T).
 351 Ibid.
 352 Ibid.
 353 U.S. Food and Drug Administration. Pharmaceutical cGMPs for the 21st Century—A Risk-Based Approach. U.S. Food and Drug Administration Final Report, September 2004. Refer to the following section: Improved Integration of the Preapproval and CGMP Inspection Programs. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/Manufacturing/QuestionsandAnswersonCurrent Good ManufacturingPracticescGMPforDrugs/ucm176374.htm. Accessed February 23, 2010.
 354 U.S. Food and Drug Administration Compliance Program Guidance Manual. Program 7346.832 Chapter 46—New Drug Evaluation. Subject: Pre-Approval Inspections. Implementation Date: May 12, 2010. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/Manufacturing QuestionsandAnswersonCurrentGoodManufacturingPracticescGMPforDrugs/ucm071871.pdf. Accessed August 20, 2010.
 355 U.S. Government Accountability Office (November 2007). Drug Safety: Preliminary Findings Suggest Weakness in FDA's Program for Inspecting Foreign Drug Manufacturers (Publication No. GAO-08-224T).
 356 U.S. Government Accountability Office (September 2008). "Better Data Management and More Inspections Are Needed to Strengthen FDA's Foreign Drug Inspection Program." Report to Congressional Requesters (Publication No. GAO-08-970).
 357 U.S. Government Accountability Office (September 2010). Drug Safety: FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed (Publication No. GAO-10-961).
 358 Ibid.
 359 Ibid.
 360 Ibid.
 361 Ibid.
 362 U.S. Government Accountability Office (November 2007). Drug Safety: Preliminary Findings Suggest Weakness in FDA's Program for Inspecting Foreign Drug Manufacturers (Publication No. GAO-08-224T).
 363 U.S. Government Accountability Office (September 2010). Drug Safety: FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed (Publication No. GAO-10-961).
 364 Ibid.
 365 21 USC §360.
 366 U.S. Government Accountability Office (September 2010). Drug Safety: FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed (Publication No. GAO-10-961).
 367 Ibid.
 368 U.S. Government Accountability Office (November 2007). Drug Safety: Preliminary Findings Suggest Weakness in FDA's Program for Inspecting Foreign Drug Manufacturers (Publication No. GAO-08-224T).
 369 U.S. Government Accountability Office (September 2010). Drug Safety: FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed (Publication No. GAO-10-961).
 370 U.S. Government Accountability Office (November 2007). Drug Safety: Preliminary Findings Suggest Weakness in FDA's Program for Inspecting Foreign Drug Manufacturers (Publication No. GAO-08-224T).
 371 Rönninger, Stephan F. Hoffmann-La Roche Ltd. EFPIA 2009 Regulatory GMP Inspection Survey. April 2010.
 372 U.S. Government Accountability Office (September 2010). Drug Safety: FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed (Publication No. GAO-10-961).
 373 U.S. Government Accountability Office (November 2007). Drug Safety: Preliminary Findings Suggest Weakness in FDA's Program for Inspecting Foreign Drug Manufacturers (Publication No. GAO-08-224T).
 374 Ibid.
 375 Ibid.
 376 André, Philippe. Director, Qualiau Pharmaceutical Auditing Co., Ltd.; Associate Professor, School of Pharmaceutical Science and Technology, Tianjin University. Direct communication, March 8, 2010.
 377 Zell, Brant. Past Chair, Bulk Pharmaceuticals Task Force, Society of Chemical Manufacturers and Associates. Vice President, Quality, Polypeptide Laboratories. Direct communication, April 10, 2010.
 378 Villax, Guy. Board Member of the European Fine Chemicals Group and Rx-360; CEO, Hovione. Direct communication. February 22, 2010.
 379 Basu, Prabir. Executive Director, National Institute for Pharmaceutical Technology and Education. Direct communication, December 17, 2009.
 380 André, Philippe. Director, Qualiau Pharmaceutical Auditing Co., Ltd.; Associate Professor, School of Pharmaceutical Science and Technology, Tianjin University. Direct communication, March 8, 2010.
