Showing posts with label verification. Show all posts
Showing posts with label verification. Show all posts

Monday, October 26, 2020

Saleable Returns Verification

Updated September 14, 2026

The original post didn't age well.

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Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/wholesale-distributor-verification-requirement-saleable-returned-drug-product-and-dispenser-0

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Read the full source article: Saleable Returns Verification Delayed to 2023 - Healthcare Packaging

According to the article:

"Additional three-year delay: FDA guidance says distributors will not be required to verify the product identifier of returned drugs before resale until Nov. 27, 2023.   ...

With the 2020 enforcement date approaching in November, FDA has announced an additional three-year delay, noting, “FDA does not intend to take action against wholesale distributors who do not, prior to November 27, 2023, verify the product identifier prior to further distributing returned product as required under the DSCSA."

View the FDA guidance document:  Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies - FDA.gov

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California Board of Pharmacy Designated Representative Training. Board-approved. Taught by SkillsPlus International Inc. for reverse distributors, wholesalers, 3PL. If you are applying for a California Designated Representative license, then you’re also going to need to include proof of required training (specifically, a training affidavit) in your license application packet. Earn a training affidavit (accepted by the Board) by taking any one of our courses.
California Board of Pharmacy Designated Representative Training. Board-approved. Taught by SkillsPlus International Inc. for reverse distributors, wholesalers, 3PL. If you are applying for a California Designated Representative license, then you’re also going to need to include proof of required training (specifically, a training affidavit) in your license application packet. Earn a training affidavit (accepted by the Board) by taking any one of our courses.


For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Tuesday, September 10, 2019

GS1 Lightweight Messaging Standard

Open the full guideline document:   GS1 Healthcare US - Implementation Guideline - Applying the GS1 Lightweight Messaging Standard for DSCSA Verification of Returned Product Identifiers (PDF)

According to the guideline document:

"In preparation, pharmaceutical supply chain stakeholders collaborated with GS1® and GS1 US® to develop a verification messaging standard to enable system interoperability and prevent the proliferation of multiple messaging formats. In addition, the GS1 Messaging Standard Workgroup collaborated with the Healthcare Distribution Alliance (HDA) Verification Routing Services (VRS) Taskforce. These efforts produced the GS1 Lightweight Messaging Standard for Verification of Product Identifiers.

The GS1 Lightweight Messaging Standard was designed to support requests and responses for verification of product identifiers for serialized pharmaceutical products. It is intended to provide a simple, standardized lightweight messaging framework for asking verification questions and receiving actionable information. Designed to support Verification Routing Services (VRS) systems for DSCSA verification, the messaging standard defines a verification request message and a corresponding response message."

Return Home:  The Designated Representative and Exemptee Blog

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The largest selection of Board-approved California Designated Representative online training programs. 3 distinct courses for wholesalers, 3PL, reverse distributors. Earns a training affidavit.
The largest selection of Board-approved California Designated Representative online training programs. 3 distinct courses for wholesalers, 3PL, reverse distributors. Earns a training affidavit.

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

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