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Electronic Code of Federal Regulations

e-CFR data is current as of November 19, 2019

Title 21Chapter ISubchapter FPart 606


TITLE 21—Food and Drugs

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

SUBCHAPTER F—BIOLOGICS

PART 606—CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS

rule

Subpart A—GENERAL PROVISIONS

§606.3
Definitions.
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Subpart B—ORGANIZATION AND PERSONNEL

§606.20
Personnel.
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Subpart C—PLANT AND FACILITIES

§606.40
Facilities.
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Subpart D—EQUIPMENT

§606.60
Equipment.
§606.65
Supplies and reagents.
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Subpart E—[RESERVED]

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Subpart F—PRODUCTION AND PROCESS CONTROLS

§606.100
Standard operating procedures.
§606.110
Plateletpheresis, leukapheresis, and plasmapheresis.
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Subpart G—ADDITIONAL LABELING STANDARDS FOR BLOOD AND BLOOD COMPONENTS

§606.120
Labeling, general requirements.
§606.121
Container label.
§606.122
Circular of information.
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Subpart H—LABORATORY CONTROLS

§606.140
Laboratory controls.
§606.145
Control of bacterial contamination of platelets.
§606.151
Compatibility testing.
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Subpart I—RECORDS AND REPORTS

§606.160
Records.
§606.165
Distribution and receipt; procedures and records.
§606.170
Adverse reaction file.
§606.171
Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and transfusion services.

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