The CARES Act and drug shortage reporting

FDA's list of firms that skipped their 2024 drug amount reports runs to 1,254 registrants with active drug listings. A second list, of registrants whose listings had been inactivated, has 6,480 more entries. The agency posted both on its drug amount reporting page¹, last updated March 31, 2026, under a reporting duty that did not exist before the pandemic.

Section 3112 of the Coronavirus Aid, Relief, and Economic Security Act, signed March 27, 2020, created that duty. Most of the law was about COVID-19 relief. Two short sections, 3111 and 3112, rewrote parts of the federal shortage system, and FDA's CARES Act page² describes them as meant to enhance "FDA's visibility into the drug and medical product supply chains."

Those changes took effect Sept. 23, 2020. Six years on, the notice changes show up in FDA's yearly counts, the risk-plan guidance is still a draft, and the volume reports have a compliance gap visible in FDA's own lists. GxRadar counted the entries in those spreadsheets; they name companies, which this piece does not. The sections below take each provision in turn.

Six changes in two sections

Source: Public Law 116-136³, sections 3111 and 3112. Section 3112(g) set the effective date at 180 days after enactment.

Notices now reach the ingredient

Before 2020, section 506C⁴ required notice when production of a finished drug stopped or stalled. CARES added the active ingredient. A manufacturer must now report a permanent discontinuance or interruption in making an API "that is likely to lead to a meaningful disruption in the supply of the active pharmaceutical ingredient of such drug."

Required content grew too. When an API is "a reason for, or risk factor in" the disruption, the notice must give "the source of the active pharmaceutical ingredient and any alternative sources" the manufacturer knows of, whether an associated device is a factor, and the expected duration. That matters because so many ingredients for US generics come from abroad, as our piece on where drug ingredients come from shows.

FDA's instructions for these notices remain a draft. Its guidance on notifying FDA⁷ of finished-product and API disruptions is labeled Revision 1, February 2024⁸, still marked "Draft, Not for Implementation."

Notice volume rose after the change, though FDA's reports credit "greater adherence" rather than any single cause.

Sources: FDA reports to Congress for 2020¹⁶, 2021¹⁵, 2022¹⁴ and 2025¹³. Counts cover drugs and biological products. FDA received 1,605 in 2023 and 1,459 in 2024.

Risk management plans, kept on file

Section 3112(b) added subsection (j) to 506C. Each manufacturer of a covered drug, its API, or an associated device used to prepare or give it "shall develop, maintain, and implement, as appropriate, a redundancy risk management plan that identifies and evaluates risks to the supply of the drug" for each establishment involved. Under the statute⁴, the plan is "subject to inspection and copying" during an inspection or on request, and FDA's draft guidance says plans "need not be submitted" as part of an ANDA, NDA, biologics application or drug master file.

FDA's guidance on risk management plans⁹ was issued as a draft in May 2022, and its page has not been updated since. The draft¹⁰ builds on the ICH Q9 quality risk management framework and recommends "at least an annual, internal review and revision" of each plan. Among the risk factors it lists are geographic hazards and political instability, "sole source manufacturers of critical components," lack of capacity "to meet an unexpected surge in demand," cybersecurity exposure, and a facility's inspection and recall history. The idea overlaps with FDA's work on quality management maturity.

The annual volume report

Section 3112(e) created section 510(j)(3)⁶: each registrant "shall report annually" the amount of each listed drug it "manufactured, prepared, propagated, compounded, or processed" for commercial distribution. That covers finished products, APIs, contract manufacturers, and repackers and relabelers². FDA says the requirement also reaches OTC monograph drugs, homeopathic products and medical gases. Registration itself is explained in our article on FDA establishment registration and listing.

FDA's final guidance¹¹ on these reports, Revision 1, dated February 2024¹², asks for amounts by National Drug Code and by month, so the agency can spot "trends associated with hurricane or typhoon seasons, or seasonal drug manufacturing campaigns." It set deadlines: reports for 2023 by July 31, 2024, and each later year by March 31 of the following year. Reports for 2020 through 2022 that were never filed "are still required under the statute," the guidance says.

FDA explains the use plainly. When a plant warns of an interruption, the volume data "can provide insight into how much manufacturing typically occurs at the affected establishment and whether the interruption may lead to a drug shortage." A 2024 HHS white paper on shortages¹⁷ described the reports as enhancing "FDA's visibility into the volume of drugs produced by FDA-registered drug manufacturers, and where these products are produced."

That visibility depends on filing. For 2024, FDA's two non-submitter spreadsheets list 7,734 entries between them, by GxRadar's count. FDA says firms on the inactive list did not review and certify their listing data, so their listings lapsed. The active list is the more telling one, because it covers registrants still listing drugs.

Inspection reports and the CMS feed

Two smaller changes connect offices. Section 3112(d) requires that inspection reports for plants making drugs that have been the subject of a 506C notice, or that appeared on the shortage list in the past five years, be sent "promptly" to FDA's shortage staff. A 2022 law added coordination duties around those reports, and FDA's CY 2025 report¹³ now describes that alignment each year. Section 3112(c) added section 506E(d)⁵, under which FDA sends CMS a report on the current shortage list every 90 days.

What to watch

FDA's CY 2025 report lists "gaining fuller insight into the supply chain" first among its priorities and cites the CARES API notices and volume reports as the tools. Reports of 2025 production were due March 31, 2026; reports for 2026 are due March 31, 2027, the same day FDA's next shortage report to Congress is due. The earlier groundwork is in our explainer on FDASIA and early notice of shortages, and the federal studies that followed are covered in HHS's supply chain resilience reports. Current listings are on our shortage tracker.