GroundRules
21 CFR 111.120: What quality control operations are required for components, packaging, and labels before use in the manufacture of a dietary supplement?
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION
- PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS
- Subpart F—Production and Process Control System: Requirements for Quality Control
Quality control operations for components, packaging, and labels before use in the manufacture of a dietary supplement must include:
(a) Reviewing all receiving records for components, packaging, and labels;
(b) Determining whether all components, packaging, and labels conform to specifications established under § 111.70 (b) and (d);
(c) Conducting any required material review and making any required disposition decision;
(d) Approving or rejecting any treatment and in-process adjustments of components, packaging, or labels to make them suitable for use in the manufacture of a dietary supplement; and
(e) Approving, and releasing from quarantine, all components, packaging, and labels before they are used.
Collected 2026-08-27T02:24:47Z. Source file · JSON