All labels and other written, printed or graphic matter upon any article or any of its containers or wrappers, or accompanying such article. The U.S. Food and Drug Administration (FDA) holds that labeling encompasses:<\/p>\n\n\n\n
Labeling accompanied by prescribing information; ads must include \u201cbrief summary\u201d<\/strong><\/p>\n\n\n\n The Significance of Compliance with The U.S. Food and Drug Administration (FDA) Labeling Requirements<\/p>\n\n\n\n The U.S. Food and Drug Administration (FDA)\u2019s labeling resources for human prescription drugs are primarily directed to industry staff who develop human prescription drug labeling. Human prescription drug labeling contains a summary of the essential scientific information needed for the safe and effective use of the drug; and includes the Prescribing Information, The U.S. Food and Drug Administration (FDA)-approved patient labeling (Medication Guides, Patient Package Inserts, and\/or Instructions for Use), and\/or carton and container labeling. <\/p>\n\n\n\n The U.S. Food and Drug Administration (FDA)-approved Prescribing Information (Prescribing Information (PI)), also known as United States Prescribing Information (USPrescribing Information (PI)), reflects The U.S. Food and Drug Administration (FDA)\u2019s finding regarding the safety and effectiveness of the human prescription drug under the labeled conditions of use. The Prescribing Information (PI) is written for the healthcare professional and must:<\/p>\n\n\n\n Be informative and accurate and neither promotional in tone nor false or misleading, and<\/p>\n\n\n\n Be updated when new information becomes available that causes labeling to become inaccurate, false, or misleading.<\/p>\n\n\n\n The Instructions for Use (Instructions for Use (IFU)) is patient labeling that can be part of The U.S. Food and Drug Administration (FDA)-approved prescription drug labeling for a biologics license application (BLA), a new drug application (NDA), or an abbreviated new drug application (ANDA). The Instructions for Use (IFU) is developed by applicants for patients (or their caregivers) who use prescription drugs that have complicated or detailed patient-use instructions. The Instructions for Use (IFU) provides detailed, action-oriented, step-by-step written and visual instructions for the patient on how to use the drug including instructions on preparation, administration, handling, storage, and disposal. The Instructions for Use (IFU) is developed by the applicant, reviewed and approved by The U.S. Food and Drug Administration (FDA), and provided to patients (or their caregivers) when the drug is dispensed. Some Instructions for Use (IFU)s are not approved by the The U.S. Food and Drug Administration (FDA). Instructions for Use (IFU) resources include:<\/p>\n\n\n\n Instructions for Use \u2014 Patient Labeling for Human Prescription Drug and Biological Products \u2014 Content and Format Guidance for Industry:<\/p>\n\n\n\n The Instructions for Use (IFU) guides the patient on how to safely and effectively use a prescription drug product and commonly includes instructions on preparation, administration, handling, storage, and disposal. The primary purpose of an Instructions for Use (IFU) is to provide detailed, step-by-step written instructions, including visuals if appropriate, in a patient-friendly manner, as visuals can complement written instructions.<\/p>\n\n\n\n Consistency with the The U.S. Food and Drug Administration (FDA)-Approved Prescribing Information<\/strong><\/p>\n\n\n\n The U.S. Food and Drug Administration (FDA) recommends that the following information, if applicable, appear in the order listed to ensure consistency and to help patients become familiar with the type and location of information in the Instructions for Use (IFU).<\/p>\n\n\n\n Important Information You Need to Know Before Injecting MYDRUG The U.S. Food and Drug Administration (FDA) recommends that the Instructions for Use (IFU) include this heading when patients should take specific actions to prepare, administer, store, and\/or dispose of the drug product to prevent or reduce potentially serious outcomes that might occur if the specific action is not followed. The U.S. Food and Drug Administration (FDA) recommends that information under this heading highlight important instructions and information to alert patients about the appropriate uses, techniques, and routes of administration that, if not followed, could result in injury or impair efficacy. If confusion could occur about the route of administration based on the dosage form, such as capsules for inhalation that may be mistaken for oral capsules, The U.S. Food and Drug Administration (FDA) recommends that the first statement in this section explain how the drug product should be administered. For example:<\/p>\n\n\n\n FORMAT:<\/strong><\/p>\n\n\n\n The following formatting recommendations are intended to make the Instructions for Use (IFU) easier for patients to read and to help them use prescription drug products safely and effectively.