Tougher Compounding Rules Finally Law

Sep 30, 2014

Stricter regulations in the state’s compounding pharmacy industry take effect Wednesday -- two years after a national outbreak of fungal meningitis killed 64 people, including seven in Florida.

Credit Centers for Disease Control and Prevention

In 2012, when the New England Compounding Center outbreak happened, the state had hundreds of unregulated, non-resident facilities providing these specialized medications to Floridians. Now, the state will require permits for any pharmacies outside state boundaries that want to ship medications in state.

Efforts to tighten oversight over compounding pharmacies started soon after contamination drugs were discovered in 2012, and state officials found more than two dozen of the 751 people infected by tainted steroid injections lived in Florida.

Eight clinics, in Ocala, Pensacola, Miami, Palm Beach Gardens and Orlando, received lots of the contaminated drug, according to a Centers for Disease Control and Prevention investigation. A total of 25 Floridians were infected and sickened, seven of whom died. 

But somehow, a bill to fix the problems fell through the cracks. Health News Florida revealed that the Florida Department of Health failed in 2013 to follow up on draft legislation requesting these tighter restrictions. It’s never been clear what happened.

Under the new law, the Florida Board of Pharmacy will have broader oversight, including the ability to issue immediate sanctions against pharmacies it suspects could cause harm. Prior to the law, based on House Bill 7077, the agency could act only after harm had been identified. The DOH also will be able to inspect more facilities.

This law is one of 32 going into effect on Wednesday. Others include:

·         A high-profile bill involving Florida’s parasailing industry, tarnished over the past several years by the deaths and serious injuries of tourists on Florida beaches. Operators must now be licensed by the U.S. Coast Guard, and they will log weather conditions before embarking on any trip. Trips will no longer be allowed during severe weather conditions, according to the law based on Senate Bill 320.

·         A bill written after a Tampa man tricked his pregnant girlfriend into taking an abortion drug, becomes law. As of Wednesday, the law based on House Bill 59 makes it a crime to cause the death of a fetus at any stage of development.

·         Increased penalties for people who make money off prostitution or the trafficking of children. House Bill 989 also removes the statute of limitations on human trafficking crimes.

--Health News Florida is part of WUSF Public Media. Contact Editor Mary Shedden at (813) 974-8636, on Twitter @MaryShedden, or email at shedden@wusf.org. For more health news, visit HealthNewsFlorida.org.