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What does 'adulterated' mean for pharmaceutical liability?


Some residents of Texas may already know that if a food product is "adulterated," it contains poisonous or other dangerous substances. While this may be one definition of the word, there are other ways in which it can used. In fact, in the context of pharmaceutical manufacturing regulation, the federal Food and Drug Administration (FDA) uses the term adulterated in a slightly differently manner.

A few weeks ago we touched on the FDA's Current Good Manufacturing Practices (CGMPs). To refresh, these are regulations set out by the FDA that are meant to ensure that drug manufacturers are using proper methods to create and produce their medications. By following these CGMPs, the drug companies are doing their best to assure the public of the quality and efficacy of the products they are providing. But what happens if a company fails to follow one or more of these regulations?

When a pharmaceutical manufacturer fails to live up to the CGMP standards in an area, the FDA will label the products produced by it as adulterated. It is important for Texans to be clear about what that means in this context. It does not, in and of itself, necessarily mean that there is something wrong with a person's specific medication. In fact, the FDA strongly advises people not to stop taking these medications without consulting with their doctors, as many times this can have deleterious health effects. Because of the wide range of possible violations under the CGMPs that could cause it to be legally considered adulterated, there is a reasonable likelihood that any particular batch of medicine is fine, depending on the circumstances. It is always a person's trusted trained health care professional who should be consulted about changes in the use of pharmaceutical treatment.

However, if a person has been harmed by taking a certain medication that was defective in some way, whether or not it had been labelled adulterated, there may be a way to legally pursue damages in a civil lawsuit. It may help to have legal and medical professionals who are aware of the situation and have experience in dealing with pharmaceutical liability assess one's case before moving forward.

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