C.F.R. » Title 21 » 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 L—Production and Process Control System: Requirements for Packaging and Labeling Operations

21 C.F.R. § 111.425

What requirements apply to a packaged and labeled dietary supplement that is rejected for distribution?

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You must clearly identify, hold, and control under a quarantine system for appropriate disposition any packaged and labeled dietary supplement that is rejected for distribution.