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Oversight still lacking in Florida for compounding pharmacies

Last November, President Obama signed a law called the “Drug Quality and Security Act,” which is designed to give the Food and Drug Administration more authority over “bulk compounders.” However, the responsibility for “traditional compounding pharmacies” still seems to be with individual states. These are terms that may be unfamiliar to most people. Compounding pharmacies “tailor-make” prescription drugs for people who can’t take the regular version. While this is supposed to be done on an individual or small-scale basis, some pharmacies have become “bulk compounders,” making and selling medication patented by other companies. However, they are outside of FDA control.

Florida’s Department of Health has made efforts to amend state law to help it regulate the hundreds of compounding pharmacies in other states that are licensed to send medication to Florida residents, but the proposed legislation was not taken up last year. The DOH says it is reviewing the language of the new federal law to determine what changes still need to be made to state law. The bill presently proposed by the DOH would allow state inspectors from Florida to look at out-of-state compounding pharmacies, at the expense of the pharmacies. Currently, monitoring of compounding pharmacies is left to the states where they are located, and Florida’s DOH has no control over them.

The dangers of poor oversight were spotlighted in 2012 when an injectable steroid made by a compounding pharmacy in New England was blamed for an outbreak of fungal meningitis. Seven of the 64 people who died from the contaminated medication were Floridians. Although that pharmacy is no longer in business, other compounding pharmacies licensed to ship medication to Florida have been determined by state or federal regulators to be “operating in dangerous conditions.”

Potentially, the most dangerous drugs are those that go straight into the bloodstream. These are known as “sterile.” In the wake of the meningitis outbreak and the gaps in the law it uncovered, the Florida Board of Pharmacy has implemented new requirements to increase regulation of sterile compounders and is considering more.

Most patients don’t know whether the medication they are taking came from a compounding pharmacy, from a traditional pharmacy or a drug manufacturer. However, the level of regulation is considerably different. With the large senior population in Florida, it is hoped that state representatives and health officials will act to rectify this difference in regulation before another deadly outbreak occurs.

Source: Health News Florida, “Time to Fix Glitch in Pharmacy Law?” Carol Gentry, Jan. 03, 2014

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