FDA Provides New Guidance on U.S. Prescription Drugs Supply Chain

WASHINGTON, D.C. — The following quote is attributed to Donald D. Ashley, J.D., Director of the Office of Compliance for FDA’s Center for Drug Evaluation and Research:

“Ensuring the quality of prescription drugs and safeguarding the integrity of pharmaceutical distribution are crucial roles the FDA plays in protecting the health of the American public. Illegitimate and unsafe products must be kept out of the U.S. drug supply chain.

“Since 2013, when the FDA began phasing in new requirements added by the Drug Supply Chain Security Act (DSCSA), we have helped create a supply chain that is better at preventing and detecting the introduction of illegitimate products. The new requirements can also enable stakeholders and the FDA to respond rapidly when such products are found.

“To help our stakeholders understand these requirements, we are issuing guidance documents intended to assist trading partners in complying with the law and achieving a safer, more secure and more trusted drug supply chain. We are also soliciting feedback for further improving the way our drug supply chain operates within the DSCSA framework. We view these guidance recommendations as an important part of implementing the robust enhanced system envisioned under DSCSA.

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We look forward to continuing open conversations on DSCSA-related issues and providing future guidance to stakeholders as part of our efforts to protect American patients and the drug supply chain we all rely on.”

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