 381 U.S. Government Accountability Office (November 2007). Drug Safety: Preliminary Findings Suggest Weakness in FDA's Program for Inspecting Foreign Drug Manufacturers (Publication No. GAO-08-224T).
 382 U.S. Government Accountability Office (September 2010). Drug Safety: FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed (Publication No. GAO-10-961).
 383 Ibid.
 384 U.S. Food and Drug Administration. "FDA Science and Mission at Risk." Report of the Subcommittee on Science and Technology, November 2007.
 385 U.S. Government Accountability Office (September 2010) U.S. Food and Drug Administration: Overseas Offices Have Taken Steps to Help Ensure Import Safety, but More Long-Term Planning Is Needed (Publication No. GAO-10-960).
 386 Ibid.
 387 Ibid.
 388 U.S. Food and Drug Administration. "Revitalizing ORA: Protecting the Public Health Together in a Changing World." Rockville, Md.: January 2008.
 389 Ibid.
 390 U.S. Government Accountability Office (November 2007). Drug Safety: Preliminary Findings Suggest Weakness in FDA's Program for Inspecting Foreign Drug Manufacturers (Publication No. GAO-08-224T).
 391 Ibid.
 392 Ibid.
 393 Ibid.
 394 Laipson, Elizabeth. FDA Answers IT Wake-up Call. Government Health IT, a publication of HiMSS Federal Health Community, November 20, 2009. http://govhealthit.com/news/fda-answers-it-wake-call-0. Accessed November 23, 2009.
 395 21 USC §355 (b)(1)(D).
 396 U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Guideline for Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Products. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM149698.pdf. Accessed August 16, 2010.
 397 21 CFR §211.184.
 398 U.S. Food and Drug Administration. Protecting Patients: FY 2011 Congressional Justification with summary table. http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM205622.pdf. Accessed May 2, 2011.
 399 U.S. Food and Drug Administration. FDA Regulatory Procedures Manual. Chapter 9: Import Operations and Actions. http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm179264.htm. Accessed January 26, 2011.
 400 Nielsen, Carl. Statement before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, U.S. House of Representatives. November 1, 2007.
 401 Ibid.
 402 Skud, Timothy E. Deputy Assistant Secretary for Tax, Trade, and Tariff Policy, U.S. Department of the Treasury. Testimony before the Subcommittee on Trade, Committee on Ways and Means, U.S. House of Representatives. Hearing on Customs Trade Facilitation and Enforcement in a Secure Environment. May 20, 2010. http://waysandmeans.house.gov/media/pdf/111/2010May20_Skud_Testimony.pdf. Accessed November 14, 2010.
 403 Kelley, Colleen M. National President, National Treasury Employees Union. Testimony before the Subcommittee On Trade, Committee On Ways And Means, U.S. House of Representatives. Hearing on Customs Trade Facilitation and Enforcement in a Secure Environment. May 20, 2010.
 404 Tanner, John S., Chairman, Subcommittee on Trade, Committee on Ways and Means, U.S. House of Representatives. Opening Statement, Hearing on Customs Trade Facilitation and Enforcement in a Secure Environment. May 20, 2010. http://democrats.waysandmeans.house.gov/Hearings/transcript.aspx?NewsID=11181. Accessed November 14, 2010.
 405 United States Department of Homeland Security. IT Program Assessment: CBP- Automated Commercial Environment (ACE)—International Trade Data System (ITDS). http://www.dhs.gov/xlibrary/assets/mgmt/itpa-cbp-ace-itds.pdf. Accessed November 14, 2010.
 406 Office of Regulatory Affairs, Office of Resource Management, U.S. Food and Drug Administration. PREDICT: Briefing Slides for Importers and Entry Filers. http://www.fda.gov/downloads/ForIndustry/ImportProgram/UCM176726.pdf. Accessed January 26, 2011.
 407 Autor, Deborah M., Director, CDER Office of Compliance. U.S. Food and Drug Administration. Email correspondence, March 20, 2011.
 408 Ibid.
 409 Federal Register, Secure Supply Chain Pilot Program; Notice of Pilot Program. January 15, 2009, Vol. 74, No. 10:2605–2608.
