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

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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