The legislation was partly in response to the deadly fungal meningitis outbreak in 2012, and consists of two components.
The first establishes an FDA-regulated framework under which compounders can register as outsourcing facilities. The second part outlines new national prescription drug tracking provisions, including requirements to add product identifiers to all drug packages (serialization) and requirements regarding transferring a product’s transaction history to the subsequent owner. Ultimately, these provisions call for an interoperable, electronic unit-level system 10 years after enactment (i.e., drug identifiers put on the smallest package and transaction histories transferred electronically among all supply chain members).
FDA will now oversee registered outsourcing facilities by maintaining records of what they produce, receiving adverse event reports regarding compounded drugs produced at a given facility, and conducting risk-based inspection. Upon enactment, the bill will create a unified, national level system, replacing state laws. The requirements for supply chain participants (e.g., manufacturers, re-packagers, wholesalers, and pharmacies) will be phased in over 10 years.
President Obama is likely to sign the bill into law within days.
For more information on the Drug Quality and Security Act, click here.