Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 2 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / 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 / § 111.120 What quality control operations are required for components, packaging, and labels before use in the manufacture of a dietary supplement?
§ 111.120 What quality control operations are required for components, packaging, and labels before use in the manufacture of a dietary supplement?
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.