Source: https://www.law.cornell.edu/cfr/text/21/312.57
Timestamp: 2015-03-29 21:45:39
Document Index: 667366577

Matched Legal Cases: ['art 312', '§ 312', '§ 54', 'art 54', '§ 320', '§ 320', '§ 320']

21 CFR 312.57 - Recordkeeping and record retention. | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter D › Part 312 › Subpart D › Section 312.57 21 CFR 312.57 - Recordkeeping and record retention.
There is 1 rule appearing in the Federal Register for 21 CFR 312. View below or at eCFR (GPOAccess)
§ 312.57
Recordkeeping and record retention.
A sponsor shall maintain adequate records showing the receipt, shipment, or other disposition of the investigational drug. These records are required to include, as appropriate, the name of the investigator to whom the drug is shipped, and the date, quantity, and batch or code mark of each such shipment.
A sponsor shall maintain complete and accurate records showing any financial interest in § 54.4(a)(3)(i), (a)(3)(ii), (a)(3)(iii), and (a)(3)(iv) of this chapter paid to clinical investigators by the sponsor of the covered study. A sponsor shall also maintain complete and accurate records concerning all other financial interests of investigators subject to part 54 of this chapter.
A sponsor shall retain the records and reports required by this part for 2 years after a marketing application is approved for the drug; or, if an application is not approved for the drug, until 2 years after shipment and delivery of the drug for investigational use is discontinued and FDA has been so notified.
A sponsor shall retain reserve samples of any test article and reference standard identified in, and used in any of the bioequivalence or bioavailability studies described in, § 320.38 or § 320.63 of this chapter, and release the reserve samples to FDA upon request, in accordance with, and for the period specified in § 320.38.
[52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 58 FR 25926, Apr. 28, 1993; 63 FR 5252, Feb. 2, 1998; 67 FR 9586, Mar. 4, 2002]
Title 21 published on 2014-04-01The following are only the Rules published in the Federal Register after the published date of Title 21.For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.2015-02-10; vol. 80 # 27 - Tuesday, February 10, 201580 FR 7318 - Individual Patient Expanded Access Applications: Form FDA 3926; Draft Guidance for Industry; Availability
Title 21 published on 2014-04-01The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 312 after this date.2015-02-10; vol. 80 # 27 - Tuesday, February 10, 201580 FR 7318 - Individual Patient Expanded Access Applications: Form FDA 3926; Draft Guidance for Industry; Availability