Track And Trace

Latest Headlines

Latest Headlines

Pharmacies want more time to comply with track-and-trace rules

This year the FDA gave drugmakers, wholesalers and logistics companies an extra four months to get on board with new regulations requiring them to be able to track lots of prescription drug products all along the chain of custody. Now pharmacy groups are asking if they could catch a similar break.

FDA delays enforcing track-and-trace rules by four months

New so-called track-and-trace rules for drugmakers, wholesalers and logistics companies went into effect Jan. 1 requiring them to be able to provide full documentation of lots of prescription drug products all along the chain of custody. They did, but--and it is a significant but--the FDA at the very last minute said it would not enforce all of the new rules before May 1.

Lilly well-positioned with track-and-trace deadlines advancing

Track-and-trace is on its way. Eli Lilly, with its 10-year history of fighting counterfeits, is in a good position to make the switch, and now it's putting the wheels in motion to get the project underway.

Lilly gets ready for track-and-trace in U.S.

Part of the new Drug Quality and Security Act, approved in the U.S. last fall, sets in motion a timeline to eventually have serialization on individual drug units and a system to track them from manufacturing to pharmacy.

$100M fund outlined for victims of NECC manufacturing problems

At year end, owners, operators and insurers of the bankrupt New England Compounding Center came to a preliminary agreement to set up a victims' fund for those who were sickened in a fungal meningitis outbreak last year and their families. 

Track-and-trace is here... and now

The industry has been talking about, and slowly working toward, track-and-trace for many years. Now Pharma faces real deadlines that require action.

U.S. approves drug tracking, compound pharmacy oversight law

The Drug Quality and Security Act, approved by the Senate Monday and now awaiting the president's signature, lays out limited FDA powers to oversee the compounding pharmacy industry and kicks off the process of establishing a so-called national track-and-trace system

Track-and-trace bill may be finished this week

A longtime goal of the FDA is for the industry to put in place a national system that would allow it to follow a drug product from manufacturer to pharmacy. After years of back-and-forth with the industry about how that would be done, it is about to get started.

10-year timeline set for unit-level drug tracking

Track-and-trace, the ability to follow a drug product from manufacturer to pharmacy, has been a longtime goal of the FDA. The agency believes it would help foil drug counterfeiting and expedite recalls for any reason. Drugmakers have said they thought it was a good idea but were reluctant to commit to a date certain since the system requires investments and coordination from every link in the supply chain. Now, a bill poised for passage has put a timeline to it: 10 years to have all the pieces in place and the system operational.

GSK adding 2-D barcodes to vaccine containers

GlaxoSmithKline is joining Sanofi in adding 2-D barcodes to the packaging for most of its vaccines sold in the U.S., allowing doctors' offices to scan crucial information into electronic medical records and potentially saving them significant time.