"When dealing with compounded ophthalmic drugs, you have to
worry about the sterility, potency and purity of any ingredients that
are used," adds Dr. Sturgeon. "You must also make sure that no partic-
ulate matter makes its way into the formulations and ensure drugs are
made in sanitary conditions."
The Drug Quality and Security Act (DQSA) was signed into law in
November 2013 in response to the 2012 fungal meningitis outbreak
that killed 64 people and sickened hundreds more. It's the deadliest
medication contamination case in U.S. history and has been linked to
tainted steroids produced at the now shuttered New England
Compounding Center in suburban Boston.
The DQSA created a new section — 503B — in the Food and Drug
and Cosmetic Act. Under section 503B, a compounder can become an
"outsourcing facility." That created a new type of compounding phar-
macy: a large-scale drug manufacturer that must adhere to strict FDA
regulation, which includes current and good manufacturing practices,
facility inspections, the proper labeling practices and stability testing
of compounded products.
"These are standards that are very close to those in the drug manu-
facturing sector," says Neal Shorstein, MD, an ophthalmologist who is
an associate chief of quality for Kaiser Permanente Northern
California in Walnut Creek, Calif. "We now have a much higher level
of quality and oversight of compounding pharmacies."
Working with 503B compounders offers some assurance of safety,
but don't assume diligent oversight is taking place, says Roger
Goldberg, MD, MBA, of Bay Area Retina Associates, a group of oph-
thalmologists who practice in and around Oakland, Calif. He advises
ophthalmic surgical facilities to partner with compounded pharmacies
that aren't afraid to open their doors to inspectors and follow USP 797,
which is the guideline for the safe preparations of sterile compounded
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