Legal and Policy Statements

We strive to provide the latest technology for solutions in healthcare to streamline pharmacy operations and improve patient safety. The Baxa Web site provides detailed information on Baxa product specifications, Technical Papers, Instructions for Use, Policy and Procedure Guidelines and more. The following are the policies and guidelines that govern the development of Web site information and other Baxa collateral and/or guide our daily operations.

If you have questions or concerns about the statements within this section, or your interactions with this Web site, contact us here or at 800.567.BAXA (2292), or by writing:

Baxa Corporation
9540 S Maroon Circle
Suite 400
Englewood, CO 80112
Attention: Marketing Department





PEDIGREE LAW STATEMENT

Under the Prescription Drug Marketing Act of 1987, the Federal Food and Drug Administration called for regulations requiring drug distributors to provide documentation of the chain of custody of drug products, otherwise known as a pedigree – throughout the distribution system. Final regulations implementing the law were published in 1999, however the FDA delayed the effectivity date because of the fear that it would be too costly for small distributors to comply.

In the meantime, individual states were encouraged to adopt their own pedigree laws. As of July 2006, the Florida Prescription Drug Act required authentication upon transfer or receipt of all drug products. Originally passed in 2003, this ‘pedigree’ law is to be phased in over three years to allow suppliers time to comply with its requirements. The law was enacted to protect Florida consumers from the risks of counterfeit drugs.

Baxa Corporation works with all major medical wholesalers to stock and deliver its medical devices to hospital and alternate-site customers. Our commitment to our customers is to provide quality products that comply with all applicable international, national and state regulations governing medical devices. At this time, Baxa devices and ‘kits’ do not include any drug products and therefore we do not have any pedigree requirements under the Florida Prescription Drug Act.

Baxa Corporation does not sell, distribute or otherwise include any drug products with our devices. We do not ship drug products to Florida or to any other state or country. As a medical device manufacturer, our products are not included in the Florida Pedigree Law or the FDA equivalent of the law.


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