Food and Drug Administration, HHS § 111.475

(c) Quality control personnel must protect against mixup, contamination, approve or reject each batch of repack- and deterioration. aged or relabeled dietary supplement (b) You must hold in-process mate- prior to its release for distribution. rial under appropriate conditions of temperature, humidity, and light. § 111.425 What requirements apply to a packaged and labeled dietary sup- § 111.465 What requirements apply to plement that is rejected for dis- tribution? holding reserve samples of dietary supplements? You must clearly identify, hold, and control under a quarantine system for (a) You must hold reserve samples of appropriate disposition any packaged dietary supplements in a manner that and labeled dietary supplement that is protects against contamination and de- rejected for distribution. terioration. This includes: (1) Holding the reserve samples under § 111.430 Under this subpart L, what conditions consistent with product la- records must you make and keep? bels or, if no storage conditions are (a) You must make and keep records recommended on the label, under ordi- required under this subpart L in ac- nary storage conditions; and cordance with subpart P of this part. (2) Using the same container-closure (b) You must make and keep records system in which the packaged and la- of the written procedures for packaging beled dietary supplement is distrib- and labeling operations. uted, or if distributing dietary supple- ments to be packaged and labeled, Subpart M—Holding and using a container-closure system that Distributing provides essentially the same charac- teristics to protect against contamina- § 111.453 What are the requirements tion or deterioration as the one in under this subpart for M written which you distribute the dietary sup- procedures? plement for packaging and labeling You must establish and follow writ- elsewhere. ten procedures for holding and distrib- (b) You must retain reserve samples uting operations. for 1 year past the shelf life date (if § 111.455 What requirements apply to shelf life dating is used), or for 2 years holding components, dietary sup- from the date of distribution of the last plements, packaging, and labels? batch of dietary supplements associ- (a) You must hold components and ated with the reserve samples, for use dietary supplements under appropriate in appropriate investigations. conditions of temperature, humidity, and light so that the identity, purity, § 111.470 What requirements apply to strength, and composition of the com- distributing dietary supplements? ponents and dietary supplements are You must distribute dietary supple- not affected. ments under conditions that will pro- (b) You must hold packaging and la- tect the dietary supplements against bels under appropriate conditions so contamination and deterioration. that the packaging and labels are not adversely affected. § 111.475 Under this subpart M, what (c) You must hold components, die- records must you make and keep? tary supplements, packaging, and la- (a) You must make and keep records bels under conditions that do not lead required under this subpart M in ac- to the mixup, contamination, or dete- cordance with subpart P of this part. rioration of components, dietary sup- (b) You must make and keep the fol- plements, packaging, and labels. lowing records: § 111.460 What requirements apply to (1) Written procedures for holding holding in-process material? and distributing operations; and (a) You must identify and hold in- (2) Records of product distribution. process material under conditions that

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