If an entity does not compound HDs, are they required to have engineering controls for handling final dosage forms?

The correct answer reflects that if an entity does not compound hazardous drugs (HDs), they may not be required to have engineering controls for handling final dosage forms unless specifically mandated by the manufacturer of those drugs. This acknowledges that the manufacturer's guidelines take precedence and may specify certain safety measures, including engineering controls, based on the drug's nature or risks associated with handling it.

Understanding this concept is essential. The handling of final dosage forms of HDs involves considerations of risk based on the drug's properties and potential exposure levels. While the guidelines around compounding (which typically necessitate stringent controls) clearly define the need for safety measures, the handling of finished products can vary based on additional factors such as the manufacturer's recommendations or facility regulations. This flexibility ensures that entities are not unduly burdened with requirements if they are not directly handling or compounding hazardous drugs.