USA: Track & Trace Realisation Postponed by a Year

Recommendation

18 June 2024
Barcelona, Spain

QP pre-course Session: Interpersonal and Soft Skills for the QP

According to the US law "Drug Supply Chain Security Act (FD&C Act)", medicinal products will have to bear a "product identifier" on every package in the future.

The "product identifier" must be installed in human-readable and in machine-readable form. The "product identifier" also contains the "standard numerical identifier". As per American law, every package must be clearly identified with the "standard numerical identifier" in the future. The batch number and expiration date must be put on the packages together with the "product identifier".

In June 2017, the FDA has now published the Draft Guidance for Industry "Product Identifier Requirements Under the Drug Supply Chain Security Act - Compliance Policy".

It was originally intended that by November 27, 2017, every drug product in the US market has to bear a "product identifier". This deadline has now been postponed by a year until November 27, 2018.

The reason given for this was that the FDA received comments and answers voicing concerns that the industry was not yet ready for the implementation, especially because the number of suppliers is limited and the capacity of contract facilities is not yet sufficient. Therefore, the FDA postponed the date for the implementation of the requirements by a year to minimise possible disruptions in the distribution of prescription drugs in the United States.

The FDA's complete draft guidance FDA Product Identifier Requirements Under the Drug Supply Chain Security Act - Compliance Policy can be viewed here.