FDA To Dispensers - Guidance on DSCSA July & Nov Timelines

The FDA published a new guidance:

DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy Guidance for Industry - FDA (PDF)

In a nutshell:

"The product tracing requirements in sections 582(d)(1) of the FD&C Act take effect for
dispensers on July 1, 2015. ... "

"FDA does not intend to take action against dispensers who, prior to November 1, 2015, accept
ownership of product without receiving the product tracing information, as required by section
582(d)(1)(A)(i) of the FD&C Act."

There's a whole lot more in the guidance, so you'll want to review it, in its entirety.

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training 
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

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

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Related articles

• 
  Who Offers Designated Representative Training?

Will The FDA Delay The DSCSA? - Rx Trace

Read the full article:  Will The FDA Delay The DSCSA? - Rx Trace:

"More and more people are asking if the FDA will delay the January 1, 2015 requirements of the Drug Supply Chain Security Act (DSCSA).  On that day, drug manufacturers, repackagers and wholesale distributors must begin exchanging Transaction Information (TI), Transaction History (TH) and Transaction Statements (TS), (dispensers join them next July) and the FDA is not even due to publish guidance on how to do that until November 27" . . .

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

- - -

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training 
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

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

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Related articles

• 
  FDA DSCSA Workshop - Meeting Materials
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  FDA Law Blog: Interoperably Exchanging Information with FDA: Agency Holds First DSCSA Public Workshop
• 
  CA Designated Representative & Exemptee Training Course - Enhanced for iPad
• 
  The Differences Between The DSCSA, FDA Rules and Guidance - RxTrace