By Melody Anderson, Head of Revenue Marketing, RxERP
For wholesale distributors, 3PLs, and manufacturers managing products affected by drug shortages.
Key takeaways
- The FDA has extended the use dates of specific lots of shortage drugs, including Bicillin L-A, based on stability data. The FDA’s list was last updated on September 21, 2026, and may grow.
- The FDA is not requiring or recommending relabeling, so the date printed on the package and the date that actually matters can be different.
- Every process that runs on expiration dates can get that wrong: available-to-sell, picking, destruction, returns, and recordkeeping.
- The fix is to keep both dates on the lot record, give “possibly extended” stock its own hold status, and keep an audit trail of every change and why it was made.
A Monday Morning Near-Miss
At 7:40 on a Monday, Priya, the inventory manager at a regional distributor, opens the weekly expiration report. Three lots of Bicillin L-A are flagged red. Their printed expiration dates passed last week, and the system has already queued them for destruction.
At 8:15, an email arrives from a clinic customer. They’re out of Bicillin L-A, the shortage has them rationing doses, and they want to know whether Priya has any to spare.
Priya has three lots. Her system says she has none.
A few minutes later, a colleague in quality mentions that the FDA has been extending use dates on certain shortage drugs. Priya pulls up the FDA’s list and checks the lot numbers one by one. Two of her three lots are on it. That product isn’t expired. It’s usable, it’s in short supply, and it was about to be thrown away.
Priya is fictional, but her Monday is a fair picture of what happens when the FDA extends a lot’s use date and the package, the barcode, and the inventory system all keep showing the old one.
What Are FDA Extended Use Dates?
FDA extended use dates are later expiration dates the FDA has approved for specific lots of drugs in shortage, based on stability data showing the product remains safe and effective past its labeled date.
The FDA’s Center for Drug Evaluation and Research keeps a searchable list of these lots on its drug shortage pages. As of its September 21, 2026 update, the list includes:
- Hospira’s Bupivacaine Spinal Injection 0.75%, in glass ampules
- Hospira’s Dextrose Injection 25%, in plastic syringes
- Pfizer’s Bicillin L-A (penicillin G benzathine), in 1,200,000-unit and 2,400,000-unit strengths
Three details from the FDA’s guidance matter most for anyone managing inventory:
- It’s lot by lot. An extension applies only to the specific lot numbers the FDA lists, not to every lot of the product.
- No relabeling. The FDA isn’t requiring or recommending that listed lots be relabeled with their new dates.
- Replace when you can. When replacement product becomes available during the extension, the FDA expects the listed lots to be replaced and properly disposed of as soon as possible.
The FDA also notes that the list can keep expanding as more stability data comes in, which is why a lot that isn’t on the list today may be on it next month.
Do You Have to Relabel Extended Lots?
No. The FDA isn’t asking anyone to relabel the listed lots, and that’s exactly what makes extensions tricky to manage.
The original expiration date stays printed on the carton. It stays encoded in the 2D barcode. When your team scans the product at receiving, that original date flows straight into your lot record. From then on, every automated decision your system makes about that lot is based on a date that’s no longer the one that counts.
Nothing about the product changed. Only the date that matters did, and it changed somewhere your scanners can’t see.
Should You Destroy Product That’s Past Its Printed Date?
Not automatically, if it’s a shortage product. Because the FDA’s list can expand, product that’s past its printed date today could be extended tomorrow.
Some public health departments are telling providers to hold on to it. In an October 7, 2026 update on Bicillin L-A, San Francisco’s health department recommended keeping all inventory past its labeled expiration, even units not in an extended lot, marking them “DO NOT DISCARD,” and storing them separately from active stock in case more lots are extended.
This isn’t a short-term problem, either. Maine CDC reported in June 2026 that the Bicillin L-A shortage is expected to continue into the fourth quarter of 2027. Distributors should plan on managing extended and possibly extended lots for a while.
The safe default is a hold, not the destruction queue. Follow the FDA’s guidance and your own procedures for what happens next.
Where a Changed Date Breaks Your Operation
When the printed date and the usable date differ, any process that runs on the expiration date can give the wrong answer. Here’s how that played out in Priya’s warehouse, and where it can show up in yours.
| Process | What goes wrong |
| Available-to-sell | An extended lot still shows as expired, so sales can’t commit product that customers need during a shortage. |
| Picking | First-expiry-first-out logic ranks the lot by its old date and sends it out ahead of, or behind, the wrong stock. |
| Expiration alerts and destruction | The lot gets flagged for destruction on its printed date, and usable product is lost. |
| Customer questions | Pharmacies and clinics see the printed date and ask whether the product is still good. Your team needs the answer and the source on hand. |
| Returns | The product identifier on the package still carries the original expiration date, so a returned unit can look expired at the dock. |
| Recordkeeping | If someone simply overwrites the date, there’s no record of what the label said, when it changed, or why. |
Priya ran into the first three before 9 AM. The other three were waiting for later in the week.
