What does adulteration refer to in the context of pharmaceuticals?

Adulteration in the context of pharmaceuticals primarily refers to the alteration or variation of a drug's composition or quality in a way that fails to meet established standards. This can include deviations from the official formulary standards, meaning that the drug may have been contaminated with impurities, not manufactured according to specified guidelines, or not contain the amount or potency of the active ingredients as claimed.

The concept of adulteration is crucial for ensuring the safety and efficacy of pharmaceuticals, as any deviation from the official standards can potentially expose patients to harmful effects or reduce the therapeutic value of the medication.

In contrast, proper labeling of drug packages pertains to the communication of information regarding the medication, while changes in drug packaging materials may not directly affect the drug's quality or efficacy. Maintaining manufacturing consistency is also important but relates more to the processes that ensure each batch of the drug is produced according to the same standards rather than the compliance with those standards themselves, which is captured under the definition of adulteration.