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State or Federal Control of Pharmacy Practice
Who should control the practice of medicine? Who should control the practice of pharmacy? of the U.S.; this has been reaffirmed since that time. It is up to the state boards of pharmacy to enforce these standards. The 1906 Federal Food and Drugs Act prohibited the sale of adulterated or misbranded drugs but did not require that drugs be approved by any agency. In 1938, in the Federal Food, Drug, and Cosmetic Act (FDCA), the U.S. Food and Drug Administration (FDA) was formally organized, and FDA approval was required for marketed drugs, which were required to be safe. In 1962, the Kefauver-Harris Amendments required that manufacturers of marketed drugs (those approved by the FDA) also be effective. It is apparent that the work of the FDA concerns “marketed” drugs or those that are manufactured. In the FDCA, the FDA was formally established to monitor the relatively young pharmaceutical industry, which had no enforceable standards at that time. The act does not refer to pharmaceutical compounding. One way the FDA has become involved in compounding is in its definition of a “new drug.” A new drug is “any that is not recognized as being safe and effective in the conditions recommended for its use among experts who are qualified by scientific training and experience.” Obviously, any compounded prescription, including intravenous admixtures, pediatric liquids, and oncology mixtures, is a “new drug.” Possibly the definition should begin: A “new drug” is any marketed/manufactured drug that is not recognized….”
Editorial Editor-in-Chief Assistant to Editor-in-Chief Contributing Authors Loyd V. Allen, Jr, PhD, RPh LaVonn Williams

Lisa D. Ashworth, RPh Gigi Davidson, BSPh, RPh, FSVHP, DICVP Shelly J. Stockton, BSPharm, PhD, RPh

Dana Reed-Kane, PharmD, FIACP, FACA, FCP, NFPPhC Medical Editor Kathryn Hale, MS, MLIS ADDRESS: 122 N. Bryant, Edmond, OK 73034-6301 USA TEL: 800-757-4572, 405-330-0094 FAX: 405-330-5622 Circulation Customer Service/Web Ad Sales Jeannie Couch TEL: (toll free) 800-757-4572 or 405-330-0094 FAX: 405-330-5622 EMAIL: jcouch@ijpc.com

Generally, state lawmakers (legislature) establish professions as legal entities by the professional practice acts of each state. After the profession is established, the state lawmakers make laws to govern that professional practice. The lawmakers also establish a “governing board” to overlook the professional practice in that state. In some states, the governing board may overlook more than one professional practice. Furthermore, the governing boards generally enact “regulations” to govern the practice. The difference between the “laws” and the “regulations” may be that the laws must be changed by the state legislature, whereas the state boards can enact and change the regulations. For physicians, the state medical boards govern the practice of medicine, enact and enforce regulations, and discipline practitioners who do not abide by the laws and regulations. For pharmacists, the state pharmacy boards govern the practice of pharmacy, enact and enforce regulations, and discipline practitioners who do not abide by the laws and regulations. There also are various standards of practice for pharmacists, including those in the United States Pharmacopeia (USP) Chapters <795> and <797>. For compounded and manufactured pharmaceuticals, some of the “standards of quality” have been established by a nongovernmental organization, the United States Pharmacopeial Convention, since 1820. In the 1906 Federal Food and Drugs Act, both the USP and the National Formulary (NF) were designated as the “Official Compendia”

Sales: CompoundingToday.com; RxTriad Wyndi Padgett, BS TEL: (toll free) 888-260-5415 or 409-753-2540 FAX: (toll free) 866-583-4572 or 409-753-2703 EMAIL: rxtriad@ijpc.com Interactive Media Interactive Media Director Advertising New Print Copy Accounts Cindy Nelson TEL: (toll free) 800-661-4572 or 409-899-4457 FAX: 409-899-4458 EMAIL: cnelson@ijpc.com The Compounders’ Network Compounders’ Network List Moderator Board of Directors Jake Beckel, PD, Chairman of the Board Mike Collins, RPh, Treasurer Pat Downing, RPh, Vice President Bob Scarbrough, BSPharm, RPh, President Loyd V. Allen, Jr, PhD, RPh Editorial Board Harvey Ahl, RPh Diane Boomsma, RPh, PharmD, FIACP Marianna Foldvari, PhD, RPh Peter R. Ford, BSPharm, FACA, FIACP Paul F. Grassby, PhD, MRPharmS Hetty A. Lima, RPh, FASHP Dave Mason, DPh, FIACP John Preckshot, RPh, FIACP Lawrence A. Trissel, BS, RPh, FASHP David J. Woods, MPharm, MRPharmS, FHPA WEBSITE www.ijpc.com Lisa D. Ashworth, RPh TEL: 972-471-2805 EMAIL: lashworth@ijpc.com Chris Burr, BBA EMAIL: cburr@ijpc.com

Loyd V. Allen, Jr., PhD, RPh

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178 Vol. 11 No. 3 May/June 2007

International Journal of Pharmaceutical Compounding

www.ijpc.com

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