What are the regulations governing the production of generic drugs?

Generic drugs are medications that are produced and sold for a lower cost than the original, brand-name product. In Washington, the Washington State Board of Pharmacy regulates the production of generic drugs. The Board sets forth standards for generic drugs to make sure that they are just as safe and effective as the brand-name products. The standards include ensuring that the generic drug is therapeutically equivalent to the brand-name product, meaning that it has the same active ingredients, dosages, route of administration, risks, strength, and quality. Manufacturers must also show that their product is bioequivalent to the brand-name drug, meaning that it is absorbed into the body in the same way as the brand-name drug. Generic drug manufacturers must obtain approval from the FDA in order to make and sell a generic version of a drug. This involves conducting studies to show that the generic version of a drug is safe and effective. The FDA also monitors the manufacturing process of generic drugs to make sure they meet safety and quality standards. In Washington, generic drugs can only be manufactured and distributed by licensed manufacturers who have received permission from the Washington State Board of Pharmacy. Additionally, pharmacies in Washington can only sell generic drugs if they adhere to the guidelines established by the Board.

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