After New England Compounding Pharmacy Outbreak, Congress Considering New Legislation
A recent opinion article by The Washington Post took an interesting look at the movement to bring compounding pharmacies under federal regulation. Congress is finally making some progress toward writing laws that would hold compounding pharmacies accountable for producing a quality product. This isn't the first time Congress has tried to do this, but following last fall's fungal meningitis outbreak because of contaminated vials from New England Compounding Center, they're realizing that laws need to change sooner rather than later.
Legislation currently on the table is The Pharmaceutical Quality, Security and Accountability Act. This would create a "compounding manufacturer" category under the regulatory control of the Food and Drug Administration (FDA). Compounding pharmacies would be required to meet current "good manufacturing practices," the high standards that are set for regular pharmaceutical manufacturers, and they would have to register with and be inspected by the FDA.
The Washington Post acknowledges that this a great step in the right direction, but they are also concerned by some exemptions in the legislation, including one for traditional compounders who mix drugs for health-care providers for use in their offices.
Though the legislation does not seem perfect, it is nice to see Congress taking the future of compounding pharmacies so seriously. We hope to never see an outbreak like the one from last fall ever again.
Were you the victim of New England Compound Center's contaminated injections? Did you contract fungal meningitis, or did someone you love die from fungal meningitis? Let us help you get the compensation and peace of mind that you deserve. Girards Law Firm is pursuing claims against this facility for patients as well as attorneys who represent injured patients. If we can assistant you or your clients, please call us toll-free at 888.897.2762 today.