9 CFR 116.8 - Completion and retention of records.

prev | next
§ 116.8 Completion and retention of records.

All records (other than disposition records) required by this part shall be completed by the licensee, permittee, or foreign manufacturer before any portion of a serial of any product may be marketed in the United States or exported. All records shall be retained at the licensed or foreign establishment or permittee's place of business for a period of two years after the expiration date of a product, or for such longer period as may be required by the Administrator.

(Approved by the Office of Management and Budget under control number 0579-0013)
[ 61 FR 52874, Oct. 9, 1996]

Title 9 published on 14-Sep-2017 03:43

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 9 CFR Part 116 after this date.

  • 2015-09-04; vol. 80 # 172 - Friday, September 4, 2015
    1. 80 FR 53475 - VSTA Records and Reports Specific to International Standards for Pharmacovigilance
      GPO FDSys XML | Text
      DEPARTMENT OF AGRICULTURE, Animal and Plant Health Inspection Service
      Proposed rule; withdrawal and reproposal.
      We will consider all comments that we receive on or before November 3, 2015.
      9 CFR Parts 101 and 116
The section you are viewing is cited by the following CFR sections.