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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION
 
PART 106INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS
 

Subpart A--General Provisions
   § 106.1 - Status and applicability of the regulations in part 106.
   § 106.3 - Definitions.

Subpart B--Current Good Manufacturing Practice
   § 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.

Subpart C--Quality Control Procedures
   § 106.91 - General quality control.
   § 106.92 - Audits of quality control procedures.

Subpart D--Conduct of Audits
   § 106.94 - Audit plans and procedures.

Subpart E--Quality Factors for Infant Formulas
   § 106.96 - Requirements for quality factors for infant formulas.

Subpart F--Records and Reports
   § 106.100 - Records.

Subpart G--Registration, Submission, and Notification Requirements
   § 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.

Authority: 21 U.S.C. 321, 342, 350a, 371.
Source: 79 FR 8059, Feb. 10, 2014, unless otherwise noted.

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