Pharma Logistics’ grand opening of its reverse-distribution center – Pharmaceutical Commerce

  • California Designated Representative Reverse Distributor Training Course. 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 this course. This is the only Board-approved training program for reverse distributors.

According to the article:

“Pharma Logistics has officially opened its new reverse-distribution center in Libertyville, expanding and combining previous operations in Mundelein and Libertyville, IN.

Part of the growth opportunity comes from the October 2019 acquisition of the pharmaceutical reverse-logistics business of Stericyle, a major player in medical waste and reverse logistics. Pharmaceutical reverse logistics was valued at $13 billion annually in a 2018 HDA study.”

Read the full source article:  Pharma Logistics’ grand opening of its reverse-distribution center – Pharmaceutical Commerce


Go to DREprof.com: The Designated Representative and Exemptee Training Website

Mediledger completes FDA blockchain pilot with 7 of top 10 pharma firms – Ledger Insights

According to the article:

“Blockchain startup Mediledger has published the results of its FDA blockchain pilot for the pharmaceutical supply chain. Numerous separate groups applied to the FDA and ran pilots for the Drug Supply Chain Security Act (DSCSA) 2023 milestone for package-level tracing, with this being one of the largest groups. Mediledger’s participants included all three major U.S. wholesalers, seven out of ten of the world’s largest pharmaceutical companies, massive dispensers Walgreens and Walmart, as well as logistics firms such as FedEx.”

Read the source article:  Mediledger completes FDA blockchain pilot with 7 of top 10 pharma firms – Ledger Insights


Go to DREprof.com: The Designated Representative and Exemptee Training Website

Here comes drug importation – Pharmaceutical Commerce

According to the article:

“The Trump Administration wants to start a drug-importation program from Canada for both small-molecule and biologic products. The program would be a “time-limited Section 804 importation program” (SIP), with the SIP program sponsored by “a pharmacist, a wholesaler, or another State or non-federal governmental entity” and subject to FDA review. Additional language in the notice of proposed rulemaking (NPRM) gives guidance on how manufacturers themselves could set up reimportation. The NPRM is available in draft form today (Dec. 18), and is expected to be published officially in the Federal Register on Dec. 23.”

Read the source article:  Here comes drug importation – Pharmaceutical Commerce


Go to DREprof.com: The Designated Representative and Exemptee Training Website

FDA Enforcement Delay of Wholesale Distributor Verification Requirement for Saleable Returns – LSPediA

“The US FDA published a compliance policy final guidance document on September 23, 2019, announcing a one-year enforcement discretion for the Wholesale Distributor Verification Requirement for Saleable Returned Drug Product.

If you’re a wholesaler or a manufacturer rushing to meet the November 2019 deadline, this guidance is significant. But before you breathe a sigh of relief, you need to read the entire guidance document and the entirety this LSPediA article.”

Read the full source article:  FDA Enforcement Delay of Wholesale Distributor Verification Requirement for Saleable Returns – LSPediA

View the FDA final guidance document:  Wholesale Distributor Verification Requirement for Saleable Returned Drug Product — Compliance Policy – Guidance for Industry (PDF)


Go to DREprof.com: The Designated Representative and Exemptee Training Website