When a drug is manufactured not in compliance with GMP, what violation is occurring?

When a drug is manufactured not in compliance with Good Manufacturing Practices (GMP), it falls under the category of adulteration. Adulteration refers to the harmful or improper alteration of a product, leading to potential safety or efficacy issues. According to the Federal Food, Drug, and Cosmetic Act, a drug is considered adulterated if it has been prepared, packed, or held under unsanitary conditions, making it unsafe for use.

Non-compliance with GMP means the manufacturing processes failed to meet the stringent standards designed to ensure quality, safety, and efficacy in pharmaceutical products. This can result in contamination, incorrect formulation, or other defects, jeopardizing patient safety and the integrity of the drug itself.

While misbranding, consumer deception, and labeling negligence are important concepts in pharmaceutical law, they do not specifically address issues arising directly from the manufacturing process. Instead, these terms relate more to the labeling of the product, the presentation of the product to consumers, or the information provided about the product, which are separate from the fundamental quality controls established by GMP. As such, the most accurate description of a violation occurring due to non-compliance with GMP is adulteration.