StacksVerified U.S. regulatory reference

21 CFR §58.107

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
Procedures shall be established for a system for the handling of the test and control articles to ensure that:
  1. (a)There is proper storage.
  2. (b)Distribution is made in a manner designed to preclude the possibility of contamination, deterioration, or damage.
  3. (c)Proper identification is maintained throughout the distribution process.
  4. (d)The receipt and distribution of each batch is documented. Such documentation shall include the date and quantity of each batch distributed or returned.