It’s still business as usual: FDA’s proposed DSCSA enforcement delay
The FDA has published draft guidance proposing a 12 month grace period on the enforcement of November’s DSCSA ( Drug Supply Chain Security Act) requirements. Even still the industry should continue serialization projects to secure supply chains ahead of 2017's deadline.
The US Food and Drug Administration is planning to postpone taking action on manufacturers that fail to meet November 2017’s conditions to verify prescription drugs at package level with an identifier. This also would cascade to apply to any downstream partners repackagers, wholesale distributors and dispenser. From November 2018, however, any product in commerce without a product identifier will be viable for investigation.
The intentions being that this delay would give manufacturers more time to implement and avoid supply disruptions.
LSPediA contends that this potential delay in enforcing the law can be attributed to:
- The limited amount of vendors able to give expertise and systems needed for facilitate serialisation measures.
- The readiness of contract manufacturers
However, this was communicated in draft guidance document. The FDA clarifies: “guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations unless specific regulatory or statutory requirements are cited.”
Respectively, pharma firms should continue with progressing in their serialization projects to comply with requirements and secure their supply chains.
Take a look at our recent serialization implementaion resources.
Disclaimer: The points expressed in this piece should not be regarded as legal advice