After Heparin: - The Pew Charitable Trusts
After Heparin: - The Pew Charitable Trusts
After Heparin: - The Pew Charitable Trusts
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REFERENCES<br />
521<br />
21 USC §828 (a).<br />
522<br />
United States Drug Enforcement Administration. Office of Diversion Control. Practitioner’s Manual. Appendix H—DEA<br />
Forms. DEA Form 222 U.S. Official Order Form for Controlled Substances. http://www.deadiversion.usdoj.gov/pubs/<br />
manuals/pract/appendices/app_h/222.htm. Accessed October 13, 2010.<br />
523<br />
21 USC §828 (c).<br />
524<br />
21 USC §827 (b).<br />
525<br />
United States Drug Enforcement Administration. Automation of Reports and Consolidated Orders System (ARCOS).<br />
http://www.deadiversion.usdoj.gov/arcos/index.html#background. Accessed October 14, 2010.<br />
526<br />
Ibid.<br />
527<br />
21 USC §353 (c)(3)(B).<br />
528<br />
Ibid.<br />
529<br />
21 CFR §205.<br />
530<br />
21 USC §353 (e)(1)(A).<br />
531<br />
Prescription Drug Amendments of 1992. Public Law 102-353, 106 Stat. 941.<br />
532<br />
21 USC §353 (e)(1)(A).<br />
533<br />
U.S. District Court, Eastern District of New York; RxU.S.A Wholesale, Inc., et al. v. U.S. Food and Drug Administration.<br />
Report and Recommendation. A. Kathleen Tomlinson, Magistrate Judge. November 30, 2006. (<strong>The</strong> injunction is based on<br />
a lawsuit that was thrown out in October 2009. At the time of this paper’s completion, the injunction against the FDA still<br />
stood.)<br />
534<br />
21 USC §353 (e)(1)(A).<br />
535<br />
U.S. Food and Drug Administration. Guidance Letter on the Prescription Drug Marketing Act Pending the Issuance of<br />
Implementing Regulations. Docket No. 88N-258L. August 1, 1988.<br />
536<br />
U.S. Food and Drug Administration. “<strong>The</strong> Prescription Drug Marketing Act: Report to Congress.” June 2001. http://www.<br />
globalcompliance.com/pdf/Prescription%20Drug%20Marketing%20Act%20%28PDMA%29%20Report%20to%20Congress.<br />
pdf. Accessed February 8, 2011.<br />
537<br />
Ibid.<br />
538<br />
U.S. District Court, Eastern District of New York; RxU.S.A Wholesale, Inc., et al. v. U.S. Food and Drug Administration.<br />
Report and Recommendation. A. Kathleen Tomlinson, Magistrate Judge. (<strong>The</strong> injunction is based on a lawsuit that was<br />
thrown out in October 2009. At the time of this paper’s completion, the injunction against the FDA still stood.)<br />
539<br />
Ibid.<br />
540<br />
21 USC §355d.<br />
541<br />
Counterfeit Pharmaceutical Inter-Agency Working Group Report to the Vice President of the United States and Congress,<br />
March 2011. http://www.whitehouse.gov/sites/default/files/omb/IPEC/Pharma_Report_Final.pdf. Accessed April 13, 2011.<br />
542<br />
Administration’s White Paper on Intellectual Property Enforcement Legislative Recommendations. March 2011. http://<br />
www.whitehouse.gov/sites/default/files/ip_white_paper.pdf. Accessed April 22, 2011.<br />
543<br />
Accenture. “Current Status of Safety of the U.S. Prescription Drug Distribution System.” Prepared for the National<br />
Association of Chain Drug Stores and the National Community Pharmacists Association. June 2008. http://www.nacds.<br />
org/user-assets/pdfs/newsrelease/2008/accentureReport061808.pdf. Accessed October 13, 2010.<br />
544<br />
Pharmaceutical Commerce. Let’s Call It Project JumpStop: NACDS/NCPA Sponsors Study Slamming Track-and-Trace<br />
Systems. June 25, 2008. http://www.pharmaceuticalcommerce.com/frontEnd/main.php?idSeccion=913. Accessed<br />
October 13, 2010.<br />
545<br />
U.S. Food and Drug Administration. Guidance for Industry: Standards for Securing the Drug Supply Chain—Standardized<br />
Numerical Identification for Prescription Drug Packages. Final Guidance. March 2010.<br />
546<br />
Ibid.<br />
102<br />
<strong>Pew</strong> Prescription Project • <strong>Pew</strong> Health Group