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Situations that may require an authority include where the drug may only have benefit in limited conditions, the true cost of the drug is high, or when there is a risk of dependence. Some states have subsets of Schedule 4 with additional requirements (see below). Schedule 4 medicines cannot be advertised directly to the public. Examples:
This is the list of Schedule IV controlled substances in the United States as defined by the Controlled Substances Act. [1] The following findings are required for substances to be placed in this schedule: [2] The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule III.
In the United States, DMFs are submitted to the Food and Drug Administration (FDA). The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application.
The United States Drug Enforcement Administration (DEA) maintains lists regarding the classification of illicit drugs (see DEA Schedules).It also maintains List I of chemicals and List II of chemicals, which contain chemicals that are used to manufacture the controlled substances/illicit drugs.
Proceedings to add, delete, or change the schedule of a drug or other substance may be initiated by the Drug Enforcement Administration (DEA), the Department of Health and Human Services (HHS), or by petition from any interested party, including the manufacturer of a drug, a medical society or association, a pharmacy association, a public ...
In the United States, the Food and Drug Administration (FDA) determines the requirements for patient package inserts. In the United States, the FDA will occasionally issue revisions to previously approved package inserts, in much the same way as an auto manufacturer will issue recalls upon discovering a problem with a certain car.
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Schedule 4 or Schedule IV may refer to: Fourth Schedule to the Constitution of India , providing for the number of Rajya Sabha (upper house of the Indian parliament) seats to each state Schedule IV Controlled Substances within the US Controlled Substances Act ( List )