21 CFR 111.77
What must you do if established specifications are not met?
21 CFR 111.77 is the regulation titled “What must you do if established specifications are not met?” in 21 CFR Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 111.113, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a drug letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 12023
- 02024
- 02025
- 02026
The regulation
Read the text of 21 CFR 111.77 (eCFR, as of Sep 1, 2026)
(a) For specifications established under § 111.70(a), (b)(2), (b)(3), (c), (d), (e), and (g) that you do not meet, quality control personnel, in accordance with the requirements in subpart F of this part, must reject the component, dietary supplement, package or label unless such personnel approve a treatment, an in-process adjustment, or reprocessing that will ensure the quality of the finished dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record. No finished batch of dietary supplements may be released for distribution unless it complies with § 111.123(b).
(b) For specifications established under § 111.70(b)(1) that you do not meet, quality control personnel must reject the component and the component must not be used in manufacturing the dietary supplement.
(c) For specifications established under § 111.70(f) that you do not meet, quality control personnel must reject the product and the product may not be packaged or labeled for distribution as a dietary supplement.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 111.77.
- 21 CFR 111.113What quality control operations are required for a material review and disposition decision?1 letter cites both
- 21 CFR 111.303What are the requirements under this subpart J for written procedures?1 letter cites both
- 21 CFR 111.315What are the requirements for laboratory control processes?1 letter cites both
- 21 CFR 111.320What requirements apply to laboratory methods for testing and examination?1 letter cites both
- 21 CFR 111.70What specifications must you establish?1 letter cites both
- 21 CFR 111.75What must you do to determine whether specifications are met?1 letter cites both
- 21 CFR 111.95Under this subpart E, what records must you make and keep?1 letter cites both
- 21 CFR 201.5Drugs; adequate directions for use1 letter cites both
Latest letters citing it
The letter citing 21 CFR 111.77 that FDA posted most recently.
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