Legislation defines when FDA can take action against compounders October 1, 2013 | By Eric Palmer

This week, Congress is expected to firm up FDA authority over compounding pharmacies like the one tied to last year's fatal outbreak of fungal meningitis. It will also give it stepped-up authority over those compounders that see enough market advantage that they volunteer to be regulated and pay a $15,000-a-year fee for the privilege.

"The question is, why would anybody ask for that? The answer is that 90% of hospitals outsource some of their compounding, and we hope that they will elect to buy from those facilities that operate under FDA oversight and those higher standards," explained Allan Coukell, a drug-policy expert at the Pew Charitable Trusts, which supports the legislation. "I think some will do it."

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Compounder issues nationwide recall of 45 products FDA has inspected 56 of the largest compounding pharmacies August 6, 2013 | By Eric Palmer

Even as other regulatory concerns have moved to the forefront, the FDA has continued its inspection march through the country's largest compounding pharmacies, seeking recalls from those it finds lacking.

The latest recall is from Beacon Hill Medical Pharmacy, which operates under the name of Rxtra Solutions. It is recalling all lots of 45 different products after the FDA "raised a question of sterility assurance" for products from the Southfield, MI, facility. The company said it has not received any reports of adverse reactions. The list of products includes everything from compounded versions of diazepam to vials of testosterone.

This year the FDA started a campaign to quickly inspect the largest compounding pharmacies, facilities that operate more like small drug manufacturers, often shipping products nationwide. The action tracks back to last year's outbreak of fungal meningitis that infected hundreds, dozens fatally. The outbreak was traced to drugs made by New England Compounding Center, which has since closed up shop. Inspections of it and and a sister business found serious issues around sterility. 

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Deja ve--FDA tracking down new outbreak tied to compounded drug May 28, 2013 | By Eric Palmer

Call it FDA déjà vu. While Congress continues to spar with the FDA over its oversight of compounding pharmacies, agency officials are running down yet another outbreak of possible infections tied to a potentially contaminated steroid manufactured by a compounding pharmacy.
The agency said in an alert that there have been 7 reports of adverse reactions after patients received injections of preservative-free methylprednisolone acetate, manufactured by Main Street Family Pharmacy, a compounding pharmacy in Newbern, TN. That is the same drug at the heart of the fungal meningitis outbreak that began last year and at last count had sickened 741 people, 55 fatally. The FDA is still figuring out what has caused the recent reactions but told providers to quarantine the drug because it is a "potentially contaminated medication."
State officials said there were reports of skin abscesses, NBC News reported. "Fortunately, we are aware of no serious events like meningitis, stroke or death in association with this cluster," Tennessee state health commissioner Dr. John Dreyzehner said in a news briefing NBC News reported. But the FDA said at least one of these adverse events appears to involve fungus.
The FDA continues to face criticism from some members of Congress for not taking a more aggressive attitude toward compounding pharmacies after the outbreak tied to the now-defunct New England Compounding Center cut a path of infection and death through much of the U.S. FDA Commissioner Margaret Hamburg has said the FDA's authority over compounders is ambiguous. They traditionally were overseen by state authorities. The agency nonetheless started a crash campaign to inspect the 30 largest compounding pharmacies in the U.S., many of whom have recalled drugs after the FDA said questionable sterility practices in their manufacturing might lead to contamination.
Hamburg has asked Congress to pass a law that gives the FDA clear authority to oversee the largest compounders. A bipartisan Senate bill making its way through Congress would establish a new category of large compounding pharmacies that would have to register with the FDA and report any adverse reactions tied to their drugs. It would not require the compounders to meet all of the strict regulations that drug manufacturers do, like getting preapproval of their products and labels. It would, however, prevent them from any longer making the most complex biologic drugs that are more easily contaminated. They also would not be allowed to make their own versions of FDA-approved drugs unless there was a shortage. And like manufacturers, they would have to kick in fees for the privilege of having FDA supervision.

- here's the FDA notice
- get the NBC News story

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Pediatric drug shortages draw Congressional attention New sterile injectable capacity may help with shortages May 9, 2013 | By Eric Palmer Read more: Pediatric drug shortages draw Congressional attention

The problem of drug shortages in the U.S. is generally discussed in the industry terms of products, plant remediation and FDA approvals. But when the human element is interjected, particularly the effects of drug shortages on infants, it takes a more tragic tone.
That is what senators from both parties hope to do with a letter to the FDA urging it to do whatever is possible to solve drug shortages for pediatric drugs. The letter was sent this week by 14 senators to FDA Commissioner Margaret Hamburg, Regulatory Focus reports. It says, "Without steady doses of total parenteral nutrition, critically ill infants are at risk of serious negative health outcomes such as painful skin lesions, poor bone health, or vitamin deficiencies. We understand that at least one manufacturer of these products is currently offline and is working with you to get back on the market. We ask that you do everything in your power to get these products back on the market quickly and safely."
The letter does not offer any suggestions on what the FDA might do differently to solve the issue. Much of the national shortage problem can be traced to production disruptions when drugmakers initiate improvements after the FDA has sent them warning letters about problems inspectors found.


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