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Title 21 Part 111 → Subpart A → §111.1

Title 21 → Chapter I → Subchapter B → Part 111 → Subpart A → §111.1

Electronic Code of Federal Regulations e-CFR

Title 21 Part 111 → Subpart A → §111.1

e-CFR data is current as of April 2, 2020

Title 21Chapter ISubchapter BPart 111Subpart A → §111.1


Title 21: Food and Drugs
PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS
Subpart A—General Provisions


§111.1   Who is subject to this part?

(a) Except as provided by paragraph (b) of this section, you are subject to this part if you manufacture, package, label, or hold a dietary supplement, including:

(1) A dietary supplement you manufacture but that is packaged or labeled by another person; and

(2) A dietary supplement imported or offered for import in any State or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.

(b) The requirements pertaining to holding dietary supplements do not apply to you if you are holding those dietary supplements at a retail establishment for the sole purpose of direct retail sale to individual consumers. A retail establishment does not include a warehouse or other storage facility for a retailer or a warehouse or other storage facility that sells directly to individual consumers.