CFR section

21 CFR 111.410(b): What requirements apply to packaging and labels?

PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS · Subpart L-Production and Process Control System: Requirements for Packaging and Labeling Operations

Key facts

Citation 21 CFR 111.410(b)
Section What requirements apply to packaging and labels?
Part PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS
Subpart Subpart L-Production and Process Control System: Requirements for Packaging and Labeling Operations
Subchapter 21 CFR B Food
Product types cited Drugs, Food/Cosmetics, General
Regulation text (excerpt) (b) You must control the issuance and use of packaging and labels and reconciliation of any issuance and use discrepancies. Label reconciliation is not required for cut or rolled labels if a 100-percent examination for correct labels is performed by appropriate electronic or electromechanical equipment during or after completion of finishing operations; and

At a glance

  • 10–99 Inspections citing this section
  • 10–99 Warning letters citing this section

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About CFR sections cited by the FDA

Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.

Source: U.S. Code of Federal Regulations (eCFR); citation statistics from FDA inspection and warning-letter data

Browse all CFR sections cited by the FDA