21 February, 2016

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 ...

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7 February, 2016

The Importance of Collaboration Across the Supply Chain

We have less then 30 days before the DSCSA March 1st deadline. The first step in becoming compliant is creating a collaboration plan with your trading partners. Collaboration by all parties in the supply chain has been ...

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31 January, 2016

What You Should Do If You Suspect a Product Is Illegitimate

Everyone involved in the supply of drugs, from the moment of manufacture to the purchase of the finished drug by the end user, must be aware of the need for accuracy and perfect performance throughout ...

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25 January, 2016

FDA Releases DSCSA Guidance Plan for 2016

The FDA has released their guidance plan for what guidance documents they will release in 2016.  Let’s examine each one: 1. Annual Reporting by Prescription Drug Wholesale Distributors and Third- Party Logistics Providers. *This pertains to ...

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23 November, 2015

What Transactions are Considered Exempt from the DSCSA?

One might think that under DSCSA, dispensers are only required to focus on the literal buying and selling of drug product when it comes to figuring out whether or not T3 compliance documentation needs to ...

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15 November, 2015

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 ...

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9 November, 2015

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 ...

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9 November, 2015

DSCSA – Standard Operating Procedure for Product Tracing

Standard Operating Procedures (SOP) are common documents that outline step-by-step processes to achieve overall results of a longer overall process. Even though it is not a requirement from the DSCSA to have a product tracing SOP, we ...

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20 October, 2015

The Penalties Under DSCSA

Hello Everyone, Chris from TrackTraceRx! We get a lot of questions asking… “What will happen if i am not ready once the deadline takes effect?” “What are the penalties?” etc… I hope this article will ...

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