differentiate small compounding pharmacies from compounders acting
as stealth manufacturers. Legislators tried in 2003 and 2007, but the
International Academy of Compounding Pharmacists beat back both
attempts, arguing that additional regulations would "negatively impact
patient access to necessary compounded prescription medications."
FDA fights back
Bloodied but unbowed, FDA crafted guidelines to help its enforcement
staff know when a compounder transmogrified into a manufacturer.
One defining practice, FDA said, was "manufacturing large quantities of
unapproved drug products in advance of receiving a valid prescription."
In its policy statement, the FDA said it would defer to state pharmacies
to prosecute small-time infractions, but would "seriously consider
enforcement action" when a compounder started to resemble a manu-
facturer.
Compounders thought that was still too strict, and in early 2005, a
group of them filed suit in Midland, Texas, challenging FDA's ability to
regulate compounding at all. In Medical Center Pharmacy vs. Gonzales,
the District Court agreed with the compounders, holding that com-
pounded drugs were "implicitly exempt" from FDA's "new drug" defini-
tion. FDA appealed, and the Fifth Circuit reversed the decision. That
court said the 503A law could remain in effect, minus the advertising
restrictions. So now in the Fifth Circuit (Texas, Louisiana and
Mississippi), section 503A appeared to be back in force, but not in states
west of the Rockies, where the Ninth Circuit decision held sway. What
to do? The FDA legal department was buffaloed.
Murky is how FDA Commissioner Margaret Hamburg, MD,
described who had legal authority over compounding in later testimo-
ny. "We have different legal frameworks that govern different states,
yet we have an industry that operates across state boundaries," she
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