FDA issues draft guidance on pharma supply chain security

The Food and Drug Administration on Aug. 18 released draft guidance outlining ways to help organizations comply with drug distribution security provisions, according to Regulatory Focus.

The Drug Supply Chain Security Act of 2013 calls for the development of an electronic, interoperable system by 2023 to track prescription drugs as they are distributed across the supply chain. The law also requires drug distributors to notify the agency of any illegitimate drug products within 24 hours. The law also places product tracing requirements on certain supply chain stakeholders like repackagers, wholesale drug distributors and third-party logistics providers.

The draft guidance seeks to clarify what provisions apply to which entities in accordance with the DSCSA.

The FDA will hold the first of three public meetings on the topic Thursday.

To view the draft guidance, click here.

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