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e-CFR data is current as of July 13, 2020

Title 21Chapter ISubchapter BPart 111 → Subpart N


Title 21: Food and Drugs
PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS


Subpart N—Returned Dietary Supplements


Contents
§111.503   What are the requirements under this subpart N for written procedures?
§111.510   What requirements apply when a returned dietary supplement is received?
§111.515   When must a returned dietary supplement be destroyed, or otherwise suitably disposed of?
§111.520   When may a returned dietary supplement be salvaged?
§111.525   What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing?
§111.530   When must an investigation be conducted of your manufacturing processes and other batches?
§111.535   Under this subpart N, what records must you make and keep?

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§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.

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§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.

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§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.

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§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.

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§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.

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§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.

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§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).

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