More than a year after a meningitis outbreak caused one of the largest public health crises in recent years, President Obama signed into law a measure giving the Food and Drug Administration (FDA) wider powers to regulate the drug-compounding industry.
In the summer of 2012, incidents of spinal meningitis were linked to the New England Compounding Center (NECC), a Massachusetts company engaged in compounding drugs for the healthcare industry. Compounded drugs are prescription medications mixed to meet specialized needs.
Individual prescriptions are compounded by local pharmacies, while large batches of compounded drugs are produced by outsourcing facilities. NECC was an outsourcing facility that produced dangerously contaminated drugs that injured more than 750 people. Of those victims, 64 people have died.
The Drug Quality and Security Act is a long-sought response to the danger of compounded drugs produced under less than hygienic circumstances. Among other powers, the measure provides the following:
- Drug compounding businesses can voluntarily register with the FDA as outsourcing facilities.
- Registration with the FDA creates a supervision process and regulatory standards for each outsourcing facility.
- Designation as an FDA-registered facility provides a measure of assurance to hospitals and other healthcare providers that compounded drugs produced by those facilities are made under federal quality standards.
- State-licensed pharmacies remain largely under the supervision of local pharmacy boards.
For patients, the new law offers protection from poor drug production practices and the hope that seeking healthcare does not result in further pain or death.
Seek skilled legal guidance if you are injured because of a medication mistake in North Carolina.