<\/p>\n\n\n\n Typeface Styling Recommendations<\/strong><\/p>\n\n\n\n The U.S. Food and Drug Administration (FDA) recommends using a sans-serif font for all text in the Instructions for Use (IFU) because sans serif is easier to read than a serif type font (American Foundation for the Blind 2020). Recommended sans-serif fonts include, but are not limited to, Verdana and Arial. The U.S. Food and Drug Administration (FDA) recommends against the use of any reverse type (such as white or neutral color type on a darker color background), lightface, shading, highlighting, condensed type, or narrow fonts. These techniques can make reading more difficult for patients.<\/p>\n\n\n\n Recommendations on font size are intended for easier readability. Overall, The U.S. Food and Drug Administration (FDA) recommends that the font size be no smaller than 10 points (1 point equals 0.0138 inches) for any section of the Instructions for Use (IFU), except that The U.S. Food and Drug Administration (FDA) recommends the following sections or terminology appear in font no smaller than 8 points:<\/p>\n\n\n\n For products marketed under an NDA or ANDA, the name and place of business of the manufacturer, packer, and\/or distributor.<\/p>\n\n\n\n For products marketed under a BLA, the name, address, and license number of the manufacturer (and, if included, the distributor).<\/p>\n\n\n\n The verbatim statement: This Instructions for Use has been approved by the U.S. Food and Drug Administration.<\/p>\n\n\n\n The month and year of initial The U.S. Food and Drug Administration (FDA) approval or revision of the Instructions for Use (IFU).<\/p>\n\n\n\n The U.S. Food and Drug Administration (FDA) recommends that the title INSTRUCTIONS FOR USE appear in all uppercase letters. The U.S. Food and Drug Administration (FDA) also recommends that the letter case of the proprietary name or nonproprietary name used in the body of the Instructions for Use (IFU) (excluding the Instructions for Use (IFU) product title) match its appearance in the Prescribing Information (PI). All other headings in the Instructions for Use (IFU) are recommended to appear in title case. The U.S. Food and Drug Administration (FDA) suggests avoiding the use of words or phrases with all uppercase letters in the body of the Instructions for Use (IFU). The abundant use of uppercased text is difficult to read and may detract from the prominence of terms that should appear in uppercase text in the Instructions for Use (IFU).<\/p>\n\n\n\n The U.S. Food and Drug Administration (FDA) recommends that the following information appear in bold type: INSTRUCTIONS FOR USE; product title (including drug name(s), pronunciation spelling, dosage form, and route of administration, and (when applicable) the controlled substance symbol); headings; step numbers; and figure titles. Bolded headings can help patients find information quickly and easily However, The U.S. Food and Drug Administration (FDA) suggests that bolding, italicizing, and underlining in the body of the Instructions for Use (IFU) be used sparingly and be limited to important phrases or concepts (for example, important information for patients to know before using the drug product, such as For oral use only).<\/p>\n\n\n\n Step-by-Step Instructions<\/strong><\/p>\n\n\n\n The U.S. Food and Drug Administration (FDA) recommends that instructions be sequentially numbered, with each step heading appearing in bold type and noted as Step 1, Step 2, etc. The U.S. Food and Drug Administration (FDA) also recommends using continuous numbering throughout the document. For example, The U.S. Food and Drug Administration (FDA) suggests avoiding more than one instance of Step 1.<\/p>\n\n\n\n The Agency recommends that action-oriented instruction appear before any supporting information particular to performing a step. The Agency also suggests that supporting information appear in bulleted text on a separate line immediately following the corresponding step.<\/p>\n\n\n\n For example:<\/strong><\/p>\n\n\n\n Step 4. Check the liquid by looking through the viewing window<\/strong><\/p>\n\n\n\n The liquid should be yellow and should have no lumps or particles.