FDA Grants Exemption to Connected Trading Partners - FDA.gov

• If your company needs a 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 

The FDA has issued another DSCSA exemption, and posted a summary of it, on their Waivers and Exemptions Beyond the Stabilization Period webpage. 

In a nutshell, in the October 9, 2024 exemption, the exemptions apply to any partners who have completed or made documented compliance efforts but still face data exchange challenges. The FDA said it is granting additional time to avoid supply chain disruptions that may impact patients’ access to needed medications.

Go to the Waivers and Exemptions Beyond the Stabilization Period webpage:  https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/waivers-and-exemptions-beyond-stabilization-period

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 Readiness - A Long Way To Go

• Board-approved training programs for California Designated Representative license applicants:
• Designated Representative - Wholesaler
• Designated Representative - 3PL
• Designated Representative - Reverse Distributor

Updated July 31, 2026

Companies Are Not Ready

The end to end pharmaceutical supply chain still isn't ready for DSCSA implementation.

Some articles are warning that the November 2023 date will be a challenge:

• Pharmaceutical supply chains raise data concerns as traceability law nears final step - Supply Chain Dive

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

Companies Collaborate on DSCSA Guideline as Deadlines Approach | RAPS

• Register now for a Board-approved California Designated Representative training course for:
       Wholesalers | 3PL | Reverse Distributors

Read the full article: Companies Collaborate on DSCSA Guideline as Deadlines Approach | RAPS:

"GS1 Guideline

The 600+ page GS1 guideline and compendia offer information and examples to the wider industry looking to meet the law's obligations and record each shipping event and data element needed to support serialization, pedigree and track and trace. The guideline also shows industry how to apply the standards to their own businesses."

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

Training for Designated Representative and Designated Representative-3PL license applicants

- - -

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 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.

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

• 
  Who Offers Designated Representative Training?

Pharmacy Groups Ask FDA to Delay Enforcement of ‘Track & Trace’ Requirement - Pharmacy Practice News

Updated March 12, 2026

You might also be interested in:

Drug Supply Chain Security Act (DSCSA) - FDA.gov

https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa

---  the original post follows below  ---

Read the full article: Pharmacy Practice News - Pharmacy Groups Ask FDA to Delay Enforcement of ‘Track & Trace’ Requirement:

"The organizations asked that the FDA use its enforcement discretion to delay the July 1 product tracing deadline for dispensers to forestall potential disruptions in the pharmaceutical supply chain."

'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

• 
  Who Offers Designated Representative Training?

e-Pedigree - Hey CA Board of Pharmacy: Your Time Is Running Out!

The Board just held their June 24, 2013 e-Pedigree meeting. Still a lot of ground to cover, and "time is running out," as Dirk Rodgers reports in his excellent analysis.

Hey California Board of Pharmacy: Your Time Is Running Out!:

" . . . disappointed that the only thing that happened was a brief discussion of each topic but seemingly no real action. It was almost as if the Board members and staff had made no progress . . . "

You might also be interested in:
e-Pedigree Committee Meeting Materials (6/24/2013 meeting) - PDF
Webcast Archive (CA Dept of Consumer Affairs) - some Board of Pharmacy meeting videos get posted here after some delay

Return Home:  The Designated Representative and Exemptee Blog

CA Designated Representative online web-based training certification by SkillsPlus Intl Inc.
FL Designated Representative online e-Learning exam preparation by SkillsPlus Intl Inc.
The Designated Representative Institute

CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc.
The Exemptee Institute

SkillsPlus Intl Info Blog