Final answer:
True, the process of reconstitution, which involves mixing or manipulating a drug as per the approved label, is neither considered manufacturing nor compounding. This is standard medical practice to prepare the medication for administration.
Step-by-step explanation:
True,The statement "Reconstitution" mixing or manipulation of material performed in accordance with directions for use on approved drugs label is neither manufacturing nor compounding," refers to the process of preparing a medication for administration. If a healthcare provider follows the instructions on the drug's FDA-approved label, this activity is generally considered neither manufacturing nor compounding. Manufacturing involves the mass production of drug products, and compounding is typically a practice where specific formulations of a drug are created to meet the unique needs of a patient when commercially available drug products are unsuitable. Reconstitution often involves mixing a powdered medication with a specific liquid to create a solution or suspension as directed by the medication's label. Since this is done to prepare the drug precisely as authorized and intended by the drug approval, it is generally accepted as a part of standard medical practice rather than a separate act of manufacturing or compounding.