We have been on a roll with DSCSA Blogs and Webinars over the past year. So, why not continue this trend by focusing on one of the main goals of DSCSA: protecting patients from medication that may be counterfeit, stolen, contaminated, or otherwise harmful.

Why are we here?

In 2013, the Drug Supply Chain Security Act (DSCSA) was passed by Congress to ensure the safety and security of the pharmaceutical supply chain in the United States. The main objectives of this act are to make the traceability of prescription drugs more effective and to protect consumers from the risks of counterfeit and unsafe medication.

The DSCSA was enacted after reports of counterfeit drugs entering the supply chain and posing a severe threat to public health. The Congress aimed to establish a more robust system for tracking and tracing prescription drugs throughout the distribution chain to quickly detect potential issues like counterfeit or contaminated drugs. This would enable removing such products from the market to safeguard consumers and identify how these illegitimate products made it into the supply chain

In summary, the Drug Supply Chain Security Act was enacted to improve the safety and security of the pharmaceutical supply chain, enhance traceability of prescription drugs, and ultimately protect the health and well-being of consumers in the United States.

Recently, in the National News.

On 12/11/2023, CNBC News aired a story about counterfeit drugs in the U.S. market, Fraud in a bottle: Big Pharma fighting counterfeit drugs . All Independent Pharmacies should watch this video since they claim this is mostly an issue with Independent Pharmacies They also posted Fraud in a bottle: How Big Pharma takes on criminals who make millions off counterfeit drugs .

First, we will talk about what suspect and illegitimate products are, and then we will identify how you and your staff can remain vigilant to prevent them in your Pharmacy.

Is this a Suspect or Illegitimate?

The U.S. drug supply chain is probably one of the safest in the world. When you identify a potentially suspect product, you will investigate it with your supplying trading partner and/or the manufacturer and the vast majority of the time the drug will be legitimate. But in some rare cases, an investigation will lead to you identifying that a product is likely illegitimate. So, what is the difference between a suspect and an illegitimate product? The FDA defines suspect and illegitimate products as:

Suspect Product

Illigitimate Product

Means a product for which these is reason to believe that such product:

(A) Is potentially counterfit, diverted, or stolen;

(B) Is potentially intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;

(C) Is potentially the subject of a fraudulent transaction; or

(D) Appears otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans.

Means a product for which credible evidence shows that the product:

(A) Is counterfeit, diverted, or stolen;

(B) Is intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;

(C) Is the subject of a fraudulent transaction; or

(D) Appears otherwise unfit for distribution such that the product would be reasonably likely to result in serious adverse health consequences or death to humans.

Some of these will be easy to determine based on the packaging and product, while others will be much more complicated, such as a diverted product.

What is a Counterfeit Product?

A counterfeit product is any drug, bottle, or label that does not match the drug, bottle, or label manufactured, produced, or printed by the lawful manufacturer. So, to put it simply, it is counterfeit if:

  • The drug does not match what was manufactured by the manufacturer.
  • The bottle is not the bottle the manufacturer used.
  • The label is not the printed label of the manufacturer.

What is a Diverted Product?

A diverted product is any product:

  • That has left the U.S. supply chain and has somehow made it back into the U.S. supply chain.
  • That is labeled for a non-U.S. market that is introduced into the U.S. supply chain.

What is a Stolen Product?

A stolen product is:

  • Any product in its entirety (i.e., the prescription drug and its packaging) that has been taken or removed without permission of the owner of the product.
  • Any packaging of a product that has been taken or removed without the consent of the owner.
  • Any prescription drug that has been taken or removed without permission of the owner of the product.
  • Any prescription drug and/or its packaging, in physical custody of a trading partner, that is missing all or any portion of the drug as a result of the drug being taken or removed without permission of the owner.

What is a Fraudulent Transaction?

A fraudulent transaction is any transaction in which the transaction information, transaction history, or transaction statement contains information knowingly falsified by a trading partner who has provided or received the information.

What is a Product that is unfit for Distribution?

A product unfit for distribution is any prescription drug that is nonsaleable because its sale would violate the FD&C Act, and there is a reason to believe or credible evidence which shows that the product would be reasonably likely to result in serious adverse health consequences or death to humans.

Identifying a Suspect Product?

Now that you understand what the FDA considers an illegitimate product (you probably already knew this), we want to discuss ways to limit your Pharmacy’s chances of potentially receiving an illegitimate product.

Trading Partners and Product Sourcing

Start at the beginning; you should look for the potentially suspect product before you even order the product by looking at your Trading Partner first. Before conducting business with a potential trading partner, you should ask a few questions.

  1. Are they licensed in your State? You can only purchase products from distributors that are licensed in your State.
  2. Are they an authorized distributor of the product? In many cases, the manufacturer of a high-cost product will have authorized distributors. You must only purchase the product from one of these authorized distributors in these cases.
  3. Does the payer require NABP’s National Drug Distributor Accreditation? If yes, I would only purchase products from an entity with Drug Distributor Accreditation (in addition to the above two items).
  4. Why is the price so low? We have all heard the phrase, if something seems too good to be true, it probably is. I would not order the product from the trading partner unless all of the above is good, and I know the trading partner well enough to trust the lives of my patients (and my livelihood) to them.

Supply, Demand, History, and Value of the Product

As always, you should look closely at all products that are in high demand or are costly. These products are targets for people trying to place counterfeit and stolen products into the supply chain. As always, take a careful look at any products that are the subject of a public alert from the FDA.

Appearance of the Product

Once the product makes it into the Pharmacy, ensure your employees look at the delivery and product packaging to ensure it matches what you were expecting. Some items you would be reviewing include:

  • Proper spelling, colors, fonts, and images.
  • There is no excessive adhesive residue (also look at the product bottle to see it appears to have had a patient prescription label on it at one point).
  • There are no foreign identifications in place of an NDC, and make sure it has the DSCSA required Product Identifier (2D barcodes and a human-readable NDC (or GTIN), Serial Number, Lot Number, and Expiration Date).
  • If you expected security features and any anti-counterfeiting features, check they are present.
  • The physical product matches the manufacturer’s documentation and what you were expecting.

Conclusion

Pharmacists play a critical role in preventing illegitimate products from reaching patients by adhering to regulatory standards, maintaining transparency in sourcing, and following FDA Guidance. Distinguishing suspected illegitimate products is vital for patient safety. Pharmacists must scrutinize trading partners, ensure wholesaler licensing, and assess product authenticity upon receipt.  A well-designed compliance program to vet your suppliers and handle the receipt and review of products is key to ensure the legitimacy of your products.

The PRS DRUGSUPPLYTrack™ and Advasur 360™ have been combined to create DSCSA 360™ to ensure your Pharmacy has the tools to be compliant today and into the future. If you have any questions about DSCSA, please do not hesitate to call us at 1-800-338-3688.

DSCSA service and solution leaders Advasur and PRS stand ready to serve dispenser pharmacies for full compliance with current and future DSCSA requirements with minimal disruption to business workflow operations and patient care.