under section 503B, which lets them distribute drugs without a
patient-specific prescription.
"We need clear, strong, consistent federal standards that will be
applied across the board to all 50 states," says FDA Commissioner
Margaret Hamberg.
Among other things, 503B facilities (osmag.net/RWb5Vh) are
required to comply with current good manufacturing practice
requirements, report adverse events to the FDA and label their prod-
ucts with certain information. The FDA notes that registration
means only that the agency has received the information required to
register the facility. It does not mean that the facility is making FDA-
approved drugs or that it is in compliance with current good manu-
facturing practice requirements. However, if you buy drugs com-
pounded at a registered outsourcing facility that has had a recent
satisfactory FDA inspection, you'll have some assurance that the
conditions at that facility met applicable current good manufactur-
ing practice standards at the time of the inspection, says the agency.
"If you register as an outsourcing facility," says Ms. Axelrad, "you're
publicly indicating that you're really stepping up your game and will
meet higher standards. 503B provides a much better place for people
to get safe compounded medications."
Compounding pharmacies operating under 503A of FD&C Act don't
have to register with the FDA. The FDA would only inspect a 503A if
it received a report of a problem. "There's no [federal] surveillance
program," says Ms. Axelrad, who issues a couple notes of caution
against 503As.
• Compounders might seek to hide out in the traditional com-
pounding category in order to escape regulatory detection.
• There's lack of clarity over whether a state or the FDA has pri-
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