21 CFR 312.57: Recordkeeping and record retention
Requires IND sponsors to keep records of investigational drug shipments and disposition, investigator financial interests, and bioequivalence reserve samples, retaining records for two years after marketing approval or after investigational shipment ends and FDA is notified.
Part 312, Investigational New Drug Application · Subpart D, Responsibilities of Sponsors and Investigators
Recent 483s citing 312.57
- Genentech, Inc. · South San Francisco, CaliforniaLack of records covering receipt and disposition of an investigational drug… Mar 12, 2024
- Lauren R. Klein, MD, MS, Sponsor-Investigator · Minneapolis, MinnesotaLack of records covering receipt and disposition of an investigational diug… Apr 23, 2019
The regulation text
§ 312.57 Recordkeeping and record retention.
(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]
Questions
What does 21 CFR 312.57 require?
Requires IND sponsors to keep records of investigational drug shipments and disposition, investigator financial interests, and bioequivalence reserve samples, retaining records for two years after marketing approval or after investigational shipment ends and FDA is notified.
Which sections are cited alongside 312.57?
In the same 483s, investigators most often also cite 312.50 (General responsibilities of sponsors), 312.20 (Requirement for an IND), 312.56 (Review of ongoing investigations), 312.60 (General responsibilities of investigators).