# Pharmacy that tests all batches of medications they sell



## Imtired (Nov 8, 2019)

A while back there was a news splash about a cancer-causing contaminate, NMDA, found in the popular OTC Zantac.  I assumed the FDA found this contaminate but it turns out it was a tiny online pharmacy called Valisure  This pharmacy tests all drugs for active ingredients, impurities, etc. before dispensing.  For me, this is a godsend.  I take a drug for a chronic condition in which the dosage is critical.  Since generics are allowed to deviate by 80% to 120% of active ingredients, I can't afford the risk, so I have to take the brand name which costs a fortune.  I've always wished there was a company that would test for the percentage of active ingredients, and now I've found there is.

The FDA does not test generics themselves, they rely on the drug manufacturers to "self-report".   Hmmm, color me skeptical but I don't trust drug companies to self-report cross-contamination, impurities, etc. 

The name of the company is Valisure.  https://www.valisure.com/    I ran across this when reading this article:  https://www.washingtonpost.com/science/a-tiny-pharmacy-is-identifying-big-problems-with-common-drugs-including-zantac/2019/11/08/6dd009ca-eb76-11e9-9c6d-436a0df4f31d_story.html


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## Bruddah IZ (Nov 8, 2019)

Imtired said:


> A while back there was a news splash about a cancer-causing contaminate, NMDA, found in the popular OTC Zantac.  I assumed the FDA found this contaminate but it turns out it was a tiny online pharmacy called Valisure  This pharmacy tests all drugs for active ingredients, impurities, etc. before dispensing.  For me, this is a godsend.  I take a drug for a chronic condition in which the dosage is critical.  Since generics are allowed to deviate by 80% to 120% of active ingredients, I can't afford the risk, so I have to take the brand name which costs a fortune.  I've always wished there was a company that would test for the percentage of active ingredients, and now I've found there is.
> 
> The FDA does not test generics themselves, they rely on the drug manufacturers to "self-report".   Hmmm, color me skeptical but I don't trust drug companies to self-report cross-contamination, impurities, etc.
> 
> The name of the company is Valisure.  https://www.valisure.com/    I ran across this when reading this article:  https://www.washingtonpost.com/science/a-tiny-pharmacy-is-identifying-big-problems-with-common-drugs-including-zantac/2019/11/08/6dd009ca-eb76-11e9-9c6d-436a0df4f31d_story.html


The agency’s testing *suggests* Pepcid, Tagamet, Nexium, Prevacid and Prilosec do not contain the chemical.   WTF?

Maybe the FDA should let the 14 employee company Valisure do more than "suggest"


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## Bruddah IZ (Nov 8, 2019)

For Valisure’s scientists, finding NDMA in ranitidine was a particularly dramatic example of the kind of discovery they make routinely. *Valisure checks the chemical makeup of drugs before it ships them to consumers, and rejects more than 10 percent of the batches because their tests detect contaminants, medicine that didn’t dissolve properly or pills that contain the wrong dose, among other issues. Since late 2018, Valisure has reported more than 50 problems directly to drug companies. Occasionally — as in the case of Zantac — their scientists find a problem so urgent they play the role of watchdog. *


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## Bruddah IZ (Nov 8, 2019)

“I had a fairly dim view of drug quality in the United States going into this, but we’ve discovered tons of problems I never even thought of — and they’re all over the place,” said Adam Clark-Joseph, one of Valisure’s founders.

*The FDA firmly rejects the idea that the drug supply is unsafe and said that one of Valisure’s conclusions — that ranitidine turns into NDMA in the stomach — is not supported by the agency’s testing.* The agency reviews reams of data before approving a drug, inspects factories that make them, runs its own tests on selected drugs and collects reports of safety problems.

Great!!


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## Imtired (Nov 8, 2019)

Bruddah IZ said:


> “I had a fairly dim view of drug quality in the United States going into this, but we’ve discovered tons of problems I never even thought of — and they’re all over the place,” said Adam Clark-Joseph, one of Valisure’s founders.
> 
> *The FDA firmly rejects the idea that the drug supply is unsafe and said that one of Valisure’s conclusions — that ranitidine turns into NDMA in the stomach — is not supported by the agency’s testing.* The agency reviews reams of data before approving a drug, inspects factories that make them, runs its own tests on selected drugs and collects reports of safety problems.
> 
> Great!!


I had never really thought twice about generics until I ran into weird side effects once I was switched to a generic.  I started doing research and was shocked to find that the FDA relies on drug companies to do their own quality testing.  There is virtually no oversight other than reading the “reams and reams of data” submitted by the drug manufacturers themselves, most of which are overseas. 









						Allegations of widespread fraud raise questions about the safety of generic drugs made overseas
					

A man's body rejected his new heart. Then his doctor looked into his anti-rejection drugs.




					www.google.com
				




Lots more articles out there with the same conclusions.


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## Imtired (Nov 8, 2019)

'Bottle Of Lies' Exposes The Dark Side Of The Generic-Drug Boom
					

A new book investigates the history of unsafe and deceptive practices by some generic-drug manufacturers, and explains why U.S. regulators struggle to keep up with a global industry.




					www.npr.org
				




That article is seriously scary but not at all surprising to me.


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## Sheriff Joe (Nov 8, 2019)

Imtired said:


> I had never really thought twice about generics until I ran into weird side effects once I was switched to a generic.  I started doing research and was shocked to find that the FDA relies on drug companies to do their own quality testing.  There is virtually no oversight other than reading the “reams and reams of data” submitted by the drug manufacturers themselves, most of which are overseas.
> 
> 
> 
> ...


A bit like the House of Representatives.


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## Imtired (Nov 9, 2019)

Sheriff Joe said:


> A bit like the House of Representatives.


My post is about the safety of generics, not about politics.  But since you seem to only believe something if it comes from a person of your political bent, here is an article written by a former Arizona State Republican congressman.   He is of the same opinion, that if consumers are going to be required by their insurers to use cheaper generic drugs, then the FDA needs to make sure they are safe.  https://thehill.com/opinion/healthcare/438782-foul-play-with-generic-drugs-threatens-american-lives


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