503A and 503B side by side
| Dimension | 503A | 503B |
|---|---|---|
| Prescription required | Patient specific | Not required for batch production |
| Primary oversight | State boards of pharmacy | Federal registration and inspection |
| Manufacturing standard | Compounding standards | Current good manufacturing practice |
| Typical customer | Individual patients | Clinics and healthcare facilities |
Relevance to research supply
None directly. Research product is not compounded medication and a research supplier is not a pharmacy. The terms appear here because operators evaluating the prescribed route will be quoted them, and because suppliers occasionally borrow the vocabulary to imply an oversight relationship that does not exist.
A claim to be careful with
A research supplier describing itself using pharmacy terminology, or implying FDA registration it
does not hold, is making a claim that underwriters and regulators both check.