FDA Issues Two DSCSA Draft Guidances

• Board-approved California Designated Representative online training programs by SkillsPlus International Inc. | Training courses for wholesalers, 3PL, and reverse distributors.

The FDA issued 2 DSCSA draft guidances:

Date Published	Type	Title
7/05/2022	Draft Guidance	Identifying Trading Partners Under the Drug Supply Chain Security Act
7/05/2022	Draft Guidance	DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs Guidance for Industry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

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

DSCSA Regulations & Guidances From The FDA Are Overdue

• California Designated Representative Training Courses - Approved by the California State Board of Pharmacy for:  wholesalers | 3PL | reverse distributors
• People also look for these FDA CGMP online training courses

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

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

FDA issues new draft documents related to compounding of human drugs

Updated November 24, 2020

Links broke in the original post.

You'll be interested in:

Human Drug Compounding - FDA.gov

- - -  original post follows below  - - -

Read the full press release, and find links to the guidances:
Press Announcements > FDA issues new draft documents related to compounding of human drugs - FDA.gov:

"Documents include draft guidances on outsourcing facility registration; outsourcing facility adverse event reporting; drug repackaging; mixing, diluting, and repackaging biological products; and a draft Memorandum of Understanding with the states"

'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