The FDA Drug Shortages database lists 87 shortage records in the oncology therapeutic category as of the June 9, 2026 extract, and 83% of them — 72 of 87 — are sterile injectable products. Of the 41 records still classified as a current shortage, 29 are a single molecule: carboplatin injection, the foundational platinum chemotherapy used across ovarian, lung, breast, testicular, and head-and-neck cancers. Behind the acute shortage sits a second, quieter problem: 46 oncology products classified as "to be discontinued," spanning 15 distinct molecules from irinotecan and pemetrexed to docetaxel and oxaliplatin, forcing therapy switches at the protocol level. The carboplatin shortage was first posted on April 28, 2023, and it is still listed as active more than three years later, even as the related cisplatin shortage was declared resolved in June 2024.
This is a category-specific read of the FDA Drug Shortages database for the oncology segment, written for Part B buy-and-bill teams, oncology pharmacy directors, specialty-distribution planners, and access teams that model supply-driven disruption to chemotherapy regimens. Every figure is computed from the public FDA Drug Shortages extract (1,680 records, export dated 2026-06-09). For the database-wide shortage picture — all therapeutic categories, anesthesia leadership, and the injectable-dominance headline — see the companion analysis of 1,146 current shortages. This article stays on oncology, where the stakes are buy-and-bill reimbursement, protocol substitution, and the compounding bridge.
Methodology, in one paragraph
The FDA Drug Shortages database records product-level entries: each shortage record is a specific package-level presentation (strength, package size, manufacturer) of a specific active ingredient from a specific company, not a single drug-level shortage. The 1,680 total records roll up to roughly 96 unique active ingredients across all therapeutic categories. The oncology read filters to records the database tags with a therapeutic category of "Oncology" (87 records). "Current," "To Be Discontinued," and "Resolved" follow the database's own status field. Injectable share treats dosage forms of Injection, Solution, Powder for Solution, and Concentrate as injectable. Active ingredients are parsed from the generic-name field by taking the first comma-delimited token, so "Carboplatin Injection" and "Carboplatin" both count as carboplatin. Availability counts ("Unavailable," "Limited Availability," "Available") follow the database's per-record availability text as of the extract date.
The oncology segment at a glance
| Metric | Count |
|---|---|
| Oncology shortage records (all status) | 87 |
| — Current shortages | 41 |
| — To Be Discontinued | 46 |
| — Resolved | 0 |
| Injectable-form records | 72 (83%) |
| Oral solid (tablet/capsule) records | 15 |
| Distinct oncology active ingredients (all status) | 18 |
| Distinct oncology molecules currently in shortage | 4 |
Two features separate the oncology segment from the shortage average. First, every single oncology record is either still current or slated for discontinuation — none is resolved. The 0% resolved rate, against a database-wide resolved share that is small but non-zero, reflects how durable these particular shortages are: once a generic sterile-oncology injectable goes short, the manufacturing economics that caused it do not self-correct quickly. Second, the current-shortage set is extraordinarily concentrated. Forty-one current records, but only four distinct molecules — and one molecule accounts for most of them.
Carboplatin is the current-shortage story
| Current oncology shortage molecule | Records |
|---|---|
| Carboplatin injection | 29 |
| Azacitidine injection | 9 |
| Streptozocin powder | 2 |
| Flurazepam hydrochloride capsule | 1 |
| Total current | 41 |
Carboplatin alone is 29 of 41 current oncology records, 71% of the active-shortage book. Its shortage was first posted on April 28, 2023 — the same week the FDA publicly announced a national carboplatin shortage, triggered by quality-control failures and a production shutdown at a single contract manufacturer that also disrupted cisplatin. The related cisplatin shortage, first posted February 10, 2023, was declared resolved by the FDA in June 2024; carboplatin, posted two months later, is still active.
The 29 current carboplatin records are not 29 different drugs. They are 29 different presentation-and-manufacturer combinations of the same molecule, because the US sterile-injectable supply for a mature generic like carboplatin is deliberately concentrated across a small number of manufacturers:
| Carboplatin supplier (current + discontinued records) | Records |
|---|---|
| Hospira, a Pfizer company | 8 |
| Teyro Labs | 8 |
| Gland Pharma | 4 |
| Accord Healthcare | 4 |
| Teva Pharmaceuticals | 4 |
| Eugia US | 2 |
| Ingenus Pharmaceuticals | 2 |
| Avyxa Pharma | 2 |
| Fresenius Kabi | 1 |
Nine companies make essentially all US carboplatin. When one of them hits a quality or capacity problem, the others cannot backfill fast — sterile-injectable manufacturing capacity is the binding constraint, not the chemistry — and a national shortage of a 1980s-era off-patent drug follows. That is the structural read: these are not R&D-driven shortages; they are manufacturing-and-margin-driven shortages on low-priced generic sterile injectables.
