HERNDON, Va., March 11, 2016 /PRNewswire-USNewswire/ -- InfiniTrak announced that it has been invited to participate in the upcoming FDA Drug Supply Chain Security Act (DSCSA) Pilot Project workshop, which is expected to focus primarily on clarifying objectives of pilot programs for serialization and serialization data exchange. The event will be the first in the agency's required series of public meetings to gather stakeholder requirements and explore approaches for DSCSA implementation. The public workshop will be held on April 5, 2016, from 9 a.m. to 5 p.m. and April 6, 2016, from 9 a.m. to 12:15 p.m. in Silver Spring, MD at the FDA's White Oak Campus.
As the leading software solution for dispensers, InfiniTrak enables customers to be fully compliant with the evolving DSCSA law. InfiniTrak has been at the forefront of ensuring that the independent pharmacies have an affordable tool that is also effective in the fight against counterfeit and diverted drugs.
InfiniTrak's Chief Compliance Officer, Denise Garcia, noted that "our focus on the independent pharmacy community began early – when there was first talk about new track and trace regulations. There is no question that it is an extremely complicated problem and that new regulations are required. However, we want to make sure these regulations are workable for the independents, and that their voice in this is heard. We are very glad to be at the FDA table."
The FDA announced the workshop last month, billing it as a "forum for discussing proposed design objectives of pilot projects that will explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain." Input at the workshop, along with public comments that can be submitted, will help direct the FDA's development of its pilot project program.
"InfiniTrak looks forward to contributing critical feedback gathered by our customers," added Garcia. "Some of the topics we expect to address include issues surrounding the implementation of the DSCSA, such as utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, and identifying the system attributes that are necessary to implement the requirements established under the DSCSA while allowing our customers to keep their organization operating without disruption. We are proud to be able to represent our customers and key stakeholders in the pharmaceutical supply chain at this important forum."
Details about the live webcast will be available by the end of the month at http://www.fda.gov/Drugs/NewsEvents/ucm481767.htm.
InfiniTrak (www.infinitrak.us) is a cloud-based, software-as-a-service, comprehensive compliance solution for aggregation and verification of track-and-trace data regarding the current and past locations of pharmaceutical products. The company, also named InfiniTrak, is headquartered in Herndon, VA.
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