vidual Rx's for individual patients, also a violation of FDA policy.
When challenged, Greg wrote back that "[w]e always compound only
the amount we anticipate will be required based on our prescribing
physician's historical … patterns. … We are a small-scale, family-run,
compounding-only pharmacy, not a manufacturer." According to FDA
Commissioner Hamburg, "NECC repeatedly disputed FDA's jurisdic-
tion over its facility."
The FDA also discovered that NECC had concocted something
called "Extra Strength Triple Anesthetic Cream," which contained
benzocaine, lidocaine and tetrocaine; and had sent samples to physi-
cians. The FDA pointed out that the ingredients could trigger a heart
attack, convulsions or allergic reactions. Like many other com-
pounders, the company was also splitting up vials of Avastin for
intravitreal injections, but NECC had poor control over the storage of
the solution and timing of the administration of the drug, increasing
the chances of infection and endophthalmitis.
In his response, Mr. Cadden was combative. FDA had no jurisdic-
tion, he argued. "NECC does not compound copies of FDA-approved
commercially available drugs, introduce unapproved new drugs into
interstate commerce, does not need approved NDAs before dispens-
ing its compounded medications and does not process or repackage
approved drugs in a manner that would subject us to FDA regulation.
… NECC dispenses compounded medications upon the receipt of
valid prescriptions."
FDA answered the letter contesting most of Mr. Cadden's claims and
advising him to correct the violations. It employed some tough language.
"Your firm must promptly correct the violations … Failure to do so may
result in … seizure of the firm's products and/or an injunction against the
firm and its principals."
The threat turned out to be empty. FDA's attorneys remained para-
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