21 CFR 610.60 - Biological Product Labeling

What it says

Each container of a biological product that is capable of bearing a full label must show specified information. This includes the proper name of the product, the name, address and license number of the manufacturer, the lot number or other lot identification, the expiration date, and other items the regulation lists, such as the recommended individual dose for multiple-dose containers. Related requirements for package labels and for containers too small for a full label are covered in neighboring sections.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Lot identification and an expiration date on every container are the basis of traceability for biologics. They allow a single container to be linked to its batch records, distribution records and, if needed, a recall.
• The license number links the product to its approved biologics license, so the label is part of the evidence that the product is what the license describes.
• Because biologics are released lot by lot, confirming that the correct label is on each lot belongs in the release process, alongside the general labeling controls in 21 CFR Part 211.

What FDA inspectors look for

• Whether container labels carry every element the regulation requires and match the approved labeling for the license.
• Whether label issuance and reconciliation controls make it unlikely that the wrong label ends up on a lot.
• Whether the expiration date assigned to each lot is consistent with the approved dating period and the supporting stability data.

Related regulations