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Excepted Substances

  • W. T. Lowry
  • James C. Garriott

Abstract

The Federal Controlled Substances Act specifically defines and lists pharmaceutical preparations that are excepted from the application of all or any part of the Act. This list, published annually in the Code of Federal Regulations-T21, is an administrative action, as specific criteria have not been established for exact definitions. For a preparation to be excepted from application of all or any part of the Act, an application must be made giving detailed information about the preparation. As set forth by Federal regulations, each application will contain the following information:
  1. 1.

    The complete quantitation composition of the dosage form

     
  2. 2.

    Description of the unit dosage form together with complete labeling

     
  3. 3.

    A summary of the pharmacology of the product, including animal investigations and clinical evaluations and studies, with emphasis on the psychic or physiological (or both) dependence liability (this must be done for each of the active ingredients separately and for the combination product)

     
  4. 4.

    Details of synergisms and antagonisms among ingredients

     
  5. 5.

    Deterrent effects of the noncontrolled ingredients

     
  6. 6.

    Complete copies of all literature in support of claims

     
  7. 7.

    Reported instances of abuse

     
  8. 8.

    Reported and anticipated adverse effects

     
  9. 9.

    Number of dosage units produced for the past two years

     

Keywords

Magnesium Hydroxide Atropine Sulfate Magnesium Trisilicate Chlorpheniramine Maleate Ergotamine Tartrate 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Plenum Press, New York 1979

Authors and Affiliations

  • W. T. Lowry
    • 1
  • James C. Garriott
    • 1
  1. 1.Southwestern Institute of Forensic SciencesDallasUSA

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