The pharmaceutical industry as we discuss it comprises manufacturers, distributors, retailers, and the FDA, which also regulates this business sector. FDA regulates active pharmaceutical ingredients (APIs), pharmaceutical excipients (substances other than the API that are used in the finished dosage form), sterile pharmaceutical products, biological products, investiga-tional pharmaceutical products for humans, herbal medicinal products, radiopharmaceutical products, and medical devices.
The extended supply chain is vulnerable to both accidental and deliberate tampering. Tampering is the unlawful corruption or contamination of a drug product and/or its labeling and can refer to intrusion at any point in the manufacturing, shipment, and sale of a drug. The sale of counterfeit drugs can be considered a form of tampering.
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