Showing posts with label trace. Show all posts
Showing posts with label trace. Show all posts

Tuesday, July 23, 2019

Our STAT Op-Ed: Drug Importation Can’t Coexist with U.S. Track-and-Trace Law - DrugChannels.net

Read the full text of the Op-Ed:  Our STAT Op-Ed: Drug Importation Can’t Coexist with U.S. Track-and-Trace Law - DrugChannels.net

From the Op-Ed:
"As we see it, there is no legal or operational way of transforming a drug packaged for a foreign market into a drug that meets the U.S. requirements of our in-progress track-and-trace system. What’s more, there is no way to alter the law to enable importation without undermining the law’s purpose and value.  ... 
Importation laws undermine the country’s progress in building a modern technology infrastructure to track and trace prescription drugs. Making exceptions to the in-progress track-and-trace system would ignore the many instances of drug diversion and counterfeiting that led to the creation and passage of the law in 2013."

The Op-Ed covers the following areas:
  • State drug importation laws undermine the process that keeps our supply chain safe
  • Why the U.S. is building a track-and-trace system 
  • How track-and-trace works 
  • Importation undermines the track-and-trace system
  • Importation enables counterfeits 
  • Forgetting the lessons 
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Thursday, August 10, 2017

Will Traceability Services Be Outsourced? | Pharmaceutical Technology

Outsourcing Traceability Services

Read the complete article: Will Traceability Services Be Outsourced? | Pharmaceutical Technology:

. . . "and in the future, we can expect some other US 3PLs to offer a similar service. Woodfield hosts TraceLink for each client and manages it for clients, along with other services."

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Monday, July 11, 2016

The Race for Track & Trace: Are 3PLs ready for serialization?

Read the full article: The Race for Track & Trace: Are 3PLs ready for serialization?:

. . ."Phase II, which goes into effect beginning in November 2017, requires item-level serialization and poses a real challenge for 3PLs.

Brian Daleiden, vice president of industry marketing at TraceLink, a cloud-based track-and-trace network, warned that many 3PLs are only starting to realize the potential issues and complications they face. “If you’re a pharmaceutical company supplying products covered under DSCSA, working with 3PLs, and you are not today having any active conversations about what your plans and expectations are, you are creating serious risk for your ability to supply products and meet the serialization deadlines,” he said. “Not to say compliance cannot be reached, but you should be having the conversation today.”"

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Monday, September 21, 2015

SAP formally introduces Advanced Track and Trace for Pharma (ATTP); Tracelink readies a counterpunch - Pharmaceutical Commerce

---  the original post follows below  ---

Read the full article: SAP formally introduces Advanced Track and Trace for Pharma (ATTP); Tracelink readies a counterpunch - Pharmaceutical Commerce:

"The battleground for IT solutions to meet the requirements of the Drug Supply Chain Security Act (DSCSA), as well as similar traceability regulations coming into force around the world, is heating up. On Sept. 15, SAP formally launched ATTP, propelled by a collaboration with nine of the top 20 pharma companies and a major US wholesaler. The software enables pharma manufacturers to generate serial numbers (random ones if desired), transmit those serial codes to packaging lines, and then track the disposition of the coded unit products into warehousing and out to trading partners. "

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Wednesday, June 24, 2015

Pharmacy Groups Ask FDA to Delay Enforcement of ‘Track & Trace’ Requirement - Pharmacy Practice News

Updated March 12, 2026

You might also be interested in:

Drug Supply Chain Security Act (DSCSA) - FDA.gov
https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa

---  the original post follows below  ---

Read the full article: Pharmacy Practice News - Pharmacy Groups Ask FDA to Delay Enforcement of ‘Track & Trace’ Requirement:

"The organizations asked that the FDA use its enforcement discretion to delay the July 1 product tracing deadline for dispensers to forestall potential disruptions in the pharmaceutical supply chain."

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Wednesday, June 10, 2015

Track and trace: Is your pharmacy in compliance with the new law? | American Pharmacists Association

Updated August 18, 2021

The original link broke.

You can still read about the same topic here:

---  the original post follows below  ---

Read the full article: Track and trace: Is your pharmacy in compliance with the new law? | American Pharmacists Association:

"Is your pharmacy ready for the new track-and-trace law? Under the Drug Supply Chain Security Act, January 1 and July 1 are the key dates in 2015 for new requirements for pharmacies.

Per the new law, as of January 1, 2015, pharmacies shall only accept drug products from authorized trading partners. Also, pharmacies are required to have processes in place to identify, quarantine, and investigate suspect products and determine whether products are illegitimate. By July 1, 2015, pharmacies must be able to capture and maintain transaction information (TI), transaction history (TH), and a transaction statement (TS)—sometimes referred to as “the three Ts”—for each drug product received for 6 years from the date of the transaction."

