The Clock is Ticking: Comments to Proposed Federal Rules For Wholesalers and 3PLs are Due June 6th and Here’s What We Think - JDSupra

• California Board-approved California Designated Representative online training courses for: Wholesalers | 3PL (third-party logistics providers) | Reverse Distributors

Updated May 27, 2022:

The FDA has extended the due date for comments. 

"The Agency has received a request for a 90-day extension of the comment period for the proposed rule. The request conveyed concern that the current 120-day comment period, which ends on June 6, 2022, does not allow sufficient time to develop a meaningful or thoughtful response to the proposed rule.

FDA has considered the request and is extending the comment period for the proposed rule for 90 days, until September 6, 2022. The Agency believes that a 90-day extension allows adequate time for interested persons to submit comments."  

Source: National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers; Extension of Comment Period - SUPPLEMENTARY INFORMATION dated May 17, 2022 - Federal Register

---  the original post follows below  ---

According to the article:

"On February 4, 2022, the FDA released its long-awaited proposed national standards for the licensure of third party logistics providers (3PLs) and wholesale drug distributors. The draft rules were years over-due and the delay increased the variation across wholesale and 3PL licensure that the federal Drug Supply Chain Security Act (DSCSA) intended to resolve. The proposed rules create more questions than answers and will likely require significant time and litigation before the rules are finalized." ...

"Here are some of the highlights we saw and questions we have about gaps or challenges in the proposed rules." ...

Read the full source article: The Clock is Ticking: Comments to Proposed Federal Rules For Wholesalers and 3PLs are Due June 6th and Here’s What We Think - JDSupra

Return Home:  The Designated Representative and Exemptee Blog

- - -

California Board-approved California Designated Representative online training courses for:

     Wholesalers | 3PL (third-party logistics providers) | Reverse Distributors

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

LA drug wholesalers accused in $20M federal 'structuring' conspiracy - MyNewsLA.com

• The top choice for Board-approved California Designated Representative training for wholesalers, 3PL, reverse distributors | Register to take an online course now!

Read the full article: LA drug wholesalers accused in $20M federal 'structuring' conspiracy - MyNewsLA.com:

"The owners of two Los Angeles-area drug wholesale companies were among four defendants arrested Wednesday on federal “structuring” charges for allegedly making millions of dollars in cash deposits to circumvent federal reporting requirements."

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

Training program for CA Designated Representative 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

All Eyes On The U.S. Senate Tonight - RxTrace

• California Board of Pharmacy Approved Designated Representative Training Courses
• Wholesaler Training Course
• 3PL Training Course
• Reverse Distributor Training Course


• Trusted FDA GMP online training courses and programs sold by SkillsPlus International Inc.

Updated November 24, 2025

The original post didn't age well.

You might also be interested in:

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

---  the original post follows below  ---

Hold your breath. Let's see if the U.S. Senate will pass this bill, H.R. 3204 (An act to amend the Federal Food, Drug, and Cosmetic Act with respect to human drug compounding and drug supply chain security, and for other purposes.)

All Eyes On The U.S. Senate Tonight - RxTrace:

"There are lots of things that would be triggered by passage of the law. No doubt, the most important one is that the California pedigree law would immediately become inoperative. That is, all of the “clocks” in that law—like January 1, 2015 for 50% of all drugs being serialized and pedigreed, etc.—would stop and disintegrate into irrelevance along with those of all other state pedigree laws."

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

Dirk Rodgers on Pedigree Law (Federal & CA) & Funding

Updated July 10, 2026

The post didn't age well.

Instead, you might like:

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  ---

The California Pedigree Law implementation date is fast approaching . . .

Would A U.S. Federal Pedigree Law Require A New UFA?:

"NOTE: We are just about 1-1/2 years away from January 1, 2015, the first date that manufacturers must serialize some of their drugs and start drug pedigrees. From this point on, time is going to go by pretty fast for companies who are not yet ready."

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

California Board of Pharmacy weighs in on RxTEC proposal

• Buy now! California Designated Representative training courses for:  Wholesalers | 3PL | Reverse Distributors

More on potential e-Pedigree touchpoints . . .

Henry Waxman, U.S. Congressman.
 (Photo credit: Wikipedia)

SecuringPharma - California Board of Pharmacy weighs in on RxTEC proposal:

"The California Board of Pharmacy in the US has written an open letter to Representative Henry Waxman calling for a federal approach to pharmaceutical traceability that provides the same or greater protection to the public as its electronic pedigree system due to come into effect between 2015 and 2017.

The letter to Waxman - who serves as ranking member of the House Energy and Commerce Committee - also takes a swipe at the Pharmaceutical Traceability Enhancement Code (RxTEC) system enshrined in the Securing Pharmaceutical Distribution Integrity Act of 2012, saying that it is a "less robust, and less secure, supply chain infrastructure.""

'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

Accused of Medicare Fraud . . .

You Gotta Know When to Hold ‘Em and Know When to Fold ‘Em:  'via Blog this'

"Let me say it again: only 3% of all the defendants accused of committing a crime in federal court walk out Scot free. I would venture to say that the statistics for those charged with Medicare fraud are even more lopsided in favor of the government and will report on that once my analysis is completed."

Uh-oh!  Best to avoid committing Medicare fraud, than trying to prove innocence.

Return Home:  The Designated Representative and Exemptee Blog

CA HMDR Exemptee online CBT training certification by SkillsPlus Intl Inc.
CA Designated Representative online CBT training certification by SkillsPlus Intl Inc.
FL Designated Representative online CBT exam preparation by SkillsPlus Intl Inc.
SkillsPlus Intl Inc. - GMP Compliance Training Experts
SkillsPlus Intl Info Blog

Related articles

• FL Certified Designated Representative - Use The Most Current CIB (skillsplusinfo.blogspot.com)
• CA Pharmacy Designated Representative - Online CBT Training (skillsplusinfo.blogspot.com)

Government Money Recovered From Medicaid Fraud Tripled

Image via Wikipedia

• People also look for Exemptee training & California Designated Representative training courses

Government triples money recovered from Medicaid scams - ABC News:

The Department of Health and Human Services show "the federal government has more than tripled the amount of money it has recovered through efforts to stop Medicaid fraud in the past six years."

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

• CA Pharmacy Designated Representative - Online CBT Training (skillsplusinfo.blogspot.com)
• CA Pharmacy Designated Representative Training - Very Popular (skillsplusinfo.blogspot.com)
• FL Certified Designated Representative - Use The Most Current CIB (skillsplusinfo.blogspot.com)