 410 Public Law 111-353—January 4, 2011. FDA Food Safety Modernization Act. Section 807(b). http://gov/fdsys/pkg/PLAW-illpub1353/pdf/PLAW-illpub1353.pdf. Accessed March 7, 2011.
 411 21 USC §381(a).
 412 Ibid.
 413 21 CFR §7.40 (c).
 414 Osborne, Walt D. MS, JD. FDA's Recall Authority Is Important Arrow in Agency's Enforcement Quiver. FDA Veterinarian Newsletter 2007 Volume XXII, No II.
 415 U.S. Food and Drug Administration. FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer. FDA News Release. November 6, 2008. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116977.htm. Accessed November 11, 2010.
 416 U.S. Department of Justice, Office of Legal Policy. Report to Congress on the Use of Administrative Subpoena Authorities by Executive Branch Agencies and Entities. http://www.justice.gov/archive/olp/rpt_to_congress.pdf. Accessed February 14, 2011.
 417 U.S. Government Accountability Office (October 2010). U.S. Food and Drug Administration: Response to Heparin Contamination Helped Protect Public Health; Controls That Were Needed for Working with External Entities Were Recently Added (Publication No. GAO-11-95).
 418 21 USC §333.
 419 U.S. Drug Enforcement Administration. Federal Trafficking Penalties. http://www.justice.gov/dea/agency/penalties.htm. Accessed February 14, 2011.
 420 Siak, Nadine Leavitt. United States Intensifies Fight against Counterfeit Drugs: Tougher Trademark Laws Considered, Say Justice Officials. USINFO. December 1, 2006. http://www.america.gov/st/washfile-english/2006/December/20061201120711LNkaiS0.2569086.html. Accessed May 3, 2010.
 421 21 CFR §211.22.
 422 21 CFR §820.20.
 423 European Parliament. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use.
 424 Fleder, John R. The Park Criminal Liability Doctrine: Is It Dead or Is It Awakening? The Food and Drug Law Institute. September/October 2009. http://www.fdli.org.
 425 FDA Webview. Top FDA Litigator Warns Industry on Misdemeanor Prosecutions. April 22, 2010.
 426 FDA Webview. FDA to Target CEOs Personally in Off-Label Promotion Suits. October 14, 2010.
 427 Hamburg, Margaret A. MD. Commissioner, U.S. Food and Drug Administration. Letter to the Honorable Charles E. Grassley, Ranking Member, Senate Committee on Finance, United States Senate. March 4, 2010. http://grassley.senate.gov/about/upload/FDA-3-4-10-Hamburg-letter-to-Grassley-re-GAO-report-on-OCI.pdf. Accessed November 14, 2010.
 428 Fleder, John R. The Park Criminal Liability Doctrine: Is It Dead or Is It Awakening? The Food and Drug Law Institute. September/October 2009. http://www.fdli.org.
 429 U.S. Supreme Court, United States v. Park, 421 U.S. 658 (1975). Argued March 18–19, 1975. Decided June 9, 1975.
 430 Fleder, John R. The Park Criminal Liability Doctrine: Is It Dead or Is It Awakening? The Food and Drug Law Institute. September/October 2009. http://www.fdli.org.
 431 FDA Webview. Top FDA Litigator Warns Industry on Misdemeanor Prosecutions. April 22, 2010.
 432 FDA Webview. FDA to Target CEOs Personally in Off-label Promotion Suits. October 14, 2010.
 433 Hamburg, Margaret A. MD. Commissioner, U.S. Food and Drug Administration. Letter to the Honorable Charles E. Grassley, Ranking Member, Senate Committee on Finance, United States Senate. March 4, 2010. http://grassley.senate.gov/about/upload/FDA-3-4-10-Hamburg-letter-to-Grassley-re-GAO-report-on-OCI.pdf. Accessed November 14, 2010.
 434 21 CFR §314.81.
 435 Sharfstein, Joshua. Testimony before the Committee on Oversight and Government Reform, U.S. House of Representatives. Hearing on Johnson & Johnson's Recall of Children's Tylenol and Other Children's Medicines. May 27, 2010.
 436 Cockburn, Robert et al. The Global Threat of Counterfeit Drugs: Why Industry and Governments Must Communicate the Dangers. PLoS Medicine, April 2005, Vol. 2, No. 4.
