Is mixing or reconstituting non-sterile products in accordance with approved labeling considered compounding?

Mixing or reconstituting non-sterile products in accordance with approved labeling is not considered compounding because compounding typically involves creating a customized medication that is not available in standard, commercially available forms. When mixing or reconstituting according to the approved labeling, the alterations made to the product are limited to what has been deemed safe and effective by the manufacturing processes and standards in place.

Compounding is generally defined as the preparation of a medication tailored to the needs of an individual patient, which might include changing the strength, formulation, or dosage form of a drug. Conversely, simply following the manufacturer's instructions for mixing or reconstituting a non-sterile product adheres to pre-established protocols and regulations, thus it does not meet the criteria of personalized compounding.

The other choices suggest specific conditions under which these actions might be considered compounding, yet none apply to the general practice of mixing or reconstituting according to approved labeling.