Compounding pharmacies need FDA oversight

Will Congress step in, to help the FDA?

Compounding pharmacies need FDA oversight - The Washington Post:

. . . Congress gave the FDA some oversight power in 1997 over compounding pharmacies, but several of the firms challenged the law in court. At issue was the FDA’s power to regulate their brochures and advertising. In 2002, the Supreme Court ruled for the pharmacies. Two appellate court decisions since then conflict about whether the original law is valid and enforceable. Congress has failed to clarify the situation. . .

"The federal government, Congress and the states all bear some blame for this lapse of oversight. There are proven methods to prevent contaminated medicine from reaching patients — methods that were simply not used in this case. Congress can remedy the situation by putting the regulation of large-scale drug compounding unequivocally under FDA control. The health and safety of Americans demand that government not fail a second time."

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FDA Statement on NECC Fungal Meningitis Outbreak: Additional Patient Notification Advised

Fda (Photo credit: Wikipedia)

Drug Safety and Availability > FDA Statement on Fungal Meningitis Outbreak: Additional Patient Notification Advised:

"At this point in FDA’s investigation, the sterility of any injectable drugs, including ophthalmic drugs that are injectable or used in conjunction with eye surgery, and cardioplegic solutions produced by NECC are of significant concern, and out of an abundance of caution, patients who received these products should be alerted to the potential risk of infection. At this time, no cases of infection have been reported in connection with any NECC-produced ophthalmic drug that is injectable or used in conjunction with eye surgery, but FDA believes this class of products could present potentially similar risks of infection. Products from NECC can be identified by markings that indicate New England Compounding Center by name or by its acronym (NECC), "

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Ensuring high-quality dietary supplements with 'quality-by-design' - QbD

The U.S. Food and Drug Administration (FDA) regulates dietary supplements as a category of foods, rather than drugs.

Ensuring high-quality dietary supplements with 'quality-by-design':

"They concluded that a QbD approach — ensuring the quality of a product from its very inception — is the best strategy. One key step in applying QbD to dietary supplements, for instance, would involve verifying the identities of the raw materials — the plants — used to make supplements. “It is clear that only a systematic designed approach can provide the required solution for complete botanical characterization, authentication and safety evaluation,” they say."

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Drugs May Last Past The Expiration Date

What Expiration? Your Drugs May Last A Long Time // Pharmalot:

"Next time you decide to toss that prescription medicine because it appears to have expired, you may want to think twice. Why? A new analysis indicates that some prescription drugs retain their potency long after the expiration date, and the finding also suggests that the healthcare system could save untold oodles of money if expiration dates were sufficiently extended.

To wit, a team of researchers analyzed 14 different medications and found that 12, or 86 percent, tested at concentrations that were at least 90 percent of the amount on the labeling. Three actually had concentrations that exceeded the labeling; just two medications had less than 90 percent of the labeled concentration, according to a research letter published in the Archives of Internal Medicine"

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For more information (link to the original Arch Intern Med article):
Stability of Active Ingredients in Long-Expired Prescription Medications

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Top counterfeit drug events in 2012

The article provides links to the related drug event stories.

Top counterfeit drug events in 2012 - FiercePharma:

"This report points to some of the most significant events in the effort to address counterfeiting this year. Maybe you know of others not mentioned. It would be great if the report could start a public discussion of which steps need to be emphasized next. There is little question that more needs to be done, and it is best if it is done with some forethought. -- Eric Palmer"

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