Final answer:
An NDC number does not guarantee FDA approval; drugs must undergo specific approval processes first. The FDA's rigorous testing safeguards the public health, but can also delay access to new drugs.
Step-by-step explanation:
An NDC number, or National Drug Code, is a unique identifier for medications in the United States; however, an NDC number alone does not guarantee that a drug is FDA approved. Drugs must undergo a rigorous New Drug Application (NDA) process for FDA approval. Prescription drugs are only available after FDA approval. Over-the-counter (OTC) drugs follow a separate process but must first be approved through an NDA. Generic drugs, which are equivalent to brand-name drugs whose patents have expired, must be shown to be interchangeable and therapeutically equivalent through an Abbreviated New Drug Application (ANDA). Some drugs may carry an NDC number but could still be awaiting approval, undergoing clinical trials, or be marketed under an FDA enforcement discretion.
When the FDA regulates a drug for safety and efficacy, it protects the public from potential harm caused by unsafe medications. This ensures that only tested and verified drugs are sold in pharmacies, which benefits the public health. However, the lengthy approval process can create 'losers' in the sense that patients may have delayed access to potentially life-saving drugs due to the time it takes for a drug to reach the market after extensive testing and regulatory review.