Final answer:
A New Drug Application (NDA) is typically not required for a compounded drug because NDAs apply to new drugs intended for mass production and public distribution. Compounded drugs are custom medications for individualized patient use, adhering to pharmacy regulations rather than the NDA process. Pharmaceutical companies must submit an NDA to the FDA for larger scale drug marketing approvals.
Step-by-step explanation:
To determine the necessity of a New Drug Application (NDA) for a compounded drug, it is important to understand what an NDA entails. According to the U.S. Food and Drug Administration, an NDA includes extensive data and information about the drug's safety, effectiveness, manufacturing, packaging, and administration. It is a rigorous process that applies to new molecular entities (NMEs) or new drugs that significantly differ from existing drugs.
Compounded drugs, however, are typically customized medications mixed by a pharmacist to meet the unique needs of an individual patient, which may not require an NDA because they are not mass-produced or sold to the general public. These are usually prepared in accordance with a prescriber's prescription where specific dosage forms or ingredients are tailored for a patient's needs. Nonetheless, compounded drugs still need to comply with relevant pharmacy regulations and standards.
An NDA is more relevant for pharmaceutical companies seeking to market a new drug on a large scale. Once the therapy clears all clinical trials demonstrating safety and effectiveness, an NDA submission to the FDA is the next step to obtain official approval to market the drug. Detailed pharmacovigilance is required even after the drug's approval to monitor its long-term safety among the broader patient population.