Title 21

PART 106

Part 106 - Infant Formula Requirements Pertaining To Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records And Reports, And Notifications

PART 106 - INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS 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.

21:2.0.1.1.6.1SUBPART A
Subpart A - General Provisions
21:2.0.1.1.6.1.1.1SECTION 106.1
   106.1 Status and applicability of the regulations in part 106.
21:2.0.1.1.6.1.1.2SECTION 106.3
   106.3 Definitions.
21:2.0.1.1.6.2SUBPART B
Subpart B - Current Good Manufacturing Practice
21:2.0.1.1.6.2.1.1SECTION 106.5
   106.5 Current good manufacturing practice.
21:2.0.1.1.6.2.1.2SECTION 106.6
   106.6 Production and in-process control system.
21:2.0.1.1.6.2.1.3SECTION 106.10
   106.10 Controls to prevent adulteration by workers.
21:2.0.1.1.6.2.1.4SECTION 106.20
   106.20 Controls to prevent adulteration caused by facilities.
21:2.0.1.1.6.2.1.5SECTION 106.30
   106.30 Controls to prevent adulteration caused by equipment or utensils.
21:2.0.1.1.6.2.1.6SECTION 106.35
   106.35 Controls to prevent adulteration due to automatic (mechanical or electronic) equipment.
21:2.0.1.1.6.2.1.7SECTION 106.40
   106.40 Controls to prevent adulteration caused by ingredients, containers, and closures.
21:2.0.1.1.6.2.1.8SECTION 106.50
   106.50 Controls to prevent adulteration during manufacturing.
21:2.0.1.1.6.2.1.9SECTION 106.55
   106.55 Controls to prevent adulteration from microorganisms.
21:2.0.1.1.6.2.1.10SECTION 106.60
   106.60 Controls to prevent adulteration during packaging and labeling of infant formula.
21:2.0.1.1.6.2.1.11SECTION 106.70
   106.70 Controls on the release of finished infant formula.
21:2.0.1.1.6.2.1.12SECTION 106.80
   106.80 Traceability.
21:2.0.1.1.6.2.1.13SECTION 106.90
   106.90 Audits of current good manufacturing practice.
21:2.0.1.1.6.3SUBPART C
Subpart C - Quality Control Procedures
21:2.0.1.1.6.3.1.1SECTION 106.91
   106.91 General quality control.
21:2.0.1.1.6.3.1.2SECTION 106.92
   106.92 Audits of quality control procedures.
21:2.0.1.1.6.4SUBPART D
Subpart D - Conduct of Audits
21:2.0.1.1.6.4.1.1SECTION 106.94
   106.94 Audit plans and procedures.
21:2.0.1.1.6.5SUBPART E
Subpart E - Quality Factors for Infant Formulas
21:2.0.1.1.6.5.1.1SECTION 106.96
   106.96 Requirements for quality factors for infant formulas.
21:2.0.1.1.6.6SUBPART F
Subpart F - Records and Reports
21:2.0.1.1.6.6.1.1SECTION 106.100
   106.100 Records.
21:2.0.1.1.6.7SUBPART G
Subpart G - Registration, Submission, and Notification Requirements
21:2.0.1.1.6.7.1.1SECTION 106.110
   106.110 New infant formula registration.
21:2.0.1.1.6.7.1.2SECTION 106.120
   106.120 New infant formula submission.
21:2.0.1.1.6.7.1.3SECTION 106.121
   106.121 Quality factor assurances for infant formulas.
21:2.0.1.1.6.7.1.4SECTION 106.130
   106.130 Verification submission.
21:2.0.1.1.6.7.1.5SECTION 106.140
   106.140 Submission concerning a change in infant formula that may adulterate the product.
21:2.0.1.1.6.7.1.6SECTION 106.150
   106.150 Notification of an adulterated or misbranded infant formula.
21:2.0.1.1.6.7.1.7SECTION 106.160
   106.160 Incorporation by reference.