Agency Publishes Guidance on Licensing Standards, Requirements
Denver, CO -- The Food and Drug Administration (FDA) has announced draft guidance to help pharmacies, manufacturers, distributors and other stakeholders in the pharmaceutical drug industry understand licensing standards and requirements under a new uniform system to track all prescription drugs from manufacture to the drug store. Colorado U.S. Senator Michael Bennet co-authored the Drug Quality and Security Act, which establishes the track-and-trace system to help secure the drug distribution supply chain.
"We're glad the FDA is moving forward to restore confidence in our drug supply chain and protect our families from potential health risks," Bennet said. "We will carefully review the FDA's guidance to ensure it works for everyone along the supply chain. Coloradans deserve to know that their prescription drugs are safe and effective, and this new track and trace system will help us accomplish that."
Bennet helped write the drug supply chain security provisions of the Drug Quality and Security Act, which are based off a bill he introduced with Senator Richard Burr (R-NC) last year after working to find consensus for several years.
Under the prescription drug security provisions of the bill, the FDA will know who has handled which drugs and when they handled them, preventing counterfeit or stolen pharmaceuticals from being sold back into the system and allowing the FDA to respond to recalls and shortages more quickly and efficiently.
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