Final answer:
An adulterated drug, as defined by the FDCA, is a drug that does not meet certain standards set by the FDA. Examples of adulterated drugs include those that contain filthy or decomposed substances, are manufactured under unsanitary conditions, or do not conform to Good Manufacturing Practice regulations.
Step-by-step explanation:
The FDCA, or the Federal Food, Drug, and Cosmetic Act, defines an adulterated drug as a drug that:
- Contains any filthy, putrid, or decomposed substance
- Has been prepared, packed, or held under unsanitary conditions
- Has been manufactured, processed, or held in conditions that do not conform to current Good Manufacturing Practice (cGMP) regulations
- Contains an unsafe color additive
- Has been declared to be adulterated by regulations issued under the FDCA
- Is an antibiotic drug manufactured using bulk drug substances that do not meet the FDA's approval standards
These are just a few examples of situations that can render a drug adulterated according to the FDCA. The Act aims to ensure that drugs are safe, effective, and properly manufactured to protect the public health.