Labeling Requirements for Prescription Drugs

Under FDA there are more than 150 labeling resources that are present for labeling prescription drugs. FDA has approved about 50+ guidances to be used while labelling cartons and containers containing prescription drugs and biological products. There is a separate website that has been designated for this and is known as the Prescription Drug Labeling Resources website. 

Prescription Drug Labeling Requirements:

Some requirements to be fulfilled for labelling such products are:

• “Prescribing Information” (PI)
• Patient Information approved by FDA to be present in the form of Patient Package Inserts.
• Patient related labelling like Instructions for Use and Medication Guides to be present on the label.
• Proper Labeling of Container and Carton.

What to be included on Drug Labels?

In a generalized form, every drug label needs to have certain data such as:

• Safe and effective usage summary related to the drug
• The label needs to be informative and all the details present should be accurate.
• Misleading or false labels and even promotional ones are to be avoided. 
• Implied suggestions of safety and efficacy without evidence should not be included.
• Safety and efficacy data should be mostly based on human experience.

Safety Related Data in Drug Labeling

There are certain safety related data that needs to present in the label of any drug as mandated by the FDA. This list includes:

• Precautions and warnings
• A section on adverse reactions
• Safety-related data on labels
• Information of drug abuse if any
• Mention of clinically significant effects of the drug

Most data is present in the FDA site for manufacturers as well as users. They can use it to clarify their queries when met with a dubious situation.