Distribution records as per USFDA CFR 211.196

Distribution records as per USFDA CFR 211.196

Distribution records shall contain –  

  • The name and strength of the product
  • Description of the dosage form
  • Name and address of the consignee
  • Date and quantity shipped
  • Lot or control the number of the drug product.

For compressed medical gas products, distribution records are not required to contain lot or control numbers.

Reference:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211