On January 19, 2018, CDER issued their updated CY2018 Guidance Agenda, which outlines new and revised draft guidances CDER plans to publish during the year.  Specifically related to supply chain security, this list includes the following planned guidances:

  • Definitions of Suspect Product and Illegitimate Product or Verification Obligations
  • Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product identifier
  • Proposed Accreditation Program Under the Drug Supply Chain Security Act
  • Proposed Licensing Program Under the Drug Supply Chain Security Act
  • Standardization of Data and Documentation Practices for Product Tracing
  • The Product Identifier for Human, Finished, Prescription Drugs: Question and Answers
  • Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs

Although FDA intents to issue these documents, they frequently do not appear in the public domain in the given year.  This is just the agenda and the Agency will likely in many cases, miss these goals.  As such, we should treat them as documents that may issue but there is no guarantee they will.

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