StacksVerified U.S. regulatory reference

21 CFR §117.420

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
  1. (a)Approval of suppliers. The receiving facility must approve suppliers in accordance with the requirements of § 117.410(d), and document that approval, before receiving raw materials and other ingredients received from those suppliers;
  2. (b)Written procedures for receiving raw materials and other ingredients.
    1. (1)Written procedures for receiving raw materials and other ingredients must be established and followed;
    2. (2)The written procedures for receiving raw materials and other ingredients must ensure that raw materials and other ingredients are received only from approved suppliers (or, when necessary and appropriate, on a temporary basis from unapproved suppliers whose raw materials or other ingredients are subjected to adequate verification activities before acceptance for use); and
    3. (3)Use of the written procedures for receiving raw materials and other ingredients must be documented.