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Information for Consumers on
the
New Requirements for Prescribing Information
Prescribing information is approved by FDA and contains the
necessary information for the safe and effective use of a
prescription drug. Prescribing information is used by healthcare
professionals, such as physicians, pharmacists, and nurses, as a
reference for questions such as:
- What diseases or conditions does the drug treat?
- What dose is needed?
- Which patients should not receive the drug?
- What other drugs should not be taken together with the drug?
- What side effects can occur?
- How should the drug be stored?
FDA has revised the requirements on what must be included in
prescribing information and how it must be organized to make it
easier for healthcare professionals to access, read, and use the
information. These changes are intended to help inform healthcare
professionals about the drugs they prescribe for their patients. In
addition, the new prescribing information emphasizes the importance
of counseling patients about their prescription drugs. For example,
one new feature is that the information that healthcare
professionals use when counseling patients is presented in a new
section called “Patient Counseling Information.” This should
facilitate communication between healthcare professionals and
patients about their prescription drugs.
New prescribing information will be phased in gradually. The
requirements will apply to new or recently approved prescription
drugs (not to “over-the-counter drugs”).
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Prescription Drug
Labeling
Date created: January 18, 2006 |
