DSCSA, FDA, Saleable Returns Verification

Why the FDA Extended The Saleable Returns Verification from 2020 to 2023

February 4, 2021 Christian Souza 2 Comments

In 2020, most things did not go as planned. Considering the overwhelming impact of the worldwide pandemic, the pharmaceutical industry was far from immune to last year’s instability. One of the major changes came with the Saleable Returns Verification’s extension. Despite being originally scheduled for a 2020 enactment, the FDA recently announced their plan to … Continue reading Why the FDA Extended The Saleable Returns Verification from 2020 to 2023 →

DSCSA

No Surprise: DSCSA Verification Delay

September 30, 2019 Dirk Rodgers 2 Comments

FDA delays one wholesaler requirement, plus, Ilisa Bernstein leaves FDA

DSCSA

Is The FDA About To Delay Enforcement Of The Wholesaler’s 2019 Mandate?

June 17, 2019 Dirk Rodgers 2 Comments

Could the FDA delay enforcement of the wholesaler’s 2019 DSCSA requirements?

DSCSA

DSCSA: What Wholesalers Want

March 8, 2019 Dirk Rodgers

Here are some resources for meeting wholesaler requests for their DSCSA obligations.

DSCSA, Verification

HDA Makes A Strong Case For ‘Reframing’ Of FDA’s Draft Guidance On DSCSA Verification Systems

February 11, 2019 Dirk Rodgers

HDA responds to FDA’s draft guidance on Verification Systems. A must-read.

DSCSA

Most Companies Will Do DSCSA Verification Wrong

February 4, 2019 Dirk Rodgers

Most companies will do verification wrong, because they haven’t read the DSCSA or FDA draft guidance…or RxTrace.

Verification

GS1’s Messaging Standard For Verification Of Product Identifiers

January 30, 2019 Dirk Rodgers

GS1’s new standard for verification messaging. Does it apply to you? Probably.

DSCSA

DSCSA: Verification Systems Draft Guidance

October 29, 2018 Dirk Rodgers

Verification Systems under the DSCSA are the things that FDA (and probably state) inspectors are going to look for whenever they visit your facilities from now on. Are you ready? This new draft guidance will help you.

RxTrace

Search Results for: wholesaler verification

Why the FDA Extended The Saleable Returns Verification from 2020 to 2023

No Surprise: DSCSA Verification Delay

Is The FDA About To Delay Enforcement Of The Wholesaler’s 2019 Mandate?

DSCSA: What Wholesalers Want

HDA Makes A Strong Case For ‘Reframing’ Of FDA’s Draft Guidance On DSCSA Verification Systems

Most Companies Will Do DSCSA Verification Wrong

GS1’s Messaging Standard For Verification Of Product Identifiers

DSCSA: Verification Systems Draft Guidance

…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance