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Electronic Code of Federal Regulations

e-CFR data is current as of December 9, 2019

Title 21Chapter ISubchapter CPart 212


TITLE 21—Food and Drugs

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

SUBCHAPTER C—DRUGS: GENERAL

PART 212—CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS

rule

Subpart A—GENERAL PROVISIONS

§212.1
What are the meanings of the technical terms used in these regulations?
§212.2
What is current good manufacturing practice for PET drugs?
§212.5
To what drugs do the regulations in this part apply?
rule

Subpart B—PERSONNEL AND RESOURCES

§212.10
What personnel and resources must I have?
rule

Subpart C—QUALITY ASSURANCE

§212.20
What activities must I perform to ensure drug quality?
rule

Subpart D—FACILITIES AND EQUIPMENT

§212.30
What requirements must my facilities and equipment meet?
rule

Subpart E—CONTROL OF COMPONENTS, CONTAINERS, AND CLOSURES

§212.40
How must I control the components I use to produce PET drugs and the containers and closures I package them in?
rule

Subpart F—PRODUCTION AND PROCESS CONTROLS

§212.50
What production and process controls must I have?
rule

Subpart G—LABORATORY CONTROLS

§212.60
What requirements apply to the laboratories where I test components, in-process materials, and finished PET drug products?
§212.61
What must I do to ensure the stability of my PET drug products through expiry?
rule

Subpart H—FINISHED DRUG PRODUCT CONTROLS AND ACCEPTANCE

§212.70
What controls and acceptance criteria must I have for my finished PET drug products?
§212.71
What actions must I take if a batch of PET drug product does not conform to specifications?
rule

Subpart I—PACKAGING AND LABELING

§212.80
What are the requirements associated with labeling and packaging PET drug products?
rule

Subpart J—DISTRIBUTION

§212.90
What actions must I take to control the distribution of PET drug products?
rule

Subpart K—COMPLAINT HANDLING

§212.100
What do I do if I receive a complaint about a PET drug product produced at my facility?
rule

Subpart L—RECORDS

§212.110
How must I maintain records of my production of PET drugs?

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