How Do You Manage Extended Lots? Five Steps
1. Check your lots against the FDA’s list on a schedule
Make checking the FDA’s list a routine for every shortage product you carry, not a one-time task. Record the date of each check, since the list is updated from time to time. Start with the products already on the list and any your customers are asking about.
2. Keep both dates on the lot
Don’t overwrite the printed expiration date. Keep it, add the extended use date next to it, and record the source: the FDA’s list and the date of that update. The printed date will stay on the package and in the barcode, so your records need to show both, and your team needs to act on the extended one.
3. Give “possibly extended” stock its own status
Product past its printed date that might still be extended shouldn’t sit with product headed for destruction. Put it on hold, physically and in your system, so it can’t ship and can’t be destroyed while you wait. Release it if the FDA extends the lot. Move it to destruction if replacement product arrives or the list doesn’t change.
4. Plan for returns and verification
Before you resell a returned unit, DSCSA requires you to verify its product identifier, which includes the lot and expiration date. An extended lot will still show its original date. Ask the manufacturer how it handles verification and returns for extended lots, and make sure your returns team knows which lots are affected before they start processing.
5. Plan the exit
The FDA expects extended lots to be replaced as soon as new product is available. Track when replacement stock arrives, move extended lots out first, and document the destruction of anything left. An extension is temporary relief, not a new shelf life.
Why This Is Harder When Your Systems Are Split
Back in Priya’s warehouse, the trouble didn’t stop at the expiration report. Her ERP, her warehouse system, and her serialization system each keep their own copy of the lot record. Updating the date in one doesn’t update the others.
So once she fixes the ERP, the warehouse system still ranks the lot by its old date for picking, and the serialization records still carry a third version of the story. Sales can now commit the product, but the warehouse may not pick it, and nobody can say with confidence which record is right.
That’s the hidden cost of split systems during a shortage. Every date change has to be made in several places, and every missed update is a chance for usable product to be destroyed, or for the wrong lot to ship.
How RxERP Handles It
RxERP tracks each lot by item, quantity, expiration, and quality status at every location, in the same system that runs orders, warehouse operations, and DSCSA serialization. There’s one lot record, not three.
Lot statuses are configurable, with options such as released, on hold, and blocked, and only users with quality assurance permissions can change a lot’s status. That gives “possibly extended” stock a clear place to sit. Lot and expiration data travel with every unit, so picking can follow expiration, and the audit log records every change, including the old and new values, who made it, and when. Audit log entries can’t be altered.
Priya’s Next Monday
Picture the same Monday a week later, with the five steps in place.
The expiration report still flags the Bicillin L-A lots, but they aren’t in the destruction queue. They’re on hold, labeled as possibly extended. Priya checks them against the FDA’s list, records the extended use date and the date of the FDA update she checked, and releases the two lots that qualify. The third stays on hold in case the list expands.
When the clinic emails, sales can commit the product, the warehouse picks the right lot, and if the clinic asks why the carton shows an old date, the answer and its source are already on the lot record.
Nothing was thrown away, and nobody had to reconstruct what happened. The record already showed it.
Five Questions to Ask Your Team This Week
- Which shortage products do we carry, and when did we last check their lots against the FDA’s list?
- If a lot’s use date were extended today, where would we record it, and would we lose the printed date?
- Is product past its printed date on hold, or is it in the destruction queue?
- Does our returns team know which lots have extended dates?
- Would a date change made in one system show up everywhere we pick, sell, and report from?
If any of those answers are “we’re not sure,” that’s the place to start. For the basics of tracking expiration across your inventory, see our guide on how to track drug expiration dates.
Book a 30-minute demo to see how RxERP tracks lot status and expiration across your inventory.
This article is for general information only and does not constitute regulatory advice. Refer to the FDA’s drug shortage pages for current extended use dates.
Sources
- U.S. Food and Drug Administration (FDA), Search List of Extended Use Dates to Assist with Drug Shortages (updated Sep 21, 2026): https://www.fda.gov/drugs/drug-shortages/search-list-extended-use-dates-assist-drug-shortages
- San Francisco Department of Public Health, Bicillin L-A expiration dates extended for some lot numbers (Oct 7, 2026): https://www.sf.gov/news-health-update-penicillin-g-benzathine-bicillin-l-a-expiration-dates-extended-for-some-lot-numbers-as-nationwide-shortage-continues
- Maine CDC, Bicillin L-A shortage extended to Q4 2027 (Jun 26, 2026): https://www.maine.gov/dhhs/mecdc/health-professionals/health-advisory-notices/bicillin-l-shortage-extended-q4-2027-fri-06262026-1200