 437 Ibid.
 438 21 USC §331(j).
 439 21 CFR §20.89.
 440 Hamburg, Margaret. Commissioner, U.S. Food and Drug Administration. Testimony before the House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations. April 13, 2011. http://republicans.energycommerce.house.gov/Media/file/Hearings/Oversight/041311/Hamburg.pdf. Accessed April 27, 2011.
 441 Ireland, J. FDA letter to Representative Barton. June 16, 2010. http://republicans.energycommerce.house.gov/Media/file/News/061610_FDA_Response_Heparin.pdf. Accessed February 17, 2011.
 442 U.S. Food and Drug Administration. Report to Committee on Appropriations on FDA's Approach to Medical Product Supply Chain Safety in Response to the Joint Explanatory Statement to Accompany H.R. 1105, the Omnibus Appropriations Act, 2009. July 2009. http://www.fda.gov/downloads/Safety/SafetyofSpecificProducts/UCM184049.pdf. Accessed January 27, 2011.
 443 International Pharmaceutical Quality. International Joint API Inspection Pilot Program Sees Positive Results. July 19, 2010. http://www.ipqpubs.com/news/international-joint-api-inspection-pilot-program-sees-positive-results/. Accessed September 15, 2010.
 444 Friedman, Rick. Director of the Division of Manufacturing & Product Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration. Remarks at Pew Health Group Conference "After Heparin: A Roundtable on Ensuring the Safety of the U.S. Drug Supply." March 14, 2011.
 445 Swain, Liz. Wyeth Rates Joint GMP Inspection by FDA and EMEA, but Sees Duplication. Inspection Monitor, August 2009. http://findarticles.com/p/articles/mi_6904/is_8_14/ai_n53201599/?tag=content;col1. Accessed September 15, 2010.
 446 Foxhall, Kathryn. FDA Getting Tougher, Faster in Drug Inspections. FDA Webview. September 14, 2010.
 447 Pharmaceutical Inspection Co-operation Scheme: Members and Partners. http://www.picscheme.org/members.php. Accessed January 27, 2011.
 448 Autor, Deborah M., Director, CDER Office of Compliance. Remarks at Pew Health Group Conference "After Heparin: A Roundtable on Ensuring the Safety of the U.S. Drug Supply." March 14, 2011.
 449 Counterfeit Pharmaceutical Inter-Agency Working Group Report to the Vice President of the United States and Congress, March 2011. http://www.whitehouse.gov/sites/default/files/omb/IPEC/Pharma_Report_Final.pdf. Accessed April 13, 2011.
 450 Hamburg, Margaret. A, Commissioner, U.S. Food and Drug Administration. Keynote presentation at the Partnership for Safe Medicines Interchange 2010, October 8, 2010. http://safemeds.typepad.com/files/safe-medicines-speech_final.pdf. Accessed October 13, 2010.
 451 Public Law 111-353—January 4, 2011. FDA Food Safety Modernization Act. Section 808. http://gov/fdsys/pkg/PLAW-illpub1353/pdf/PLAW-illpub1353.pdf. Accessed March 7, 2011.
 452 U.S. Government Accountability Office (September 2010). Drug Safety: FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed (Publication No. GAO-10-961).
 453 21 USC §381(a).
 454 21 CFR §820.40 and 21 CFR §820.50.
 455 European Parliament. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use.
 456 Fein, Adam J. 2011 MDM Market Leaders: Top Pharmaceutical Wholesalers. Modern Distribution Management. May 26, 2011. http://mdm.com/2011_pharmaceutical_mdm-market-leaders. Accessed May 30, 2011.
 457 Vastag, Brian. Alarm Sounded on Fake, Tainted Drugs: Some Wholesalers Are a Weak Link in a Dangerous Chain. JAMA. 2003, 290:1015–1016.
 458 United States Census Bureau. 2007 data. http://factfinder.census.gov/servlet/IBQTable?_bm=y&-ds_name=EC0742I3&-NAICS2007=4242|42421|424210&-ib_type=NAICS2007&-geo_id=&-_industry=4242&-_industry=42421&-_industry=424210&-_lang=en&-fds_name=EC0700A1. Accessed February 8, 2011.
