FDA Deputy Director Bernstein Shares What FDA is Doing To Enforce the Drug Supply Chain Security Act
Deputy Director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research Ilisa Bernstein, describes what efforts the FDA is making to enact the drug safety requirements of the Drug Supply Chain Security Act (DSCSA), and invites stakeholders in the fight against counterfeit drugs to answer questions regarding the security and safety of the U.S. drug supply chain.
In her current blog entry, “Creating a New System to Improve the Security of the Drug Supply”, Deputy Director Bernstein describes the DSCSA, explaining, “It will be an ‘interoperable’ system, meaning that different stakeholders in the drug supply chain will be able to communicate with each other and share information about the drug and its location.”
The Drug Supply Chain Security Act, or DSCSA was signed into law on November 23, 2013. It is designed to create a fluid electronic system wherein prescription drug distribution can be monitored throughout their path from manufacturers to patients. Over the next 10 years, the FDA will work with manufacturers and repackagers to have unique product identifiers on certain prescription drug packages. For example, they may use a bar code that could be read electronically.
Additionally the FDA will coordinate with manufacturers, wholesaler drug distributors, repackagers, and many dispensers, who are primarily pharmacies, to implement the following provisions:
- Product tracing: Stakeholders in the drug supply chain will provide information about a drug and who handled it each time it is sold in the U.S. market.
- Product verification: Stakeholders will establish systems and processes to be able to verify the product identifier on certain prescription drug packages.
- Detection and response: Stakeholders will quarantine and promptly investigate a drug that has been identified as suspect, meaning that it may be counterfeit, unapproved, or potentially dangerous.
- Notification: Stakeholders will establish systems and processes to notify FDA and other stakeholders if an illegitimate drug is found.
Wholesale drug distributors will report their licensing status and contact information to FDA. This information will then be made available in a public database. Third-party logistic providers, those who provide storage and logistical operations related to drug distribution, will obtain a state or federal licenses.
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As Dr. Bernstein explains, “Time is of the essence because the law requires FDA to issue a draft guidance document with initial standards by Nov. 27, 2014, and for many stakeholders to establish systems and processes that will enable them to comply by Jan. 1, 2015.”
Deputy Director Bernstein spoke about the new law at the 2013 Interchange. She explained the importance of stakeholder participation in such an effort, saying, “Health care providers need to be responsible, and understand that safe buying practices will greatly minimize the chance of getting a substandard or counterfeit product.”