A rule which prescribes, for a drug or class of related drugs, the kinds and amounts of ingredients which it may contain, the conditions for which it may be offered, and directions for use, warnings and other information which its labeling must bear. Drug monographs established by FDA state conditions under which drugs may be marketed as safe and effective and not adulterated or misbranded, and thus without an approved new drug application. FDA is establishing monographs for non-prescription (over-the-counter) drugs and in the future plans to develop monographs for certain established prescription drugs. Special statutory provisions already authorize use of monographs for antibiotic drugs. Once a monograph is promulgated, anyone who meets its requirements can market the product (absent patent protection) without seeking approval of a new drug application.
A publication that specifies for a drug (or class of related drugs) the kinds and amounts of ingredients it may contain, the conditions and limitations for which it may be offered, directions for use, warnings, and other information that its labeling must contain. The monograph may contain important information concerning interactions with other drugs.