Legal Definitions - adulterated drug

An adulterated drug refers to any drug product that fails to meet the required standards for purity, quality, strength, or manufacturing. This can occur if the drug is contaminated, contains incorrect or harmful ingredients, is manufactured under unsanitary conditions, or has deteriorated due to improper storage or handling, making it unsafe, ineffective, or otherwise unfit for its intended use.

Here are some examples to illustrate this concept:

• Example 1: Contaminated Manufacturing Process

  A pharmaceutical company manufactures a batch of over-the-counter allergy medication. During a routine inspection, it is discovered that the manufacturing equipment was not properly cleaned between production runs, leading to traces of a different, unrelated chemical compound being present in the allergy pills. This chemical is not listed on the label and could cause adverse reactions.

  Explanation: The allergy medication is considered an adulterated drug because it contains an unintended contaminant due to a failure in the manufacturing process, making it impure and potentially unsafe for consumers.

• Example 2: Incorrect Strength or Composition

  A generic drug manufacturer produces a batch of a common antidepressant. Quality control tests reveal that some pills in the batch contain significantly less of the active pharmaceutical ingredient than stated on the label, while others contain substantially more. This inconsistency means patients might receive an ineffective dose or an overdose.

  Explanation: This antidepressant batch is an adulterated drug because it does not meet the specified strength or composition, meaning it is not what it purports to be and could be ineffective or harmful to patients.

• Example 3: Improper Storage Leading to Deterioration

  A shipment of insulin, which requires refrigeration to maintain its potency, is left in a hot warehouse for several days due to a logistical error. The high temperatures cause the insulin to degrade and lose its effectiveness, even though the packaging remains sealed and undamaged.

  Explanation: The insulin is an adulterated drug because improper storage conditions have caused it to deteriorate and lose its therapeutic properties, rendering it ineffective and unfit for its intended medical purpose.