As of today, the federal government remains shut down. That means agencies like the FDA and HHS are operating under contingency plans—many employees furloughed, and some regulatory functions paused. For pharmacies, wholesalers, and secondary-market buyers, this creates real operational risk.
At Masters, we’re here to help you stay steady while Washington is at a standstill.
1. Lock in What’s Paused—and What’s Still Moving
The FDA is not accepting new FY 2026 user-fee submissions (new drug, biologic, or device applications).
However, safety-critical work—recalls, for-cause inspections, and adverse-event monitoring—continues using carry-over user-fee funds.
🔗 HHS FDA Contingency Plan
🔗 FDA Lapse in Funding Information
2. Map Your At-Risk SKUs
Identify which products are tied to pending submissions, import approvals, or inspections—those items are at highest risk for delay.
Use the FDA’s risk-management framework to prioritize which drugs to protect first.
🔗 Risk Management Plans to Mitigate the Potential for Drug Shortages — FDA Guidance Page
3. Activate & Validate Backup Suppliers
Your secondary suppliers are now mission-critical.
Re-verify licensure, import eligibility, and quality systems.
And remember: Masters Pharmaceutical remains a trusted secondary partner you can count on for reliable supply throughout this shutdown.
🔗 ASHP Guidelines on Managing Drug Product Shortages
4. Rebalance Safety Stock—Surgically
Add inventory buffer for critical and long-lead medications, but avoid over-committing capital on expensive products.
ASHP’s shortage guidance recommends proactive inventory assessment and diversified sourcing to preserve patient access.
🔗 ASHP Guidelines on Managing Drug Product Shortages (PDF)
5. Tighten QA & Documentation
With routine inspections delayed, internal oversight carries more weight.
Strengthen batch reviews, deviation tracking, and documentation to maintain compliance and patient safety.
🔗 ISMP Community Pharmacy Safety Best Practices
🔗 ISMP Community Pharmacy Handout (PDF)
6. Monitor Official Updates in Real Time
Stay informed through official FDA and HHS channels for live updates on operations, drug shortages, and safety alerts.
🔗 FDA Lapse in Funding Hub
🔗 FDA Drug Shortages Dashboard
7. Communicate & Coordinate
Be transparent with staff, suppliers, and partners about your contingency actions.
Review contracts for regulatory-delay or force-majeure clauses that allow flexibility.
Formal communication and shortage policies are key parts of ASHP’s shortage-management guidance.
The Bottom Line
A government shutdown slows oversight—but patient needs don’t pause.
By reinforcing quality systems, activating trusted suppliers, and staying informed, pharmacies can protect continuity of care until full operations resume.
At Masters Pharmaceutical, we’re committed to keeping you supplied, compliant, and confident—whatever Washington does next.