Description
This guidance is intended to assist applicants in developing the PATIENT COUNSELING INFORMATION section of labeling required under § 201.57(c)(18) (21 CFR 201.57(c)(18)). 2 The recommendations in this guidance are intended to help ensure that this section of labeling is clear, useful, informative, and to the extent possible, consistent in content and format.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
5guidance applies to drugs regulated under section 505
Requires analytical comparability per ICH Q5E
Labeling must include strategies for reducing drug-resistant bacteria.
Example of a product where keeping away from children is particularly relevant.
Class of drugs associated with neuroleptic malignant syndrome.
Stakeholders
4Entity submitting development data and knowledge; Entity performing the work process for change
Physicians, veterinarians, dentists, and other licensed professionals
Way questions are framed is critical to collecting unbiased patient input
It may be a hardship for patients and/or caregivers to attend in-person; Individuals who may assist patients or provide observations when patients cannot self-report.; conducted with caregivers to obtain similar feedback
Regulatory Context
Regulatory Activities
2The primary regulatory activity addressed in the guidance
REMS program elements that impact patients must be referenced.
Document Types
8Summarizes information a health care provider should convey to a patient; Written for use by a health care provider to identify topics for a counseling discussion with the patient.; Section of labeling intended to facilitate provider-patient discussion.
Reference to such labeling must be included if applicable; Includes Patient Package Inserts, Medication Guides, and Instructions for Use.; Patient-specific labeling that must be referenced in the counseling section.
content and format of DI information; The complete labeling document for a drug.; The complete labeling document for prescription drugs; The complete labeling document (FPI) containing detailed drug interaction sections.; Section of drug labeling
Patient Information
Required patient labeling
Reagent stability studies should support conditions outlined in the IFU; Labeling for lay users at no higher than a 7th grade reading level.
Labeling section containing storage and handling information.
Full Prescribing Information section of labeling
Attributes
1Determines the order of topics in the counseling section.
Technical Details
Substances
3Example drug causing urine discoloration.
Example drug with multiple serious drug interactions.
Fictitious drug used in labeling example
Processes
1Recommendations for disposal of injectable drug components.
Clinical Concepts
7The most common side effects which may occur with PROPRIETARY NAME include: <list adverse reactions here>.
Example of a serious allergic reaction requiring immediate medical attention.
Specific population for which risk information may be required.
Specific population for which risk information may be required.
Potential harm to a male fetus from handling broken tablets.
Example of a contraindication history that informs prescribing decisions.
A potential serious adverse reaction from antipsychotic drugs.
Related CFR Sections (4)
- 21CFR201.57§ 201.57 Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1) .
The requirements in this section apply only to prescription drug products described in § 201.56(b)(1) and must be implemented according to the schedule specified in § 201.56(c) , except for the requirement in paragraph (c)(18) of this section to reprint any FDA-approved patient labeling at the end oRead full regulation →
- 21CFR201.56§ 201.56 Requirements on content and format of labeling for human prescription drug and biological products.
(a) General requirements. Prescription drug labeling described in § 201.100(d) must meet the following general requirements:Read full regulation →
- 21CFR201.80§ 201.80 Specific requirements on content and format of labeling for human prescription drug and biological products; older drugs not described in § 201.56(b)(1) .
Each section heading listed in § 201.56(d) , if not omitted under § 201.56(d)(3) , shall contain the following information in the following order:Read full regulation →
- 21CFR201.24§ 201.24 Labeling for systemic antibacterial drug products.
The labeling of all systemic drug products intended for human use indicated to treat a bacterial infection, except a mycobacterial infection, must bear the following statements:Read full regulation →
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (8)
- Labeling for Human Prescription Drug and Biological Products - Implementing the PLR Content and Format Requirements (Status: Final)
- Classification Categories for Certain Supplements Under BsUFA III (Status: Final)
- Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies: Guidance for Industry (Status: Final)
- Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Biologics Marketing Applications: Guidance for Industry (Status: Final)
- FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information: Guidance for Industry (Status: Final)
- Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format: Guidance for Industry (Status: Final)
- Useful Written Consumer Medication Information (CMI) (Status: Final)
- Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims: Guidance for Industry (Status: Final)