Labeling for prescription medicines is FDA’s primary tool for...

Labeling for prescription medicines is FDA’s primary tool for communicating drug information to healthcare professionals, and patients and their caregivers. Labeling for prescription medicines includes:

• Prescribing Information (labeling for healthcare professionals),
• Carton and container labeling (cartons and containers are outside packaging that contain information about prescription medicines), and
• Labeling for patients or caregivers (e.g., Medication Guides, Patient Package Inserts, and Instructions for Use).

Labeling for prescription medicines is required for all FDA-approved prescription medicines. Such labeling is:

• Proposed by the drug company,
• Reviewed by the FDA, and
• If acceptable, approved by the FDA. If the labeling for a new medicine is found to be unacceptable by the FDA, the medicine will not be approved by the FDA.

All prescription medicines have Prescribing Information and carton and/or container labeling and many, but not all, have labeling for patients or caregivers. See The Ins and Outs of Prescription Drug Labeling for a background about prescription drug labeling (2021 presentationExternal Link Disclaimer) and Frequently Asked Questions about Labeling for Prescription Medicines (2022 Presentation).

The above was taken from FDA website, it has a good breakdown of the process here:

https://www.fda.gov/drugs/fdas-labeling-resources-human-prescription-drugs/frequently-asked-questions-about-labeling-prescription-medicines

Labeling is a broad term used to cover many pieces of agreement between FDA and the applicant. So there will be constant discussion now between BOT and FDA as we try to get agreement on the final pieces.