Drug verification is at the heart of most pharma serialization regulations. It is the point at which someone in the supply chain or a patient uses the unique identifier on the drug package to determine that the drug is probably authentic, or definitely is not. We can tell a lot about the intent of a given serialization regulation by looking at the specific language that determines by whom and when a unique identifier must be verified. Continue reading Drug Verification: EU Vs US
Tag Archives: DQSA
FDA Limits Ongoing Dispenser Enforcement Discretion To First Responders
Back in October the FDA announced the extended use of enforcement discretion to temporarily set aside the data exchange provisions of the Drug Supply Chain Security Act (DSCSA) for dispensers until March 1, 2016 (see “FDA Extends Dispenser Delay in DSCSA Enforcement“). That was itself an additional four month extension to the four month enforcement discretion they originally announced on June 30 (see “FDA Publishes New Guidance Delaying Dispenser 3T Requirements Until November 1, 2015“). Many dispensers were hoping for another extension in these last few days of February. It turns out, the enforcement discretion will be extended until further notice, but apparently mostly just for first responders. Continue reading FDA Limits Ongoing Dispenser Enforcement Discretion To First Responders
Sponsored: The Many Faces Of The FDA
Why is there such a wide gap between the actions of the UDI face of the FDA and the DSCSA face?
The U.S. Food and Drug Administration (FDA) is an agency of the U.S. government that falls under the Department of Health and Human Services, which is under the leadership of the current Presidential Administration through a cabinet seat. But it is also a concept, and the concept has been conceived, modified, adjusted, influenced and expanded—especially expanded—by many thousands of members of Congress that have served from 1906 to 2016. It started as a nearly powerless monitoring agency in 1906 with the passage of the Federal Food and Drugs Act. But in the aftermath of a number of widely-reported incidents of harm and deaths caused by cosmetics and medicines, the Congress passed the original Food, Drug and Cosmetics Act (FD&C) in 1938 and President Franklin D. Roosevelt signed it into law.
Right from the beginning you had an agency with at least three faces: foods, drugs and cosmetics. Continue reading Sponsored: The Many Faces Of The FDA
Meeting U.S. and E.U. Drug Serialization Requirements With A Single Solution
As serialization mandates sweep the world you would think that drug manufacturers and repackagers would just deploy one generic “serialization application” and simply turn it on for any drugs that requires it, and turn it off for any that do not. That’s probably what the legislatures and regulators who create the requirements think. RxTrace readers know it’s not nearly that easy.
The problem is that every regulation requires something different. The only common thread is that there is always a “serial number” requirement in there somewhere (thus the name). But the serial number itself is usually defined differently and everything else that surrounds the serial number is often not the same. It’s not a matter of just turning it on and off, it’s a matter of changing a bunch of parameters, which result in significantly more complexity in the setup, testing and validation of the system for each market. Continue reading Meeting U.S. and E.U. Drug Serialization Requirements With A Single Solution
FDA To Hold DSCSA Pilots Workshop
As we saw last fall, the FDA is planning to conduct at least one pilot project in 2016 to fulfill its DSCSA mandate to do so. The pilot should focus on the 2023 DSCSA technologies and processes (see “FDA Looking For Consulting Org To Run DSCSA Pilots“). Today we learned that a pilot will indeed occur this year, and the FDA wants your input into its design and goals. To accomplish that quickly, the FDA will establish a docket next Tuesday for collecting written comments, and a public workshop for collecting verbal comments.
The last DSCSA public workshop Continue reading FDA To Hold DSCSA Pilots Workshop
U.S. Drug Wholesale Distributors Provide Direction To Manufacturers
Over the next few years, the U.S. drug wholesale distributors are going to start dictating their specific requirements related to the Drug Supply Chain Security Act (DSCSA) to their suppliers. For the “Big 3” U.S. wholesale distributors, those suppliers happen to be nearly every drug manufacturer who markets drugs in the United States. The “Big 3” include McKesson, AmerisourceBergen and Cardinal Health, which together distribute about 85% of all drugs that pass through the domestic supply chain.
Of course, each segment has Continue reading U.S. Drug Wholesale Distributors Provide Direction To Manufacturers
FDA Announces OMB Approval Of One DSCSA Draft Guidance
It’s funny. Here we are waiting for the FDA to publish four new Drug Supply Chain Security Act (DSCSA) guidance documents (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?“), when an unexpected notice is published about an older draft DSCSA guidance document. When I first looked at the title of the notice I had to read it four times before I could get myself to believe what I was seeing.
That’s right, this morning the FDA Continue reading FDA Announces OMB Approval Of One DSCSA Draft Guidance
Announcing: The Second Edition of The Drug Supply Chain Security Act Explained
This past week I have been on a vacation with my family in the Caribbean so I do not have a topical essay for you this week, except to announce the availability of the second edition of The Drug Supply Chain Security Act Explained. The full title is “The Drug Supply Chain Security Act Explained: Second Edition, Plus Explanations Of Key FDA DSCSA Guidances”. This time the book is available as a paperback and at the much more affordable price of only US$59.99.
I am working on Continue reading Announcing: The Second Edition of The Drug Supply Chain Security Act Explained
