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e-CFR data is current as of October 22, 2020

Title 21 → Chapter I → Subchapter F → Part 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.
rule

Subpart B—ORGANIZATION AND PERSONNEL

§606.20
Personnel.
rule

Subpart C—PLANT AND FACILITIES

§606.40
Facilities.
rule

Subpart D—EQUIPMENT

§606.60
Equipment.
§606.65
Supplies and reagents.
rule

Subpart E—[RESERVED]

rule

Subpart F—PRODUCTION AND PROCESS CONTROLS

§606.100
Standard operating procedures.
§606.110
Plateletpheresis, leukapheresis, and plasmapheresis.
rule

Subpart G—ADDITIONAL LABELING STANDARDS FOR BLOOD AND BLOOD COMPONENTS

§606.120
Labeling, general requirements.
§606.121
Container label.
§606.122
Circular of information.
rule

Subpart H—LABORATORY CONTROLS

§606.140
Laboratory controls.
§606.145
Control of bacterial contamination of platelets.
§606.151
Compatibility testing.
rule

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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