e-CFR data is current as of December 9, 2019
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
Subpart A—GENERAL PROVISIONS
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| What are the meanings of the technical terms used in these regulations? |
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| What is current good manufacturing practice for PET drugs? |
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| To what drugs do the regulations in this part apply? |
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Subpart B—PERSONNEL AND RESOURCES
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| What personnel and resources must I have? |
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Subpart C—QUALITY ASSURANCE
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| What activities must I perform to ensure drug quality? |
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Subpart D—FACILITIES AND EQUIPMENT
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| What requirements must my facilities and equipment meet? |
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Subpart E—CONTROL OF COMPONENTS, CONTAINERS, AND CLOSURES
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| How must I control the components I use to produce PET drugs and the containers and closures I package them in? |
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Subpart F—PRODUCTION AND PROCESS CONTROLS
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| What production and process controls must I have? |
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Subpart G—LABORATORY CONTROLS
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| What requirements apply to the laboratories where I test components, in-process materials, and finished PET drug products? |
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| What must I do to ensure the stability of my PET drug products through expiry? |
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Subpart H—FINISHED DRUG PRODUCT CONTROLS AND ACCEPTANCE
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| What controls and acceptance criteria must I have for my finished PET drug products? |
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| What actions must I take if a batch of PET drug product does not conform to specifications? |
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Subpart I—PACKAGING AND LABELING
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| What are the requirements associated with labeling and packaging PET drug products? |
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Subpart J—DISTRIBUTION
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| What actions must I take to control the distribution of PET drug products? |
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Subpart K—COMPLAINT HANDLING
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| What do I do if I receive a complaint about a PET drug product produced at my facility? |
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Subpart L—RECORDS
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| How must I maintain records of my production of PET drugs? |
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