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New Law Designed to Improve Medication Safety, Security

Jacqueline OlinOver the last two years, you may have seen news stories about outbreaks of fungal meningitis that were occurring across the country. This national health care scare was traced back to contaminated epidural steroid injections made by the New England Compounding Center (NECC) in Framingham, Mass. This tainted medication had been injected into the spinal cord area of people, usually to treat back pain.

The effects of the NECC scandal have been widespread. As of the date of this blog (February 2014), 751 people in 20 states had been sickened by the contaminated medications, and 64 deaths had been reported. It has truly been a tragic story for many families across the U.S.

The NECC situation wasn’t the only story in the news over the past two years about unsafe medications. Consumers also learned that counterfeit vials of an important and widely used cancer drug had been brought into the U.S. from an overseas drug wholesaler.

To ensure that consumers receive medicines that are safe and effective, Congress held hearings and passed the Drug Quality and Security Act in November 2013. Shortly thereafter, President Obama signed the Act into law.

The Drug Quality and Security Act contains two sections: One focuses on medication compounding quality, and the other is designed to ensure that America’s drug supply is safe and secure.

It’s important to understand what the word “compounding” means. This term refers to instances when a medicine has to be prepared because the strength, concentration, or dosage that is needed for a particular patient is not available from drug manufacturers. Compounded medicines can be capsules, creams, gels, oral liquids, or injections.

The Compounding Quality Act creates a new type of compounding pharmacy called a “voluntary outsourcing facility.” Before the law was passed, some pharmacies had moved beyond compounding single medications for specific patients and started creating medications on a larger scale for sale to hospitals, clinics, and physicians for future use. This mass production of drug products, coupled with limited oversight and supervision by federal and state agencies, led to the quality issues we saw with the NECC scandal.

Now, facilities that make larger amounts of compounded medications under the supervision of a licensed pharmacist can register with the Food & Drug Administration (FDA) to be a “voluntary outsourcing facility.” These facilities must now comply with safety and quality requirements set forth in the Drug Quality and Security Act, including reporting data to the FDA and submitting to FDA inspections.

It’s important to note that the new law does not prevent companies that don’t register with the FDA from compounding larger quantities of medications and selling them to the public. However, the law leaves it in the hands of customers to determine whether they are comfortable purchasing from a non-FDA registered facility vs. one that chooses to register under the newly created “outsourcing” category. 

To make sure that a compounded medicine you may be taking is being made at a facility that has this kind of FDA oversight, click here.

The other part of the law, called the Drug Supply Chain Security Act, creates a set of standards to track medications as they are distributed in the U.S. This is designed to help prevent the introduction of counterfeit medications into America’s drug product supply chain. The Act applies a national, uniform standard to this critical public safety process.

There is no way to fully remedy the tragic events that happened to so many patients and their families through the NECC scandal and the counterfeit medications events. But, hopefully, this new legislation will go a long way toward improving the safety and security of the medications we take.

If you want to know more about the Drug Quality and Security Act, click here. And, of course, if you have any questions about the medicine you take, simply ask your pharmacist.

Terri Albarano, M.S., Pharm.D., Clinical Marketing Manager, Specialty Pharmaceuticals / Nutrition, Baxter Healthcare Corporation