Overview
- State investigators say roughly 30,000 doses were compounded beginning in September 2024, with production exceeding 1,000 doses per day.
- Medications were made in uninspected rooms at the main site and transferred to a second building for inspection, verification, and packaging that had not been approved by the State Board of Pharmacy.
- During four inspections from November 2024 through March 2025, staff did not disclose the ongoing compounding or the use of the unlicensed processing location.
- Under a consent agreement, Boothwyn admitted violations, placed $500,000 of the penalty in escrow, must pay the remaining $500,000 within a year, secure Board inspection approvals, and obtain National Association of Boards of Pharmacy compounding accreditation before seeking removal of probation.
- The enforcement action tracks with the FDA’s phase-out of broad GLP-1 compounding after shortages ended, and the pharmacy says it has since passed a state inspection and reports no known patient adverse events.