Final answer:
The repackaging process for drugs or devices must be supervised and approved by a pharmacist. This is in line with FDA guidelines ensuring drug safety and efficacy. Particularly, new drugs undergo a thorough NDA process before they're considered safe for prescription use.
Step-by-step explanation:
When drugs (or devices) are repackaged, the repackaging process must be supervised & approved by a pharmacist. This ensures adherence to safety protocols and maintains the integrity of the drug or medical device. It is part of the rigorous standards set by agencies such as the FDA, which require that drugs, especially new drugs, meet specific criteria before receiving approval. The FDA's Center for Drug Evaluation and Research mandates distinct standards for new drugs, generic drugs, and over-the-counter drugs. A new drug, for instance, has to go through an extensive evaluation via a New Drug Application (NDA) and is generally prescription-based unless a separate process reclassifies it as over-the-counter.