Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format | Guideline Explorer

Description

This guidance provides recommendations for developing the content and format of a patient Instructions for Use (IFU) document for human prescription drug and biological products, as well as drug-led or biologic-led combination products submitted under a new drug application (NDA) or a biologics license application (BLA).

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

5

Combination Product

Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.

Biological Product

Regulated under section 351(i) of the PHS Act; Virus, therapeutic serum, toxin, vaccine, or protein applicable to prevention or treatment; Alternative regulation category for products meeting device definition

Chemotherapeutic drug products

Products requiring special disposal procedures

Transdermal systems

Products requiring specific disposal instructions to prevent risk

Drug-led, drug-device combination product

Guidance recommends visuals of the device constituent parts for these products.

Stakeholders

6

Caregivers

Individuals providing information for medical product development; Participants in facilitated discussions and observational studies

Packer

Entity whose name appears on the label

Distributor

Entity responsible for submitting NDINs

Manufacturer

Entity responsible for submitting NDINs

Patient

Way questions are framed is critical to collecting unbiased patient input

Applicant

Entity submitting development data and knowledge; Entity performing the work process for change

Regulatory Context

Regulatory Activities

6

NDA

New Drug Application

Approved

The IFU must state it has been approved by the FDA

BLA

Biologics License Application

ANDA

Abbreviated New Drug Application

PDUFA VI

Sixth authorization of the Prescription Drug User Fee Act

IND

Investigational New Drug submissions

Document Types

2

Instructions for Use

Reagent stability studies should support conditions outlined in the IFU; Labeling for lay users at no higher than a 7th grade reading level.

Prescribing Information

The primary section of drug labeling where SLCs are implemented

Attributes

4

Readability

Content recommendation for patient labeling

Sans-serif font

Recommended typeface styling for readability

Expiration date

should be based on appropriate supportive stability data

Controlled substance schedule

Information to be included in the product title if applicable

Technical Details

Substances

1

Suppositories

Dosage form requiring the action verb 'insert'

Processes

5

Administration Instructions

Specific content section required in the IFU

Disposal Instructions

Specific content section required in the IFU

Reconstitution

Automated mixing of drug prior to injection.

Dilution

Preparation of a drug before administration

Priming

Instructions for priming topical or inhaled products.

Clinical Concepts

1

Adverse reactions

Increased risk when daily wear lenses are worn overnight

Identified Hazards

Hazards

5

Use-related risks

Risks identified through URRA that may warrant an IFU

Needle stick injury

Risk associated with sharps like auto-injectors and pens

Injury

Failure to follow instructions could result in injury.

Secondary exposure

Instructions to prevent or mitigate the risk of secondary exposure to a drug.

Medication errors

Risk of inappropriate administration of extra doses

Standards & References

External Standards

1

Guidelines for Prescription Labeling and Consumer Medication Information for People With Vision Loss

External guidelines referenced for patient labeling design

Specifications

3

Room temperature

Time needed for a refrigerated product to warm to room temperature.

8 points font size

Minimum font size for specific technical sections like manufacturer address

10 points font size

Minimum recommended font size for most IFU sections

Related CFR Sections (10)

21CFR3.2§ 3.2 Definitions.
For the purpose of this part:Read full regulation →
21CFR201.100§ 201.100 Prescription drugs for human use.
A drug subject to the requirements of section 503(b)(1) of the act shall be exempt from section 502(f)(1) if all the following conditions are met:Read full regulation →
21CFR201.1§ 201.1 Drugs; name and place of business of manufacturer, packer, or distributor.
(a) A drug or drug product (as defined in § 320.1 of this chapter ) in finished package form is misbranded under section 502 (a) and (b)(1) of the act if its label does not bear conspicuously the name and place of business of the manufacturer, packer, or distributor. This paragraph does not apply toRead full regulation →
21CFR314.93§ 314.93 Petition to request a change from a listed drug.
(a) The only changes from a listed drug for which the agency will accept a petition under this section are those changes described in paragraph (b) of this section. Petitions to submit ANDAs for other changes from a listed drug will not be approved.Read full regulation →
21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.
(a) Changes to an approved NDA.Read full regulation →
21CFR601.12§ 601.12 Changes to an approved application.
(a) General.Read full regulation →
21CFR314.50§ 314.50 Content and format of an NDA.
NDAs and supplements to approved NDAs are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the NDA are required: An archival copy, a review copy, and a field copy. An NDA for a new chemical enRead 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 →
21CFR201.57§ 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 →
21CFR600.3§ 600.3 Definitions.
As used in this subchapter:Read full regulation →

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

Misbranded drug

26

False or misleading claims concerning the compounder

22

Introduction of misbranded drugs into interstate commerce

2

Introduction of misbranded products into interstate commerce

1

Recent Cases

Related Warning Letters (10)

Related MFDS Guidelines

Korean regulatory guidelines covering similar topics