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FDA Ruling to take effect on 10/15/2015

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The FDA has recently published the final rule implementing section 708 of the Food and Drug Administration Safety and Innovation Act (FDASIA). The rule provides the FDA  with an administrative process for the destruction of certain drugs refused admission to the United States. Many of these drugs come into the United States via international mail.

The pharmaceutical industry provides products to millions of consumers that rely on these products to live a healthier life.  These companies spend countless hours validating, labeling and ensuring their products meet strict requirements and arrive to the consumer properly.  Unfortunately not all products that reach customers meet these rigorous standards and the FDA is doing their part by destroying them.

As of October 15, 2015 the FDA has the ability to confiscate and destroy any products entering the United States that do not meet the following criteria:

-Doesn’t contain the active ingredient that patients need for treatment or disease

-Too much or too little of an active ingredient

-Contains the wrong active ingredient

-Contains toxic ingredients

Included in this are dietary supplements that have been found to contain high levels or pharmaceutical ingredients.

Before this ruling products that met the above were simply refused delivery into the United States and the company’s manufacturing these products were not impacted heavily.  Destroying these products will result in huge financial losses and the hope that companies producing these dangerous products will close their doors.

To view the full article click below:

http://blogs.fda.gov/fdavoice/index.php/2015/09/destroying-certain-imported-drugs-a-new-rule-to-protect-patients/

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