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  2. Prescription monitoring program - Wikipedia

    en.wikipedia.org/.../Prescription_monitoring_program

    v. t. e. In the United States, prescription monitoring programs ( PMPs) or prescription drug monitoring programs ( PDMPs) are state-run programs which collect and distribute data about the prescription and dispensation of federally controlled substances and, depending on state requirements, other potentially abusable prescription drugs.

  3. Ohio Automated Rx Reporting System - Wikipedia

    en.wikipedia.org/wiki/Ohio_Automated_Rx...

    The Ohio Automated Rx Reporting System (OARRS) is Ohio's state Prescription Monitoring Program (PMP) and is controlled by the Ohio State Board of Pharmacy. [1] The law permitting the Board of Pharmacy to create the PMP was signed on March 18, 2005, and became effective January 1, 2006. The OARRS program began operation on October 2, 2006.

  4. Comprehensive Drug Abuse Prevention and Control Act of 1970

    en.wikipedia.org/wiki/Comprehensive_Drug_Abuse...

    The Comprehensive Drug Abuse Prevention and Control Act of 1970, Pub. L. 91–513, 84 Stat. 1236, enacted October 27, 1970, is a United States federal law that, with subsequent modifications, requires the pharmaceutical industry to maintain physical security and strict record keeping for certain types of drugs. [1]

  5. Prescription Drug User Fee Act - Wikipedia

    en.wikipedia.org/wiki/Prescription_Drug_User_Fee_Act

    Signed into law by President George H. W. Bush on October 29, 1992. The Prescription Drug User Fee Act ( PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. The Act provided that the FDA was entitled to ...

  6. Abbreviated New Drug Application - Wikipedia

    en.wikipedia.org/wiki/Abbreviated_New_Drug...

    An Abbreviated New Drug Application ( ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug . The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, which provides for the review and ultimate approval of a generic drug product.

  7. Drug Master File - Wikipedia

    en.wikipedia.org/wiki/Drug_Master_File

    Description. Drug Master File (DMF) is a document containing complete information on an Active Pharmaceutical Ingredient (API) or finished drug dosage form. It is known as European Drug Master File (EDMF) or Active Substance Master File (ASMF) and US-Drug Master file (US-DMF) in Europe and United States respectively.

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