The VA Federal Supply Schedule (FSS) Program has announced that it will resume full enforcement of the existing AS1346 Labeler Codes requirement for non-covered drugs under the 65 I B Schedule.
The clause itself is not new. What is changing is enforcement. VA FSS acknowledged that this requirement has not been consistently enforced for an extended period and is giving industry 30 days to prepare.
What Changes on September 4, 2026
For companies that want their non-covered drugs to participate in the VA Pharmaceutical Prime Vendor (PPV) program:
- New FSS offers must use the submitting company’s own FDA-approved labeler code.
- New product additions must also use the contractor’s own labeler code.
- Dealers that do not currently have their own labeler code will need to obtain approval from the FDA before submitting affected products.
- Non-compliant products will not be added to the VA PPV program.
What Existing Contractors Should Know
This change does not mean VA will begin removing affected products already awarded to existing FSS contracts.
Products currently on contract are exempt from this enforcement requirement for the remainder of the current contract term.
The enforcement applies going forward to new offers and new product additions.
Why This Matters
For pharmaceutical dealers relying on another manufacturer’s or supplier’s labeler code, this can affect both future catalog expansion and eligibility for PPV participation.
Contractors planning product additions should review their pipeline now rather than discovering the issue during submission. New offerors should also determine early whether an FDA labeler code application is required, since the requirement must be satisfied before contract award.
Key Date: September 4, 2026
That is when the 30-day notice period closes, and VA FSS begins enforcing AS1346 for affected new submissions.
