Strategies for Meeting DSCSA-Triggered Business Requirements
Do you need to adjust your plan for meeting DSCSA requirements?
The U.S. Drug Supply Chain Security Act (DSCSA) contains many explicit regulatory requirements. Today, most companies are either working on meeting those regulatory requirements or planning how they will meet them. However, there are other requirements that stem from the DSCSA that are not explicitly mentioned in the text of the law. These are DSCSA-implied, or DSCSA-triggered business requirements.
These requirements are technically not “regulatory requirements”— if you don’t meet them, you will not be in violation of the law — but instead, they are requirements that companies must meet in order to continue participating in the U.S. pharma supply chain after one of the dates called out in the law.
These business requirements are triggered by one change or another to the operation of the supply chain as the result of the DSCSA. Because these DSCSA-triggered business requirements are not explicit, they may be easy to miss. Companies need to be aware of these requirements and must prepare for meeting them before the triggering date.
From this webinar you will learn:
- What is a "DSCSA-triggered business requirement"
- Examples of DSCSA-triggered business requirements
- Strategies for meeting these requirements
Regulatory Strategist, Systech International
Dirk Rodgers is an independent consultant and founder of RxTrace.com where he writes regularly in an exploration of the intersection between the pharmaceutical supply chain, track and trace technology, standards and regulatory compliance.