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§ 226.80 - Packaging and labeling.

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Packaging and labeling operations shall be adequately controlled:

To assure that only those Type A medicated article(s) that have met the specifications established in the master-formula records shall be distributed.

To prevent mixups during the packaging and labeling operations.

To assure that correct labeling is employed for each Type A medicated article(s).

To identify Type A medicated article(s) with lot or control numbers that permit determination of the history of the manufacture and control of the batch of Type A medicated article(s).

Packaging and labeling operations shall provide:

For storage of labeling in a manner to avoid mixups.

For careful checking of labeling for identity and conformity to the labeling specified in the batch-production records.

For adequate control of the quantities of labeling issued for use with the Type A medicated article(s).

Type A medicated article(s) shall be distributed in suitable containers to insure the safety, identity, strength, and quality of the finished product.

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§ 226.58 - Laboratory controls.
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§ 226.102 - Master-formula and batch-production records.