Description
This guidance is intended to assist manufacturers of prescription drugs approved under section 505 of the Federal Food, Drug, and Cosmetics Act (the Act) (21 U.S.C. 355) that are required to have an FDA-approved Medication Guide. On July 1, 2009, FDA expects affected entities to be in compliance with 21 CFR 208.20(b)(7)(iii), which requires that Medication Guides contain a verbatim statement that includes: (1) FDA’s toll-free MedWatch phone number and (2) a statement that the number is to be used for reporting purposes only, not to receive medical advice (the side effects statement). Manufacturers must also notify the Agency that the side effects statement has been added to their Medication Guides.
Scope & Applicability
Product Classes
3Products subject to program fees; Specific strength or potency of a drug in final dosage form
Non-prescription drugs subject to specific packaging requirements
products subject to DSCSA tracing requirements
Stakeholders
4Entity responsible for submitting NDINs
Entity whose name appears on the label
Entity responsible for submitting NDINs
manufacturers are responsible for ensuring that their labels conform to all applicable FDA labeling laws
Regulatory Context
Attributes
2Minimum type size for the side effects statement.
Verbatim statement including a toll-free number for reporting
Related CFR Sections (2)
- 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.
(a) Changes to an approved NDA.Read full regulation →
- 21CFR208.20§ 208.20 Content and format of a Medication Guide.
(a) A Medication Guide shall meet all of the following conditions:Read full regulation →
See Also (8)
- Format and Content for the CMC Section of an Annual Report (Status: Final)
- PAC-ATLS: Postapproval Changes - Analytical Testing Laboratory Sites: Guidance for Industry (Status: Final)
- CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports (Status: Final)
- Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (Small Entity Compliance Guide) (Status: Final)
- Product Identifiers under the Drug Supply Chain Security Act - Questions and Answers: Guidance for Industry (Status: Final)
- Development and Submission of Near Infrared Analytical Procedures (Status: Final)
- Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief (Status: Draft)
- Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products (Status: Draft)