§111.130. What quality control operations are required for returned dietary supplements?
21 C.F.R. § 111.130
Quality control operations for returned dietary supplements must include:
Conducting any required material review and making any required disposition decision; including—
Determining whether tests or examination are necessary to determine compliance with product specifications established in accordance with § 111.70(e); and
Reviewing the results of any tests or examinations that are conducted to determine compliance with product specifications established in accordance with § 111.70(e);
Approving or rejecting any salvage and redistribution of any returned dietary supplement;
Approving or rejecting any reprocessing of any returned dietary supplement; and
Determining whether the reprocessed dietary supplement meets product specifications and either approving for release, or rejecting, any returned dietary supplement that is reprocessed.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42 U.S.C. 264.
Source
Source: 72 FR 34942, June 25, 2007, unless otherwise noted.