What is the legal framework governing the manufacture of drugs?

In Illinois, manufacturing drugs is subject to stringent regulations provided by the US Food and Drug Administration (FDA) and the Illinois Department of Public Health (IDPH). The FDA oversees the safe and effective manufacture of drugs while the IDPH implements and enforces the applicable laws regarding the production, distribution, and sale of pharmaceuticals. The FDA requires that drug companies submit detailed information and safety data to the agency before they are able to begin manufacturing and selling a drug. The drug manufacturers must also demonstrate to the FDA that the drug is safe and effective for its intended use and that it is made in accordance with FDA regulations. All drug companies must also maintain a good manufacturing practice in order to meet the FDA’s quality standards. The IDPH provides supervision of the approval of drugs licensed in the state, as well as the enforcement of state laws governing drug safety and efficacy standards. This includes the inspection of drug manufacturing facilities and the investigation of any violations of state laws. IDPH also requires drug companies to submit reports on their manufacturing activities and to keep records of their production and distribution. In summary, the legal framework governing the manufacture of drugs in Illinois is overseen by both the FDA and the IDPH. Drug companies must comply with regulations from both federal and state agencies in order to legally manufacture drugs in the state.

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What is the legal framework governing the manufacture of drugs?

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