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Counterfeit Ozempic Once Again Found in the U.S. Supply Chain

Posted by bryan hanley On April 17, 2025 at 6:11 pm | Comments Closed

Counterfeit Ozempic Label

Ozempic: Back in the News

In what has become a sad yet true frequent occurrence, counterfeit Ozempic has once again been found in the U.S. supply chain.

On April 3rd, 2025 the FDA was notified by Novo Nordisk that several hundred units of counterfeit Ozempic (semaglutide) injection 1mg were distributed outside of their authorized supply chain. Nonetheless, these drugs have ended up in the hands of either patients, wholesalers, retail pharmacies, and/or healthcare professionals, with the FDA seizing a few identified counterfeit products on April 9th, 2025.

The FDA advises associated parties to check Ozempic products carefully, and to not use, distribute, or sell those with the lot number PAR0362 and serial numbers beginning with 51746517. Products within lot number PAR0362 that do not contain serial numbers beginning with 51746517 are still legitimate.

A Common Theme

Semaglutide and other Glucagon-like-Peptide-1 (GLP-1) medications have become popular for their treatment of type-2 diabetes, obesity, and cardiovascular complications. Their popularity has resulted in product shortages, further incentivizing counterfeiters and channel-diverters to manufacture counterfeit goods that put pharmaceutical vendors and their patients at risk.

When product is deemed potentially counterfeit, manufacturers launch investigations, impose quarantines, and destroy product to prevent these products from infiltrating the legitimate supply chain. The U.S. Code of Federal Regulations states that when a pharmaceutical manufacturer cannot differentiate between good and bad product, the entire returned shipment must be destroyed. However, quarantining and destroying highly-demanded products (like Ozempic) further contributes to the shortage issue if these products are legitimate.

The Importance of VRS Systems in Action

Product verification through Verification Router Service (VRS) systems alleviate this problem, helping pharmaceutical vendors quickly identify counterfeit goods. By facilitating the request for verification of the product identifier applied to a serialized product, VRS systems accurately pinpoint the source of product in seconds, confirming product came from a certified manufacturer and is suitable for subsequent commerce.

It’s hard to differentiate between a legitimate and counterfeit product without VRS systems. As a buyer of product, you can confirm the lot number, expiration date, and GTIN are all legitimate; however, it’s hard to tell if a serial number is legitimate without confirmation from the manufacturer. That’s where VRS systems come in.

VRS Systems are an efficient solution to preventing illegitimate product from entering the supply chain, while also preventing legitimate product from mistakenly being discarded or quarantined. Their continued implementation and widespread use will simplify product verification, prevent unnecessary shortages, and make our supply chains safer.

Unguessable Serialization

This instance of counterfeiting also demonstrates another major issue: consecutive serialization. As demonstrated by the above image, the FDA was able to conclude that potential counterfeits all begin with the same lot number, PAR0362, and contain serial numbers beginning with 51746517.

With consecutive serialization, counterfeiters are more easily able to guess which serial numbers occur next in the sequence. When serial numbers are randomized, non-sequential, they become unguessable and difficult to counterfeit.

Randomized serial numbers make it impossible for counterfeiters to identify a pattern when generating new, illegitimate serial numbers. Reverse-engineering from a genuine product becomes useless, as that single data point provides no reliable way to create other valid serial numbers.

Checking Serialized Product Identifiers

Lastly, continually checking the serialized product identifier as product travels throughout the supply chain ensures detection of counterfeit or diverted product before it reaches patients. In the absence of distributors scanning serialized product identifiers, counterfeit or diverted product can seep into the legitimate supply chain.

As identified in this instance, the importance of VRS Systems, unique serialization, and checking serialized product identifiers cannot be overlooked. Stop guessing and start checking.

Visit our website to learn more: https://gatewaychecker.com/

Trump’s Tariffs and Drug Prices

Posted by bryan hanley On December 11, 2024 at 12:18 pm | Comments Closed

Following his election victory, president-elect Donald Trump announced intentions of implementing tariffs on Canada, Mexico, and China; these tariffs include 25% tax on imports from both Mexico and Canada, and an additional 10% increase on the tariffs already in place on Chinese exports to the United States. The goals of these imports, according to the Trump administration, are to protect U.S. manufacturing; incentivize companies to build facilities in the U.S. (and create American jobs); provide billions to the federal reserve to help offset the cost of tax cuts; and deter the flow of illegal immigrants, fentanyl, and other illicit drugs.

However, those opposed to the tariffs (including many economists) emphasize how taxing goods could result in price increases for consumers, including prescription drugs. About 85% of the Active Pharmaceutical Ingredients (APIs) used by U.S. manufacturers for generic pharmaceuticals are from India and China; Mexico and Canada are also exporters of these materials. Taxing these APIs as they enter the United States could result in higher prices for finished goods. Companies importing these goods may simply pass the cost of the tariffs to end consumers, who are already burdened by inflation.

