Pharmacy Courses

Content and Format of the Dosage and Administration Section of Labeling

This guidance is intended to assist applicants in developing the DOSAGE AND ADMINISTRATION section of labeling as described in 21 CFR 201.57(c)(3), a regulation governing the content and format of this section of human prescription drug and biological product labeling, to ensure that this section contains the dosage- and administration-related information needed for safe and effective use of a drug.

Applicants should follow the recommendations in this guidance when developing the DOSAGE AND ADMINISTRATION section for a new drug submitted to FDA under a new drug application under section 505(b) of the FD&C Act or a biologics license application under section 351(a) of the PHS Act, and when revising existing information in the labeling for a currently approved drug in a supplement to such applications.

This guidance provides examples (denoted with a sawtooth line in the left margin) of required and recommended information in the DOSAGE AND ADMINISTRATION section.

Information in the DOSAGE AND ADMINISTRATION section should be organized and presented in a manner that promotes comprehension and readability. Because the amount and type of information in this section vary considerably across drugs, a range of different organizational schemes may adequately achieve comprehension and readability.

The sequence of dosage- and administration-related information in this section should be based on its relative clinical importance.

  • The most clinically relevant dosage- and administration-related information should generally appear first (e.g., the recommended dosage for each indication and subpopulation, the route(s) of administration, instructions on how and when to administer an orally administered drug relative to the ingestion of food or food substances).
  • Other types of dosage- and administration-related information (e.g., dosage modifications for drug interactions, instructions on how to reconstitute the supplied lyophilized powder,instructions on how to administer a solid oral dosageform with qualified liquids or soft foods) should generally appear later in the section.

Information that must appear in the DOSAGE AND ADMINISTRATION section includes, but is not limited to, the drug’s recommended dose and, as appropriate:
  • The dosage range,
  • An upper limit beyond which safety and effectiveness have not been established, or beyond which increasing the dose does not result in increasing effectiveness,
  • Dosages for each indication and subpopulation,
  • The intervals recommended between doses,
  • The optimal method of titrating dosage,
  • The usual duration of treatment when treatment duration should be limited,
  • Dosing recommendations based on clinical pharmacologic data,
  • Specific direction on administration of the dosage form (e.g., route(s) of administration)
Previous Post Next Post