• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

  • Print
  • Share
  • E-mail
-

The information on this page is current as of April 1 2017.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

New Search
Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2017]
[CITE: 21CFR111]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION
 
PART 111CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS
 

Subpart N--Returned Dietary Supplements

Sec. 111.503 What are the requirements under this subpart N for written procedures?

You must establish and follow written procedures to fulfill the requirements of this subpart.

Sec. 111.510 What requirements apply when a returned dietary supplement is received?

You must identify and quarantine returned dietary supplements until quality control personnel conduct a material review and make a disposition decision.

Sec. 111.515 When must a returned dietary supplement be destroyed, or otherwise suitably disposed of?

You must destroy, or otherwise suitably dispose of, any returned dietary supplement unless the outcome of a material review and disposition decision is that quality control personnel do the following:

(a) Approve the salvage of the returned dietary supplement for redistribution or

(b) Approve the returned dietary supplement for reprocessing.

Sec. 111.520 When may a returned dietary supplement be salvaged?

You may salvage a returned dietary supplement only if quality control personnel conduct a material review and make a disposition decision to allow the salvage.

Sec. 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing?

(a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in accordance with 111.70(e); and

(b) Quality control personnel must approve or reject the release for distribution of any returned dietary supplement that is reprocessed.

Sec. 111.530 When must an investigation be conducted of your manufacturing processes and other batches?

If the reason for a dietary supplement being returned implicates other batches, you must conduct an investigation of your manufacturing processes and each of those other batches to determine compliance with specifications.

Sec. 111.535 Under this subpart N, what records must you make and keep?

(a) You must make and keep records required under this subpart N in accordance with subpart P of this part.

(b) You must make and keep the following records:

(1) Written procedures for fulfilling the requirements of this subpart N.

(2) Any material review and disposition decision on a returned dietary supplement;

(3) The results of any testing or examination conducted to determine compliance with product specifications established under 111.70(e); and,

(4) Documentation of the reevaluation by quality control personnel of any dietary supplement that is reprocessed and the determination by quality control personnel of whether the reprocessed dietary supplement meets product specifications established in accordance with 111.70(e).

Authority: 21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42 U.S.C. 264.
Source: 72 FR 34942, June 25, 2007, unless otherwise noted.

-
-