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A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680.
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 Administrative Controlled Substances Code Number for each substance is included.
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. Although the list is controlled by the Attorney General, the list is considered a DEA list because the DEA publishes and enforces the list.
The three treaties are complementary and mutually supportive. [1] They serve to maintain a classification system of controlled substances, including psychoactive drugs and plants, and chemical precursors, to ensure the regulated supply of those substances determined to be useful for medical and scientific purposes, and to otherwise prevent production, distribution and use, with some limited ...
From Schedules II to V, substances decrease in potential for abuse. The schedule a substance is placed in determines how it must be controlled. Prescriptions for drugs in all schedules must bear the physician's federal Drug Enforcement Administration (DEA) license number, but some drugs in Schedule V do not require a prescription.
In Germany, several laws govern drugs (both recreational and pharmaceutical). Narcotic Drugs Act (Betäubungsmittelgesetz, BtMG), regulates narcotics and contains explicit lists of those covered: Anlage I (authorized scientific use only), Anlage II (authorized trade only, not prescriptible) and Anlage III (special prescription form required).
The drug or other substance has a currently accepted medical use in treatment in the United States. Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule IV. The complete list of Schedule V substances is as follows.
Drugs that have an EU licence (provided by EMA) should have a link to the EMA site. EMA licences are by INN. The list if EMA licences (INNs) per June 2017 is here (623 INNs). he link is added by setting |licence_EU=yes. The infobox will then show an external link to the EMA licence page (EPAR publications).