DSCSA Regulations & Guidances From The FDA Are Overdue

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Updated Nov 26, 2019.  You might also be interested in:

• FDA guidance and policy documents related to the DSCSA

- - -  the original post follows below  - - -

This should interest wholesale drug distributors and third-party logistics providers (3PLs).

A total of four DSCSA regulations and guidances were expected from the FDA by November 27, 2015 (Source: Drug Supply Chain Security Act (DSCSA) Implementation Plan; view the text version of the graphic):

Section of DSCSA	Deliverable Type	Deliverable Description	Estimated Target Date
202	Guidance	Publish guidance on processes for waivers, exceptions, exemptions	11/27/2015
202	Guidance	Publish final guidance on grandfathering product	11/27/2015
204	Regulation	Develop regulations establishing standards for licensing of wholesale drug distributors	11/27/2015
205	Regulation	Develop regulations establishing standards for licensing of third-party logistic providers	11/27/2015

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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