What are the regulations regarding the manufacture of pharmaceuticals?

In Tennessee, the regulations for manufacturing pharmaceuticals are mainly found within the Pharmacy Practice Act or PPA. This Act states that only certain people are allowed to make pharmaceuticals. Generally, only licensed pharmacists and pharmacy technicians can manufacture and compound medications. This ensures that the medications are created with proper safety precautions and of the highest quality. Additionally, any medication must be thoroughly tested before it is marketed to ensure its safety and efficacy. The Pharmacy Practice Act also requires that, prior to the manufacture or sale of any pharmaceuticals, a license must be acquired from the Tennessee Board of Pharmacy. The Board may issue two types of licenses: a full license for a pharmacy that dispenses medications to the public, and a restricted license for a pharmacy that only compounds and dispenses medications to other healthcare providers. The Act also requires that the premises of any pharmacy that manufactures and dispenses medications must be in compliance with certain regulations. The pharmacy must have adequate storage and equipment, must be maintained in a neat and clean condition, and must be in compliance with all applicable federal and state laws. Furthermore, the pharmacy must keep proper records and maintain a valid license. In summary, the regulations in Tennessee for the manufacture of pharmaceuticals are set forth primarily in the Pharmacy Practice Act. In order to manufacture and distribute pharmaceuticals, one must obtain a license from the Tennessee Board of Pharmacy and ensure that all applicable laws and regulations are followed.

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What are the regulations regarding the manufacture of pharmaceuticals?

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