Friday, May 1, 2020

DSCSA Exemption And Exclusion For COVID-19 | FDA Guidance

Open the complete guidance:  Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency - FDA Guidance (PDF)

According to the guidance document:

"Due to the COVID-19 pandemic, FDA has been monitoring requests related to provisions of the Drug Supply Chain Security Act (DSCSA) because the provisions may affect the prescription drug supply chain during the COVID-19 outbreak. FDA is issuing this guidance to clarify the scope of the public health emergency exemption and exclusion under the DSCSA for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS)" . . .

Return Home:  The Designated Representative and Exemptee Blog

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California Designated Representative Training Programs - Board-Approved - For wholesalers, 3PL, reverse distributors - Earns a training affidavit
California Designated Representative Training Programs - Board-Approved - For wholesalers, 3PL, reverse distributors - Earns a training affidavit


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. You might also be interested in the FDA's webpages about the: Drug Supply Chain Security Act (DSCSA)

    ReplyDelete
  2. If your company needs an additional 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

    ReplyDelete

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