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VRS - Verification Router Services Introduction: Complying With The DSCSA Saleable Returns Requirements

The purpose of the Drug Supply Chain Security Act (DSCSA) is to ensure the safety of drug products as they pass through the supply chain and end up in the hands of consumers. But there are so many provisions to the act that people in the pharmaceutical industry sometimes have a hard time figuring out how to handle certain situations.

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FDA Issues Last Minute Draft Guidance to Address Human Readable Identifiers

As the November deadline for the DSCSA serialization quickly approaches, pharmaceutical manufacturers and other stakeholders within the drug supply chain have been working hard to ensure that they meet compliancy standards, especially considering that the approaching deadline is the cumulation of a year long extension granted by the FDA.

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What Happens to DSCSA Requirements in the Event of a Public Health Emergency?

The purpose of the DSCSA, more formally known as the Drug Supply Chain Security Act, is to create a system that makes it easier to track and trace prescription medications along the drug supply chain in the United States. Initiated in 2013, the DSCSA regulates transactions along the supply chain, including manufacturers, repackager, distributors, pharmacies and other dispensers.

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What DSCSA Means For Pharmacists

Since 1st November 2015, everyone dispensing prescription medicine in the US must comply with the Drug Supply Chain Security Act (DSCSA). That means every pharmacy, and every clinic, hospital, care facility and physician involved in the dispensing of any prescription medicine. DSCSA casts its net wide.

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The Importance of Lot Numbers to Dispensers Under DSCSA

It seems a common question that has arisen since the implementation of DSCSA is whether or not to enter a lot number when drug product changes hands, especially if the lot number isn’t received with a shipment from a wholesale distributor.

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A DSCSA Random Study Request

Today we received a request from one of our customers for assistance in responding to a particular letter they received from the U.S. Department of Health and Human Services, Office of Inspector General. We have assisted customers during audits in the past, but never seen a letter request like this one. Our customer was nice enough to allow us to share the contents of the letter for educational purposes.

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The Penalties Under DSCSA

The DSCSA regulation roll-out not only comes with complex compliance requirements, but also features some harsh penalties for those who fail to follow them. The FDA has already given extensions on some deadlines that recently passed,

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