There was a silver lining to the NECC mess: Congress responded
in 2013 by passing the Drug Quality and Security Act (DQSA), which
established 503B outsourcing facilities. The suppliers who work
under that label are permitted to compound drugs in bulk and there-
fore are held to higher safety standards. They're also required by law
to register with the FDA, comply with Current Good Manufacturing
Practice (CGMP) standards and to meet certain other quality
requirements such as reporting adverse events to the FDA and pro-
viding the agency with information about the products they com-
pound.
"Because compounds are made under CGMP standards at facilities
inspected regularly by the FDA, drugs from 503B facilities are less
likely to be contaminated, more likely to be of the appropriate poten-
cy and more likely to be chemically stable," says Jane A. Axelrad,
principal at Axelrad Solutions and former FDA drug regulatory policy
chief who was instrumental in getting DQSA passed.
2. Is it FDA-registered?
Despite passage of the DQSA, not all pharmacies that compound
drugs register with the FDA. To ensure you work with a reputable
supplier, check the updated list of FDA-registered compounding facili-
ties: osmag.net/KmAA2h. The list also provides contact names and
phone numbers of each facility.
Your work isn't done when you reach out to an FDA-registered 503B
facility. Knowing the right questions to ask and the correct responses
to receive is critical. The American Society of Health-System
Pharmacists (ASHP) Research and Education Foundation developed
the "Outsourcing Sterile Products Preparation Vendor Assessment
Tool," a free online guide you can use when asking compounders
about their processes. Download a PDF at
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