 459 Provost Peters, Christie. Fundamentals of the Prescription Drug Market. National Health Policy Forum. NHPF Background Paper, August 24, 2004. The George Washington University, Washington, D.C.
 460 U.S. Food and Drug Administration. "The Prescription Drug Marketing Act: Report to Congress." June 2001.
 461 Melville, Scott. Senior Vice President of Government Relations, Health Distributors Management Association. Direct communication, November 4, 2009.
 462 United States Attorney's Office. "Boca Raton Man and New Jersey Man Sentenced in $7 Million Human Growth Hormone and Tax Scheme." Press release, July 31, 2008. http://www.justice.gov/usao/fls/PressReleases/080731-01.html. Accessed January 1, 2009.
 463 United States Attorney's Office. "Three Indicted for Diversion of Prescription Drugs." Press release, Southern District of Florida. March 18, 2010. http://www.justice.gov/usao/fls/PressReleases/100318-01.html. Accessed October 13, 2010.
 464 Serono, Inc. "Serostim [Somatropin (rDNA Origin) for Injection]." Press release, January 2001. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm173895.htm. Accessed February 17, 2011.
 465 Otto, Alex. Counterfeit Serostim Found Nationwide. Pharmacy Today, American Pharmacists Association. March 1, 2001. http://www.medscape.com/viewarticle/406804. Accessed October 13, 2010.
 466 Dutchess Business Services, Inc., v. Nevada State Board of Pharmacy. No. 46345. September 11, 2008. http://caselaw.findlaw.com/nv-supreme-court/1219556.html. Accessed February 17, 2011.
 467 Williamson Joyce, P. Statement of Serono before the Task Force on Drug Importation. April 5, 2004. http://archive.hhs.gov/importtaskforce/session2/presentations/Serono.pdf. Accessed February 17, 2011.
 468 U U United States Attorney’s Office. “Boca Raton Man and New Jersey Man Sentenced in $7 Million Human Growth Hormone and Tax Scheme.” Press release, July 31, 2008. http://www.justice.gov/usao/fls/PressReleases/080731-01.html. Accessed January 1, 2009.
 469 I Ibid.
 470 I Ibid.
 471 I Ibid.
 472 I Ibid.
 473 I Ibid.
 474 U U United States Attorney’s Office, Southern District of Florida. “Three Indicted for Diversion of Prescription Drugs. ” Press release, March 18, 2010. http://www.justice.gov/usao/fls/PressReleases/100318-01.html. Accessed October 13, 2010.
 475 I Ibid.
 476 I Ibid.
 477 U U U.S. Food and Drug Administration. FDA Cargo/Warehouse Letter to Stakeholders, April 28, 2010. http://www.fda.gov/ICECI/CriminalInvestigations/ucm209979.htm. Accessed February 17, 2011.
 478 U U U.S. Food and Drug Administration. Update to FDA Alert about Stolen Insulin. August 26, 2009. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm180320.htm. Accessed November 12, 2010.
 479 M M Michelle M. Ciolek, Special Agent, Office of Criminal Investigations, U.S. Food and Drug Administration. Affidavit in Support of Search Warrant. July 21, 2009. USA v. Altec Medical Inc and RX Healthcare Inc. Document number: 8:09-cr-00814-WMC.
 480 I Ibid.
 481 I I Ibid.
 482 U U U.S. Food and Drug Administration. Update to FDA Alert about Stolen Insulin. August 26, 2009. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm180320.htm. Accessed November 12, 2010.
 483 Pharmaceutical Commerce. Eli Lilly suffers $75-million burglary of branded products stolen from a Connecticut warehouse. March 24, 2010. http://www.pharmaceuticalcommerce.com/frontEnd/main.php?idSeccion=1405. Accessed Novemer 19, 2010.
 484 FreightWatch International. 2010 Bi-Annual Cargo Theft Report. http://freightwatchintl.com/sites/default/files/FreightWatch%202010%20Biannual%20cargo%20Theft%20Special%20Report.pdf. Accessed May 3, 2011.
