Showing posts with label pedigree. Show all posts
Showing posts with label pedigree. Show all posts

Monday, April 10, 2017

How two California startups are preparing pharma companies for blockchain - MedCity News

  • California Designated Representative Training. 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 for wholesalers, 3PL, reverse distributors.
Read the full article & learn about blockchain: How two California startups are preparing pharma companies for blockchain - MedCity News:

"But perhaps the best suited medical application for blockchain, the underlying technology of Bitcoin and other crypto-currencies, is also the one being upended by federal legislation passed in 2013: tracking and tracing the movement of prescription drugs from manufacturer to the pharmacy to prevent counterfeit or dangerous drugs from entering the supply line."

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Related to:
Track & trace, traceability, DSCSA, pedigree

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Wednesday, November 23, 2016

Companies Collaborate on DSCSA Guideline as Deadlines Approach | RAPS

Read the full article: Companies Collaborate on DSCSA Guideline as Deadlines Approach | RAPS:

"GS1 Guideline

The 600+ page GS1 guideline and compendia offer information and examples to the wider industry looking to meet the law's obligations and record each shipping event and data element needed to support serialization, pedigree and track and trace. The guideline also shows industry how to apply the standards to their own businesses."

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Training for Designated Representative and Designated Representative-3PL license applicants


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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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Tuesday, June 23, 2015

California Man Pleads Guilty in Prescription Drug Diversion Scheme | OPA | Department of Justice


Read the full article: California Man Pleads Guilty in Prescription Drug Diversion Scheme | OPA | Department of Justice:

"According to court documents, from May 2010 through December 2012, Vin Nguyen, 45, and others conspired to distribute illegally-diverted prescription drugs while concealing the true, illicit sources of the drugs.  Nguyen purchased prescription drugs, including HIV medications, anti-psychotic medications and other brand name drugs, from various unlicensed and illegal sources in California and Florida.  Working with co-conspirators, Nguyen then sold the drugs to other drug diverters without the statutorily required pedigree documents stating the origin of the drugs.  Nguyen and his co-conspirators sold more than $6.5 million worth of diverted drugs. "

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Tuesday, February 11, 2014

California's E-Pedigree Law Preempted

Updated September 24, 2020

The link in the original post broke.

Here's the full text article from the California State Board of Pharmacy.  Source:  The Script (Spring 2014, page 4) - California State Board of Pharmacy: E-pedigree Pre-empted by National Tracking System Law .

"On November 27, 2013, President Obama signed Public Law
113-54, which contains provisions for a national tracking system
for prescription medication.

Included within this law are provisions that pre-empt
California’s e-pedigree requirements that were enacted originally
in 2004 and were to be in full effect by July 2017. California’s
Business and Professions Code contains provisions that
effectively preempt California’s provisions if federal legislation
in this area is enacted.

The board is required to post a message about the
inactivation of California’s e-pedigree provisions. This notice
is provided below; it also will be published in the California
Regulatory Notice Register and posted on our website. Also, this
year the board will sponsor legislation to repeal the e-pedigree
provisions that are now inactive provisions in California law.

The board thanks the many individuals including
pharmaceutical supply chain companies, computer and
technology firms, policy makers, staff of the California
delegation and the many others who worked with the board over
the last 10 years to develop e-pedigree provisions and implement
a system to strengthen the integrity of the US drug supply.

We especially thank the early adopters and those who
worked on pilot projects to ensure California’s provisions
would be implemented by the coming deadlines. It was a large
endeavor and we trust that what was learned to “get ready for
California” will be transferable to the national system that is now
under development. We are grateful to have played a role in this
important area of public safety and health.

Public Notice:

Pursuant to Business and Professions Code section 4034.1,
which provides in pertinent part that “[u]pon the effective date
of federal legislation . . . addressing pedigree or serialization
measures for dangerous drugs, Sections 4034, 4163(c)
– (g), 4163.1, 4163.2, 4163.4, and 4163.5 shall become
inoperative,” and which requires that within 90 days of the
enactment of such legislation the board publish a notice regarding
the invalidation of these statutes, the California State Board of
Pharmacy is hereby publishing notice that federal legislation
meeting the requirements of section 4034.1 has been enacted, and
that Business and Professions Code sections 4034, 4163, 4163.1,
4163.2, 4163.4, and 4163.5 became inoperative as of November
27, 2013."

