E-DRUG: Two drug systems in the U.S. (4)
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Greetings all e-druggers,
Both points are very insightful about the relationship between the State
and the professions when it comes to drug definition and
standards-setting. In the US context, the repeal of the compounding
provisions in the 1997 Food and Drug Administration Act (FDAMA) Section
503A (111 Stat. 2328, 21 U.S.C. 353a) were upheld by the US Supreme
Court (5-4 with Justice O'Connor writing the majority opinion) in Tommy
G. Thompson, Secretary of Health and Human Services, et al. Petitioners
v. Western States Medical Center, et al. on writ of certiorari to the
United States Court of Appeals for the Ninth Circuit (535 U.S. 01-344
(2002)). As the law currently stands, pharmacists AND physicians are
exempted from manufacturing provisions provided they do not meet the
3-pronged Central Hudson test (447 U.S. 557, 566 (1980)). See
http://www.uspharmacist.com/index.asp?show=article&page=8_1182.htm for
more information and analysis from a pharmacy law expert.
Regards,
Richard
Richard H. Parrish II, Ph.D., R.Ph.
Assistant Professor
Department of Pharmacy Practice
Bernard J. Dunn School of Pharmacy
Shenandoah University
Faculty Senate Secretary - 2004-5
1775 North Sector Court
Winchester, VA 22601 USA
tel: +1 540 678 4392
fax: +1 540 665 1283
email: RParrish@su.edu