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 ...

Read More
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FDA Issues Last Minute Draft Guidance to Address Human Readable Identifiers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 ...

Read More
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 ...

Read More
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 ...

Read More
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 ...

Read More
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 ...

Read More
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 ...

Read More
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 ...

Read More
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 ...

Read More
1 2 3 4

talk to our experts

Drop us a line! We will be happy to speak with you.

I would like to discuss: