Congress Considering Federal Regulation for Compounding Pharmacies
With compounding pharmacies growing in both size and numbers, Congress is looking for a way to better regulate the facilites. The goal is to ensure the drugs are properly manufactured and distributed to reduce the odds of tainted drugs like those allegedly connected to a string of dangerous bacterial infections found in Corpus Christi, Texas.
What are Compounding Pharmacies?
- According to Medscape, the role of a compounding pharmacy is to adjust a prescription drug, making it suitable for a specific patient or a group with medical needs that cannot be met by commercially available pharmaceutical products.
- The compounding of medications may include adjusting dosage. A commercial drug manufacturer may develop a drug and distribute it in 10mg and 20mg tablets. If a patient is in need of a 5mg or 15mg tablet of that drug, a compounding pharmacy would take the commercially available drugs and make the necessary adjustment presenting a tablet with the needed dosage.
- Compounding pharmacies may also take a tablet for drug and make it into a liquid form that would be more suitable for small children to avoid choking hazards.
- A final role compounding pharmacies often take is the removal of certain ingredients form a drug. If a patient is allergic to an ingredient like a coloring agent, the compounding pharmacy would remove the agents so that the drug may be administered.
- Thus, a compounding pharmacy finds their business in making patient-specific adjustments to mass produced drugs that would not be economically viable or profitable for larger drug manufacturers.
How are Compounding Pharmacies Regulated?
- While federal litigation plays a role in the rules a compounding pharmacy must follow, they are primarily monitored and regulated by state pharmacy boards.
With a recent surge in the number of compounded products being manufactured and compounding pharmacies beginning to act like small drug manufacturers, two aspects have come into question:
- Do states have sufficient resources to monitor and regulate both the growing number and growing size of compounding pharmacies?
- At what point do compounding pharmacies stop being monitored by the state, and become small drug manufacturers subject to FDA regulation?
- Case in point, Time reported that New England Compounding Center was still under state regulation when, in 2012, it allegedly prepared and distributed corticosteroids that led to serious fungal infections putting roughly 13,000 people in 23 states at risk.
- The distributions resulted in 700 patients developing serious infections and the deaths of 63 people according to the Centers of Disease Control and Prevention.
A more recent outbreak has occurred in Corpus Christi, Texas after patients being treated with an allegedly tainted batch of calcium gluconate developed bacterial infections. Two of the infected patients have died; investigators are still working to confirm a positive link to the coupounding facility. The pharmacy has recalled all unexpired sterile products as a result.
- The compounding pharmacy near Austin, Texas, Specialty Compounding, had recently received a FDA Form 483 after inspectors observed behaviors and conditions which could violate the Food Drug and Cosmetic Act. The FDA inspections of compounding pharmacies were part of renewed interest brought about by the New England Compounding Center case.
- Outbreaks like these have caused Congress to question the current regulations leading to a new bill proposal that will clarify the government’s role in overseeing the production and distribution of compounded products.
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