Final answer:
The claim that new over-the-counter drug ingredients must undergo the FDA New Drug Application process, just as prescription drugs do, is true. All drugs, regardless of how they are eventually sold, must receive NDA approval to ensure they are safe and effective.
Step-by-step explanation:
The statement suggests that new over-the-counter (OTC) drug ingredients must go through the same U.S. Food and Drug Administration (FDA) New Drug Application (NDA) process as prescription drugs. This claim is True. All new drugs, whether they are destined for OTC or prescription use, must first be approved through an NDA. This ensures that every new medication on the market is safe and effective when used as directed. The NDA process will evaluate the drug for its safety, efficacy, and quality before it can be legally sold in the United States.
New drugs are subject to extensive scrutiny before FDA approval and are generally available only by prescription initially. If a drug is considered "new" because it is made by a different manufacturer, it uses different excipients or inactive ingredients, it is used for different purposes, or it has undergone any substantial change, it must be approved through the NDA process. A separate application must be submitted for a drug to change from prescription status to OTC status, but the initial approval must be through an NDA regardless of the drug's eventual distribution method.