Which information is mandated by the FDA to be published in a medication's monograph?

The information that is mandated by the FDA to be published in a medication's monograph includes contraindications. This is essential because contraindications provide critical safety information regarding which patient populations should avoid using the drug based on potential adverse effects or interactions. By including contraindications in the monograph, the FDA ensures that healthcare providers and patients have access to vital information that can prevent harmful situations and improve the safe use of medications.

Dosage forms are indeed important and included in monographs; however, they do not carry the same level of safety concern as contraindications. Patient testimonials are not considered a reliable or scientific basis for including information in a monograph and are therefore not mandated. While drug interactions are significant to a medication's safe use and are typically included, the term "contraindications" highlights specific situations where the drug should not be used, making it a crucial requirement in the context of safety that takes precedence over the others.