How does the law regulate the manufacture of counterfeit drugs?

In Illinois, pharmaceutical law regulates the manufacture and sale of counterfeit drugs. According to state law, drug manufacturers must register with the Illinois Department of Financial and Professional Regulation and obtain a Certificate of Registration. The manufacturing process must also be in compliance with current Good Manufacturing Practices (cGMPs). The cGMPs are a set of standards that ensure the safety, identity, quality, and purity of drugs. In addition, drug manufacturers must not manufacture, distribute, or sell counterfeit drugs. Counterfeit drugs are meds that are illegally produced, labeled, and/or sold. Counterfeiting can have serious health consequences, as the drugs may be ineffective, contain toxic substances, or be contaminated with bacteria. In order to prevent the manufacture of counterfeit drugs, Illinois has implemented measures that require manufacturers to obtain materials only from reliable suppliers and ensure the identity of medications throughout the manufacturing process. In addition, manufacturers must verify that the drugs are properly labeled and that their facilities and equipment used to manufacture the drugs are periodically inspected and meet cGMPs. Manufacturers are also expected to maintain custody of drug samples so that they can be used for authentication tests to ensure their authenticity. Finally, manufacturers must obtain product approvals for any drugs they produce and must adhere to all requirements set forth by the state. These measures help ensure that counterfeit drugs are not manufactured in Illinois.

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