Table 3.
Basic comparison of 503a vs 503b compounding pharmacies | ||
503a | 503b | |
Regulatory supervision | State Boards of Pharmacy | US Food and Drug Administration |
Who do they compound for? | Individual prescriptions for individual Patients | Both individual prescriptions and large batches of product which can be distributed to healthcare facilities |
Ship products across state lines? | No (<5% of sales must be across state lines) | Yes |
Several caveats and further key regulatory differences exist but are outside the scope of this discussion.