Thursday, February 25, 2016
Study: States Ignore New Federal Compounding Law
By Walter F. Roche Jr.
A study by led by a non-profit agency has found that the majority of state pharmacy boards are allowing sterile drugs to be compounded without a patient-specific prescription in apparent violation of a 2013 federal law.
The study issued by the Pew Charitable Trusts found that 28 of 43 states that responded to a survey were allowing sterile drugs to be compounded without prescriptions for a specific patient. According to the study, 21 of those states did place some limits on the numbers of nameless prescriptions that could be issued, while seven had no limits.
The study findings, which also cited the virtual lack of any state regulation of drugs compounded in physicians' offices, comes nearly four years after a Massachusetts drug compounding firm triggered a nationwide fungal meningitis outbreak sickening 778 patients, 76 fatally.
The outbreak, caused by thousands of fungus loaded vials of a spinal steroid, led to the new law and a federal probe resulting in the indictment of 14 people on charges ranging from mail fraud to second degree murder. All have entered not guilty pleas and face a September trial in Boston, Mass.
The Pew study focused on the actions of state pharmacy boards in the wake of the outbreak and the passage of the Drug Quality and Security Act of 2013. The federal statute created a new category of licenses for manufacturers producing large quantities of compounded drugs subject to new federal controls.
The study describes drug compounding as a "longstanding practice"under which a pharmacist prepares a drug tailored to a patient's specific needs."
"State policies permitting compounding without a prescription for human use conflict with recently clarified federal law," the report states.
The Pew study focused on drug compounding not subject to the new federal law but still under state regulation.
The study relied on information posted on state and the District of Columbia pharmacy board web sites and the responses to a detailed questionnaire. Eight states including Alabama, Delaware, Florida, Georgia and Ohio never bothered to respond.
"State policies vary significantly in their policies for sterile drug compounding," the report states, adding, "it appears that states have not moved quickly to synchronize their regulations to the federal policy."
In addition to the widespread failure to require patient specific prescriptions, the report cites the apparent lack of any regulation over drug compounding in physicians' offices.
According to the report only Idaho directly oversees compounding activities in physicians' offices.
"There is little to no clarity on which quality standards apply to sterile compounding in physicians' offices," the report states, "and often no mechanisms exist to track adverse events in these settings.
Among the overall findings were: less than half of the 43 states reported using the U.S. Pharmacopeia standard for compounding sterile drugs; 26 of the 43 don't require the reporting of adverse events, 24 boards track the number of drug compounders, nine require separate licenses for drug compounders.