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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2016.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C--DRUGS: GENERAL
 
PART 212CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS
 

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?

Subpart B--Personnel and Resources
   § 212.10 - What personnel and resources must I have?

Subpart C--Quality Assurance
   § 212.20 - What activities must I perform to ensure drug quality?

Subpart D--Facilities and Equipment
   § 212.30 - What requirements must my facilities and equipment meet?

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?

Subpart F--Production and Process Controls
   § 212.50 - What production and process controls must I have?

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?

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?

Subpart I--Packaging and Labeling
   § 212.80 - What are the requirements associated with labeling and packaging PET drug products?

Subpart J--Distribution
   § 212.90 - What actions must I take to control the distribution of PET drug products?

Subpart K--Complaint Handling
   § 212.100 - What do I do if I receive a complaint about a PET drug product produced at my facility?

Subpart L--Records
   § 212.110 - How must I maintain records of my production of PET drugs?

Authority: 21 U.S.C. 321, 351, 352, 355, 371, 374; Sec. 121, Pub. L. 105-115, 111 Stat. 2296.
Source: 74 FR 65431, Dec. 10, 2009, unless otherwise noted.

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