Code of Federal Regulations (Last Updated: April 5, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter C - Drugs: General |
Part 211 - Current Good Manufacturing Practice for Finished Pharmaceuticals |
Subpart J - Records and Reports |
§ 211.196 - Distribution records.
Latest version.
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§ 211.196 Distribution records.
Distribution records shall contain the name and strength of the product and description of the dosage form, name and address of the consignee, date and quantity shipped, and lot or control number of the drug product. For compressed medical gas products, distribution records are not required to contain lot or control numbers.
(Approved by the Office of Management and Budget under control number 0910-0139)
[49 FR 9865, Mar. 16, 1984]