The Houston pharmaceutical injury attorneys at Denena & Points remark that compounding pharmacies play a strong role in the U.S. medication market, producing roughly 10% of the medications used in patients. Often, these specialized compounding pharmacies take manufactured pharmaceutical products and re-compound them into different individualized doses. Or they add a bulk ingredient to the medication to make it more suitable for certain patients’ individual needs.
Why compund?
Compounding might occur to change the flavor of a medication, or to change it from a liquid medication to a solid pill (or vice versa). Sometimes compounding pharmacists remove an ingredient to which certain patients have allergies.
Who regulates compounding pharmacies?
Because these compounding pharmacies aren’t “manufacturers,” the U.S. FDA does not regulate their production. Our Houston pharmaceutical injury attorneys emphasize that these pharmacy companies are regulated instead by the state pharmacy boards, which don’t have the resources, manpower, budget, or knowledge to provide full oversight of these companies’ operations.
The products of a compounding pharmacy are generally made in response to prescriptions for compounded medications prepared by your physician. Back in the day, before large pharmaceutical companies mass-produced and mass-marketed medications beginning around 1950, compounding was a common activity of pharmacists. But now our Houston pharmaceutical injury attorneys understand that compounding is far less common and few pharmacists are qualified to perform the task.
When your doctor deems it necessary however, a compounding pharmacist might be asked to compound a specific medication for the reasons mentioned above or for the following needs:
Different areas of the U.S oversee compounding pharmacies differently
The U.S. Supreme Court addressed some of the issues regarding compounding pharmacies in Thompson v. Western States Medical Center (535 U.S. 357, 2002). The Supreme Court addressed a provision of the FDAMA statute and held that it was unconstitutional to restrict advertising by compounding pharmacies.
The FDAMA statute also contained a provision mostly exempting compounding pharmacies from FDA control because they do not produce “new” drugs. Our Houston pharmaceutical injury attorneys note that this standard is similar to the FDA expedited approval process standard of substantial similarity for medical devices being introduced to the market. The Supreme Court did not rule on how broadly to interpret that provision nor on if it was severable from the advertising provision it struck from the regulation.
As such, a split now exists among the U.S. circuit courts regarding these questions. So depending on which circuit court governs your state, the strictures regarding compounding pharmacies could be quite different.
Get help if you’ve been injured by a flawed pharmaceutical product
If you or a family member have experienced pain, disability, illness, or injury because of a flawed pharmaceutical product, contact our dedicated Houston pharmaceutical injury attorneys for a free and confidential legal consultation. With more then 14 years of experience addressing the complex issues of causation, liability, and injury related to defective drugs, we could help you understand your eligibility for financial compensation for your injury.
Our sound legal counsel could help you make informed choices among your available legal options to suit the needs of yourself and your family. Call or email the Houston pharmaceutical injury attorneys at Denena & Points today for your free case evaluation consultation and get started on your road to recovery.