21 CFR 312.57
Recordkeeping and record retention
21 CFR 312.57 is the regulation titled “Recordkeeping and record retention” in 21 CFR Part 312, Investigational New Drug Application. Since 2021, 3 FDA warning letters have cited it.
- Letters citing it
- 3 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 1 on the same dates in 2025
- Most often cited with
- 21 CFR 312.2, in 2 letters
- Closed out
- 33% of these letters have a published close-out
Letters citing it, by year issued
Most are drug letters (2 of 3). 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 312.57 most often, as written in the letters.
- 1 letterYou failed to maintain adequate records showing the receipt, shipment, or other disposition of the investigational drug (21 CFR 312.57(a))
- 1 letterYou failed to maintain adequate records showing the receipt, shipment, or other disposition of the investigational drug [21 CFR 312.57(a)]
The regulation
Read the text of 21 CFR 312.57 (eCFR, as of Sep 1, 2026)
(a) 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.
(b) 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.
(c) 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.
(d) 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]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 312.57.
- 21 CFR 312.2Applicability2 letters cite both
- 21 CFR 312.20Requirement for an IND2 letters cite both
- 21 CFR 312.60General responsibilities of investigators2 letters cite both
- 21 CFR 312.40General requirements for use of an investigational new drug in a clinical investigation1 letter cites both
- 21 CFR 312.50General responsibilities of sponsors1 letter cites both
- 21 CFR 312.62Investigator recordkeeping and record retention1 letter cites both
- 21 CFR 312.7Promotion of investigational drugs1 letter cites both
- 21 CFR 50.20General requirements for informed consent1 letter cites both
Latest letters citing it
The 3 letters citing 21 CFR 312.57 that FDA posted most recently.
- BiologicsView Amy Lightner, MDinvestigational product under IND (b)(4)IssuedMar 25, 2025PostedJun 3, 2025
- DrugsView Randy J. Epstein, M.D./Chicago Cornea Consultants, Ltd.PXL-330IssuedJun 14, 2023PostedJun 20, 2023
- DrugsView KDunn and Associates, P.A. dba HealthQuiltSponsor of a clinical study of an investigational drug for COVID-19IssuedFeb 16, 2021PostedMar 2, 2021
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Counts include every citation in a letter, as the Letters filter does. How this database is built.