Availability, today
Of the 41 current oncology records, the per-record availability as of the extract date breaks down as:
| Availability | Current oncology records |
|---|---|
| Unavailable | 17 |
| Limited availability | 10 |
| Available | 14 |
Seventeen current oncology shortage records report a product that is fully unavailable, and another ten report limited availability. The fourteen "available" records remain tagged as shortages because the database considers them restored-to-sufficient only when supply stably exceeds demand — a bar that carboplatin, in particular, has not cleared across the full supplier base.
The discontinuation wave, and the switch problem
A second oncology access problem sits behind the acute shortage. Forty-six oncology records are classified as "to be discontinued," covering 15 distinct molecules, and 32 of those 46 are injectables. These are not transient supply disruptions; they are voluntary manufacturer exits from older oncology products, and each one forces a formulary or protocol switch.
| Molecule (to-be-discontinued) | Records | Dosage form |
|---|---|---|
| Irinotecan hydrochloride | 6 | Injection |
| Carboplatin | 6 | Injection |
| Pemetrexed disodium | 4 | Injection |
| Docetaxel | 4 | Injection |
| Oxaliplatin | 4 | Injection |
| Allopurinol | 4 | Tablet |
| Dacomitinib | 3 | Tablet |
| Gemcitabine hydrochloride | 3 | Injection |
| Nilutamide | 2 | Tablet |
| Idelalisib | 2 | Tablet |
| Decitabine | 2 | Injection |
| Pemetrexed ditromethamine | 2 | Injection |
| Palbociclib | 2 | Capsule |
| Tazemetostat hydrobromide | 1 | Tablet |
| Arsenic trioxide | 1 | Injection |
The list mixes two economies. The injectables (irinotecan, pemetrexed, docetaxel, oxaliplatin, gemcitabine, decitabine, arsenic trioxide) are mature generic chemotherapy backbones that certain manufacturers are exiting because the margin is too thin — the same dynamic that drives the carboplatin shortage. The oral oncolytics (dacomitinib, nilutamide, idelalisib, palbociclib capsule, tazemetostat) are a different problem: branded or recently-generic targeted agents where a specific presentation is being wound down, often a dose strength or capsule count that oncologists must now re-prescribe around. For Part D and specialty pharmacy teams, the oral discontinuations generate prior-authorization and quantity-limit rework; for Part B buy-and-bill teams, the injectable discontinuations generate inventory and substitution risk on regimens that may not have a clean alternative.
Why sterile-oncology injectables are structurally fragile
The FDA's own framing of the carboplatin and cisplatin crisis, articulated by the agency's oncology leadership during the 2023 shortage, is that sterile injectable products are the segment most vulnerable to shortage because their manufacturing process — aseptic filling, sterility assurance, and complex supply of glass vials and stoppers — is harder to run and remediate than solid-oral manufacturing, and because the products are low-priced generics that do not attract enough manufacturers to create resilience. When quality issues close one facility, the remaining capacity cannot absorb demand, and a ripple effect moves patients onto alternatives (during the cisplatin shortage, substitution drove carboplatin use up sharply, which then overstressed carboplatin supply).
The economic driver is buy-and-bill reimbursement. Carboplatin, cisplatin, irinotecan, oxaliplatin, docetaxel, pemetrexed, and gemcitabine are Medicare Part B drugs reimbursed on average sales price (ASP) plus a margin. ASP-based reimbursement on decades-old generics produces a thin, declining gross margin that has pushed manufacturers out of the category and concentrated remaining supply in a handful of sterile-injectable producers — Pfizer/Hospira, Fresenius Kabi, Sandoz, Teva, Hikma, Accord, and a set of Indian contract and finished-dose makers (Gland, Eugia, Teyro). The concentration is the fragility: the oncology shortage book is, molecule for molecule, a map of where that concentration has broken.
A USP supply-chain vulnerability analysis quantifies how tight that concentration is. As of January 2025, roughly 42% of US cisplatin volume came from India, with a single Indian facility producing an estimated 24% of US cisplatin, 84% of temsirolimus injection, 43% of carmustine, and 8% of carboplatin. When one facility sits across multiple essential oncology molecules, a single quality event becomes a multi-drug shortage — which is exactly the cascade the 2023 cisplatin–carboplatin crisis followed. USP's framework isolates four structural risk factors for these shortages, and the platinum agents score high on all of them: low price, manufacturing complexity (sterile injectable), geographic concentration of finished-dose and API production, and dependence on a small number of suppliers.
