Page 1, 2, 3
Notes
1. 21 USC353a Section 503A Pharmacy compounding. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm376733.htm. Page last updated Dec. 2, 2013. Accessed June 12, 2014.
2. Ibid. USC353a.
3. USC 21 Section 351. Adulterated drugs and devices. http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapV-partA-sec351.htm. Accessed June 12, 2014.
4. USC 21 Section 352. Misbranded drugs and devices. http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapV-partA-sec352.htm. Accessed June 17, 2014.
5. USC 21 Section 355. New drugs http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapV-partA-sec355.htm. Accessed June 17, 2014.
6. USC 21 Section 503B (a) General. http://www.gpo.gov/fdsys/pkg/PLAW-113publ54/html/PLAW-113publ54.htm. Accessed June 17, 2014.
7. Ibid. Section 503B (d)(4)(A) I.
8. Ibid. Section 503B (a)(2).
9. USC 21 353a Section 503A Pharmacy compounding. http://www.fda.gov/Drugs/GuidanceComplianceRegulatory Information/PharmacyCompounding/ucm376733.htm. Page last updated Dec. 2, 2013. Accessed June 12, 2014.
10. Letter to Commissioner Hamburg. June 27, 2014. Available at http://iacprx.affiniscape.com/associations/13421/files/Griffith%20Green%20DeGette%20Office
%20Use%20and%20Repackaging%206%2027%2014.pdf. (One link, two lines.) Accessed June 28, 2014.
11. Alexander, Senate Committee direct FDA to meet with doctors, patients, pharmacists on compounding law [blog post]. US Senate. http://www.help.senate.gov/newsroom/press/release/?id=d840c1ed-900a-48b4-b98e-f13877fed770&groups=Ranking. Page last updated May 23, 2014. Accessed June 29,2014.
12. Prescriptions: questions and answers. What is a prescription? [Web page]. US Drug Enforcement Administration. http://www.deadiversion.usdoj.gov/faq/prescriptions.htm. Assessed June 17, 2014.
13. USC 21 Section 503B Section 103. PENALTIES. (a) PROHIBITED Acts. http://www.gpo.gov/fdsys/pkg/PLAW-113publ54/html/PLAW-113publ54.htm. Accessed June 17, 2014.
14. FDA. Registered outsourcing facilities [Web page]. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm378645.htm. Page last updated June 17, 2014. Accessed June 18, 2014.
15. IACP issues nominations for FDA's request for bulk drug substances - for both 503A & 503B facilities [online notice]. IACP. http://www.iacprx.org/?page=881&hhSearchTerms=%22fda+and+approval+and+bulk+and+drug%22. Accessed June 19, 2013.
16. Bulk drug substances that may be used to compound drug products in accordance with Section 503B of the Federal Food, Drug, and Cosmetic Act, concerning outsourcing facilities; request for nominations [Web page]. Regulations.gov. http://www.regulations.gov/#!docketBrowser;rpp=25;po=0;D=FDA-2013-N-1524. Accessed June 19, 2014.
17. Additions and modifications to the list of drug products that have been withdrawn or removed from the market for reasons of safety or effectiveness [online document]. Federal Register. https://www.federalregister.gov/articles/2014/07/02/2014-15371/additions-and-modifications-to-the-list-of-drug-products-that-have-been-withdrawn-or-removed-from#h-20http://www.gpo.gov/fdsys/pkg/FR-1999-03-08/html/99-5517.htm. Accessed July 3, 2014.
18. Accredited pharmacies [Web page]. Pharmacy Compounding Accreditation Board (PCAB). http://www.pcab.org/accredited-pharmacies. Accessed June 28, 2014.
19. Verified pharmacy program [Web page]. National Association of Boards of Pharmacy (NABP). http://www.nabp.net/programs/licensure/verified-pharmacy-program. Accessed June 28, 2014.
20. ISO 9000 quality management [Web page]. International Standards Organization. http://www.iso.org/iso/home/standards/management-standards/iso_9000.htm. Accessed June 28, 2014.
21. "Off-label" and investigational use of marketed drugs, biologics, and medical devices - information sheet [Web page]. FDA. http://www.fda.gov/regulatoryinformation/guidances/ucm126486.htm Page last updated Aug. 10, 2011. Accessed June 18, 2014.
22. Compounding and the FDA: are compounded drugs approved by the FDA? [Web page]. FDA. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/
PharmacyCompounding/ucm339764.htm#approved. (One link, two lines.) Page last updated Dec. 2, 2013. Accessed June 18, 2014.
23. About USP [Web page]. U.S. Pharmacopeial Convention. http://www.usp.org/about-usp. Accessed June 28, 2014.
24. USP statement on public standards for compounding [Web page]. U.S. Pharmacopeial Convention. http://www.usp.org/about-usp/our-impact/statements-usp-standards/statement-public-standards-compounding Accessed June 28, 2014. (Editor note: Link does not work.)
25. USP & healthcare professionals [Web page]. U.S. Pharmacopeial Convention. http://www.usp.org/usp-healthcare-professionals Accessed June 28, 2014.
26. Alliance for Natural Health USA [website]. http://www.anh-usa.org. Accessed June 21, 2014.
 Ronald M. McGuff is the owner of McGuff Company Inc., a national and international medical products wholesale company. "McGuff" consists of four companies: McGuff Compounding Pharmacy Services Inc. (sterile and nonsterile compounded drugs); McGuff Pharmaceuticals Inc., a FDA-registered drug manufacturer (aseptically filled drugs); McGuff Medical Canada Inc. (Canada drug distribution); and McGuff Company Inc. (wholesale medical products). As president and CEO, Mr. McGuff chairs the management team that crafts policy and determines company resources and direction for all major programs. Mr. McGuff is a member of the International Society of Pharmaceutical Engineers and of Orange County Regulatory Affairs Discussion Group, and associate clinical professor, Clinical Pharmacy Department, University of California, San Francisco, School of Pharmacy. He has been an invited lecturer to speak on such topics as "IV Solutions and Additives Utilized in Therapeutic Solutions," "Therapeutic IV Solutions," and "Safe and Effective Administration of Chelating Agents," and is a consultant for Guidepoint Global. Mr. McGuff has been actively supporting complementary and alternative medicine (CAM) physicians for over 35 years and continues to support clinical trials that may lead to new treatment options for CAM physicians.
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