Wednesday, July 6, 2022

FDA Issues Two DSCSA Draft Guidances

The FDA issued 2 DSCSA draft guidances:

Date PublishedTypeTitle
7/05/2022Draft GuidanceIdentifying Trading Partners Under the Drug Supply Chain Security Act
7/05/2022Draft GuidanceDSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs Guidance for Industry

View the full list of Drug Supply Chain Security Act Law and Policies - FDA.gov

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For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
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3 comments:

  1. People who follow the DSCSA might also be interested in Board-approved California Designated Representative online training programs:
    - Wholesaler Training Course
    - 3PL Training Course
    - Reverse Distributor Training Course

    ReplyDelete
  2. Many times when the FDA issues a guidance document, it has been so thoroughly reviewed it is just about ready for implementation. So, I usually start working on implementation when the guidance is in a final draft so my team is ready for the new practice.

    ReplyDelete

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