What this means for Part B and oncology access teams
- Model carboplatin as chronically fragile. Three years of continuous shortage, nine suppliers, and still 17 unavailable and 10 limited-availability records is not a transient event. Oncology buy-and-bill planning should assume ongoing carboplatin allocation and keep protocol alternatives validated (for example, cisplatin where clinically equivalent, or carboplatin dose adjustment under pharmacist protocols).
- The discontinuation wave is the forward-looking risk. The 46 to-be-discontinued records are manufacturers signaling exits. Track which molecules drop from two suppliers to one, because a single-source sterile injectable is the next shortage candidate. Pemetrexed, oxaliplatin, and docetaxel each still have multiple suppliers, but the trajectory is down.
- 503B outsourcing facilities are the bridge, not the fix. During the 2023 peak, FDA-enforced discretion allowed 503B outsourcing facilities to compound short-supply sterile oncology injectables. That compounding bridge restored some supply, but compounded product is not a permanent substitute for an approved generic — it does not carry the same labeling, stability commitments, or reimbursement coding certainty, and access teams should treat it as a stopgap.
- Regimen-level, not drug-level, monitoring. A carboplatin shortage is a TNBC Keynote-522 sequencing problem, an ovarian-cancer first-line problem, and a head-and-neck radiosensitization problem simultaneously. Track shortage impact at the regimen level, because the substitution decision and its cost and outcomes consequences live there, not at the NDC level.
- Expect the prior-authorization rework. When a regimen changes under shortage, payers often treat the modified regimen as a new authorization. In one practice survey, 86% of centers reported that a treatment modification before or during a shortage triggered re-prior-authorization. Build the substitution alternatives into the original PA submission where possible, and budget hub and appeals capacity for the disruption window, not just the drug itself.
Sources
- US FDA, Drug Shortages database, public extract (1,680 records, export dated 2026-06-09). Oncology-segment aggregates computed by PharmaDossier from the FDA Drug Shortages data. https://www.accessdata.fda.gov/scripts/drugshortages/
- US FDA, "FDA marks cisplatin drug shortage as resolved" (cisplatin shortage posted February 10, 2023; resolved June 2024; carboplatin shortage posted April 28, 2023). https://www.fda.gov/drugs/drug-shortages
- "Real-world impact of the platinum chemotherapy shortage on US patients with advanced cancer" (Flatiron Health analysis of the cisplatin and carboplatin shortage period, February 2023–January 2024). https://pmc.ncbi.nlm.nih.gov/articles/PMC12145908
- US FDA, Center for Drug Evaluation and Research, "The State of Pharmaceutical Quality" (sterile-injectable manufacturing concentration as a root cause of oncology drug shortages; cisplatin and carboplatin case). https://www.fda.gov/media/170765/download
- US Oncology Network / ASCO Post, "Cisplatin Shortage Led to Treatment Alternatives for Head and Neck Cancer, Significantly Increasing Cost" (carboplatin substitution +40%, paclitaxel +24%, fluorouracil +5.3%, cetuximab +15% during the shortage period). https://ascopost.com/news/september-2024/cisplatin-shortage-led-to-treatment-alternatives-for-head-and-neck-cancer-significantly-increasing-cost
- National Comprehensive Cancer Network (NCCN), Best Practices Committee carboplatin and cisplatin shortage survey results (93% of centers lacking carboplatin at June 2023 peak, declining to 11% by June 2024). https://www.nccn.org
- US FDA, Center for Drug Evaluation and Research, oncology-drug-shortage testimony and reporting (14 oncology drugs among 138 in shortage during 2023; sterile-injectable fragility framework). https://www.fda.gov/drugs/drug-shortages
- US Pharmacopeia, "Oncology Drug Shortages: Impacts, Policy Reforms, and Advocacy" / USP Medicine Supply Map (US production-volume shares by location and facility-level vulnerability: one Indian facility producing ~24% of US cisplatin, ~8% of carboplatin, 84% of temsirolimus, 43% of carmustine; four structural shortage risk factors). https://pmc.ncbi.nlm.nih.gov/articles/PMC12459138
- US Pharmacist, "Oncology Drug Shortages" (practice-survey mitigation strategies; 86% of centers required re-prior-authorization when treatment plans were modified during a shortage; vinblastine, etoposide, and topotecan as frequently short NCCN category-1 agents). https://www.uspharmacist.com/article/oncology-drug-shortages
