New Rule Passed to Regulate Compounding Facilities

As many Dallas residents remember the meningitis outbreak that swept across our country last year. The epidemic was caused by a compounding agency -- specifically the New England Compounding Center -- that made steroid injections that were tainted with meningitis bacteria. The doctors using these shots and the patients receiving them had no idea that the compounding agency was unclean, or that the injections were dangerous in that way.

Many people died as a result of NECC's unsafe compounding practices, and it opened up the entire compounding industry to scrutiny. Previously, compounding agencies (which do serve a vital purpose in creating customized and effective drugs that help hospitals keep up with patient demands) were practically unsupervised in their ways. There was little regulation of the sector.

That all changed when the NECC debacle occurred, and now new legislation will further help keep this industry under control so that patients don't needlessly suffer. The new rule called the Drug Quality and Security Act, will place new regulations on the industry and create new categories for compounding facilities.

The one potential flaw with the rule is that compounding facilities will have the option to register with the Food and Drug Administration. Since it won't be required, some compounding facilities may slip through the cracks -- but the hope is that hospitals will naturally choose FDA-approved facilities.

Even with the new rules, the chance of a defective drug negligently making it into the market is always there. Patients who suffer as a result need to consider their legal options, as such pharmaceutical liability cases could help them pay off astronomical medical bills relating to their suffering.

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