production outsourcing pharmacies that distribute a high volume of
compounded drugs, without prescription, based on anticipatory
requests from physicians (503B). Under DQSA, 503B compounders
have the option of signing up for direct surveillance from the FDA via
routine inspections. A current list of registered operations is available at
fda.gov.
NECC often sent facilities compounded medications in bulk, not in
response to patient-specific prescriptions. A growing number of states
restrict compounding only to patient-specific prescriptions.
The U.S. Pharmacopeial Convention (USP) sets standards for the
identity, strength, quality and purity of medicines compounded at tradi-
tional 503A facilities. Some state boards of pharmacy, largely responsi-
ble for enforcement, have adopted USP standards fully; others, not so
much, which is why
it's important to ask
503A compounders
how they plan to com-
ply with the relevant
chapter. You can also
check out the yearly
surveys conducted by
Pharmacy
Purchasing and
Products magazine
(pppmag.com), in
which compounders
report how well — or
poorly — they've fol-
lowed USP standards.
"There's a lot of
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