Friday, December 9, 2016

DSCSA Identification of Suspect Product and Notification - FDA Final Guidance

The FDA released this final guidance:
Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification FDA Guidance for Industry (PDF)

In brief:
This guidance identifies specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain; provides recommendations on how trading partners can identify a product and determine whether a product is a suspect product as soon as practicable; and sets forth the process by which trading partners should notify FDA of illegitimate product or products with a high risk of illegitimacy, and how they must terminate the notifications, in consultation with FDA.

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

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

2 comments:

  1. Who Are You Going To Call? These Collaboration Partners - (for all things pharma & drug distribution related).

    ReplyDelete
  2. When the time comes, and your company needs another California Designated Representative - Wholesaler, or a California Designated Representative - 3PL, they'll need Board-approved training to apply for their Designated Representative license application.

    Board-approved California Designated Representative courses:
    - Wholesaler Training Course
    - 3PL Training Course
    - Reverse Distributor Training Course

    California Board of Pharmacy Designated Representative - Training Solutions

    SkillsPlus International Inc. is proud of our high student volume. Nearly 10,000 students have taken our state license-related courses, demonstrating the popularity and trust in our approved training programs and courses.

    ReplyDelete

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