Question

Medicare Part D drugs must be:

1. __________ by the FDA for sale in the US
2. Available only by ___________
3. Medically necessary and for a "medically accepted indication"

Answer 1

Medicare Part D drugs must be approved by the FDA, available only with a prescription, and used for a medically accepted indication. The FDA ensures drugs meet safety standards through NDAs for new drugs and ANDAs for generic drugs. The Medicare Prescription Drug and Modernization Act of 2003 helps the elderly and disabled with prescription costs.

Step-by-step explanation:

Medicare Part D drugs must adhere to specific guidelines to ensure safety and efficacy for consumers. Firstly, these drugs must be approved by the FDA for sale in the U.S., indicating they have passed rigorous testing to be deemed safe and effective for use. Secondly, Medicare Part D drugs are available exclusively by prescription, aligning with the regulatory standards that maintain controlled access to medical drugs. Lastly, these medications should be medically necessary and used for a 'medically accepted indication,' ensuring that the drugs not only meet legal thresholds but are also purposeful in treating specific medical conditions. The Food and Drug Administration regulates the medicines by requiring new drugs to go through a New Drug Application (NDA), and for generic drugs, an Abbreviated New Drug Application (ANDA) is required. The Medicare Prescription Drug and Modernization Act of 2003 sought to provide relief by introducing prescription drug benefits to aid the elderly and disabled.