MedicationsQuestion 16 of 100
In the FDA Orange Book, an 'AB' therapeutic equivalence code means that the product:
a.Has been approved for the same indications but was never compared with the brand
b.May be dispensed only with written permission from the prescriber
c.Contains a different active ingredient that produces a similar effect
d.Has demonstrated bioequivalence and may be substituted for the reference listed drug
Explanation
An AB code means actual or potential bioequivalence problems have been resolved with adequate in vivo or in vitro data, so the product is therapeutically equivalent to the reference listed drug and can be substituted. It does not mean the ingredient differs, and no special prescriber permission is required beyond ordinary state substitution rules.
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