FDA Outsourcing Facility
FDA Outsourcing Facility, What does it mean to you?
Olympia Pharmacy is now a registered FDA Outsourcing Facility. Outsourcing Facilities are sometimes referred to as 503B facilities because 503B refers to the filling of “office use” or “office administered” medications. The FDA created this new designation of compounding pharmacy to establish a new level of patient care and safety. Outsourcing facilities must comply with strict cGMP (current good manufacturing practices) guidelines, which is the same standards that pharmaceutical manufacturers follow. The Outsourcing Facilities are now the ONLY pharmacy’s permitted, under the new law, to provide compounded medications for use in physician’s offices, clinics and hospitals. Because the new rules are so stringent, only a handful of compounders in the United States have elevated their pharmacies’ to the new FDA Outsourcing Facility designation.
Olympia is the ONLY Outsourcing Facility in Central Florida. In fact, Olympia’s current facility, which launched in June of 2014, was built from the ground up as an FDA Outsourcing Facility.
At an Outsourcing Facility, safety starts each day even before compounding begins. Air and surface samples are taken in each clean room and each technician is fully gowned and participates in fingertip testing before entering the compounding environment.
When a batch of medication is completed, it is placed in a special “quarantine” area while samples from the batch are sent off for independent, third party, laboratory testing. Independent lab tests are performed for sterility, endotoxins and potency. This testing normally takes fourteen days to complete. When the tests come back satisfactory, the medications are then released from quarantine and are available to be dispensed to patients or physician / clinic offices.
The procedures above are just some of the guidelines that make an Outsourcing Facility, by far, the safest place to obtain medications from.