GroundRules
21 CFR 1.326: Who is subject to this subpart?
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 A—GENERAL
- PART 1—GENERAL ENFORCEMENT REGULATIONS
- Subpart J—Establishment, Maintenance, and Availability of Records
(a) Persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States are subject to the regulations in this subpart, unless you qualify for one of the exclusions in § 1.327. If you conduct more than one type of activity at a location, you are required to keep records with respect to those activities covered by this subpart, but are not required by this subpart to keep records with respect to activities that fall within one of the exclusions in § 1.327.
(b) Persons subject to the regulations in this subpart must keep records whether or not the food is being offered for or enters interstate commerce.
Collected 2026-08-27T02:24:47Z. Source file · JSON