U.S. proposes charging compounding pharmacies for oversight

BOSTON Fri Mar 22, 2013 6:42pm EDT

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BOSTON (Reuters) - The head of the U.S. Food and Drug Administration has proposed charging compounding pharmacies fees to pay for the oversight needed to prevent a recurrence of the meningitis outbreak that killed 50 people and sickened hundreds more.

FDA Commissioner Margaret Hamburg said in an official blog post on Friday that serious problems continue to take place at compounding pharmacies and she is hopeful that the Senate committee with jurisdiction over the issue "will yield strong legislation for patients across the nation."

The post can be found at: here

Hamburg said a possible mechanism for funding the additional oversight could include registration or other fees of the kind Congress has authorized in other instances. Pharmaceutical companies, for example, pay fees to help fund the FDA's drug review process.

Hamburg would like to explore more ideas with Congress, including requiring compounded drugs to have clear labels identifying the nature and source of the product.

The meningitis outbreak was linked to a tainted steroid shipped last year by the New England Compounding Center (NECC), which filed for bankruptcy protection in December after U.S. authorities shut down its pharmacy operations in Framingham, Massachusetts.

Since the NECC case came to light, the FDA has insisted that its authority over specialty pharmacies is too limited.

"Even during this time of heightened awareness, our inspectors are being delayed in their work or denied full access to records at some of the facilities we are inspecting," Hamburg said.

She added that serious problems at compounding pharmacies continue to occur. This week, there had been two recalls of sterile compounded and repackaged drug products.

In one, the presence of floating particles later identified to be a fungus were reported in five bags of magnesium sulfate intravenous solution, resulting in a nationwide recall. In the other, all sterile drug products from a second pharmacy were recalled after reports that five patients suffered serious eye infections associated with a repackaged product.

(Reporting by Tim McLaughlin in Boston, additional reporting by Toni Clarke in Washington; Editing by Leslie Gevirtz)

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Comments (3)
Alexxxx wrote:
Isn’t this avastin the compounded drug that Congress supported being substituted for the FDA approved drug, Lucentis, because it was cheaper? And the opthamology doctors also supported using a compounded drug instead of an FDA approved drug? Who is looking out for patients here?

Mar 23, 2013 9:28pm EDT  --  Report as abuse
IHB wrote:
Before imposing further regulations and fee and FDA oversight we need to realize that NICC was licensed as “Compounding pharmacy” and functioning also as “Manufacturer”. There are different standards and requirements for “Compounding Pharmacy” and for “manufacturing”.
Compounding pharmacies provide “patient specific” medication based on prescriptions. Manufacturers compound in bulk and distribute it,not necessarily end user. Their product could be sitting on the shelf before it is given to the end-user. The State Board of Pharmacy needs to make sure “Compounding Pharmacies” are not functioning as “Manufacturers”. All these compounding pharmacies were manufacturing in bulk and supplying to various clinics for use on “as needed” basis. Implementing existing regulations by Pharmacy Boards is the key here and not imposing more regulations and fee on compounding pharmacies.

Mar 25, 2013 12:22pm EDT  --  Report as abuse
arros wrote:
I wouldn’t say NECC was functioning as a manufacturer. It was a licensed compounding pharmacy, therefor it was a compounding pharmacy. It was licensed to do so.

Thought I do agree that more regulations and fees aren’t the answer. The FDA has been fishing for complete control over compounding ever since big Pharma saw compounding as a threat to its business model. It isn’t about the safety, its about controlled damage to big pharma. Whats needed is the CURRENT oversight by CURRENT regulations with CURRENT state-inspectors. State Board of Pharmacy inspectors should be well-aware of the critical nature of compounding pharmacies, and the need for those pharmacies to be operating in accordance to regulations for patient safety.

Half of the blame should rest with the Pharmacy Board of Massachusetts. They KNEW that pharmacy wasn’t doing all they could to make sure their products were sterile, but they chose not to pull the pharmacy’s license. The amount of injectables being compounded (not to be confused with manufacturing) isn’t the problem….its that the quality checks weren’t being done to needed levels and the oversight of those regulations weren’t being enforced.

Mar 29, 2013 5:50pm EDT  --  Report as abuse
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