Under the Drug Supply Chain Security Act (DSCSA), manufacturers, packagers, and repackagers of human prescription drugs must affix or imprint a “product identifier” to each package and homogenous case of product intended to be introduced in a transaction into US commerce. This process is known as “serialization”.
Compliance Deadlines
Manufacturers, packagers and repackagers of human prescription drugs must comply with this new requirement by November 27, 2018. After this date, the U.S. Food and Drug Administration (FDA) will consider drug products that do not bear a product identifier to be misbranded and in violation of FDA regulations.
Furthermore, industry will not be permitted to buy or sell prescription drug products that are not encoded with a product identifier after the following dates:
- November 27, 2018 for repackagers.
- November 27, 2019 for wholesale distributors.
- November 27, 2020 for dispensers.
