Are You Prepared For The U.S. Enhanced Drug Distribution Security (EDDS) Requirements? – BioProcess Online

According to the article:

“The Drug Quality and Security Act (DQSA) was signed into law almost seven years ago on Nov. 27, 2013. Title II of this Act, known as the Drug Supply Chain Security Act (DSCSA), …

… initial requirements of the DSCSA, introduced in a phased manner, were deliberately structured and timed to allow industry to thoughtfully design and implement the required capabilities in preparation for the pinnacle requirement, which goes into effect on Nov. 27, 2023: the implementation of Enhanced Drug Distribution Security (EDDS) capabilities. EDDS will be enabled by the establishment of standards for the interoperable exchange of data, combined with the inclusion of individual serial numbers in the product shipment transaction information transmitted for the NDCs/Lot #s sold and distributed. …

There is little doubt that the prescription drug product traceability and reporting requirements at the individual, serialized unit-level will require considerable planning, assessment, decision-making, change control, and execution. Manufacturers need to proceed quickly but thoughtfully and should approach this upcoming era of serialized product traceability holistically by expanding their objectives beyond achieving and maintaining compliance.”

Read the full source article: Are You Prepared For The U.S. Enhanced Drug Distribution Security (EDDS) Requirements? – BioProcess Online


California Board of Pharmacy Designated Representative Training - online training programs by SkillsPlus International Inc. for wholesalers, 3PL, reverse distributors. Board Approved. 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 Course – by SkillsPlus International Inc. – for California Board of Pharmacy Designated Representative applicants

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

Designated Representative Training Courses – California and Florida

Designated Representative Training Courses - for Florida and California
Designated Representative Training Courses – for California and Florida

Designated Representative Training Courses for:

California

California Board of Pharmacy Designated Representative Training Courses – by SkillsPlus International Inc.

  • 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.

Florida

Florida CDR Training Services – by CDR Resource Center


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

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

Exemptee Training – California Department of Public Health

California Department of Public Health – Food and Drug Branch

California Home Medical Device Retail (HMDR) Exemptee Training Certification

If you are applying for a California Home Medical Device Retail (HMDR) Exemptee license, then you’ll need to include proof of required training in your Exemptee license application packet.

SkillsPlus International Inc. is the experienced provider of Exemptee training, offering an Exemptee training class continuously since 2002. Upon successful course completion, you’ll earn a course completion certificate that’s accepted by the State (the California Department of Public Health — Food and Drug Branch). Simply include the completion certificate (as proof of training) in your Exemptee license application.

Follow this link to download the California HMDR Exemptee Application: CDPH 8695


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

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