Oncology Compliance: FDA Enforcement and Drug Supply Chain Security

What changed: The Drug Supply Chain Security Act (DSCSA) is now being enforced at the medical practice level. Any medical practice that purchases, stores, or administers drug products in-office is subject to FDA supply chain compliance inspections, not just manufacturers, wholesale distributors, and retail pharmacies. Infusion practices and oncology practices, which routinely handle some of the highest-cost drug products in medicine, are among the highest-priority targets as enforcement moves downstream.

The Drug Products at Issue in Oncology & Infusion Practices

If your practice purchases and administers any of the following, federal drug supply chain requirements apply regardless of whether you operate a pharmacy or dispense under a buy-and-bill arrangement:

CHEMOTHERAPY & TARGETED AGENTS

• Taxanes (paclitaxel, docetaxel, Abraxane)

• Platinum agents (carboplatin, cisplatin, oxaliplatin)

• Anthracyclines (doxorubicin, epirubicin, liposomal doxorubicin)

• Alkylating agents (cyclophosphamide, ifosfamide, bendamustine)

• Antimetabolites (gemcitabine, fluorouracil, pemetrexed)

• Topoisomerase inhibitors (irinotecan, etoposide, topotecan)

MONOCLONAL ANTIBODIES & CHECKPOINT INHIBITORS

• Anti-PD-1/PD-L1 (Keytruda, Opdivo, Tecentriq, Imfinzi)

• Anti-CTLA-4 (Yervoy ipilimumab)

• Anti-HER2 (Herceptin, Perjeta, Kadcyla, Enhertu)

• Anti-VEGF (Avastin bevacizumab and biosimilars)

• Anti-CD20 (Rituxan, Gazyva and biosimilars)

• Anti-EGFR (Erbitux, Vectibix)

BIOLOGICS, BIOSIMILARS & SUPPORTIVE AGENTS

• Biosimilars all FDA-approved biosimilar references

• G-CSF / GM-CSF (Neulasta, Neupogen, Granix, Zarxio)

• Erythropoiesis agents (Procrit, Aranesp, Retacrit)

• Iron infusion products (Injectafer, Venofer, Monoferric)

• IV immunoglobulin (IVIG Gamunex, Privigen, Octagam)

• Antiemetics and supportive Rx infusion agents

HORMONE THERAPIES, CAR-T & EMERGING AGENTS

• LHRH agonists / antagonists (Lupron, Eligard, Firmagon)

• Bone-modifying agents (Zometa, Xgeva — zoledronic acid, denosumab)

• CAR-T cell therapies (Kymriah, Yescarta, Carvykti)

• ADC therapies (Enhertu, Padcev, Trodelvy)

• Oral oncolytics dispensed or administered in-office

• Compounded chemotherapy preparations from 503B facilities