FDA Names 7,700+ Companies Noncompliant with Drug Amount Reporting Requirements

On January 6, 2025, FDA published a list of 7,734 establishments that failed to comply with drug amount reporting requirements under 21 CFR 207.25(d). The agency issued a mass warning that noncompliant entities risk enforcement action, including possible exclusion from manufacturing or distributing FDA-regulated products. Wholesale drug distributors, third-party logistics providers, and repackagers registered with FDA under the Drug Listing program must verify their reporting status immediately.

Regulatory Background

The Drug Listing Act of 1972, codified at 21 U.S.C. 360, requires entities that manufacture, repack, relabel, or salvage drugs to register with FDA and list the drugs they handle. This includes wholesale distributors that repack or relabel prescription drugs, as well as 3PLs that perform these activities on behalf of trading partners.

In June 2016, FDA finalized amendments to 21 CFR Part 207 establishing new drug listing and establishment registration requirements. The amended regulation at 21 CFR 207.25(d) mandates that registrants submit the amount of each drug introduced or delivered for introduction into interstate commerce during the previous 12-month reporting period. The first annual reporting period under this requirement began June 1, 2023.

Entities must submit drug amount data electronically through FDA's Unified Registration and Listing System (FURLS) or Electronic Submissions Gateway (ESG). The reporting period runs annually from June 1 through December 31. Entities that manufactured, repacked, relabeled, or salvaged zero units during the reporting period must still file a report indicating zero amount.

FDA's Enforcement Action

FDA's January 2025 notice identifies 7,734 establishments across multiple facility types:

• Foreign drug manufacturers
• Domestic drug manufacturers
• Repackagers and relabelers
• Wholesale distributors engaged in repackaging
• Third-party logistics providers performing drug handling activities

The list is published on FDA's website under the Drug Establishment Current Registration Site (DECRS). Each noncompliant establishment is identified by FDA Establishment Identifier (FEI) number, legal business name, and physical address.

FDA stated that entities on the noncompliance list have 30 days from the publication date to submit the required drug amount data. After 30 days, FDA may pursue enforcement actions including:

• Warning letters citing failure to maintain accurate drug listing under 21 CFR 207.41
• Facility inspections focused on data integrity and record-keeping practices
• Potential inclusion in FDA's Import Alert system for foreign manufacturers
• Referral for injunction or seizure proceedings under 21 U.S.C. 332 and 334

The agency emphasized that establishments failing to submit drug amount data may be deemed in violation of their registration and listing obligations, which could impact their legal status to engage in interstate drug commerce.

Impact on Wholesale Distributors and 3PLs

Wholesale drug distributors registered with FDA under 21 CFR 207.21 must assess whether their operations trigger drug amount reporting obligations. The requirement applies specifically to entities that:

1. Repackage or relabel prescription drugs (e.g., breaking down bulk shipments into smaller units for downstream distribution)
2. Perform salvaging operations on returned or outdated drug products
3. Act as private label distributors with NDC numbers assigned to repackaged drugs

Wholesale distributors engaged solely in storage and distribution of manufacturer-sealed containers are exempt from drug listing under 21 CFR 207.13(b). However, entities operating under NABP's Verified-Accredited Wholesale Distributors (VAWD) program or state wholesale distributor licenses may still hold FDA establishment registration numbers if they previously engaged in repackaging activities.

Third-party logistics providers face similar scrutiny. 3PLs registered with FDA under 21 CFR 207.20(c) must verify whether their scope of services includes activities that constitute "manufacture" under 21 U.S.C. 321(a)(1). Contract repackaging, relabeling, or drug product assembly performed on behalf of a client triggers both registration and drug amount reporting requirements.

Entities uncertain about their reporting status should cross-reference their FEI number against FDA's noncompliance list and review their FURLS submission history for the June 1, 2023–May 31, 2024 reporting period. Firms that hold FDA registration solely for 3PL or wholesale distribution storage activities should confirm whether their registration type code (47521 for 3PL, 47558 for wholesale distributor) aligns with their actual operations.

What ColdChainCheck Data Shows

ColdChainCheck tracks FDA registration status for 1,234 of the 1,275 wholesale drug distributors and 3PLs in the directory. FDA registration contributes 20 points to the overall compliance score, meaning entities on FDA's noncompliance list may face score reductions if their registration status becomes compromised.

The current average compliance score of 51/100 across the directory places most entities in the "Fair" tier. 919 entities (72%) fall into this category, suggesting baseline regulatory compliance but limited verification across multiple data dimensions. Only 28 entities hold "Excellent" scores (80-100 points), while 38 entities score in the "Poor" range (20-39 points). Entities appearing on FDA's noncompliance list risk downward score movement if enforcement actions result in registration suspensions or warning letters.

Of the 1,234 entities with verified FDA registration in ColdChainCheck's database, the subset engaged in repackaging or relabeling activities faces immediate exposure to this enforcement action. While ColdChainCheck does not currently distinguish between registration types (manufacturer vs. repackager vs. 3PL storage-only), the presence of FDA registration signals that an entity has some level of federal oversight obligation.

Immediate Actions for Compliance Officers

• Cross-reference trading partners: Use the ColdChainCheck directory to identify which wholesale distributors and 3PLs in your supply chain hold FDA registration. Entities with verified FDA registration may appear on the noncompliance list if they engage in repackaging.
• Request FEI verification: Ask registered trading partners to confirm their FDA Establishment Identifier and provide proof of drug amount reporting submission for the June 1, 2023–May 31, 2024 period. Entities should be able to produce FURLS confirmation receipts.
• Review contractual language: Contracts with 3PLs and contract repackagers should include clauses requiring compliance with all FDA registration and listing obligations. Noncompliance may constitute a material breach.
• Monitor for warning letters: ColdChainCheck tracks FDA enforcement actions, including warning letters issued under 21 CFR 207.41. 73 entities in the directory currently have recalls on record. Entities receiving warning letters for drug amount reporting failures will see compliance score impacts.

FDA's 30-day cure period ends February 5, 2025. Compliance officers should verify trading partner status before that date and document due diligence efforts. For entities on the noncompliance list that fail to remediate, consider whether continued business with those partners creates unacceptable supply chain risk.

ColdChainCheck will update entity compliance scores as FDA issues enforcement actions related to this noncompliance list. See the wholesale distributor compliance guide for ongoing monitoring of FDA registration, NABP accreditation, and state licensing requirements.

Disclaimer: This article is for informational purposes only and does not constitute legal or regulatory advice. Entities subject to FDA drug listing requirements should consult with qualified legal counsel and verify their compliance status directly with FDA through FURLS or ESG.