Site Feedback

Title 21

Displaying title 21, up to date as of 8/06/2026. Title 21 was last amended 8/06/2026.
eCFR Content

The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government. The Electronic Code of Federal Regulations (eCFR) is a continuously updated online version of the CFR. It is not an official legal edition of the CFR.

Learn more about the eCFR, its status, and the editorial process.

Title 21Food and DrugsPart / Section
Chapter IFood and Drug Administration, Department of Health and Human Services1 – 1299
Subchapter BFood for Human Consumption100 – 199
Part 111Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements111.1 – 111.610
Subpart FProduction and Process Control System: Requirements for Quality Control111.103 – 111.140
§ 111.103What are the requirements under this subpart F for written procedures?
§ 111.105What must quality control personnel do?
§ 111.110What quality control operations are required for laboratory operations associated with the production and process control system?
§ 111.113What quality control operations are required for a material review and disposition decision?
§ 111.117What quality control operations are required for equipment, instruments, and controls?
§ 111.120What quality control operations are required for components, packaging, and labels before use in the manufacture of a dietary supplement?
§ 111.123What quality control operations are required for the master manufacturing record, the batch production record, and manufacturing operations?
§ 111.127What quality control operations are required for packaging and labeling operations?
§ 111.130What quality control operations are required for returned dietary supplements?
§ 111.135What quality control operations are required for product complaints?
§ 111.140Under this subpart F, what records must you make and keep?