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Title 21

Displaying title 21, up to date as of 6/08/2026. Title 21 was last amended 6/05/2026.
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Title 21Food and DrugsPart / Section
Chapter IFood and Drug Administration, Department of Health and Human Services1 – 1299
Subchapter BFood for Human Consumption100 – 199
Part 106Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications106.1 – 106.160
Subpart AGeneral Provisions106.1 – 106.3
§ 106.1Status and applicability of the regulations in part 106.
§ 106.3Definitions.
Subpart BCurrent Good Manufacturing Practice106.5 – 106.90
Subpart CQuality Control Procedures106.91 – 106.92
§ 106.91General quality control.
§ 106.92Audits of quality control procedures.
Subpart DConduct of Audits106.94
§ 106.94Audit plans and procedures.
Subpart EQuality Factors for Infant Formulas106.96
§ 106.96Requirements for quality factors for infant formulas.
Subpart FRecords and Reports106.100
§ 106.100Records.
Subpart GRegistration, Submission, and Notification Requirements106.110 – 106.160
§ 106.110New infant formula registration.
§ 106.120New infant formula submission.
§ 106.121Quality factor assurances for infant formulas.
§ 106.130Verification submission.
§ 106.140Submission concerning a change in infant formula that may adulterate the product.
§ 106.150Notification of an adulterated or misbranded infant formula.
§ 106.160Incorporation by reference.