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Valisure®

Valisure’s Pharma Testing Offers Quality Assurance and Peace of Mind

As America’s first analytical pharmacy, Valisure lets customers know what’s really in their medicine. Valisure is so named for its ability to validate and assure. And if there ever were an industry that needs validation and assurance, it’s the two trillion-dollar pharmaceutical industry. With 80% of drug ingredients manufactured via highly complex supply chains, pharmaceutical defects and inconsistencies aren’t just rampant, they’re potentially life-threatening. Valisure aims to fix such dangerous cracks in the industry. Launched in 2018, Valisure is the first and only pharmacy where every batch of medication is chemically analyzed and sold with a certificate of analysis. Founder and CEO David Light explains how Valisure works on validating the drugs that they sell, so consumers know what they’re really getting when they take their medicine. 

Lauren parker: How did Valisure come about?
David Light:
Many people take maintenance medications on a daily basis and refill each month, but sometimes they’ll notice variabilities, which pharmacists might shrug off as a “bad batch” from the complex global supply chain. This hit home when our co-founder Adam Clark-Joseph, who I knew from our days at Yale, suffered serious complications from an anticonvulsant medication he’d taken for years. In our research to find out how this happened, we discovered that drug variability is a huge, pervasive problem throughout the pharmaceutical industry.

“Drug variability is
a huge, pervasive problem throughout the pharmaceutical industry.”

Valisure Founder and CEO David Light

L: Well, that’s pretty terrifying. 
D:
It is. There are roughly four drug recalls in the U.S. every day and about 100 of those recalls every year are Class I, meaning they’re considered life threatening. Valisure is the only pharmacy in the United States that conducts its own chemical analysis on every batch of every medication that it dispenses. Other pharmacies might look for inconsistencies in color or texture, but we crush up pills and chemically test them with a laser-based approach. People think the FDA does such testing, but usually it’s the overseas manufacturers themselves who conduct chemical testing—on small batches—then self-report the results. The New York Times best-selling book Bottle of Lies exposes mistakes and rampant fraud in the generic drug industry, which is 90% of drugs. Even branded medicine isn’t foolproof. Doctors and pharmacists have been talking about this for years. The prestigious Cleveland Clinic has a blacklist of suppliers they won’t buy from.

L: How has Valisure become the expert in independent validation and assurance so quickly?
D:
I came from the biotech world and teamed up with scientists and pharmacy experts to root out low-quality medications and develop a solution. We quickly proved the importance of what we do and have become the leaders in medication quality assurance. We’ve testified before the United States Senate and presented before the American Medical Association and American Hospital Association, underscoring the importance of independent chemical testing.

L: What does the testing look like at the consumer level?
D:
For merely a penny or less per pill at the retail level, we’re able to offer consumers validation and assurance. But we don’t just put a sticker on the bottle to say it was Valisure tested.

L: What does the testing look like at the consumer level?
D: For merely a penny or less per pill at the retail level, we’re able to offer consumers validation and assurance. But we don’t just put a sticker on the bottle to say it was Valisure tested. It’s an assessment explained in a Certificate of Analysis, similar to what you would see on food labeling. It shows what we tested, how we tested it, and what we tested for. We test for correct dosage, major inactive ingredients, proper dissolution (how the drug dissolves in the body), and the presence of carcinogens. We reject over 10% of on-market medication batches (over-the-counter and prescription). When we identify bad batches of medications, we alert the manufacturers. With something especially concerning, as was the case with Zantac/ranitidine and most recently metformin, we file an FDA Citizen Petition urging them to act and recall these drugs.

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