Final answer:
Repackaging OTC products or changing their labels falls under FDA regulation to ensure drugs remain safe and effective. The NDA process is rigorous for new drugs to guarantee safety and efficacy. OTC repackaging must meet standards to prevent consumer misinformation.
Step-by-step explanation:
When pharmacies repackage over-the-counter (OTC) products or change the wrapper, container, or labeling, this is considered a regulatory concern that falls under the auspices of the Food and Drug Administration (FDA). The Center for Drug Evaluation and Research (CDER) has different requirements for the three main drug product types, which are new drugs, generic drugs, and OTC drugs. Repackaging drugs can change their stability, integrity, and effectiveness, and must comply with specific regulations to ensure that the drugs remain safe and effective for consumer use.
New drugs, as per the FDA, merit a New Drug Application (NDA) which involves extensive scrutiny before they are approved. This assessment ensures that the drug is safe and effective when used as directed. The NDA process is rigorous, focusing heavily on a drug's components, usage, and the substantial changes it undergoes. OTC drugs, though less stringent in regulatory requirements compared to prescription drugs, still need to adhere to certain standards when it comes to repackaging and labeling to avoid misleading consumers.