 485 FreightWatch International. Bi-Annual Cargo Theft Report (January–June 2009). http://www.freightwatchintl.com/sites/default/files/FreightWatch%20Special%20Report%202010%20US%20Cargo%20Theft%20Report.pdf. Accessed January 20, 2010.
 486 FreightWatch International. FreightWatch Annual Report, US Cargo Theft: 2010. January 18, 2011. http://www.freightwatchintl.com/?q=webfm_send/34. Accessed February 8, 2011.
 487 U U U.S. Food and Drug Administration. Counterfeit Drug Task Force Report: June 2006. http://www.fda.gov/Drugs/DrugSafety/ucm172759.htm. Accessed February 8, 2011.
 488 Bernstein, Ilisa. Deputy Director, Office of Compliance, Center for Drug Evaluation and Research, FDA. Presentation at the Pew Health Group conference “After Heparin: A Roundtable on Ensuring the Safety of the U.S. Drug Supply.” March 15, 2011. http://prescriptionproject.org/assets/pdfs/Bernstein.pdf. Accessed May 5, 2011.
 489 I Ibid.
 490 Florida Department of Law Enforcement. Florida Diversion Response Teams, Annual Report July 1, 2006 to June 30, 2007. August 2007. http://www.fdle.state.fl.us/Content/getdoc/1299e7be-e6fe-46e1-867e-d046f3d90ccc/DRTAnnualReport0607_4.aspx. Accessed November 23, 2009.
 491 Bernstein, Ilisa. Deputy Director, Office of Compliance, Center for Drug Evaluation and Research, FDA. Presentation at the Pew Health Group conference “After Heparin: A Roundtable on Ensuring the Safety of the U.S. Drug Supply.” March 15, 2011. http://prescriptionproject.org/assets/pdfs/Bernstein.pdf. Accessed May 5, 2011.
 492 Thompson, Cheryl A. Counterfeit Drugs Arise from Various Sources; Wholesalers Blamed for Promoting Drug Diversion. Am J Health-Syst Pharm, Vol. 60, August 1, 2003.
 493 Eban, Katherine. Testimony before the Subcommittee on Criminal Justice, Drug Policy, and Human Resources, Committee on Oversight and Government Reform U.S. House of Representatives. Hearing on “Sick Crime: Counterfeit Drugs in the United States,” November 1, 2005.
 494 Thompson, Cheryl A. Counterfeit Drugs Arise from Various Sources; Wholesalers Blamed for Promoting Drug Diversion. Am J Health-Syst Pharm, Vol. 60, August 1, 2003.
 495 EEban, Katherine. Testimony before the Subcommittee on Criminal Justice, Drug Policy, and Human Resources, Committee on Oversight and Government Reform U.S. House of Representatives. Hearing on “Sick Crime: Counterfeit Drugs in the United States,” November 1, 2005.
 496 Y Y Young, Donna. Counterfeit Drug Lawsuit Points Finger at Wholesaler, Pharmacy. Am J Health-Syst Pharm, Vol. 61, October 1, 2004.
 497 21 USC §353 (e)(1)(A).
 498 Y Y Young, Donna. Counterfeit Drug Lawsuit Points Finger at Wholesaler, Pharmacy. Am J Health-Syst Pharm, Vol. 61, October 1, 2004.
 499 Fagan, Kevin. Testimony before the Subcommittee on Criminal Justice, Drug Policy, and Human Resources, Committee on Oversight and Government Reform U.S. House of Representatives. Hearing on “Sick Crime: Counterfeit Drugs in the United States,” November 1, 2005.
 500 Butler, James M. Testimony before the Subcommittee on Criminal Justice, Drug Policy, and Human Resources, Committee on Oversight and Government Reform, U.S. House of Representatives. Hearing on “Sick Crime: Counterfeit Drugs in the United States,” November 1, 2005.
 501 Fagan, Kevin. Testimony before the Subcommittee on Criminal Justice, Drug Policy, and Human Resources, Committee on Oversight and Government Reform U.S. House of Representatives. Hearing on “Sick Crime: Counterfeit Drugs in the United States,” November 1, 2005.
