old section 503A to remove the unconstitutional advertising and pro-
motion provisions. "503A" pharmacies are still legal, and regulated by
the state pharmacy boards, not FDA, but they have to be making indi-
vidual Rx's for individual patients and have valid prescriptions to
show for it.
It also lets compounding pharmacies register as "503B" facilities.
These facilities choose to be regulated by FDA. They are allowed to
make drugs that are "essentially a copy" of currently FDA-approved
drugs as long as they appear on the FDA's drug shortage list. They
cannot make drugs that have been withdrawn from the market for
safety reasons. They don't need individual Rx's for patients. But they
must comply with the FDA's Current Good Manufacturing Processes,
minimum requirements that all drug makers must meet to assure that
the products are high quality. They are also subject to FDA inspection,
and there are rigid reporting requirements.
Far from over
NECC and Ameridose are closed, and all the principals have surren-
dered their pharmacy licenses. Experts praise the Drug Quality and
Security Act (DQSA), but they say the problems with compounding
labs aren't over.
Even without the NECC disaster, compounded pharmaceuticals
have had a less-than-stellar track record. Between 2001 and 2011, FDA
documented at least 25 deaths and 36 serious injuries linked to large-
scale drug compounders, including 13 deaths in 2011 alone. A sepa-
rate accounting of problems linked to compounders between 1988
and 2005 reveals at least 38 deaths and 210 injuries from contaminat-
ed, mislabeled or superpotent drugs.
In the first year after the NECC outbreak, at least 10 companies
recalled compounded drugs, and at least 11 companies were ordered
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