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Wednesday, July 23, 2014

HDMA Revises 856 Advance Ship Notice Documentation

Read the full article: HDMA revises 856 Advance Ship Notice documentation:

"That HDMA has come out twice with updates is a testament to the urgency of getting data-forwarding practices in order among US drug distributors: come January, distributors will need to be able to verify shipments (at the lot level) to pharmacies and other customers. This is the legislated mandate from Congress when it passed the Drug Quality and Security Act (of which DSCSA is a part); FDA is on call to Congress to issue guidelines for drug tracking by late November."

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Wednesday, December 4, 2013

Full-line distributor sales topped $300 billion in 2012 - DQSA lot/item level tracking stats

Full-line distributor sales topped $300 billion in 2012, representing 91% of pharma sales - Pharmaceutical Commerce:

"The Factbook contains operational details often of high interest to vendors serving wholesalers’ infrastructure needs. One particular number to call out: two out of three HDMA members are already tracking lot-level barcodes through their systems for at least some of their products. Lot-level tracking is now the centerpiece of the Drug Quality and Security Act, which will mandate such tracking over the next four years. Data on item-level tracking (the next stage in DQSA) is occurring, but at significantly lower percentages."

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Thursday, November 28, 2013

Obama signs Drug Quality and Security Act into law - SecuringIndustry.com


SecuringIndustry.com - Obama signs Drug Quality and Security Act into law:

"President Obama has signed H.R. 3204 into law, setting the wheels in motion for the FDA to develop a national track-and-trace system to secure the pharmaceutical supply chain.

The aim of the Drug Quality and Security Act (DQSA) is to "minimise opportunities for contamination, adulteration, diversion, or counterfeiting," whilst also clarifying the FDA's authority to regulate compounding pharmacies, according to the White House."

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Monday, November 18, 2013

Breaking news: US Senate clears track-and-trace bill - SecuringIndustry.com

SecuringIndustry.com - Breaking news: US Senate clears track-and-trace bill:

"The US Senate passed H.R. 3204 by unanimous voice vote today, bringing a national track-and-trace system for medicines and new laws governing compounding pharmacies to the brink of fruition.

With the House having given its blessing to H.R. 3204- also known as the Drug Quality and Security Act (DQSA) - at the end of September, all that remains now is for the bill to be passed to President Obama for signature."

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HDMA’s 2013 Track-and-Trace Conference: Right Here Waiting for H.R. 3204 - FDA Law Blog

FDA Law Blog: HDMA’s 2013 Track-and-Trace Conference: Right Here Waiting for H.R. 3204:

"With fingers crossed, attendees looked ahead to the future of track-and-trace. Panelists expressed that the national system will hopefully make it harder for bad actors to corrupt the integrity of the supply chain, as the current patchwork of state pedigree laws allows bad actors to shop around for more lenient states. It is hoped that this bill will put everyone on a level playing field and reduce loopholes."

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All Eyes On The U.S. Senate Tonight - RxTrace


Updated November 24, 2025

The original post didn't age well.

You might also be interested in:

---  the original post follows below  ---

Hold your breath. Let's see if the U.S. Senate will pass this bill, H.R. 3204 (An act to amend the Federal Food, Drug, and Cosmetic Act with respect to human drug compounding and drug supply chain security, and for other purposes.)

All Eyes On The U.S. Senate Tonight - RxTrace:

"There are lots of things that would be triggered by passage of the law. No doubt, the most important one is that the California pedigree law would immediately become inoperative. That is, all of the “clocks” in that law—like January 1, 2015 for 50% of all drugs being serialized and pedigreed, etc.—would stop and disintegrate into irrelevance along with those of all other state pedigree laws."

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Saturday, November 9, 2013

End game for US medicines traceability bill? - SecuringIndustry.com

Updated Oct 28, 2015:  It passed, and is now enacted. Here's the full text:
Text of the Drug Quality and Security Act (govtrack.us)

= = = original post follows = = =

Prospects for the Drug Quality and Security Act (H.R. 3204) are not so promising . . .

SecuringIndustry.com - End game for US medicines traceability bill?:

"Govtrack.us is currently putting the chances of the bill being enacted at 42 per cent. The Congressional Budget Office (CBO) estimates that H.R. 3204 will authorise the collection of $27m in user fees for fiscal years 2014-2018."

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Friday, September 27, 2013

Congress Clarifies Drug Compounding, Tracking Policies

Updated 12/12/2022

The links in the original post broke.

