Last November, the Drug Quality and Security Act (DQSA), which focuses on compounding and a track-and-trace system, was signed into law. In an effort to detect and remove potentially dangerous drugs, including those that could be counterfeit or contaminated, the U.S. Food and Drug Administration (FDA) has begun its efforts to implement the DQSA.

The DQSA requires that the FDA and groups throughout the supply chain set up systems to verify a product identifier for every package that comes through and to provide information about who handles drug packages. Those who handle drug packages are required to quarantine and investigate any drug that has been identified as suspect, and then notify the FDA and other stakeholders if an illegitimate drug is found in the supply chain.

As a starting point in February 2014, the FDA designated 13 companies to participate in its Secure Supply Chain Pilot Program, which is meant to help the agency focus resources on preventing the entry of high-risk drugs that pose a great risk to consumers. If the program is successful, the FDA may establish a more permanent program and expand it to include more companies.

Additionally, in an effort to collect feedback and ideas, in Federal Register notice 79 Fed. Reg. 9745, the FDA asked stakeholders and interested parties to provide comments on their current practices with respect to verification requests and notifications for suspect or illegitimate drug products. At the same time, the FDA issued a notice for a public workshop for stakeholders and interested parties to share information on current practices, research, and ideas regarding tracking of products throughout the supply chain.

The FDA recently created a website that summarizes the implementation timeframes created for the DQSA. According to the timeline, the FDA will use the information it gathers from stakeholders to issue a draft guidance document with initial standards by Nov. 27, 2014. According to a recent FDA blog post by Ilisa Bernstein, Pharm.D., J.D., Deputy Director of the Office of Compliance in  FDA’s Center for Drug Evaluation and Research, the law requires FDA and other stakeholders to establish systems and processes that will enable them to comply with the DQSA by Jan. 1, 2015.

We at CSIP are encouraged by what the FDA and other stakeholders are doing to implement processes for improved detection and removal of potentially dangerous drugs from the drug supply chain. We concur with the FDA that U.S. consumers deserve safe, effective and high-quality prescription medications, and will continue to do our part to increase awareness among U.S. consumers about online pharmacies before they buy.

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The Center for Safe Internet Pharmacies (CSIP) and our 13 member companies have the shared goal of helping address the growing problem of consumer access to illegitimate pharmaceutical products on the Internet. Continue to read this blog for updates on CSIP’s education, enforcement and information-sharing efforts.

This item was highlighted in CSIP’s February 2015 newsletter.