FDA Drug Product Labels: PACKAGING and LABELING CONTROL Sections 211.122, 125, & 130
A firm must establish written labeling procedures covering the receipt, identification, storage, handling and examination of all labeling. Procedures should cover the reconciliation, issuance, returns, and security of labeling. There must be written procedures to assure that the correct label is used on the drug product, including the identification of each batch with a lot number.
All high pressure cylinders, large cryogenic vessels and cryogenic home vessels are required to bear an adequate drug product label. This label is usually the responsibility of the manufacturer, filler, transfiller, etc.
There can be only one drug label on a high pressure cylinder or cryogenic vessel, and that label is usually applied by the manufacturer, filler, transfiller, etc. of the drug product. Cryogenic home vessels come from the manufacturer with a DEVICE label, which should not be confused with the required drug label. Further, the device label must not be removed. Cylinders owned by one company, but filled by another company may bear a small ownership or possession sticker in addition to the drug product label.
Upon receipt from the printer, a new batch of labels must be counted to verify the quantity of labels received, and they should be examined and compared against the approved master label to assure correctness.
If a firm uses a small, grocery-store type sticker to contain an expiration date or a lot number, then this practice should be addressed in a firm’s written procedures. Further, these stickers must not fall off, or the drug product is misbranded.
Section 503 of the Act requires prescription drugs to bear the statement: “Rx Only.”
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