The biggest difference between the 503A and 503B designations is that 503B facilities are required to have every process validated, whereas 503A facilities are not.
What does that mean for 503B facilities? Every batch of medication must be submitted for testing prior to being released to market. This guarantees that all batches are consistent and meet FDA and CGMP standards. Additionally, testing methods, equipment and compounding rooms and must be validated to ensure accuracy as per CGMP guidelines.