 502 Thompson, Cheryl A. Counterfeit Drugs Arise from Various Sources; Wholesalers Blamed for Promoting Drug Diversion. Am J Health-Syst Pharm, Vol. 60, August 1, 2003.
 503 I I International Medical Products Anti-Counterfeiting Taskforce, World Health Organization. “Counterfeit Drugs Kill!” Updated May 2008. Accessed April 12, 2011. http://www.who.int/impact/FinalBrochureWHA2008a.pdf.
 504 U U U.S. Food and Drug Administration. “Federal Authorities Cease Sale and Distribution of Counterfeit Lipitor.” Press release, August 31, 2005. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2005/ucm108483.htm. Accessed February 8, 2011.
 505 Department of Justice, U.S. Attorney’s Office, Southern District of Texas. “Distributor of Counterfeit Pharmaceutical Drugs Sentenced.” Press release, January 15, 2009. http://www.justice.gov/criminal/cybercrime/XuSent.pdf. Accessed May 5, 2011.
 506 World Health Organization. “Medicines: Counterfeit Medicines.” Fact sheet N°275. January 2010. http://www.who.int/mediacentre/factsheets/fs275/en/index.html. Accessed February 8, 2011.
 507 U U U.S. Food and Drug Administration. “FDA Sounds Alarm on Phony Tamiflu.” FDA Consumer Alerts. June 17, 2010. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm216009.htm. Accessed October 14, 2010.
 508 I Ibid.
 509 U U U.S. Food and Drug Administration. “FDA Warns Consumers about Counterfeit Drugs from Multiple Internet Sellers.” Press release, May 1, 2007. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108904.htm. Accessed October 14, 2010.
 510 U U United States Immigration and Customs Enforcement. “Dallas Man Convicted for Distributing Counterfeit Pharmaceutical Drugs.” Press release, March 23, 2009. http://www.ice.gov/news/releases/0903/090320portland.htm. Accessed October 15, 2010.
 511 U U U.S. Food and Drug Administration. “FDA Issues 22 Warning Letters to Web Site Operators.” Press release, November 19, 2009. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm191330.htm. Accessed November 23, 2009.
 512 National Association of Boards of Pharmacy. Verified Internet Pharmacy Practice Sites. http://vipps.nabp.net. Accessed October 14, 2010.
 513 U U U.S. Food and Drug Administration. Information on Importation of Drugs Prepared by the Division of Import Operations and Policy, http://www.fda.gov/ForIndustry/ImportProgram/ucm173751.htm. Accessed May 3, 2010.
 514 S.525: The Pharmaceutical Market Access and Drug Safety Act of 2009. Sponsors: Sen. Dorgan, Sen. Snowe. Introduced March 4, 2009.
 515 National Association of Boards of Pharmacy. Model Rules for the Licensure of Wholesale Distributors. Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy. August 2010. http://www.nabp.net/government-affairs/model-actrules/. Accessed October 14, 2010.
 516 Healthcare Distribution Management Association. Distributor Licensing and Pedigree Requirements by State. http://www.healthcaredistribution.org/gov_affairs/.state/state_legis-static.asp. Accessed February 8, 2011.
 517 Herold, Virginia. Executive Officer, California State Board of Pharmacy. Direct communication, June 30, 2011.
 518 National Association of Boards of Pharmacy. Model Rules for the Licensure of Wholesale Distributors. Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy. August 2010. http://www.nabp.net/publications/assets/ModelAct.doc. Accessed October 14, 2010.
 519 Novo Nordisk. Novo Nordisk Warns Customers about Stolen Insulin. Press release. June 13. http://press.novonordisk-us.com/index.php?s=43&item=204. Accessed February 8, 2011.
 520 21 USC §823.
 521 21 USC §828 (a).
 522 U U United States Drug Enforcement Administration. Office of Diversion Control. Practitioner’s Manual. Appendix H—DEA Forms. DEA Form 222 U.S. Official Order Form for Controlled Substances. http://www.deadiversion.usdoj.gov/pubs/manuals/pract/appendices/app_h/222.htm. Accessed October 13, 2010.
 523 21 USC §828 (c).
 524 21 USC §827 (b).
