Geoff LeCain

Individual Manufactured Product The individual manufactured product is broken down into 6 distinct areas: Manufactured Product –NDC Product Code, form code, proprietary name, marketing category an...

Answer: The SPL style sheet populates the table of contents with the text associated with the “Title” elements of each major section. To prevent the “Recent Major Changes” text from showing in the ...

The “Manufactured Product” section allows users to populate the following data associated to each manufactured product formulation: NDC Product Code Form Code Proprietary Name Marketing Category S...

Answer: The SPL schema does not support centering tables, therefore, the SPL Portal application does not allow for a table to be centered in relation to the body of the document. The text in the ce...

The “Active Ingredients” section allows users to define the active ingredient based on the FDA rules.  Users should define the basis of strength, active ingredient, strength, and active moiety.  Th...

Answer: To select a previous draft, select the “Previous Version” radio button located at the top of the Content Editor. Then select which previous draft you want from the drop-down menu. The examp...

The “Inactive Ingredients” section allows users to define the inactive ingredient based on the FDA rules.  Users should define the inactive ingredient and strength if required by FDA guidelines.  T...

Answer: The FDA style sheet links the “17” in the “See 17 for PATIENT COUNSELING INFORMATION” text with the “Information for Patients Section” LOINC. If there are multiple sections associated to th...

The “Characteristics” section allows users to define the physical characteristics of the manufactured product based on the FDA rules.  Select a value from the predefined list of characteristic and ...

Answer: If you have a Patient Package Insert in your label it should have the SPL Patient Package Insert LOINC associated to it and it should be a base section (not a child section).