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Pharmaceutical Labeling Requirements

The label plays an important role which allows the customer to have complete information regarding the product which includes ingredients, usages etc.
The label plays an important role which allows the customer to have complete information regarding the product which includes ingredients of the product, its usage, and caution in use, precautions to be taken while using it, manufacturing date, batch number etc. Drug labeling refers to all the information printed which includes instructions, ingredients, and a lot more information that accompanies a drug including the label, the wrapping, and the packaging insert. The department of food and drug administration's division of drug marketing, advertising, and communications regulates the labeling of drugs. These regulations apply to prescription drugs, over-the-counter drugs, and dietary supplements.

The prime motive of prescription drug labeling is to provide healthcare professionals the required information they need to prescribe drugs correctly. Labeling provides the information of directions to administer the drug, the necessary warnings, and dosage specification.

Why more emphasis on the labeling?
Over the years, prescription drug labeling grew in length, detail, and complexity.

The older format
• Did not identify the approval date.
• Did not indicate whether there were any recent changes to the labeling.
• Made locating and using information difficult.
• Did not facilitate finding answers to specific questions.
• Eventually, in many cases, labeling lost its user focus.

It became a document to assure completeness for possible litigation instead of a source of easy-to-use medical information.

Generally, a label contains the following information about the following things:
• Summary of necessary scientific information for the safe and effective use of the drug
• Be precise and accurate
• No use of language that is promotional in tone, false, or misleading
• Not make false claims or suggest uses for drugs when there is not sufficient evidence of safety and substantial evidence of effectiveness
• Contain information based whenever possible on data derived from human experience
• The labeling must also be updated when new information becomes available that causes it to become Inaccurate, False, (or) Misleading.

New Labeling Format
Based on the changes implemented by the FDA a new labeling format has been designed.
It consists of the following divisions that have been added to the format of the label.

1. Highlights: This is perhaps the most significant change in the new labeling rule.
• It provides the overview of a drug’s benefits and risks that healthcare professionals said were most important to them.
• The Highlights section guides healthcare professionals to sections in the “Full Prescribing Information” where detailed information about the product can be obtained.
• The highlight section consists of information that is not repetitive but contains a concise summary of crucial prescribing information.
• Essentially, the Highlights section is a brief one-half-page summary of the more descriptive product labeling.
The highlight section consists mainly of the following parts:-
1. Limitations Statement
2. Product Names and Date of Initial U.S. Approval
3. Boxed Warning
4. Recent Major Changes
5. Indications and Usage
6. Dosage and Administration
7. Dosage Forms and Strengths
8. Contraindications
9. Warnings and Precautions
10. Adverse Reactions
11. Drug Interactions
12. Use in Specific Populations
13. Patient Counseling Information Statement.

At the top of each highlights page, you will see a "Limitations Statement." For example, “These Highlights do not include all the information needed to use the drug safely and effectively. The most important change made in the new type of labeling format includes BOXED WARNING. As in the old product labeling, the revised product labeling may contain a boxed warning, also referred to as a BLACK-BOX WARNING. The boxed warning in the Highlights section uses bullets for ease of reading and is limited to 20 lines. The complete boxed warning in the Full Prescribing Information may be longer and contain a more thorough explanation of the risks.

2. Contents: Another format feature all prescription drug products will share is the new “Contents” section.
• This provides detailed safety and efficacy information.
• The Contents section addresses prescribers' concern “that it was difficult to use the old labeling format” to find specific information.
• The Contents serve as a navigational tool to all sections and subsections in the Full Prescribing Information and provide electronic hyperlinks to those sections.

3. Reordering and Reorganizing of the sections: The next and most important change made to the labeling includes re-ordering and re-organizing the sections.
• The "Indications and Usage" and the "Dosage and Administration" sections (information that healthcare professionals refer to most frequently and consider most important) are located at the beginning of the prescribing information.
• Product identification information such as color and scoring is located in both the ''Dosage Forms and Strengths" and the ''How Supplied" sections to preserve the integrity and understanding of both sections. 

4. Revisions and improvements: This section deals with revisions that have been made to the labeling
• Specifically, new changes can be seen in the ''Contraindications" section, the ''Warnings and Precautions" section, and the ''Adverse Reactions" section. 

• Includes known hazards. i.e. likelihood of occurrence and the size of the population is affected. 
• The statement ALLERGIC to a specific component of the drug has been removed.

Warnings and precautions section
• Warnings and precautions have been made into one section and have been expanded to include the Clinically significant adverse reactions.

What Information is required for labeling?
A statement of prior identity, indicating the nature, composition, and use of the product, must be identifiable, by means of either the common or usual name, a descriptive name, understood by the public, or an illustration. An accurate statement stating the net quantity of contents, in terms of weight, measure, numerical count or a combination of numerical count and weight or measure.

Anuj Pathak
Assistant Professor
KIET School of Pharmacy
Ghaziabad, India
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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