Final answer:
The Food and Drug Administration (FDA) requires all prescription medications to come with a package insert from the manufacturer. This helps ensure patient safety and drug efficacy but can also delay drug availability and challenge small pharmaceutical companies.
Step-by-step explanation:
The agency that requires all prescription medications to have a package insert when coming from the manufacturer is the Food and Drug Administration (FDA). This insert, commonly referred to as the prescribing information, includes details such as the drug's medical uses, dosage and administration instructions, side effects, contraindications, and other essential information to ensure patient safety and the drug's efficacy. Pharmacies in the United States are regulated by the FDA to ensure that the medicines they sell meet these stringent requirements, which sometimes leads to a lengthy drug approval process.
While this system benefits the public by protecting them from unsafe drugs, there are some anonymous losers in this strict regulatory environment. These typically include patients who may suffer from delayed access to potentially life-saving medications due to the long drug development and review process. Additionally, small pharmaceutical companies may struggle with the financial and logistical demands of the regulatory process, which can stunt innovation and reduce competition in the drug market.