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What are the labeling requirements for drugs dispensed from Telepharmacy?

User FBB
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Final answer:

The FDA enforces stringent regulations on the safety and efficacy of drugs, benefiting the public by preventing the use of unsafe medications. However, the patients needing access to innovative treatments and smaller pharmaceutical companies may suffer from these regulations due to delays and financial challenges.

Step-by-step explanation:

The Food and Drug Administration (FDA) regulates the safety and efficacy of medicines that pharmacies can sell in the U.S. This includes new drugs, generic drugs, and over-the-counter drugs. New drugs in particular face rigorous testing and review through a New Drug Application (NDA) before they can be approved for prescription use. There are clear winners in this system, namely the public, who are protected from potentially unsafe drugs. However, there are also anonymous losers, which generally consist of patients who might wait years for potentially lifesaving medication due to the length of the regulatory process, or smaller pharmaceutical companies that struggle to shoulder the financial burden of such extensive requirements.

Advertising for drugs is also strictly regulated. For prescription drugs, the Office of Prescription Drug Promotion oversees advertising to ensure a balance between benefits and risks is communicated. On the other side, advertising for over-the-counter drugs falls under the jurisdiction of the Federal Trade Commission.

User Joelm
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