11 March, 2019

FDA Violation issued! Form 483 Letter to one of Country’s Largest Wholesale Distributor

2018 was a pretty significant year for the Drug Supply Chain Security Act (DSCSA) with a major deadline occurring last November. With this, there have been some rumblings in the industry as to when we ...

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29 January, 2019

What’s Next for the DSCSA in 2019?

TrackTraceRx will be at USA pavillion, Hall 1 Booth F37 at the Arab Health DUBAI. Stop by and say hello!   Members of the drug supply chain in the United States breathed a collective sigh of relief ...

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12 December, 2018

7 Important Questions Answered About the DSCSA and Product Identifiers

Members of the drug supply chain, specifically wholesalers and manufacturers, have been working furiously towards meeting product identifier requirements for a fast approaching deadline. The deadline requires that pharmaceutical manufacturers adhere product identifiers to every ...

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18 November, 2018

FDA Issues Last Minute Draft Guidance to Address Human Readable Identifiers

Before jumping into today's article we wanted to thank everyone that visited us at the HDA conference in Washington D.C. and everyone that we met in Europe during the and Web Sub Summit. More ...

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16 October, 2018

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 ...

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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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