Smart Packaging and Anti-Counterfeit Technologies

Smart Packaging and Anti-Counterfeit Technologies for [Diabetic Test Strips](/sell-diabetic-supplies/)

Counterfeit test strips are a documented problem. In the fall of 2006, more than one million counterfeit blood glucose test strips were sold to U.S. consumers at drugstores in more than 35 states [2]. The protections against fakes come in layers: features on the box that a person can check by eye, identifiers on the label that a scanner can read, and records kept as boxes move from the factory to the pharmacy. One layer that shows up in many descriptions, an electronic lockout inside the meter, is one we couldn't confirm.

Physical Security Measures

Holograms, color-shifting inks and tamper-evident seals are the visual features usually associated with anti-counterfeit packaging, and the idea is that a pharmacist or buyer can spot a fake box by eye. Here's what surprised us: a 2009 article in the Journal of Diabetes Science and Technology argued that checking packaging and labeling is no longer enough to identify counterfeit medical products. Fake packaging has become cheap and easy to produce, and the authors used the 2006 counterfeit strips as their example [2].

Supply Chain Serialization

FDA's Unique Device Identification (UDI) rule requires device labelers, usually the manufacturer, to put a UDI on device labels and packages, with some exceptions [3]. The UDI appears in plain text and in a machine-readable form that FDA calls automatic identification and data capture (AIDC): any technology that lets a computer system read the identifier automatically [3]. On strip boxes this is often a 2D DataMatrix barcode. Each UDI has two parts. The device identifier is fixed and names the labeler and the model, while the production identifier holds the production details on the label, such as the lot number, expiration date or serial number [3].

FDA says the system exists to identify devices from manufacturing through distribution to patient use, and to modernize how devices are monitored after they reach the market [4]. There is a limit we didn't expect. FDA's public Global Unique Device Identification Database (GUDID) stores only the device identifier, not the production identifier [3]. The public record tells you which product a box is, so tracing a specific lot still depends on the production data printed on the label itself. The European Union has its own device identification rules.

You may also see the Drug Supply Chain Security Act (DSCSA) cited as the serialization rule for strips. That law covers prescription drugs: it defines a "product" as a prescription drug in finished dosage form [1]. Blood glucose test strips are regulated as devices, under FDA's glucose test system regulation (21 CFR 862.1345) [5], so DSCSA tracing requirements don't apply to them.

Intrinsic Authentication (DRM)

DRM, short for digital rights management, means technology that stops a product from working with unapproved parts. Some writing on test strips claims that meters read a proprietary electrical signature on each strip and lock out any strip that doesn't match. We looked for that in FDA records and published studies and couldn't find it described. What the records do describe is a meter sending small electrical signals through the blood sample to measure the sample itself.

FDA's decision summary for Roche's Accu-Chek Guide system says the DC (direct current) produced by the enzyme reaction gives the glucose result, while "the sample and the environmental conditions are evaluated using AC and DC signals" (AC is alternating current) [5]. A 2019 study described another meter that uses an AC signal to measure hematocrit, the share of blood made up of red blood cells, and then adjusts the glucose result for it [6]. That is an accuracy feature, because hematocrit is known to skew readings on some meters [6]. Our hematocrit and interference correction article covers how those corrections work.

FDA reviewed the Accu-Chek Guide meter and its test strips together, as one blood glucose monitoring system [5]. Whether a given meter can tell a well-made counterfeit strip from a genuine one is a question we couldn't answer from public records. Our article on counterfeit vs. generic strips looks at how fakes differ from third-party compatible strips.