FDA Flags Gaps in CARES Act Drug Volume Reporting—Enforcement Likely Next
The FDA’s latest State of Pharmaceutical Quality report surfaces an uncomfortable truth: many companies still aren’t meeting the CARES Act §3112 requirement to report the amount of drug product manufactured for U.S. commercial distribution. Congress created this mandate in March 2020 to strengthen visibility into supply and help prevent drug shortages; FDA finalized guidance in February 2024 to clarify who reports, what to report, and when. Yet compliance remains uneven.
What FDA’s Data Shows
2023 reporting (Figure 2): FDA received volume data for 72% of National Drug Codes (NDCs) covering drugs and biologics overall—much lower for generics (61%) and OTC medicines (45%).
2024 year-to-date: 71% of NDCs for biologics, 65% for drugs, 60% for generics, and just 37% for OTC have reported.
Important: Companies can still submit 2024 data until December 31, 2025, so these percentages may rise—but FDA has now put the gap on record.
Why This Matters
Section 3112 reporting is not a box-check—it’s a shortage mitigation tool. FDA aggregates these data to:
Detect fragile supply lines and demand spikes sooner
Coordinate responses to quality disruptions, recalls, or ingredient shortages
Inform risk-based inspections and policy decisions
By calling out lagging compliance in an official report, FDA is signaling that tolerance is waning. Expect sharper reminders, targeted outreach, and—if needed—enforcement against persistent noncompliers.
Who’s Most Exposed?
Generic and OTC manufacturers show the lowest reporting rates—precisely the segments that supply high-volume, price-sensitive products where shortages hit patients hardest.
CMO-heavy programs with complex product/NDC portfolios may face data ownership confusion, increasing the risk of missed submissions.
Action Plan for Manufacturers (Do This Now)
Name an owner. Assign a cross-functional lead (RA or Supply Chain) accountable for §3112.
Audit your NDC universe. Reconcile active NDCs against internal SKU lists and FDA listings; close gaps.
Automate the feed. Stand up a monthly extract from manufacturing/ERP systems to capture units produced per NDC; include contract sites.
Validate and archive. Apply QA checks (outliers vs. historical runs, zeros vs. shutdowns); maintain evidence for inspections.
Calendar the deadline. Build a recurring submission schedule with reminders and executive visibility.
Paper your governance. Update SOPs/work instructions and train site and CMO partners; define who certifies completeness and accuracy.
Escalate blockers. If data rights with CMOs or systems access are issues, escalate commercially and legally now—before FDA does.
What to Watch
FDA communications: watch for additional guidance, Dear Manufacturer letters, or compliance program updates emphasizing §3112.
Inspection read-throughs: investigators may start sampling evidence of completed submissions and data traceability.
Public shortage signals: improved reporting could tighten FDA’s early-warning triggers, changing the tempo of shortage communications.
Bottom Line
CARES Act §3112 is becoming a must-do with teeth. The agency’s public scorecard shows who’s keeping pace—and who isn’t. Treat drug volume reporting like any other critical compliance obligation: institutionalize the process, automate the data, and verify before you submit. The cost of catching up under enforcement pressure will be far higher than getting it right today.
