More fake drugs now using active ingredients

SecuringIndustry.com - Many more fake drugs now using real APIs, US official says:

"The US Department of Commerce reports that more and more counterfeit pharmaceuticals are using real APIs to trick patients.

Globalisation of the active pharmaceutical ingredient (API) supply chain means raw materials are more readily available in countries where counterfeit manufacturing takes place.

The trend has helped counterfeiters change the composition of their products, Security Management reports.

"Twenty years ago most counterfeit medicines did not contain any medicinal ingredients. They had ground up dry wall, sawdust, anything to make the product look real," said Jeffrey Gren, director, Office of Health and Consumer Goods at the US Department of Commerce, said."

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FDA Supplement Guidance Not Strict Enough, MD Says

This is pretty controversial stuff, as the dietary supplement industry largely opposes the draft regulation

Medical News: FDA Supplement Guidance Not Strict Enough, MD Says - in Public Health and Policy, FDA General from MedPage Today:

"An FDA proposal to require dietary supplement manufacturers to submit data proving their product is safe doesn't go far enough, according to a physician writing in the New England Journal of Medicine.  

More than 100 million Americans spend more than $28 billion on vitamins, minerals, herbal ingredients, amino acids and other natural products in the form of dietary supplements each year, "assuming they are both safe and effective," wrote Pieter A. Cohen, MD, of Harvard Medical School and the Cambridge Health Alliance. 

But they have no assurance that the products are safe because FDA regulation of supplements is too weak, Cohen wrote in a Perspective piece."

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Read more about this:

FDA Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues

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Drugs Posing as Supplementals May Contain Dangerous Ingredients - NYTimes.com

Drugs Posing as Supplementals May Contain Dangerous Ingredients - NYTimes.com ('via Blog this')

A good read on the shaky tension between legitimate, tainted, and dangerous supplements. The supplement industry blames the FDA for failing to institute mandatory recalls and seize tainted goods.

In a nutshell:

Daniel Fabricant of the FDA says, "the growing availability of tainted products represents a serious public health problem, one that could taint the dietary supplement industry as a whole."

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Watch Out For CEP Problems in 2011

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The European Directorate for the Quality of Medicines and Healthcare (EDQM) suspended or withdrew 19 certificates for active pharmaceutical ingredients in the latter half of 2010 because their manufacturers failed or refused inspections*. These are the main points:

1. Virtually all of the suppliers included in the list was from Asia.
2. The EDQM awards a CEP if the company declares GMP compliance (without a pre-approval inspection).
3. The EDQM conducts periodic inspections of API manufacturers, however, the EDQM has inspection capacity constraints and can only inspect about 30 sites a year.

This is important to follow, as you can expect the huge number of API suppliers to continue to come from that part of the world,

Acronyms:
-  Certificates of Suitability (CEPs)
-  Active pharmaceutical ingredient (API)

* EDQM suspends, withdraws 19 API certificates in 2H10 - Securing Industry

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Electronic Orange Book Online

Updated Aug 18, 2016:

FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)

Updated Feb 3, 2016:
It's here! The latest Orange Book Annual Edition

You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

- - - original post below - - -

The FDA offers an electronic (online) version of the Orange Book, also known as Approved Drug Products with Therapeutic Equivalence Evaluations.

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Global Supply Chain - Counterfeiting - Sobering

This Q & A article from PharmTech is an interesting read, Preventing counterfeits from entering the supply chain. I find it sobering that a small percentage of drugs are counterfeit, yet counterfeited drugs represent a growing and substantive volume of tampered, contaminated, diluted, substituted, adulterated, and misrepresented ingredients. 

Previous Posts: Rx-360 - A non-profit to help secure the supply chain (podcast) FDA On Drug Counterfeiting 

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