Under what condition must all individuals preparing radioactive drugs be licensed as manufacturers?

Individuals preparing radioactive drugs must be licensed as manufacturers under specific conditions that relate to the location and intent of the drug preparation. One of the primary conditions is if the preparation is physically attached to a medical facility. This means that the facility may need a manufacturer's license because the drugs prepared in such settings are considered part of the overall medical facility’s operation, impacting regulations that govern how drugs are manufactured, administered, or distributed.

Additionally, if the drug is patient-specific and ordered by a physician, it is also crucial to consider licensing. Patient-specific preparations imply that there is a requirement for compliance with certain regulatory standards that govern the safe and effective compounding of medications, especially those involving radioactive materials.

By integrating the requirements of both conditions, the option suggesting that both must be met covers a broader range of regulatory compliance. Therefore, both the physical connection to a medical facility and the nature of the drug as patient-specific ordered by a physician necessitate that individuals involved in the preparation of radioactive drugs be licensed as manufacturers.

This combined consideration of conditioning underlines the importance of adhering to strict regulatory frameworks in the handling of radioactive substances, which is crucial for patient safety and effective healthcare practices.