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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. The list is designated within the Controlled Substances Act [ 1 ] but can be modified by the U.S. Attorney General as illegal manufacturing practices change.
This is the list of Schedule II controlled substances in the United States as defined by the Controlled Substances Act. [1] The following findings are required, by section 202 of that Act, for substances to be placed in this schedule: The drug or other substance has a high potential for abuse.
Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act). The Hatch-Waxman Act was created to '"strike a balance between two competing policy interests:
The act also created a new category of regulated entity: human drug compounding outsourcing facilities. A typical community pharmacy (503A), or specialty pharmacy (503A) may compound only under specific conditions as noted in section 503A of the FD&C Act. A significant portion of the provision that allows this states the compounded product is ...
The drug or other substance has a high potential for abuse. The drug or other substance has no currently accepted medical use in treatment in the United States. There is a lack of accepted safety for use of the drug or other substance under medical supervision. The complete list of Schedule I substances is as follows. [1]
The drug or other substance has a potential for abuse less than the drugs or other substances in schedules I and II. The drug or other substance has a currently [1] accepted medical use in treatment in the United States. Abuse of the drug or other substance may lead to moderate or low physical dependence or high psychological dependence.
This is the list of Schedule V 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 IV.
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