FDA And Industry Experts Offer Guidance For DQSA Preparation

By Trisha Gladd, Editor, Life Science Connect

It’s been over three months since President Obama signed the Drug Quality and Security Act (DQSA) into law, and some of the industry is still unsure how to proceed with preparation for Title II, which outlines the plan for supply chain security. The first requirement stemming from the DQSA goes into effect on January 1^st 2015. Under this section of the law, manufacturers, wholesalers, and re-packagers must be able to capture and provide the next owner in the supply chain an electronic or paper transaction history, information, and statement. From there, requirements will continue to roll out, and it’s imperative to know which ones affect your company.

In a recent discussion with Pharmaceutical Online, Ilisa Bernstein, Pharm.D, JD, Deputy Director of the U.S. FDA Office of Compliance in the Center for Drug Evaluation and Research (CDER), encouraged the industry to familiarize itself with the law and the requirements under it. “If you are a manufacturer, wholesaler, or packager, know what you need to do and by when it is stated in the law,” says Bernstein. “There are some things FDA will be providing guidance on as additional regulations under the law, but in the meantime, the stakeholders need to know what is coming and what they need to do.”