Compounding pharmacies provide customized prescription medications for patients who are unable to take conventional versions that are produced on large scales. It is understandable that California patients might be under the impression that these compounding pharmacies are as closely monitored as other manufacturers, but the U.S. Food and Drug Administration does not require these pharmacies to adhere to several of the labeling and manufacturing requirements imposed on typical drug makers. This lack of oversight can lead to serious drug injuries that can be compensated by product liability suits.
Patients who use compounded drugs often do so for a variety of reasons. A patient might have a serious allergy to a typical drug component or have difficulty swallowing a pill and need an alternative liquid version instead. These unique needs are understandable, but while the FDA acknowledges that there is an increased risk of these compounded drugs, these pharmacies are not required to report any type of adverse drug reactions.
One of the more recent deaths caused by a compounded medication affected a young child. The 8-year-old was in need of a liquid version for a medication used to treat a sensory processing disorder, but the pharmacy created a version with a dose approximately one thousand times stronger than the average. Incorrect dosages are one of the commonly acknowledged risks associated with compound drugs.
Until the FDA begins to hold compounding pharmacies to the same level of labeling, manufacturing and reporting as it does with other drug makers, patients who need the special services provided by these pharmacies will continue to face an increased risk of injury. This can be especially distressing to California patients who have no choice but to continue taking these drugs for their health. When prescription medications cause serious and even irreversible harm to patients, they often choose to address their physical, financial and emotional damages through the successful navigation of a product liability claim.
Source: Forbes, “Lax FDA Oversight of ‘Compounded Drugs’ Is A Matter Of Life And Death“, Henry I. Miller, July 18, 2016