State pharmacy boards are supposed to help protect consumers from bad pharmacies and pharmaceutical companies; however, staff shortages and the lack of funding have made state boards unable to protect consumers, especially from compounding pharmacies. Traditionally, state pharmacy boards have overseen compounding pharmacies in which medications, injections, and creams are mixed according to specific formulas; however, policing the larger compounding operations has been difficult for state officials to do.
After the deadly meningitis outbreak last year, state boards attempted to reduce other contaminated medications made by compounding pharmacies, but they need more support and funding. Because of this and because large compounding pharmacies are more like pharmaceutical companies than small local pharmacies, state pharmacy boards are asking for more oversight by the U.S. Food and Drug Administration (FDA).
The FDA has not governed compounding pharmacies in the past, as regulating compounding pharmacies has been a gray area between the state and federal authorities. However, because of the deadly nationwide outbreaks that have occurred recently, the National Association of Boards of Pharmacy welcomes the FDA’s involvement to bring stricter oversight to the compounding industry.
In order to prevent what happened last year – contaminated injections made by a Massachusetts compounding pharmacy that led to over 50 deaths and more than 700 people sickened – state pharmacy boards know that they cannot regulate compounding pharmacies on their own.
To catch unsanitary conditions and make sure a compounding pharmacy is operating within its pharmacy license, regulation by the FDA is needed. Many compounding pharmacies make thousands of drug combinations without prescriptions and ship them across state lines, thus operating outside of their state-issued pharmacy licenses.
Many feel that because the large compounders are manufacturing medications in bulk, they are essentially drug manufacturers and should be regulated by the FDA just like the pharmaceutical giants. After much debate surrounding this issue, the Senate panel recently approved a bill calling for tighter oversight of compounding pharmacies; however, the smaller compounding operations would still be regulated by state pharmacy boards. The bill is headed to the Senate now, but the House has not reached any such agreement. Our pharmacy malpractice lawyers will bring you updates on any changes affecting the state pharmacy boards and how compounded medicine will be regulated.
If you were harmed by a pharmacy, call Kennedy Hodges at 888-526-7616 for a free consultation and a FREE copy of our report, How to Make Pharmacies Pay for Your Injuries Caused by Medication Errors.