Tag: Pharmaceuticals

Finally! Publication of DSCSA Grandfathering Guidelines
November 30, 2017

Finally! Publication of DSCSA Grandfathering Guidelines

The pharmaceutical industry has reason to celebrate. After a 2-year delay, the U.S. Food and Drug Administration (FDA) has published a grandfathering policy, which specifically
Read More...
Defining DSCSA Trading Partners
August 21, 2017

Defining DSCSA Trading Partners

Today FDA issued draft DSCSA compliance guidance on how to identify DSCSA Trading Partners. This draft guidance provides clarity on how to classify trading partner
Read More...
Unmarked Product to Become Risky
July 7, 2017

Unmarked Product to Become Risky

One Year Enforcement Delay – Not!? Hidden Timetable in DSCSA Product Identifier Requirements With about 100 working days left until the November 27, 2017 deadline
Read More...
FDA Proposes 1 Year Enforcement Delay
June 30, 2017

FDA Proposes 1 Year Enforcement Delay

Product Identifier Requirements would take effect no later than November 27, 2018 June 30, 2017 FDA issues a draft DSCSA compliance guidance delaying enforcement action
Read More...
Interoperability Enables Traceability
November 12, 2015

Interoperability Enables Traceability

Understand the Challenges and Opportunities Pharmaceutical traceability is the new regulatory reality. Within the next five years, most markets will mandate pharmaceutical serialization at the
Read More...
FDA warns Doctors about Risks of Purchasing Unsafe Medications
June 2, 2015

FDA warns Doctors about Risks of Purchasing Unsafe Medications

As of January 1, 2015 the DSCSA mandated that all healthcare practitioners who dispense or administer prescription drugs to patients must purchase their prescription drug
Read More...
Shortage of Saline Solution may Threaten Hospital Patients
January 23, 2014

Shortage of Saline Solution may Threaten Hospital Patients

The FDA recently warned health care providers of a shortage of saline solution used for intravenous (IV) solutions, such as 0.9% sodium chloride injection.  A
Read More...
Plans to Defeat Piracy?
December 20, 2012

Plans to Defeat Piracy?

Piracy is a business.  High quality counterfeits can wreak havoc on brand integrity and customer loyalty.  Piracy is another form of competition, perhaps more dangerous
Read More...
A Serious Threat to Supply Integrity?
December 20, 2012

A Serious Threat to Supply Integrity?

Spend enough time investigating brand piracy and you begin to question everything.  When we first started designing brand integrity solutions for leading branded companies in
Read More...
Serialization in a CMO Environment
December 19, 2012

Serialization in a CMO Environment

Strategic Approaches for Becoming Serialization-Ready By Gary Lerner, Todd Applebaum and Jim Dougherty, Clarkston Consulting and BrandSure, LLC Published May 30, 2012, in Contract Pharma;
Read More...