Security & Supply Chain: Drug Supply Chain Security Act

by Sterling J. Scott, Marketing Communications Coordinator, MHI | @mhi_sterling

The Food and Drug Administration (FDA) just released a draft guidance in June 2014 for Drug Quality and Security Act (DQSA) implementation. President Obama signed the DQSA into law in November 2013 as Title II of the Drug Quality and Security Act with broad bipartisan support. The act outlines measures to build an electronic system for the identification and tracing of prescription drugs as they are distributed in the United States. This will allow verification of drug product identifier legitimacy at the package level, detect illegitimate products in the drug supply chain; and improve the drug recall process.

The act outlines key provisions to be implemented within ten years of being signed into effect:

Product identification: Manufacturers and repackagers to put a unique product identifier on certain prescription drug packages, for example, using a bar code that can be easily read electronically.

Product tracing: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) in the drug supply chain to provide information about a drug and who handled it each time it is sold in the U.S. market.

Product verification: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to establish systems and processes to be able to verify the product identifier on certain prescription drug packages.

Detection and response: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to quarantine and promptly investigate a drug that has been identified as suspect, meaning that it may be counterfeit, unapproved, or potentially dangerous.

Notification: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to establish systems and processes to notify FDA and other stakeholders if an illegitimate drug is found.

Wholesaler licensing: Wholesale drug distributors to report their licensing status and contact information to FDA. This information will then be made available in a public database.

Third-party logistics provider licensing: Third-party logistic providers, those who provide storage and logistical operations related to drug distribution, to obtain a state or federal license.

– FDA (2013)

The implementation of the provisions of the Act require supply chain solutions that provide greater visibility and traceability as well as enhanced labeling and packaging capabilities. Visit www.mhi.org to connect with supply chain and material handling companies that have solutions and products to help secure your supply chain.

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