In the wake of the Product Identifiers Under the Drug Supply Chain Security Act, FDA decided to publish guidance so that people can find valid information about the terms and conditions of the act.
According to FDA, the DSCSA was signed into law on November 27, 2013, and this was all to outline critical steps that are essential to building an interoperable electronic system, scheduled for November 27, 2023.
The main goal of building this system is to establish a new strategy for tracing and identifying certain prescription drugs during their distribution in the United States.
The DSCSA established new verification requirements and definitions related to drugs dispensers, wholesale distributor, repackagers, manufacturers, as well as product identifier and product tracing.
This is all to help facilitate more effective tracing of a certain product, as it is being distributed through the pharmaceutical distribution supply chain.
With all that in mind, this guidance is supposed to help repackagers and manufacturers fully comprehend those definitions and requirements so that they can imprint or affix each homogenous case and product package that’s about to be introduced in a transaction into commerce.
Before any product can be properly introduced into commerce, it will have to satisfy the product identifier requirement of section 582 of the FD&C Act.
Linear Barcode Requirements
When it comes to DSCSA, FDA stated that this guidance is addressing the issue of linear barcode requirements under the law. According to them, repackagers and manufacturers have already asked the agency about the linear barcode requirements regarding some products.
Since FDA already published a rule about certain biological product and human drug labels being required to have linear barcodes, these barcodes have to at least contain the drug’s NDC number.
Every private label distributor, relabeler, repackager, and manufacturer of over-the-counter drug products, biological products, and human prescription drug products that are either commonly used in hospitals or dispensed pursuant to order are subjects to the aforementioned linear barcode requirement.
There are clear sections in the FD&C Act stating that every drug label must contain the linear barcode and it should be on the outside wrapper and container, as well as on the immediate container.
The only exception is if the barcode is already machine-readable and readily visible through the outside wrapper or container. As usual, there are a few prescription drug products that aren’t required to follow these linear barcode requirements.