Dispensing Legend Drugs

Adulterated Drugs
Under Section 301 of the FD&C Act, the
introduction or delivery into interstate commerce
of any food, drug, device, or cosmetic that is
adulterated is prohibited.
Section 501 of Title 21 defines what constitutes an
adulterated drug.
Simply stated, drugs that contain unsanitary
components, lack adequate control in
manufacture, differ in strength th from that
t
recognized in the official compendium, or that are
mixed with another substance to reduce their
quality or strength are considered to have been
adulterated.