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Electronic Code of Federal Regulations

e-CFR data is current as of February 19, 2020

Title 21Chapter ISubchapter BPart 106


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION

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

rule

Subpart A—GENERAL PROVISIONS

§106.1
Status and applicability of the regulations in part 106.
§106.3
Definitions.
rule

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.
rule

Subpart C—QUALITY CONTROL PROCEDURES

§106.91
General quality control.
§106.92
Audits of quality control procedures.
rule

Subpart D—CONDUCT OF AUDITS

§106.94
Audit plans and procedures.
rule

Subpart E—QUALITY FACTORS FOR INFANT FORMULAS

§106.96
Requirements for quality factors for infant formulas.
rule

Subpart F—RECORDS AND REPORTS

§106.100
Records.
rule

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.

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