About: Pharmaceutical Product Expiration Date     Goto   Sponge   NotDistinct   Permalink

An Entity of Type : owl:Class, within Data Space : linked.opendata.cz associated with source document(s)

AttributesValues
rdf:type
rdfs:label
  • Pharmaceutical Product Expiration Date
rdfs:subClassOf
Semantic_Type
  • Temporal Concept
Preferred_Name
  • Pharmaceutical Product Expiration Date
UMLS_CUI
  • C1709516
Contributing_Source
  • BRIDG
Legacy_Concept_Name
  • Pharmaceutical_Product_Expiration_Date
FULL_SYN
  • Product Expiration DateSYNCI
  • Expiration DateSYNCI
  • expirationDatePTBRIDG
  • Pharmaceutical Product Expiration DatePTNCI
  • Drug Expiration DateSYNCI
DEFINITION
  • As part of the CGMP regulations, the FDA requires that drug products bear an expiration date determined by appropriate stability testing (21 CFR 211.137 and 211.166), after which the product may not meet the appropriate regulatory agencies requirements.. The FDA defines an expiration date as "the date placed on the container/labels of a drug product designating the time during which a batch of the product is expected to remain within the approved shelf life specifications if stored under defined conditions, and after which it may not be used." Expiration dates are generally limited to no more than 3 years after production, but longer stability periods are allowed for some very stable materials.NCI
code
  • C42693
is rdfs:subClassOf of
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