7.5: Labeling

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Page ID: 39516

Jack O'Grady
Austin Community College

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Labeling

Labeling here is referring to the display of written or printed material on the container or an enclosed document. Labeling includes both FDA approved labelings such as container labels, professional labeling in the package insert (PI – prescribing information), patient labeling (PPI – patient package inserts), medication guides, and instructions for use. But also, any promotional material.

Four Types of Prescription Drug Labeling

Professional Labeling: Also referred to as prescribing the information and package insert contains the necessary information for a safe and effective product for use by the healthcare provider (doctor). The Physician Labeling Rule (PLR) applies here and is covered by 21 CFR 201.56-57. This label has three sections: Full prescribing information, highlights of prescribing information, and the table of contents.
Patient Labeling: This includes PPI and medication guides for patients and is covered by 21 CFR 208.1(a) and (b). Medication guides are required when it could help prevent a severe adverse effect by providing the patient with information about a known serious side effect and how the patient should adhere to the directions of use when crucial to the effectiveness of the drug.
Container Label: The container or carton labels for biologicals are covered under 21 CFR 610.60- 61 and must contain the name of the product, the manufacturer's name and contact information, lot identifiable number, expiration date, recommended dose, for prescriptions must state ‘Rx only,' and must include the medication guide. In certain cases, this list may be expanded to include such things as storage conditions, preservatives, adjuvant, if present, and product source.
Structured Product Label (SPL): SPLs are posted publicly at labels.fda.gov/, an online label repository, which allows consumers to research labels and download information from this repository. The purpose of this site is to provide a single place where healthcare providers can access accurate and up to date information quickly.

Advertising and Promotion

The FDA distinguishes in its regulations between promotional and non-promotional activities. Product communications intended to be non-promotional must not make product claims, or they will be subject to FDA regulations. Regulated promotional materials may include advertisements on TV, in magazines, on the radio, and even on social media! For prescription advertising, the FDA has jurisdiction, and both CDER and CBER are responsible for promotional labeling for biologics. In CBER, APLB oversees labeling (OPDP in CDER). The bottom line for advertising is the labeling must be consistent with the FDA-approved labeling, must be backed by considerable evidence, and must not be misleading.