LLY · 10-Q · 2026Q3 · Full report

FDA Compounding Restrictions

ELI LILLY & Co · 2026-10-29 · Importance 26 · Surprise 24

Lilly says production, marketing, and sale of counterfeit, misbranded, adulterated, and mass-compounded incretins continue, creating patient-safety concerns and potentially undermining the drug-approval process. The FDA has declared that compounding pharmacies are required to cease mass production, although Lilly cannot guarantee adequate regulation or compliance. Lilly says it will consider options, including lawsuits, to address unlawful practices and risks from unapproved, untested, and manipulated drugs.

Key facts

• Lilly will consider all options, including filing lawsuits where appropriate, to address unlawful practices and patient-safety risks involving unapproved, untested, and manipulated drugs. source
• Lilly continues to see production, marketing, and sale of counterfeit, misbranded, adulterated, and mass-compounded incretins, which may affect patient safety and undermine regulatory drug approval processes. source
• Although the FDA has declared compounding pharmacies are required to cease mass production, Lilly cannot guarantee adequate regulation or compliance. source