injection. The drug was available in preserved form as Depo-Medrol.
But pain specialists preferred the unpreserved variety for epidural
injections. The Caddens and Conigliaros apparently saw that in certain
areas, NECC could basically be a drug manufacturer masquerading as
a pharmacy, without observing the FDA regulations drug manufactur-
ers must endure.
Between the cracks
For their enterprise, the regulatory karma could hardly have been bet-
ter. All pharmacies, including compounding pharmacies, had been
until that time regulated by state pharmacy boards. FDA had no
authority over them, a fact that was chafing FDA Commissioner David
Kessler. Two years earlier, in 1996, he prophetically warned Congress
that drug-compounding pharmacies that were mass-producing drugs
without observing Good Manufacturing Practices would create a
"shadow industry of unapproved drugs that could result in serious
adverse effects, including death."
So the next year, in the massive Food and Drug Modernization Act,
Congress clarified the rules. Section 503A essentially endorsed com-
pounding done by a licensed pharmacist or physician, but only if the
professional were making the drug for an individual patient with a
valid Rx, and only if an FDA-approved drug would not serve. Any
other drug production would be deemed manufacturing, and place the
pharmacy under the same rigid FDA restrictions companies like
Merck and Pfizer had to observe. The law also restricted the types of
drugs pharmacists could make and the materials from which they
could make them. Finally, the law prohibited compounding pharma-
cists from soliciting prescriptions and advertising the drugs they
made. They could only advertise their services.
That last provision proved to be a debacle. The next year, 7 com-
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