What are the requirements for the evaluation of drugs?

In Tennessee, the evaluation of drugs by the Tennessee Department of Health is regulated by pharmaceutical law. Prior to selling a drug in Tennessee, the manufacturer must submit an application to the Department of Health. This application must include sufficient evidence to support the safety, purity, and efficacy of the drug. This evidence must be submitted in the form of a pharmacological and toxicological profile, as well as any study results that may be needed to support the therapeutic effects of the drug. The safety profile of the drug must include data documenting any adverse events associated with its use. The efficacy of the drug must be supported by clinical trials which demonstrate its effectiveness in treating the conditions for which it is intended. The Department of Health will review these documents and make a decision as to whether or not the drug is safe and effective enough to be marketed in Tennessee. If approved, the drug will be placed on a list of approved drugs and be available for sale in Tennessee. In addition to the evaluation of drugs, pharmaceutical law also requires that pharmacies in Tennessee obtain approval from the Department of Health prior to dispensing any drugs. This approval process requires pharmacies to submit documentation that their facility is compliant with relevant state and federal regulations, as well as evidence that they are staffed by qualified personnel. The approval process also involves an inspection to ensure that the pharmacy is appropriately stocked and equipped to handle the drugs they are dispensing.

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What are the requirements for the evaluation of drugs?

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