What are the requirements for the evaluation of drugs?

In North Carolina, pharmaceutical law requires that all drugs that are distributed in the state must be evaluated to ensure they are safe for public use. This evaluation process is composed of a number of steps that must be taken before a drug can be made available to the public. The first step of the evaluation process is the submission of a pharmaceutical application which includes data that serves as evidence that the drug is safe, effective, and of adequate quality. This data must be provided by the manufacturer and submitted to the North Carolina Board of Pharmacy. The board will review the data and determine if the drug meets the standards for safety and quality. Next, the board will conduct a laboratory test on the drug in order to assess its properties and to ensure that it will provide the intended therapeutic effects. After the laboratory test is completed, the board will review the sample to determine its safety and make sure the manufacturer has followed GMP guidelines (good manufacturing practices). Finally, the board of Pharmacy will issue a certificate of approval if the drug meets all of the safety and quality requirements. This certificate will allow the manufacturer to legally distribute the drug in North Carolina. It is important to note that the Board of Pharmacy reserves the right to reject any applications that do not meet the necessary criteria.

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