CFR - Code of Federal Regulations Title 21

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

[Code of Federal Regulations]

[Title 21, Volume 4]

[CITE: 21CFR212]

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C - DRUGS: GENERAL

PART 212 CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS

Subpart L - Records

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

(a) Record availability. Records must be maintained at the PET drug production facility or another location that is reasonably accessible to responsible officials of the production facility and to employees of FDA designated to perform inspections.

(b) Record quality. All records, including those not stored at the inspected establishment, must be legible, stored to prevent deterioration or loss, and readily available for review and copying by FDA employees.

(c) Record retention period. You must maintain all records and documentation referenced in this part for a period of at least 1 year from the date of final release, including conditional final release, of a PET drug product.

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.