F R O M T H E E D I T O R

Pre cription
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 Editorial
prohibited the sale of adulterated or mis- Editor-in-Chief Loyd V. Allen, Jr, PhD, RPh
branded drugs but did not require that Assistant to Editor-in-Chief LaVonn Williams
drugs be approved by any agency. In 1938, Contributing Lisa D. Ashworth, RPh
in the Federal Food, Drug, and Cosmetic Authors Gigi Davidson, BSPh, RPh, FSVHP, DICVP
Act (FDCA), the U.S. Food and Drug Shelly J. Stockton, BSPharm, PhD, RPh
Administration (FDA) was formally organ- Dana Reed-Kane, PharmD, FIACP, FACA, FCP, NFPPhC

Generally, state lawmakers (legislature)
establish professions as legal entities by the
professional practice acts of each state. After
the profession is established, the state law-
makers make laws to govern that profes-
sional practice. The lawmakers also
establish a “governing board” to overlook
the professional practice in that state. In
some states, the governing board may over-
look more than one professional practice.
Furthermore, the governing boards gener-
ally enact “regulations” to govern the prac-
tice. 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
ized, and FDA approval was required for Medical Editor Kathryn Hale, MS, MLIS
ADDRESS: 122 N. Bryant, Edmond, OK 73034-6301 USA
marketed drugs, which were required to be
TEL: 800-757-4572, 405-330-0094 FAX: 405-330-5622
safe. In 1962, the Kefauver-Harris Amend- Circulation
ments required that manufacturers of mar- Customer Service/Web Ad Sales Jeannie Couch
keted drugs (those approved by the FDA) TEL: (toll free) 800-757-4572 or 405-330-0094
also be effective. It is apparent that the work FAX: 405-330-5622
of the FDA concerns “marketed” drugs or EMAIL: jcouch@ijpc.com
those that are manufactured.
Sales:
CompoundingToday.com; RxTriad Wyndi Padgett, BS
In the FDCA, the FDA was formally TEL: (toll free) 888-260-5415 or 409-753-2540
established to monitor the relatively young FAX: (toll free) 866-583-4572 or 409-753-2703
pharmaceutical industry, which had no EMAIL: rxtriad@ijpc.com
enforceable standards at that time. The act Interactive Media
does not refer to pharmaceutical com- Interactive Media Director Chris Burr, BBA
EMAIL: cburr@ijpc.com
pounding.
Advertising
New Print Copy Accounts Cindy Nelson
One way the FDA has become involved
TEL: (toll free) 800-661-4572 or 409-899-4457
in compounding is in its definition of a FAX: 409-899-4458
“new drug.” A new drug is “any that is not EMAIL: cnelson@ijpc.com
recognized as being safe and effective in the The Compounders’ Network

enforce regulations, and discipline practition-
ers who do not abide by the laws and regula-
tions.
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 Pharma-
copeia (USP) Chapters <795> and <797>.
For compounded and manufactured
pharmaceuticals, some of the “standards of
quality” have been established by a nongov-
ernmental 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”
conditions recommended for its use among
experts who are qualified by scientific train-
ing and experience.” Obviously, any com-
pounded prescription, including intravenous
admixtures, pediatric liquids, and oncology
mixtures, is a “new drug.” Possibly the defi-
nition should begin: A “new drug” is any
marketed/manufactured drug that is not
recognized….”
Loyd V. Allen, Jr., PhD, RPh
Compounders’ Network List Lisa D. Ashworth, RPh
Moderator TEL: 972-471-2805
EMAIL: lashworth@ijpc.com
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
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International Journal of Pharmaceutical Compounding www.ijpc.com

178 Vol. 11 No. 3 May/June 2007