 525 U U United States Drug Enforcement Administration. Automation of Reports and Consolidated Orders System (ARCOS). http://www.deadiversion.usdoj.gov/arcos/index.html#background. Accessed October 14, 2010.
 526 I I Ibid.
 527 21 USC §353 (c)(3)(B).
 528 I Ibid.
 529 21 CFR §205.
 530 21 USC §353 (e)(1)(A).
 531 Prescription Drug Amendments of 1992. Public Law 102-353, 106 Stat. 941.
 532 21 USC §353 (e)(1)(A).
 533 U U U.S. District Court, Eastern District of New York; RxU.S.A Wholesale, Inc., et al. v. U.S. Food and Drug Administration. Report and Recommendation. A. Kathleen Tomlinson, Magistrate Judge. November 30, 2006. (The injunction is based on a lawsuit that was thrown out in October 2009. At the time of this paper’s completion, the injunction against the FDA still stood.)
 534 21 USC §353 (e)(1)(A).
 535 U U U.S. Food and Drug Administration. Guidance Letter on the Prescription Drug Marketing Act Pending the Issuance of Implementing Regulations. Docket No. 88N-258L. August 1, 1988.
 536 U U U.S. Food and Drug Administration. “The Prescription Drug Marketing Act: Report to Congress.” June 2001. http://www.globalcompliance.com/pdf/Prescription%20Drug%20Marketing%20Act%20(PDMA)%20Report%20to%20Congress.pdf. Accessed February 8, 2011.
 537 I I Ibid.
 538 U U U.S. District Court, Eastern District of New York; RxU.S.A Wholesale, Inc., et al. v. U.S. Food and Drug Administration. Report and Recommendation. A. Kathleen Tomlinson, Magistrate Judge. (The injunction is based on a lawsuit that was thrown out in October 2009. At the time of this paper’s completion, the injunction against the FDA still stood.)
 539 I Ibid.
 540 21 USC §355d.
 541 Counterfeit Pharmaceutical Inter-Agency Working Group Report to the Vice President of the United States and Congress, March 2011. http://www.whitehouse.gov/sites/default/files/omb/IPEC/Pharma_Report_Final.pdf. Accessed April 13, 2011.
 542 Administration’s White Paper on Intellectual Property Enforcement Legislative Recommendations. March 2011. http://www.whitehouse.gov/sites/default/files/ip_white_paper.pdf. Accessed April 22, 2011.
 543 Accenture. “Current Status of Safety of the U.S. Prescription Drug Distribution System.” Prepared for the National Association of Chain Drug Stores and the National Community Pharmacists Association. June 2008. http://www.nacds.org/user-assets/pdfs/newsrelease/2008/accentureReport061808.pdf. Accessed October 13, 2010.
 544 Pharmaceutical Commerce. Let’s Call It Project JumpStop: NACDS/NCPA Sponsors Study Slamming Track-and-Trace Systems. June 25, 2008. http://www.pharmaceuticalcommerce.com/frontEnd/main.php?idSeccion=913. Accessed October 13, 2010.
 545 U U U.S. Food and Drug Administration. Guidance for Industry: Standards for Securing the Drug Supply Chain—Standardized Numerical Identification for Prescription Drug Packages. Final Guidance. March 2010.
 546 I I Ibid.
 547 Cardinal Health, Inc. “Pharmaceutical RFID Report: Cardinal Health Releases RFID Pilot Results.” November 17, 2006. RFID Industry. http://www.rfid-industry.com/app/rx/pharmaceuticalsrfidsystems.htm. Accessed February 16, 2011.
 548 U U UPS Supply Chain Solutions. “RFID in Healthcare—A Panacea for the Regulations and Issues Affecting the Industry?” White Paper. 2005. http://www.ups-scs.com/solutions/white_papers/wp_RFID_in_healthcare.pdf. Accessed February 16, 2011.
 549 National Association of Boards of Pharmacy. Model Rules for the Licensure of Wholesale Distributors. Section 1. Requirements for Licensure and Section 2. Minimum Qualifications. Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy. August 2010. http://www.nabp.net/government-affairs/model-actrules/. Accessed October 14, 2010. 

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