According to the Active Pharmaceutical Ingredient Innovation Center (APIIC), this overreliance on China, India, and other foreign nations for most of our APIs is detrimentally impacting the supply of essential medications in the United States. The APIIC also believes rising imports of pharmaceuticals to the U.S. “creates serious risks to national security and patient safety.” In the past decade, the number of API-facility locations has decreased by 61%, while foreign nations continue to scale their operations. Reshoring the manufacturing process could help mitigate these concerns, and eliminate the financial risk of higher costs associated with tariffs; could Trump’s tariff plan present further opportunity to invest in domestic API production facilities?

What do you think about the impact of tariffs on drug prices? Will tariffs raise prescription drug prices, or could the benefits of in-country production outweigh the potential-price hikes in the long run?

Beware of Counterfeit Ozempic, says FDA

Posted by bryan hanley On October 15, 2024 at 1:05 pm | Comments Closed
Authentic Ozempic needle side by side with a fraudulent needle

Counterfeiting: A Major Issue with Drastic Consequences

On October 2nd, the FDA released an article highlighting the risk of unapproved weight loss drugs, including semgalutide and tirzepatide. These drugs pose a major risk to patients due to their lack of quality assurance. 

Illegally marketed versions of these drugs have infiltrated pharmaceutical supply chains, most notably, Ozempic. Counterfeit versions of the drug have been marketed as authentic, but could contain too much, too little, no active ingredient, or harmful ingredients. These illegal drugs pose a risk to consumers; in fact, according to a December 2023 report, 2 people died and three people were hospitalized after consuming counterfeit Ozempic.

Another DSCSA Delay

The FDA October 9th that they were delaying implementation of Enhanced Drug Distribution Security requirements, along with other requirements of section 582(g) of the Drug Supply Chain Security Act. This compliance extension would only be for trading partners who have made a documented attempt to complete data connections with immediate trading partners, or those who are already doing so. 

The FDA has emphasized the decision came from a concern over potential drug supply shortages. In the release, the FDA referenced trading partners’ struggles “resolving issues involving missing or erroneous data in electronic DSCSA transaction information and transaction statements” without delaying product distribution (including those in shortage) downstream. 

The concern for preventing supply shortages downstream is real. Preventing shortages can help minimize the risk of counterfeit products, given how shortages lead to higher rates of counterfeits as consumers are willing to pay higher prices for goods. However, what’s also important to consider is the reason behind creating Enhanced Drug Distribution Security (EDDS) requirements in the first place. 

Counterfeit Crisis: DSCSA’s Role

The Enhanced Drug Distribution Security requirements under the DSCSA were created for instances like this. Counterfeiters have become increasingly deceitful in their craft: packages with authentic lot numbers and detailed inventory trails make it very difficult to determine the legitimacy of drugs. Sight alone is simply not enough to authenticate legitimate drugs from counterfeits, especially for end consumers—just look at the image above!

Enhanced Drug Distribution Security requirements drastically reduce this risk, mandating product-level traceability and interoperability. Flagging down counterfeit Ozempic is much easier to do with EDDS requirements in place; the FDA delaying these requirements again could pose risks similar to what we’ve seen with Ozempic. 

While it’s essential to acknowledge the FDA’s commitment to preventing drug shortages, delaying EDDS requirements may bring about its own consequences.

The Importance of Anti-Counterfeiting Solutions

Posted by bryan hanley On January 11, 2024 at 11:00 am | Comments Closed

Published January 11th, 2024

The global pharmaceutical industry faces a significant challenge with counterfeit medicines, estimated to be one in 10 medical products in low- and middle-income countries, leading to a $30.5 billion spending on substandard drugs.

Counterfeit medicines, often indistinguishable from genuine ones, pose severe risks, including toxic ingredients that can be life-threatening.

The US pharmaceutical supply chain is among the safest and most secure especially when medicines are exclusively supplied through authorized trading partners. Nonetheless, recent counterfeit Ozempic and Muro 128 products remind us that risks from fake medicines remain.

To combat this, healthcare and pharmaceutical organizations must embrace innovative anti-counterfeit technology solutions, prioritizing simplicity, ease of deployment across the supply chain, and adherence to standards.

Mapping the supply chain, leveraging digital tracking, financial transaction analysis, and evaluating delivery infrastructure can identify vulnerabilities, while trusted champions in the supply chain can be crucial in verifying authenticity.

While you can’t prevent counterfeiting, you can make it harder to do, and criminals easier to catch. And this all starts with implementing a traceability solution that protects the integrity of your supply chain.

See how Gateway Checker makes this possible.