What are the regulations governing the production of generic drugs?

In Illinois, regulations governing the production of generic drugs are established by the Illinois Pharmacy Practice Act. Under this act, all pharmacies manufacturing, compounding, or repackaging drugs must meet strict standards set by the state. This includes licensing requirements and inspection of their facilities to make sure that all procedures are in compliance with the law. The facility must be registered with the Illinois Department of Financial and Professional Regulation and must be inspected and approved according to the rules set forth in the act. Additionally, the act specifies that all generic drugs produced must meet uniform national standards and must be approved by the Food and Drug Administration (FDA). The manufacturing process for generic drugs must be the same as for brand-name drugs, as long as the active ingredient, strength, dosage form, route of administration, and quality requirements are met. The packaging must also be consistent with the brand-name drug and must have a label that is easily discernible from that of the brand-name drug. Finally, all generic drugs must go through a rigorous review process, including clinical trials, to ensure safety and efficacy. This review process must be conducted by an independent regulatory agency outside of the pharmacy or manufacturer. After approval, the generic drug must be approved for sale by the FDA before it can be sold in Illinois.

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What are the regulations governing the production of generic drugs?

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