When Food and Drug Administration (FDA) enacted the Drug Supply Chain Security Act (DSCSA) in 2013, it set a 10-year timeline for full implementation.
A significant portion of this last milestone requires the entire supply chain to become interoperable using secure and electronic means. One requirement that is included in Title II of the Act calls for product tracing at the package level, which had not been explored widely by the industry until recently. Our DSCSA State Regulator Pilot project tested a system for sharing this information between regulators and trading partners, including distributors, manufacturers, and others. You can learn more about the project and next steps in this report.
As we finalize this communication system and assist the boards of pharmacy, you might wonder what your pharmacy can do to prepare. Plenty, as you can see below!
What are your responsibilities today?
- Ensure you are only doing business with authorized trading partners (ie wholesalers that are properly licensed and registered to ship into your state).
- Receive, store, and provide product tracing information:
- Only accept prescription drugs that are accompanied by the transaction information, transaction history, and transaction statement.
- Establish procedures to investigate and properly handle suspect and illegitimate drugs.
How can you prepare for DSCSA Compliance?
- Be ready to receive or exchange transaction information (with specific product identifiers for each package) and transaction statements electronically.
- Implement systems/processes for package level verification when needed, such as in the case of investigating suspicious product.
- Implement systems/processes to produce serialized transaction information if the FDA, a state regulator, or a trading partner requests information for an investigation.
- Talk to your wholesaler(s) or any direct suppliers of drug product to see how they may be able to assist in storing transaction information.
Learn All You Can About DSCSA Requirements
Given the complexity of the DSCSA requirements, educate yourself now on how to comply. Stay up to date with these resources:
- This list of FDA guidance.
- NABP home study webinar:
- A website for dispensers that we put together with our partner organizations.
Also, feel free to reach out to our staff with questions. The new requirements will be here before you know it. Check out these resources, our website, and additional future communications for updates. We are eager to help your pharmacy reach compliance.