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Product Liability And The Compounding Pharmacy Bill

Craig McClellan

The legislative response to the health crisis caused by the New England Compounding Center has been finalized. Critics contend that the measure may do little to avoid the problem of deadly products reaching consumers. Some even claim that the law will actually make it easier for compounding pharmacies to get substandard products into the hands of consumers.

Time will tell whether the Drug Quality and Security Act will help prevent future outbreaks like the one that has claimed more than 60 lives and left roughly 700 people to deal with a rare form of fungal meningitis. In the meantime, if you are suffering as a result of pharmaceutical error, contact The McClellan Law Firm’s San Diego personal injury lawyers for experienced legal advice!

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Drug Quality & Security Act

A primary area of concern about the bill is that it allows compounding pharmacies to do something that was previously forbidden. Compounding pharmacies were, by law, required to only produce drugs to fit individual prescriptions. The restriction was not obeyed by the NECC, which was producing mass quantities of the steroid injections connected to the meningitis outbreak. Under the new bill, compounding pharmacies will be able to voluntarily register with the Food and Drug Administration if they choose to produce drugs without a prescription.

If a compounding pharmacy chooses not to register with the FDA, it will not be required to follow the rigorous sterility testing and quality guidelines as other drug manufacturers. As before, such pharmacies would be limited to producing drugs for individual patients. The bulk production of medications that led to the NECC disaster would continue to be illegal. In that sense, it is not clear that anything has changed.

Updated February 2016

In January 2015, manufacturers were required to begin capturing the transaction history and movement of a pharmaceutical product through the supply chain and store the information for at least six years.

While that began implementation, other participants in the pharmaceutical supply change were required to develop methods to determine the validity of a product. If a product is illegitimate, the participant is required to notify its partners of the product and stop its circulation. The goal of the Drug Quality and Security Act is to establish an interoperable, electronic tracing system for pharmaceutical products within 10 years from the date of enactment.