It’s still business as usual: FDA’s proposed DSCSA enforcement delay

Chan
Posted: 07/14/2017

The FDA has published draft guidance proposing a 12 month grace period on the enforcement of November’s DSCSA ( Drug Supply Chain Security Act) requirements.  Even still the industry should continue serialization projects to secure supply chains ahead of 2017's deadline.

The US Food and Drug Administration is planning to postpone taking action on manufacturers that fail to meet November 2017’s conditions to verify prescription drugs at package level with an identifier. This also would cascade to apply to any downstream partners repackagers, wholesale distributors and  dispenser.  From November 2018, however, any product in commerce without a product identifier will be viable for investigation.

The intentions being that this delay would give manufacturers more time to implement and avoid supply disruptions.  

LSPediA contends that this potential delay in enforcing the law can be attributed to:

  •          The limited amount of vendors able to give expertise and systems needed for facilitate serialisation measures.  
  •          The readiness of contract manufacturers

However, this was communicated in draft guidance document. The FDA clarifies: “guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations unless specific regulatory or statutory requirements are cited.”

Respectively, pharma firms should continue with progressing in their serialization projects to comply with requirements and secure their supply chains. 

Take a look at our recent serialization implementaion resources. 

Pharmaceutical Serialization & Traceability 2017 Market Research

Security & Authentication Factsheets

Serialization: The World Beyond Compliance

Serialization: Your Implementation Guide

Disclaimer: The points expressed in this piece should not be regarded as legal advice 

Chan
Posted: 07/14/2017

Join for Free

EVENTS OF INTEREST

The Ritz-Carlton Coconut Grove, Miami, FL, United States
May 20 - 22, 2018
Twickenham Stadium, London, United Kingdom
January 29 - 01 February, 2018

You Might Also Like

Pharma M&As and Their Impacts On Cold Chain
Val Petursson, Managing Director PTC/PP & Logistics - Intl, Allergan speaks to Chanice Henry,... Read more
Alan k
When it comes to integrating the pharma cold-chain, technology is invariably seen as having a big... Read more
Contributor: Alan Kennedy
What’s on the horizon for GMP Compliance
At the recent MHRA GDP & GMP Symposium Martine Powell, GMDP inspector examined the known future... Read more
Contributor: Miss Chanice Henry
Top Content For 2015
Cold Chain IQ and Pharma IQ present the top content pieces for 2015 in this annual bumper, so you... Read more