The hospital pharmacy is unable to purchase an IV medication from their wholesale distributor and it is in short supply. Which option is appropriate?

• A. Purchase the product from a 503B outsourcing facility.
• B. Import the product from abroad without verification.
• C. Order from a non-licensed supplier.
• D. Hold patients until the supply becomes available.

Answer: (A)

When a hospital can’t get an IV medication from its usual distributor during a shortage, the appropriate path is to obtain the product from an outsourcing facility registered under the 503B provision. These facilities are FDA-regulated and operate under current good manufacturing practices to produce sterile injectable drugs in larger quantities for supply to hospitals and clinics. This setup ensures the product is manufactured and tested to appropriate quality standards, helping maintain patient safety while addressing limited availability. Importing from abroad without verification and buying from unlicensed suppliers bypass regulatory safeguards and can introduce safety and legal risks. Holding patients while waiting for supply is not acceptable because it jeopardizes patient care and outcomes.