DSCSA Compliance for Independent Pharmacies – Building Your Action Plan
Part 3 of 3
By Martin Dennis, Pharmacist
If the DSCSA law feels like overreach, revisit Part 1 of this series and check out the resources linked there. I believe this law is not only necessary but long overdue. Whether you agree or not, it’s here—and it’s time to act, here is
Here’s How You Can Comply
Start by leveraging available resources like utilizing guidance documents, webinars, and training programs offered by the FDA, NABP, your wholesaler, state board, professional organization, or buying group and using them to write up a compliance plan.
Examples:
- Cardinal Health – DSCSA Frequently asked questions
- Cencora – Ensuring DSCSA Compliance
- McKesson – Navigating Pharmaceutical Supply Chain Security
A compliance plan should address the following:
- Trade partner verification
- Obtaining transaction invoice information
- Implementing the serialization and verification process
- Store Transaction information
- Responding to suspect and illegitimate drugs
- Plan for and respond to verification requests
- Train your staff and stay informed
Trade partner verification:
Verifying that your trade partner is properly licensed can be accomplished in two ways: by doing your due diligence or by using a service provider. Performing your due diligence can be accomplished by asking for a copy of the following:
- State license for the wholesaler or FDA registration number
- Compare the state license of the vendors and verify it against the information on the licensing board website. They should be licensed in the same state as your store.
- Check the FDA registration number against the this database.
Take a screenshot of the license on the official website, match it to the license presented by the trade partner.
- Store the provided license and the screenshot electronically or on paper.
- Create a calendar reminder to review this information, based on the expiration date of the license.
Congratulations!
You have just done the same due diligence that Fortune 500 wholesale vendors do in your store. Bear in mind, you should perform this same process if you trade with local pharmacies.
Obtaining transaction invoice information:
DSCSA-compliant invoices will have the following information:
- proprietary name of the product
- strength
- dosage form
- national drug code
- container size
- number of containers
- lot number
- transaction date
- shipment date if different
- name and address of the seller
- buyer serial number
- expiration date
- invoices should include a transaction statement from the seller confirming that they are authorized under DSCSA, and that the product was acquired from an authorized source. The product has not been knowingly altered or counterfeited. And that system is in place to comply with verification and notification requirements.
Implementing serialized verification:
If we go back to the first blog on Crime in Pharmacy, we can deduce that anyone who can fake a brand-name drug label will not have any issue with faking the information required to be put on an invoice, in step two above. But here is where the magic happens. Scanning in the product you receive and reconciling it, using the EPCIS (Electronic Product Code Information Services) database, you will now compare the serial numbers of the products you have received against the movement of that product through the entire Drug Supply Chain using Global Location Numbers of each legal entity! This is a significant milestone! For the first time, you can verify a product’s journey from the manufacturer to your store’s shelves. With full faith, you can now trust that the product in your hand is not fake, adulterated, diluted, or illicit. Liberty’s PharmacyOne software is ready for this moment. PharmacyOne can accept EPCIS files; it has a reconciliation tool that can be utilized to compare what your store receives in the delivery totes to the data sent on the EPCIS file. It also has a workflow process to manage any discrepancies that are discovered.
Store the transaction information
You will need to store your invoices with the transaction history for six years. You will need to be able to retrieve it and scrub it of patient information upon request within 24 hours. Your primary wholesaler is probably going to keep copies of the transaction data for your store for 6 years. Check with them and verify. Find out how you can access it and how long it will take; document this process. You will need to address what to do with all the secondary vendors with whom you do business. This is where your software vendor can come in. Can they store this information for you, or will you need to sign a contract with an agency or service? Your last resort is to store these files in an organized and retrievable manner manually. PharmacyOne is ready to assist. Our software system will store data for you, and if you do not receive EPCIS data from your secondary vendor, you can scan the barcodes into PharmacyOne and the system will store them for reference.
Respond to suspect and illegitimate drug:
If you receive an extra product in your tote, or another store’s tote, how will your staff handle it? If the EPCIS file comes back with an alert, does that mean the serial data doesn’t match what you do? Document a plan that follows the following format: Segregate, Report, and Return and know that PharmacyOne has a process to reconcile and assist with discrepancies.
Plan for and respond to verification requests:
A multitude of agencies could request your transaction history for a variety of reasons, but in all likelihood the first this happens will be for a PBM Audit. When this happens you don’t want you don’t want to be stuck retrieving 1200 invoices from storage
Train your staff and stay informed
DSCSA was signed into law in 2013. Twelve years later, we are still approaching full implementation. Things will change. Keep abreast of developments on this subject by creating Google feeds to your inbox, regularly keeping up with industry periodicals, and networking with peers. Be proactive in your planning. Document your plans and train your staff to a standard.
Liberty Software makes DSCSA compliance simple, helping you meet requirements, protect your patients, and keep your pharmacy running smoothly.
