VA Labeler Code Enforcement: Why Pharmaceutical Manufacturers Should Prepare Now

If your pharmaceutical company relies on a third-party dealer to access the U.S. Department of Veterans Affairs (VA) market, recent activity from the VA Federal Supply Schedule (FSS) Service warrants attention.

What changed: VA Revisited AS1346 Enforcement

On July 31, 2026, the VA announced plans to resume enforcement of AS1346, Labeler Codes, a long-standing requirement under the VA Schedule 65 I B pharmaceutical solicitation.

The provision requires dealers (distributors) offering certain non-covered drugs through the Pharmaceutical Prime Vendor program to use their own FDA-assigned labeler code within the product’s National Drug Code (NDC). The VA also acknowledged that the requirement has historically not been consistently enforced for an extended period.

The VA subsequently updated and superseded its initial notice, and the proposed implementation timeline did not remain in effect. However, pharmaceutical manufacturers should NOT assume the issue has gone away

Key takeaway: The VA has renewed attention on an existing labeler-code requirement. Manufacturers relying on dealer-held VA FSS contracts should prepare for the possibility of future enforcement.

Why AS1346 Matters for Dealer-Based VA Market Access

Many pharmaceutical manufacturers access the VA market through third-party dealers rather than holding their own VA FSS contract. In some arrangements, the dealer holds the contract while the product continues to use the manufacturer’s NDC and labeler code.

If the VA resumes enforcement of AS1346 as previously described, some of these arrangements may need to change. Potential implications could extend beyond the labeler code itself, affecting product listings, contracting, distribution, commercial operations, and continued participation in the Pharmaceutical Prime Vendor program.

Manufacturers should be asking:

If the VA enforces AS1346, can our current dealer arrangement continue without changes?

Two Paths Manufacturers Should Evaluate

1. Reassess the Dealer and Labeler-Code Structure

One potential option may be for the dealer or contracting firm to obtain its own FDA labeler code and structure the product accordingly.

However, this is not simply an administrative update. It could involve additional considerations related to:

• NDC assignments and drug listings
• Private-label distribution arrangements
• Product packaging and supply-chain operations
• Commercial agreements and pricing
• Regulatory and legal requirements

Manufacturers considering this approach should evaluate the full implications with their dealer and appropriate legal and regulatory advisors before assuming it will provide a workable solution.

2. Prepare for Direct VA FSS Contracting

Another option may be for the manufacturer to pursue its own VA Federal Supply Schedule contract.

A manufacturer does not need to submit a VA FSS offer immediately to begin preparing. Building contract readiness now can reduce lead time and potential disruption if the company later decides that direct VA contracting should become part of its federal strategy.

How to Become VA Contract-Ready

Pharmaceutical manufacturers can begin preparing by:

• Reviewing the current VA Schedule 65 I B solicitation
• Confirming that the company’s SAM.gov registration is active and accurate
• Gathering required pricing, commercial, corporate, and regulatory information
• Reviewing current dealer, NDC, and labeler-code arrangements
• Identifying internal ownership for the VA FSS offer and review process
• Evaluating whether direct VA contracting aligns with the company’s long-term federal market strategy

The goal is not necessarily to submit an offer tomorrow. It is to avoid starting from zero if the VA moves forward with enforcement.

How Prescription Analytics Supports VA FSS Readiness

FDA labeler-code assignments and private-label distribution structures should be evaluated with qualified legal and regulatory advisors. Prescription Analytics complements that work by helping pharmaceutical manufacturers understand and address the VA FSS contracting implications of their available options.

Our team can help manufacturers:

• Assess VA contracting considerations associated with dealer and direct-contracting models
• Evaluate readiness for a direct VA FSS contract
• Prepare and submit VA Schedule 65 I B offers
• Navigate the VA review and negotiation process
• Manage post-award administration and ongoing VA FSS contract requirements

For manufacturers that have historically relied on a dealer-held contract, now is the time to reassess that strategy and establish a contingency plan.

The VA’s enforcement timeline may be uncertain. Your ability to respond does not have to be.