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How Do FDA Manufacturing Practices Apply to Defective Drugs?


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One of the miracles of modern medicine is the wide variety of pharmaceutical drugs available. For millions of people, the relief brought by the use of various drugs is a boon that improves their lives every day. Of course, as Texas residents may be aware, medicine can be dangerous as well. For example, medications could come with adverse side effects or improper instructions. But what if a drug is manufactured incorrectly, for example by being made too strong, or with improper ingredients? Then the dangers of taking that medicine may multiply.

The federal agency responsible for ensuring that the pharmaceutical industry is providing safe and effective products is the federal Food and Drug Administration (FDA.) This agency has a myriad of enforcement powers and regulations it uses to police drug manufacturers. One of these is the publication of Current Good Manufacturing Practices (CGMPs.) CGMPs are meant to allow drug companies to use a flexible business model to comply with standards that help keep a consistent quality of U.S. pharmaceuticals.

The CGMPs require manufacturers to do certain things to procure a certain standard of ingredient quality for their products. For example, companies need to use strong quality control systems, maintain well-run and effective lab testing facilities, have appropriate procedures for general operations, and must specifically investigate and remedy any inconsistencies. If these guidelines are put into practice, drug companies may be able to prevent situations such as errors, contamination, and other mistakes that could lead to medicines with dangerous effects.

Of course, no system is perfect and sometimes mistakes are made. Further, some companies may be less ethical than others or may try to cut corners in certain areas in order to reduce expenses or increase revenues. When things like this happen and someone is injured by a defective drug, there may be a way to hold the responsible party accountable. People who have been harmed in this way may wish to consider seeking the help they need to understand their options.

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