Which change most clearly makes a compounded product NOT an essential copy: different API or only different excipient?
QUESTION
Which factor is most relevant to "commercially available" status: FDA approval or whether a pharmacy can obtain it promptly?
QUESTION
What does "commercially available" generally mean for essential-copy determinations?
Tap to flip before you grade
ANSWER
FDA-approved and available on the market (not discontinued or unavailable). Commercial availability requires active marketing and accessibility, ensuring compounding is not used as a substitute for obtainable approved drugs.