StacksVerified U.S. regulatory reference

21 CFR §111.315

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
You must establish and follow laboratory control processes that are reviewed and approved by quality control personnel, including the following:
  1. (a)Use of criteria for establishing appropriate specifications;
  2. (b)Use of sampling plans for obtaining representative samples, in accordance with subpart E of this part, of:
    1. (1)Components, packaging, and labels;
    2. (2)In-process materials;
    3. (3)Finished batches of dietary supplements;
    4. (4)Product that you receive for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier); and
    5. (5)Packaged and labeled dietary supplements.
  3. (c)Use of criteria for selecting appropriate examination and testing methods;
  4. (d)Use of criteria for selecting standard reference materials used in performing tests and examinations; and
  5. (e)Use of test methods and examinations in accordance with established criteria.