Part 106 — Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications
Current through Sep 8, 2026
Authority: 21 U.S.C. 321, 342, 350a, 371.
Source: 79 FR 8059, Feb. 10, 2014, unless otherwise noted.
Editorial Note: Nomenclature changes to part 106 appear at 81 FR 49895, July 29, 2016.
Sections
- § 106.1 Status and applicability of the regulations in part 106.
- § 106.3 Definitions.
- § 106.5 Current good manufacturing practice.
- § 106.6 Production and in-process control system.
- § 106.10 Controls to prevent adulteration by workers.
- § 106.20 Controls to prevent adulteration caused by facilities.
- § 106.30 Controls to prevent adulteration caused by equipment or utensils.
- § 106.35 Controls to prevent adulteration due to automatic (mechanical or electronic) equipment.
- § 106.40 Controls to prevent adulteration caused by ingredients, containers, and closures.
- § 106.50 Controls to prevent adulteration during manufacturing.
- § 106.55 Controls to prevent adulteration from microorganisms.
- § 106.60 Controls to prevent adulteration during packaging and labeling of infant formula.
- § 106.70 Controls on the release of finished infant formula.
- § 106.80 Traceability.
- § 106.90 Audits of current good manufacturing practice.
- § 106.91 General quality control.
- § 106.92 Audits of quality control procedures.
- § 106.94 Audit plans and procedures.
- § 106.96 Requirements for quality factors for infant formulas.
- § 106.100 Records.
- § 106.110 New infant formula registration.
- § 106.120 New infant formula submission.
- § 106.121 Quality factor assurances for infant formulas.
- § 106.130 Verification submission.
- § 106.140 Submission concerning a change in infant formula that may adulterate the product.
- § 106.150 Notification of an adulterated or misbranded infant formula.
- § 106.160 Incorporation by reference.