OUTSOURCING VS. COMPOUNDING PHARMACIES
Why FDA Registered Pharmacies
A COMPOUNDING PROBLEM.
The pharmacy landscape has undergone a dramatic shift in recent years. This is largely due to a 2012 fungal meningitis outbreak that took 64 lives and injured another 751 across the United States. The culprit? A New England-based 797 Compounding Pharmacy that produced and distributed contaminated medications. Subject only to periodic general inspections by the Board of Pharmacy, compounding pharmacies do not meet the same protocols, sterility, and potency testing as FDA-registered facilities. The result is cheaper medications for purchasers and windfall profits for Compounding Pharmacies—all at the expense of patient safety.
A VITAL SOLUTION.
To help protect patients, the federal government recently passed the Drug Quality and Security Act prohibiting healthcare practices and institutions from ordering sterile medications in bulk from any 503A compounding pharmacy. This legislation led to the formation of 503B specialty outsourcing pharmacies. Regulated by the FDA, this new breed of pharmacy is held to the same FDA-approved common good manufacturing process (cGMP) protocols as large pharmaceutical manufacturers. As such, they are permitted to sell medications to healthcare practices and institutions without patient-specific prescriptions and are free to back-order medications.
|Outsourcing vs. Compounding||503B Outsourcing Facility||503A Compounding Pharmacy|
|Registered with the Food and Drug Administration||YES||NO|
|Follow cGMP (Current Good Manufacturing Practices)||YES||NO|
|Provide office use sterile medications without patient specific scripts||YES||NO|
|Daily environmental testing||YES||NO|
|Extensive testing for sterility and potency of products||YES||NO|
|Equipment/Supplies routinely validated and calibrated for accuracy||YES||NO|
|Under FDA regulatory authority||YES||NO|
|Detailed labels to help reduce medical errors||YES||NO|
|Extensive reporting required by FDA||YES||NO|