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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Just Throw Them Out - referring to drugs

Just Throw Them Out | The Scientist:

"The researchers compared three possible disposal methods: flushing the drugs, returning them to a pharmacy for incineration, or throwing them away. While incineration rendered the drugs completely inactive, the annual cost of a national drug take-back program could be as high as $2 billion. Flushing the drugs down the toilet would result in the highest environmental exposure to the chemicals. On the other hand, prior research had suggested that leaching from a landfill was not a significant source of pollution. Therefore, trash disposal is the simplest and most economical strategy."

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Source:
Life Cycle Comparison of Environmental Emissions from Three Disposal Options for Unused Pharmaceuticals

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Related articles

• Drug Disposal - National Take-Back Initiative (drughealth.blogspot.com)

FDA Global Initiative

Updated June 30, 2024

The original links broke.

You might also like:

Office of Global Policy and Strategy - FDA.gov

---  the original post follows below  ---

FDA’s success in protecting the U.S. public depends increasingly on its ability to reach beyond U.S. borders and engage with its government regulatory counterparts in other nations, as well as industry and regional and international organizations, to help ensure the quality and safety of products before they reach the United States.

Through effective global engagement, FDA is working with its many international partners to weave a global safety net that benefits public health in the United States and around the world.

• Report: Global Engagement (PDF - 5 MB)

FDA Global Initiative: 


"Global production of FDA-regulated products has quadrupled over the last decade and continues to grow.  Today, FDA-regulated products originate from more than 150 countries, 130,000 importers and 300,000 foreign facilities.


Almost 40 percent of the fruits and nuts and 85 percent of the seafood consumed in America comes from abroad.  Similarly, more than 80 percent of the active pharmaceutical ingredients used to make medicines are imported. The growth in imports has been rapid and promises to accelerate.


Globalization has fundamentally altered the economic and security landscape and demands a major change in the way FDA fulfills its mission.  Over the next decade, FDA will transform from a predominantly domestically-focused agency operating in a globalized economy to a modern public health regulatory agency fully prepared for a complex globalized regulatory environment."

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