What are the requirements for the production of drugs?

In Kansas, businesses that manufacture and market pharmaceuticals are subject to both federal and state laws. To be compliant with these laws, producers of drugs must first obtain approval from the Kansas State Department of Health and Environment (KDHE). The KDHE reviews drug manufacturing protocols and facilities to ensure that they meet the standards set by the Food and Drug Administration (FDA) and that the drugs produced are safe and effective. Drug manufacturers must also operate in compliance with FDA Good Manufacturing Practices (GMP) and submit to the KDHE any changes they make to their protocols or facilities. GMP is a set of regulations that outlines the production, control, storage and handling of drugs. These regulations are designed to guarantee the safety, effectiveness, and quality of drugs by requiring certain steps in the drug production process. In addition to GMP, drug producers must also adhere to regulations that govern the labeling, packaging, labeling, and dispensing of drugs. All drug labeling must accurately describe the drug’s name, active ingredients, dosage form, and use instructions. Packaging for drugs must follow FDA requirements for containers and closures. Similarly, all drug dispensing must be in accordance with FDA-approved processes and procedures. By complying with these requirements, pharmaceutical manufacturers in Kansas can help ensure that the drugs they produce are safe and effective for use.

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What are the requirements for the production of drugs?

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