Meningitis Outbreak Spurs Call for New Regulations
A multi-state outbreak of fungal meningitis linked to contaminated steroidal back injections produced at a Massachusetts compounding center has spurned a call for tighter rules on compounding pharmacies.
What is a Compounding Pharmacy?
- Compounding pharmacies are different from traditional pharmacies in that pharmacists are able to combine or process ingredients to create medications.
- Compounding pharmacies produce medications which are individually formulated to meet patient needs, based on a doctor’s prescription.
- Pharmacists might change the form of a medication from a solid pill to a liquid or re-process a medication to remove a non-essential ingredient, or even to add flavor to a medication.
- Compounding pharmacies are not regulated in the same way as drug companies because the FDA is restricted in their ability to monitor their activities.
- Compounding pharmacies are monitored by state pharmacy boards, not the FDA.
Lawmakers Call for Increased Regulation of Compounding Pharmacies
- On Tuesday (October 9, 2012), Democratic Representatives Rosa DeLauro and Edward Markey indicated they will draft legislation aimed to give the FDA more authority to monitor the safety of drugs produced at compounding pharmacies.
- Specifically, the lawmakers believe the FDA should have authority to bar compounding pharmacies from using ingredients that haven't been cleared by the agency and that the pharmacies should be required to report all safety issues to the FDA.
Contact an Experienced Product Liability Attorney
Thomas J. Henry are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division has extensive knowledge and resources in order to represent our clients efficiently and aggressively.
If you or someone you love contracted fungal meningitis after being injected with Methylprednisolone Acetate produced at New England Compounding Pharmacy, contact Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.