Finally! Publication of DSCSA Grandfathering Guidelines

Posted on November 30th, by Eran Strod in News, Pharmaceuticals, Regulations.

November 27, 2017: After a 2-year delay, the FDA has published a grandfathering policy, which specifically exempts certain prescription drugs from the Drug Supply Chain Security Act (DSCSA) requirement to apply a product identifier. Product packaged prior to November 27, 2018, is considered grandfathered. Without specific guidance, how does the supply network distinguish compliant from non-compliant product?

Foodservice Standards Initiative Releases GDSN Guidance

Posted on November 29th, by Eran Strod in Food & Beverage, News.

June 19, 2017: Over 130 foodservice organizations have banded together to create efficiencies, increase safety and improve quality in the foodservice industry through the Foodservice GS1 US Standards Initiative. Applying GS1 Standards, these organizations are creating a roadmap for the foodservice industry supply chain of the future.

Defining DSCSA Trading Partners

Posted on August 21st, by Gary Lerner in News, Pharmaceuticals, Regulations.

August 21, 2017: FDA issues draft compliance guidance on how to identify the 5 key types of DSCSA Trading Partners. This document clarifies the DSCSA participants and their role in facilitating compliance.

Unmarked Product to Become Risky

Posted on July 7th, by Gary Lerner in Integrity Matters, News, Pharmaceuticals.

Some manufacturers might be lulled into thinking a one-year enforcement delay is a good opportunity to relax serialization efforts. However, a more thorough understanding of the revised product identifier requirements suggests that time is of the essence.

FDA Proposes 1 Year Enforcement Delay

Posted on June 30th, by Gary Lerner in News, Pharmaceuticals, Regulations.

This new guidance informs manufacturers and other supply chain stakeholders that although manufacturers are to begin including a product identifier on prescription drug packages and cases on November 27, 2017, the FDA is delaying enforcement of those requirements until November 2018 to provide manufacturers additional time and avoid supply disruptions. While manufacturers work to meet product identifier requirements, they must comply with other DSCSA requirements.

Interoperability Enables Traceability

Posted on November 12th, by Gary Lerner in Integrity Matters, Pharmaceuticals.

Pharmaceutical traceability is the new regulatory reality. Within the next five years most markets will mandate pharmaceutical serialization at the item-level as a means to enable traceability.
A key enabler of pharmaceutical traceability is the ability of manufacturing, packaging, distribution, dispensing and patient to share information in an interoperable manner.

FDA warns Doctors about Risks of Purchasing Unsafe Medications

Posted on June 2nd, by Gary Lerner in News, Pharmaceuticals, Regulations.

To minimize the chance of patients receiving an unapproved, counterfeit, unsafe, or ineffective medication, FDA is requesting that the medical practices stop administering drugs purchased from any foreign or unlicensed source.

Know Your Source

Posted on June 2nd, by Gary Lerner in Medical Devices, News, Pharmaceuticals, Regulations.

FDA is using four flyers to educate and alert medical professionals on the risks and liabilities of purchasing medications from unauthorized or unethical wholesalers.

Establishing Supply Network Visibility

Posted on May 27th, by Gary Lerner in Integrity Matters, Medical Devices, Pharmaceuticals.

The need to establish item level serialization presents the opportunity to develop an information architecture that not only meets DSCSA compliance regulations but also provides business intelligence on supply integrity.

FDA Announces DSCSA Enforcement Delay

Posted on January 6th, by Gary Lerner in News, Pharmaceuticals, Regulations.

FDA has delayed enforcement of Drug Supply Chain Security Act (DSCSA) to minimize possible disruptions of the prescription medicine supply.
FDA intends to delay product tracing information requirements for 5 months.