US Senate to decide on track and trace today

By Gareth Macdonald contact

- Last updated on GMT

US Senate to decide on track and trace today
US Senate to decide on track and trace today

Related tags: United states senate, Barack obama

US Senators will debate pharmaceutical track and trace legislation later today in a session that could have a dramatic impact on how drug supply chains in the country are monitored.

According to the official calendar for the US Senate​ politicians will meet to discuss the “Drug Quality and Security Act” – HR 3204​ – later today, just a few weeks after the US House of Representatives​ passed their version of the legislation.

If the Senate passed HR 3204 – the debate will be streamed online – it could be signed into US law by President Barack Obama in 10 days and make efforts by legislators in various States redundant, notably those in California working on e-pedigree.

Details

If the law is passed by the Senate tonight and signed into law soonafter manufacturers will have to provide electronic transactions information and histories.

In addition, they will have to affix a product identifier to each package and keep the identifier on the package for a minimum of six years after the date of the transaction.

The information will have to include:

— The proprietary or established name or names of the product;

— The strength and dosage form of the product;

— The National Drug Code number of the product;

— The container size;

— The number of containers;

— The lot number of the product;

— The date of the transaction and the date of the shipment; and

— The business name and address of the person from whom ownership is being transferred and the business name and address of the person to whom ownership is being transferred.

Related topics: Regulatory & Safety, Regulations, QA/QC

Related news

Show more

Related products

How to resolve sticking issues in tablet production

How to resolve sticking issues in tablet production

I Holland Limited - Tabletting Science | 24-Jun-2019 | Case Study

Tablet sticking is one of the most common problems in tablet manufacture. Find out how I Holland used the TSAR scientific predictive model and expert tablet...

How to measure powder and granule flow properties

How to measure powder and granule flow properties

Stable Micro Systems | 01-Apr-2019 | Technical / White Paper

Being able to predict, optimise and control powder flow is of prime importance to manufacturers in ensuring high quality standards. Download this free...

Related suppliers