<\/p>\n\n\n\n You may see air bubbles. This is normal. If a patient needs to skip a specific step or set of steps that are not necessary for each dose, The U.S. Food and Drug Administration (FDA) recommends that the Instructions for Use (IFU) refer the patient to the next appropriate step. If a patient needs to repeat a step or steps, The U.S. Food and Drug Administration (FDA) recommends that, if appropriate, the Instructions for Use (IFU) refer the patient back to the listed step or steps (for example, \u201cRepeat Steps 10 to 13 a second time, then continue to Step 14\u201d).<\/p>\n\n\n\n For example:<\/strong><\/p>\n\n\n\n Step 6. Close your eye for one minute and gently press at the corner of that eye nearest your nose.<\/strong><\/p>\n\n\n\n Step 7. If you have been instructed by your health care provider to use drops in both eyes, repeat Steps 3 to 6 in the other eye. If not, continue to Step 8.<\/p>\n\n\n\n Visuals help patients comprehend instructions. Visuals can be useful for action tasks and informational text that help a patient understand and safely prepare, administer, store, or dispose of the drug product. The U.S. Food and Drug Administration (FDA) recommends that visuals be easy to understand; be of adequate size to allow patients to see the focal point; and demonstrate one concept, single idea, or point of information. Photographs can be compelling because they show the most accurate visual representation of a product. However, in some instances, the use of line drawings and sketch illustrations may be most helpful to simplify complexities and highlight key components or avoid distracting details.<\/p>\n\n\n\n The U.S. Food and Drug Administration (FDA) recommends that visuals be placed immediately adjacent to the related instructional step. The Agency also recommends that visuals be labeled alphabetically in bold type (such as Figure A, Figure B, etc.). Steps with corresponding figures are recommended to reference the appropriate figure or figures at the end of the step.<\/p>\n\n\n\n The U.S. Food and Drug Administration (FDA) recommends that the Instructions for Use (IFU) maintain a sufficient balance of text, visuals, and white space. White space can be used carefully to keep the document from appearing cramped, overwhelming, or too spread out (for example, at a minimum, The U.S. Food and Drug Administration (FDA) recommends adding a single line before each heading). For ease of reading, The U.S. Food and Drug Administration (FDA) suggests using white space or blocks of text to separate concepts and to indicate change. Additionally, consider increasing the amount of white space around important text and visuals for emphasis.<\/p>\n\n\n\n The U.S. Food and Drug Administration (FDA) recommends that the Instructions for Use (IFU) be presented in black type on a white background to facilitate readability. This combination maximizes contrast and legibility and also facilitates uniform reprinting of the document. Colored text and visuals may be useful as long as all text and visuals maintain clarity and remain legible when the Instructions for Use (IFU) is printed in black and white or in grayscale.ilitate readability. This combination maximizes contrast and legibility and also facilitates uniform reprinting of the document. Colored text and visuals may be useful as long as all text and visuals maintain clarity and remain legible when the IFU is printed in black and white or in grayscale.<\/p>\n\n\n <\/p>\n","protected":false},"excerpt":{"rendered":" All labels and other written, printed or graphic matter upon any article or any of its containers or wrappers, or accompanying such article. The U.S. Food and Drug Administration (FDA) holds that labeling encompasses: Substantiation Labeling accompanied by prescribing information; ads must include \u201cbrief summary\u201d The Significance of Compliance with The U.S. Food and Drug […]<\/p>\n","protected":false},"author":1,"featured_media":3531,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[646],"tags":[157,158,144,159,156],"class_list":["post-3508","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-otc","tag-compliance-guide","tag-drug-labeling","tag-fda","tag-labeling-guidelines","tag-labeling-regulations"],"yoast_head":"\r\n\n
Key Terminology in The U.S. Food and Drug Administration (FDA) Labeling Regulations<\/h2>\n\n\n\n
Contain a summary of the essential scientific information needed for the safe and effective use of the human prescription drug,<\/h2>\n\n\n\n
General Content Recommendations<\/h2>\n\n\n\n
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1. Font and Font Size<\/h3>\n\n\n\n
2. Letter Case<\/h3>\n\n\n\n
3. Bold, Italicized, or Underlined Text<\/h3>\n\n\n\n
4. Page Layout and Design Recommendations<\/h4>\n\n\n\n
Visuals for Step-by-Step Instructions<\/h3>\n\n\n\n
Spacing<\/h3>\n\n\n\n
Color<\/h3>\n\n\n\n