Tamper evident labels are labels that are designed to show evidence of tampering or unauthorized opening of drug containers and packages. They are an essential part of pharmaceutical labeling, as they help to protect products from counterfeit and ensure that consumers are getting the correct medication. According to the World Health Organization (WHO), counterfeit drugs account for up to 10% of the global pharmaceutical market and pose serious risks to public health and safety. Tamper evident labels can help to prevent counterfeit drugs from entering the supply chain and reaching consumers by making it difficult or impossible to remove or replace them without leaving visible traces. The Food and Drug Administration (FDA) has specific regulations for tamper evident seals that pharmaceutical manufacturers should follow in order to comply with the law and ensure the quality and security of their products.
One of these regulations is 21 CFR 211.132, which applies to over-the-counter (OTC) human drug products and requires them to be packaged in a tamper-resistant package with clear indicators and statements for consumers.
Tamper evident labels work by using various mechanisms such as adhesives, perforations, holograms, void patterns, seals, or indicators that change color or appearance when exposed to heat, light, moisture, or chemicals. These mechanisms make it easy for consumers to identify if a product has been opened or altered in any way. There are different types of tamper evident labels available for different products and surfaces such as bottles, vials, syringes, blister packs, cartons, bags, boxes etc. Some examples of tamper evident labels are:
- Security tapes: These are adhesive tapes that have a printed message or pattern that appears when the tape is removed or repositioned.
- Tamper-evident seals: These are plastic or metal rings that fit around the neck or cap of a container and break when the container is opened.
- Tamper-evident bands: These are shrink-wrapped bands that cover the opening or closure of a container and tear when the container is opened.
- Tamper-evident indicators: These are labels that have a feature that changes color or appearance when exposed to heat, light, moisture, or chemicals.
Tamper evident labels have helped to prevent or detect counterfeit drugs in many cases in the past. For example:
- In 2015, a shipment of fake Viagra was seized in Switzerland with tampered blister packs and holograms.
- In 2018, a recall of Valsartan (a blood pressure drug) was issued in several countries due to contamination with a carcinogenic impurity detected by tamper evident seals.
- In 2020, two Ukrainian men admitted to selling counterfeit versions of Merck & Co’s Keytruda (a cancer immunotherapy) and other drugs in the US.
Tamper evident labels have many benefits for consumers, manufacturers, and regulators. For consumers, tamper evident labels provide assurance that they are getting a genuine and safe product that they paid for. They also help them to report any suspicious or defective products to authorities. For manufacturers, tamper evident labels protect their brand reputation and reduce their liability for any harm caused by counterfeit drugs. They also help them to comply with regulatory requirements and avoid legal penalties. For regulators, tamper evident labels facilitate their inspection and enforcement activities and help them to trace and recall any faulty products.
Tamper evident labels are a critical tool for ensuring the safety and quality of pharmaceutical products. They help to prevent counterfeit drugs from entering the market and reaching consumers by making it hard or impossible to tamper with them without leaving visible traces. They also provide benefits for consumers, manufacturers, and regulators by increasing their confidence, protection, and compliance. Tamper evident seals should be used by all pharmaceutical manufacturers as part of their labeling strategy in accordance with FDA regulations. Further research on this topic could explore how tamper evident labels can be improved with new technologies such as RFID tags, QR codes, or blockchain.
NovaVision offers a wide variety of high quality, tamper-evident security products. We can provide you with a custom solution that meets your needs. Visit novavisioninc.com or call (800) 336-6636 to learn more about our products and speak to one of our security experts.