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---  the original link follows below  ---

Congress Clarifies Drug Compounding, Tracking Policies:

"After months of public hearings and negotiations, Democrat and Republican leaders of the House Energy & Commerce Committee and the Senate Health, Education, Labor and Pensions Committee unveiled a compromise bill last week. No one gets all they wanted from H.R. 3204, the Drug Quality and Security Act, but it provides more clarity and predictability to drug oversight programs and moves forward initiatives designed to enhance the safety and quality of medicines in the US."

Follow this link to the draft bill, Drug Quality and Security Act (PDF)

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Thursday, September 26, 2013

US Senate & House - Drug Quality and Security Act

Updated May 3, 2023

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---  the original post follows below  ---

This is promising news, cooperation and agreement between the House and Senate (and across the aisle), to converge on what could likely become final legislation. Stay tuned!

US Senate Committee on Health, Education, Labor, & Pensions: Newsroom - Press Releases:

" “This legislation will improve the safety of compounded drugs by clarifying the oversight responsibilities of the FDA over large-volume compounders and by holding facilities to high quality standards. This bill also calls for an unprecedented tracing system that will track prescription drugs from manufacturing to distribution. I commend the bipartisan spirit that brought this compromise proposal together.” "

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Thursday, September 19, 2013

CA To Amend Track-and-Trace Law re: ‘Drop Shipments’

Updated October 2, 2025

The original link broke.

You can still read about the same topic here:
InBrief: California Proposes Breakthrough ePedigree Regulation On Drop Shipments - RxTrace
https://www.rxtrace.com/2013/09/inbrief-california-proposes-breakthrough-epedigree-regulation-on-drop-shipments.html/


---  the original post follows below  ---

California to amend track-and-trace law to deal with ‘drop shipments’:

"The proposal specifies that in the case of a drop shipment, the manufacturer would “omit data elements from the pedigree showing transfers of ownership to and from the wholesale distributor, including any certifications of receipt and delivery of the drug by the wholesaler.”

The electronic pedigree, however, would need to be “conveyed directly from the manufacturer to the authorized purchaser prior to or contemporaneously with the delivery” of the drug, according to the board."

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Monday, September 16, 2013

House Version of Compounding Legislation Emerges, Contrasts With Senate Approach

Updated November 22, 2025

You might also like:

Human Drug Compounding - FDA.gov:
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding

---  the original post follows below  ---

House Version of Compounding Legislation Emerges, Contrasting Sharply With Senate Approach:

"Now legislators will be tasked with negotiating out differences in their legislative approaches. The PQSA is significantly more rigorous toward the compounding industry than the Compounding Clarity Act, and also includes track and trace legislative measures. The significant differences and approaches between the two pieces of legislation mean it could be months before any legislation stands a chance of reaching President Barack Obama's desk."

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Saturday, August 3, 2013

Senate In Recess - Didn't Vote On Track-and-Trace, Compounding Bill

Updated December 30, 2025

The original link didn't age well.

You might still be interested in:
FDA - Human Drug Compounding:
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding

---  the original post follows below  ---

Senate puts off vote for track-and-trace, compounding bill | Drug Store News:

"The Senate was expected to take up a bill designed to secure the drug supply chain and establish a list of "do not compound" medications, but left for recess Friday without voting on it.

The bill, S. 959, the Pharmaceutical Quality, Security and Accountability Act, had received some support from groups like the National Community Pharmacists Association, which supported the bill's goal of enhancing security, but expressed reservations about the compounding provision."

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Monday, November 19, 2012

FDA Law Blog: FDA and CA Board of Pharmacy Talk Pedigree - Annual HDMA Track and Trace Conf

FDA Law Blog: FDA and California Board of Pharmacy Talk Pedigree at Annual HDMA Track and Trace Conference:

"The Healthcare Distribution Management Association (“HDMA”) held its annual Track and Trace Technology Seminar on November 12 – 14, 2012, designed to address drug pedigree and track and trace requirements being developed in the United States and to explore how stakeholders will play a role---and what those roles may be---going forward.  Perhaps most interesting at the conference was the seemingly unanimous support from industry for the implementation of a national pedigree program in some form.  What follows below are some of the highlights of the conference speakers. . . ."

'via Blog this'

In case you're interested:
The CA Board of Pharmacy announced that its Licensing Committee Meeting meeting will be combined with its Board meeting in which regulations for e-Pedigree will be discussed. The meeting is scheduled for December 13, 2012. For a complete list of meetings please go to: http://www.pharmacy.ca.gov/about/meetings.shtml

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