Putting a Compliance Solution in Place
September 15, 2015
The FDA’s DSCSA enforcement discretion for dispensers ends on March 1. By that date, your hospital, pharmacy, clinic, or long-term care facility must have a plan in place to meet the requirements or you will be out of compliance. Still weighing your options? With less than two months left, the time to make a decision is now: once you select a solution, your implementation could take up to six weeks. Read on to understand everything that needs to happen after your contract is signed and why it's time to move forward.
Week One: Engage
You have key data to provide to your solutions partner:
- Gather trade partner data: Who are all the different suppliers – including wholesalers, manufacturers, and potentially other dispensers – from whom you purchase product?
- Gather product data: Some solution providers may tell you they’ll only rely on Red Book, but that’s a messy endeavor: T3 documentation will be created for every item you receive, whether it’s subject to DSCSA compliance rules or not. It’s a much cleaner, more manageable process to set up your specific product data – and rely on Red Book only for outlying products for which you might not have data.
Week Two: Design
Before your configuration begins, you need to evaluate a few relevant business operations:
- Determine DSCSA requirements: If you only dispense medications directly to patients, you are considered a dispenser. However, if you resell, barter, or loan drugs to organizations that are not under common ownership with your pharmacy, you must also comply with wholesale distributor requirements, which will impact your setup.
- Decide how to manage multiple locations: You will want to store all T3 in your central repository, but will you provide access to individual locations to check documentation themselves? If so, staff at those locations need to be involved in the training process.
Week Three: Execute
As your provider moves forward with system configuration, they will need your help to:
- Coordinate with trade partners: Onboarding your supply chain partners will allow you to receive the proper compliance documentation from them.
- Perform final data checks: Resolving any outstanding data errors or corrections now will lead to smooth sailing once your system goes live.
Week Four: Staff Preparation & Testing
With your system now configured, you are ready to test it and involve key staff:
- Confirm core functionality: you and your solution provider will test all features to insure that you will be able to complete compliance tasks.
- Designate DSCSA point people: You’ve had your decision makers involved all along, but which staff will work with the system on a daily basis, processing shipments and handling inquiries? It’s time to identify everyone that needs training.
Week Five: Training and Final Details
Just prior to full deployment, you have a few final but important tasks to complete:
- Complete systems training: All staff administrators should be prepared to manage incoming shipments, returns, drop ships, possible exceptions, verification inquiries and other compliance scenarios with your solution.
- Confirm procedural changes: In addition to managing compliance in your new system, DSCSA impacts your operations. For instance, if you need to quarantine product, where are you going to put it? Finalize and communicate all process changes, as well.
Week Six: Deployment
You are ready to go live and begin receiving compliance documentation from your trading partners!
If all necessary decisions have been made in advance and key information is readily available, then implementation can take a fraction of this time. But if your business – like most others pursuing DSCSA compliance – will need to assemble data, collaborate between departments, and chase down trading partners, you will likely need most or all of the six-week timeframe. So if you haven’t taken any action yet, it’s time to get started.