- - -  original post follows below  - - -

California Board of Pharmacy - Information on E-Pedigree:

"Public Notice:

Pursuant to Business and Professions Code section 4034.1, which provides in pertinent part that “[u]pon the effective date of federal legislation . . . addressing pedigree or serialization measures for dangerous drugs, Sections 4034, 4163(c) – (g), 4163.1, 4163.2, 4163.4, and 4163.5 shall become inoperative,” and which requires that within 90 days of the enactment of such legislation the board publish a notice regarding the invalidation of these statutes, the California State Board of Pharmacy is hereby publishing notice that federal legislation meeting the requirements of section 4034.1 has been enacted, and that Business and Professions Code sections 4034, 4163, 4163.1, 4163.2, 4163.4, and 4163.5 became inoperative as of November 27, 2013."

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Drug Wholesalers & 3PL.  If you're applying for a California Designated Representative license, you must include a training affidavit (proof of required training) in the application. Take these California Designated Representative training courses & get a training affidavit.

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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

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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Thursday, September 26, 2013

US Senate & House - Drug Quality and Security Act

Updated May 3, 2023

You might also be interested in:

---  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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Wednesday, June 26, 2013

Tuesday, May 28, 2013

Dirk Rodgers on Pedigree Law (Federal & CA) & Funding

Updated July 10, 2026

The post didn't age well.

Instead, you might like:

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  ---

The California Pedigree Law implementation date is fast approaching . . .

Would A U.S. Federal Pedigree Law Require A New UFA?:

"NOTE: We are just about 1-1/2 years away from January 1, 2015, the first date that manufacturers must serialize some of their drugs and start drug pedigrees. From this point on, time is going to go by pretty fast for companies who are not yet ready."

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Wednesday, March 27, 2013

CA Pedigree Law Exemptions

Purchase now to enroll in a California Designated Representative Training Course for:


---  the original post follows below  ---

Are Your Drugs Exempt From The California Pedigree Law?:
"Not all prescription drugs will need to comply with the California pedigree law on January 1, 2015 or 2016. In fact, there are a number of important exemptions that cover entire classes of certain drugs and certain types of transactions for all drugs. The volume of drug packages that could escape being serialized and pedigreed by those effective dates is not huge, but if you are a manufacturer or wholesaler, you should familiarize yourself with the list of exemptions. If you are lucky enough to make or handle any of the exempt drugs or transactions you might as well take advantage of your exemption." . . .   . . .

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Thursday, January 24, 2013

Dirk Rodgers on Inference

Another excellent article by Dirk Rodgers and touchpoints with California law.  The following snippet just happened to catch my eye.

How Should Inference Work?:

" . . . Companies will need to create and document their Standard Operating Procedures (SOPs) for making use of the container serial number hierarchy when they infer the contents in each business process.  According to the law, this will need to include some kind of statistical sampling process for determining the accuracy of the aggregation information provided to them.  The SOPs will need to be available for the Board to review them. . . ."

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Writing Procedures: Drug & Device Wholesalers and HMDR - Online Study Course

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Tuesday, December 18, 2012

CA Board of Pharmacy - Use Of GS1 EPCIS - Pedigree

Follow the link below, to Dirk Rodgers post on the December 4th Board meeting, that touches on some important points surrounding CA pedigree law. . .

California Board of Pharmacy Clarifies Use Of GS1 EPCIS:

". . . transcribed the exchange below as it happened because I think it provides a number of important clarifications about the technologies that can successfully be used to meet the California pedigree law and I think it should be read by everyone who has an interest in that."

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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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TrackBack URL for the referenced article:
http://www.typepad.com/services/trackback/6a00d8341d150c53ef017ee557842d970d

Friday, November 9, 2012

Will The CA e-Pedigree Dates Slip Again?

Updated November 24, 2025

"In response to enactment of the [DSCSA] Act, the California Board of Pharmacy (Board) has issued a public notice stating that California's e-Pedigree provisions have been inactivated. The Board also noted that it will sponsor legislation this year to repeal the e-Pedigree provisions that have been inactivated."

Source:  
California Board of Pharmacy issues notice stating that it has inactivated California's e-Pedigree provisions:
https://www.lexology.com/library/detail.aspx?g=39a9104b-16b0-4b3b-8560-3053977dc425#

---  the original post follows below  ---

Another good read from Dirk Rodgers . . .

Will The California ePedigree Dates Slip Again?:

". . . AND MY PREDICTION IS…

I predict that it will NOT get delayed again.  Here’s how I arrive at that prediction.

Things are different now than any time prior to any of the earlier delays. . . ."

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