"Bill on Drug Compounding Clears Congress a Year After a Meningitis Outbreak," is the New York Times report by Sabrina Tavernise.
A bill that would give the Food and Drug Administration more power to police compounding pharmacies passed its final hurdle in Congress on Monday, in what experts said was an important step to a safer drug supply in the United States.
The bill, which cleared the Senate without opposition, stops short of giving the F.D.A. complete authority over pharmacies that tailor-mix drugs for individual patients, a process known as compounding. But the bill still provides significant new safeguards, which have earned it the support of public health advocates around the country.
“It has very sharp teeth,” said Sarah Sellers, a drug safety consultant who has tracked the issue for years.
Just over a year ago, tainted injectable drugs from a compounding pharmacy in Massachusetts caused a meningitis outbreak that killed 64 people across the country, according to the Centers for Disease Control and Prevention. The bill, which took shape in the months after the outbreak, was designed to prevent such events.
“This bill will improve oversight of high-risk drug compounding,” said Senator Tom Harkin, Democrat of Iowa, who was one of the authors. President Obama is expected to sign the bill into law.
The practice of compounding has expanded drastically in recent decades, driven partly by the economics of hospitals, which now outsource large parts of their drug mixing. Some pharmacies moved beyond the business of mixing medicines for individual patients to become mini-manufacturers.
But while compounders were subject to state law, the federal authorities had limited power over them. Unlike drug makers, they were not subject to federal requirements that they report problems to the F.D.A. or open their records to federal inspectors.
"Congress Approves More Scrutiny For Compounding Pharmacies," is AP coverage by Matthew Perrone. It's via public radio station WBUR-FM.
Congress is taking a half step toward increasing federal oversight of so-called compounding pharmacies that custom mix medications in bulk, a year after a meningitis outbreak from contaminated steroid pain injections killed at least 64 people and sickened hundreds more.
The Senate approved the bill Monday by voice vote, sending it to President Obama for his signature. The legislation also creates a national system for tracking prescription drugs from manufacturers to retail pharmacies, first through serial numbers on bottles and later through electronic codes. The House passed it in September.
Last year’s meningitis outbreak was eventually traced to a now-closed pharmacy in Framingham, Mass., the New England Compounding Center, where inspectors found mold, standing water and other unsterile conditions. The company shipped more than 17,600 doses of the implicated steroid injection to 23 states. More than 750 people were sickened.
And:
The bill attempts to sort out the legal gray area that allowed the Massachusetts pharmacy and similar businesses to skirt both state and federal regulations. The measure clarifies the FDA’s authority over high-volume compounding pharmacies that mass-produce medications, rather than fill doctors’ prescriptions.
Under the bill, pharmacies can voluntarily register with the FDA and submit to federal quality standards and inspections. FDA officials previously said requiring compounding pharmacies to register with the agency was crucial to preventing future outbreaks.
The bill’s supporters acknowledge that a voluntary approach will succeed only if doctors and hospitals choose to do business with FDA-registered pharmacies.
“Nobody will be required to register in this new category,” said Allan Coukell, drug safety expert with the Pew Charitable Trusts, which lobbied to pass the bill. “The success of the voluntary category will depend on hospitals, clinics and doctors choosing to buy from these FDA-registered facilities.”
In Texas, the Corpus Christi Caller-Times reports, "State health department ties compounding pharmacy to bacterial outbreak at local hospitals earlier this year," by Rhiannon Meyers.
The state Monday tied a Cedar Park compounding pharmacy to a local bacterial outbreak, announcing that an unopened bag of sterile drugs contained the same bacteria that sickened people at Corpus Christi Medical Center hospitals earlier this year.
"Lab tests provide link between Cedar Park pharmacy and 15 ill patients," is the Austin American-Statesman report by Mary Ann Roser.
Laboratory tests show that a sealed medication bag from a Cedar Park pharmacy contained the same bacteria that sickened 15 Corpus Christi patients receiving the pharmacy’s drug this summer, a state health department spokesman said.
Although the lab results are another link between the bacterial outbreak and Specialty Compounding LLC, state investigators have not yet reached any conclusions, Department of State Health Services spokesman Chris Van Deusen said.
“We’re still evaluating what these results mean,” he said Tuesday. “We’re not saying who contaminated” the drugs.
He did not know when the state would finish the months-long investigation.
"Pharmacy: Bacteria That Affected Patients Was Not In Our Medications," is from KZTV-TV.
On Friday, the Food and Drug Administration announced their investigation had found five kinds of bacteria in the calcium gluconate:
- Kocuria kristinae
- Kocuria varians
- Gardnerella vaginalis
- Streptococcus pluranimalium
- Streptococcus thoraltensis
The agency recommended the company no longer produce any medication that requires an IV or injection.
In North Carolina, AP reports, "Asheville compounding pharmacy recalls products." It's via the News & Observer of Raleigh.
A compounding pharmacy in Asheville is recalling sterile products because of the possibility of contamination.
Nature's Pharmacy and Compounding Center is voluntarily recalling sterile products produced over a six-month period, The Asheville Citizen-Times (http://avlne.ws/185xx3j ) reported.
The U.S. Food and Drug Administration said the recall comes because of concerns about the quality control procedures that could pose a potential risk about the sterility of the products.
Owner Bill Cheek says the recall involves around 300 prescriptions distributed from May 4 through Nov. 4.
Earlier coverage of the federal legislation for regulating compounding pharmacies begins at the link.
With this post, I'm adding compounding pharmacies to the category index, and will be updating earlier posts.
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