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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Serious Gaps in US Drug Safety

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Updated February 2, 2021:

Links in the original post broke.

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This caught my eye in the National Journal, Pew Study Finds Gaps in FDA Oversight of Imported Drugs.

In a nutshell, Pew Finds Serious Gaps in Oversight of U.S. Drug Safety points to the Pew white paper that finds that increased outsourcing of manufacturing, a complex and globalized supply chain and criminal actors create the potential for counterfeit or substandard medicines to enter the supply chain and reach patients.

FDA Wants Your Input On Tobacco Regulation

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Updated March 2, 2020

The links in the original post broke.

You might also be interested in:
Tobacco Products - Rules, Regulations, and Guidance (on FDA.gov)

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The U.S. Food and Drug Administration (FDA) announced that it is seeking public input on the implementation of its historic new authority overseeing tobacco products in the United States. If you feel strongly about tobacco as I do, I hope you'll submit some feedback to the FDA.

More References:
The Federal Register Notice
FDA and Tobacco Regulation

Related Posts:
NPR On FDA Tobacco Oversight (audio)
Smoking Is Too Expensive - It is time to quit
e-Cigarettes In The News (video)
Fire Safe Cigarettes Are A Good Thing
3rd Hand Tobacco Smoke - A Danger To Your Loved Ones

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NPR On FDA Tobacco Oversight (audio)

This audio news story, Talking Tobacco Companies Into FDA Oversight, fresh from NPR:

The Food and Drug Administration (FDA) will have regulatory authority over the $89 billion tobacco industry as soon as President Obama puts his signature to a bill passed by Congress. The change took decades to happen — the industry fought hard to keep the FDA out — but finally succumbed to changing social norms and the guidance from one in its own ranks. Guest host Alison Stewart speaks with Steve Parrish, a former Altria executive and who pushed the company to support FDA regulation of the tobacco industry, and Dr. David Kessler, who was head of the FDA in the mid-1990s.

As a non-smoker, I'm thrilled to see this new day of FDA oversight. As a country we should be paying more attention to improving population health. 

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Should The FDA Oversee Nanotechnology Dietary Supplements?

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Updated October 15, 2022:

Some links broke.

You might also be interested in:

GUIDANCE DOCUMENT - Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry - APRIL 2022 - FDA.gov

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If you read this Project On Emerging Nanotechnologies publication, you'll probably say yes, A Hard Pill to Swallow - Barriers to Effective FDA Regulation of Nanotechnology-Based Dietary Supplements. Historically, the regulation of dietary supplements has been a significant challenge for the U.S. Food and Drug Administration (FDA), and the fact that some of these products are now being manufactured using nanotechnology creates an additional layer of complexity. The use of engineered nanoparticles in dietary supplements raises serious questions about whether such products are safe. Congress has generally allowed dietary supplements to be marketed without any pre-market demonstration of safety, based largely on the assumption that these products have been used for many years. There is, however, no basis for concluding that dietary supplements containing engineered nanoparticles are safe. The authors ask, "Is FDA equipped to meet the emerging regulatory challenge of dietary supplements that use engineered nanomaterials?" Here's their conclusion . . .

• There is no basis for concluding that dietary supplements containing engineered nanoparticles are safe.
• While it is not possible to determine the prevalence of dietary supplements containing engineered nanoparticles, it is likely that the public’s exposure to these products will grow significantly in the next several years. Congress should adopt legislation granting FDA the authority to collect additional information about these products and to ensure that they are tested for their effects on human health. Such legislation should prohibit the sale of new dietary supplements containing engineered nanoparticles until they have been demonstrated to be safe, and it should provide FDA with sufficient resources to regulate these products.
• Until Congress acts, consumers who take dietary supplements containing engineered nanoparticles will be at additional, unknowable, and potentially serious risk.

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FDA - Global Drug Supply Chain Needs Better Oversight

Updated August 3, 2024

The original link broke.

You might also like:

Office of Global Policy and Strategy - FDA.gov

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We're still reeling from the tainted heparin situation, and I suspect that it's only the tip of the iceberg. A rising percentage of drugs are coming from China and India, reports this ASHP News article, "World's Drug Supply Chain Needs Better Oversight, FDA Says." The associate commissioner for policy and planning at FDA is quoted, and here's a small sample of highlights . . .

• "where there are economic incentives and/or there is lax regulatory oversight, there is going to be greater opportunity for risky or criminal behavior"
• "If we have good behavior, we want to facilitate compliance. If we have risky behavior, we want to provide deterrence. And with criminal behavior, we need rapid detection and aggressive enforcement. And electronic track and trace can play an important role in it."

Previous Posts:
Gambling With Life - Counterfeit Drugs - Like ED Drugs (Viagra)
Counterfeiters Can Get Life In Jail

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