Drug Supply Chain Security Act (DSCSA) Implementation Timeline

The Drug Quality and Security Act (DQSA) was enacted on November 27, 2013.  Title II of the DQSA is the Drug Supply Chain Security Act (DSCSA).  The enactment of the DSCSA started the clock on a 10 year implementation plan to track pharmaceuticals as they make their way from the manufacturer to the pharmacy.

There are many activities described in the law that need to happen during the long implementation process that FDA will oversee.  Everything from guidance and assessments to regulations will be issued from FDA on a staggered basis between now and approximately the year 2024.  The DSCSA also requires many public meetings where stakeholders will be able to give their input on what will become the final regulations.  Below is an overview of the timeframes for the DSCSA.

from FDA

Sales of Counterfeit Drugs on Rise

Getting a prescription filled at a cheaper online pharmacy is tempting for many of us.  But, if your online pharmacy is not verified, there’s a chance you are being ripped off or worse yet, putting your life in danger.

The World Health Organization reports that in more than 50% of cases, medicines purchased over the Internet from illegal sites that conceal their physical address have been found to be counterfeit.

In many cases, the drugs do not have their intended ingredients in them. Patients who unknowingly obtain and use the counterfeit drugs are not getting the medical treatment they need and many unsuspecting patients are dying from the counterfeit medicines.

A federal track and trace bill was recently signed into law. The law, known in Congress as the Drug Quality and Security Act means pharmaceutical companies will have to adopt a track and trace system for their medicines.

Individual packs of drugs will need serial numbers within four years of the bill becoming law, which is November 27, 2017. In 10 years, medicine will need to be traceable as it makes its way from the manufacturer to a pharmacy.  Countries in other parts of the world have already implemented similar regulations.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet these regulations. Our track and trace team will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to foreign medical agency databases for pharmaceutical tracking. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.

Data Encryption Key to Cloud Security

The most effective way to maintain data security is with data encryption.  Data encryption is the process of turning data into a secret code so third parties can’t read it, unless they are authorized.  Data is usually encrypted using an algorithm.  Any unauthorized party who sees the data won’t be able to determine its contents without an encryption key, which many of us refer to as a password.  If someone does gain unauthorized access to your data, encryption will ensure it is not readable.

A critical part of data encryption is encryption key management.  Secure key management solutions are the only way to use the Cloud securely and maintain compliance with government regulations, such as HIPAA.

USDM Life Sciences specializes in providing answers and solutions for life science companies looking to move their software and servers to the Cloud.  For more information, visit our Life Sciences Cloud page.

Database of Medical Devices is Public

The Global Unique Device Identification Database (GUDID) is part of the FDA’s Unique Device Identification (UDI) Rule.  The database is managed by the FDA and is accessible to the general public.  The database is a reference catalog for every medical device with a Unique Device Identifier (UDI) attached to it.
 
According to the Draft Guidance for Industry, the database will contain product information, such as registered trade name, dimensions, storage conditions and packaging hierarchy.

The FDA says A UDI system has the potential to improve the quality of information in medical device adverse event reports, which will help the FDA identify product problems more quickly, better target recalls and improve patient safety. In developing the proposed UDI system, the FDA worked closely with industry, the clinical community and patient and consumer groups, and conducted four pilot studies.

Medical device manufacturers are required to have UDIs on their products and submit product information to the GUDID by September 24, 2014.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet these regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID database. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.

Cloud Computing Expected to Grow in 2014

Five years ago, cloud computing was controversial and data security was a big concern.  Fast forward five years -- cloud computing industry experts expect the industry to grow significantly in 2014.  In fact, many expect cloud computing to turn mainstream in the next few years.

The reason many expect cloud computing to continue to grow is because of the advantages that are quickly being integrated into software and hardware solutions.  For example, cloud software facilitates engagement of an entire team – regardless of location.  The cloud allows teams to share and co-author computer files.  Files are stored in the Cloud where they can be accessed and modified by anyone on your team.  Now, there is a growing number of software developers that are creating brand new solutions based on Cloud technology.  In the hardware world, companies are able to utilize servers and IT infrastructure on the Cloud, which saves a lot of money on maintenance, replacement and staffing costs.  Subscriptions to cloud based services are cheaper than in house IT solutions.

Some companies are still hesitant to move to the Cloud because of security concerns.  Cloud security is effective only if security controls are put in place and used properly.

USDM Life Sciences specializes in providing answers and solutions for life science companies looking to move their software and servers to the Cloud. In fact, many of the largest software and hardware companies in the world come to USDM Life Sciences for business intelligence answers.

Companies need to consider data security, data migration, and data integrity, while ensuring that Cloud vendors provide necessary functionality to meet FDA and other regulations around the world.

As a recognized global leader in life sciences compliance, USDM Life Sciences solutions provide security, grow profits and ensure compliance with government regulations.

How UDI and GUDID Maintain Patient Privacy

A Unique Device Identifier (UDI) on a medical device will allow more accurate reporting, reviewing and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly.

As part of the UDI system, the FDA is also creating the Global Unique Device Identification Database (GUDID) which will include basic identifying elements for each device with a UDI. Most of this information will be made available to the public so that users of a medical device can easily look up information about the device. The UDI does not indicate, and the database will not contain, any information about who uses a device, including personal privacy information.  (From FDA website)

Healthcare providers have the ability to store the UDI of a medical device used on a patient in the patient’s medical record.  In the event of a problem or recall of a device, healthcare providers could search their records for patients that were treated with the problem device.  But, patient information is never submitted to the GUDID.  The privacy of patient records is protected by the HIPAA privacy law.

Medical device companies will have to include a UDI on some of their products and submit identifying information about those products to the GUDID starting on September 24, 2014.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet the new regulations. Our team of experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID database. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.

Unique Device Identification: Are You Ready?

In less than a year, class III medical devices will need to have a Unique Device Identification (UDI) on them. The deadline means manufacturers of class III devices will soon need to comply with the FDA’s new UDI rule.  Deadlines for class II and class I devises take effect on a progressive basis over the next five years.

The UDI regulations will impact many aspects of medical device businesses.  Companies will be required to integrate the UDI into their information systems, submit product information to the Global Unique Identification Database (GUDID), and train employees.

For many medical device companies, developing solutions to comply with UDI requirements is complicated. For example, some of the world’s largest medical device companies have more than one thousand devices and sometimes dozens of versions of each one.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. +USDM Life Sciences assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID database. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.