Tag Archives: California Pedigree Law

Will The DSCSA Cause Drug Shortages After January 1?

FDALogoDr. Connie T. Jung, Acting Associate Director for Policy & Communications, Office of Drug Security, Integrity and Recalls, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, spoke last week at the 2014 Healthcare Distribution Management Association (HDMA) Traceability Seminar in Arlington, VA.

The presentation was similar to those given in the past except she provided an update on the progress of the next draft guidance the Agency is expected to publish on standards for data exchange (see “DSCSA: Many Questions, Few Answers”).  The deadline imposed on the FDA by the Drug Supply Chain Security Act (DSCSA) is November 27, 2014 for that draft, but during the FDA DSCSA Workshop last spring (see “The 2014 FDA DSCSA Workshop”), Dr. Jung said that the Agency recognized the need to publish earlier than that.  Last week she indicated that they will Continue reading Will The DSCSA Cause Drug Shortages After January 1?

Global Traceability Data Exchange: Troubled Waters Ahead

iStock_000008540261SmallerAs we near the end of 2014, several important pharma traceability deadlines around the world are approaching.  Besides the U.S. Drug Supply Chain Security Act (DSCSA), these include deadlines in Brazil and South Korea.  Of course, each regulation is different.  Now that the initial implementation of the exchange of transaction data in the U.S. is widely being implemented in Electronic Data Exchange (EDI) Advance Ship Notices (ASNs), the next hurdle for drug manufacturers will be to deploy serialization technologies on their U.S. and Korea market packaging lines.  The data exchange technology problem will shift to Brazil, and that’s where I see trouble. Continue reading Global Traceability Data Exchange: Troubled Waters Ahead

The GS1 Healthcare US Guidance For DSCSA, Vsn 1.1

GS1 US logoA few weeks ago, GS1 Healthcare US published version 1.1 of their guidance for using the GS1 Electronic Product Code Information Services (EPCIS) standard to meet the U.S. Drug Supply Chain Security Act (DSCSA).  See “GS1 Healthcare US Publishes Updated Guidance For DSCSA”.  I was too busy at that time to review the document properly, but it is an important addition to the spectrum of information that companies can use to help them understand how to best meet the requirements of the DSCSA so I wanted to get back to it when I had time.  That time is now.

As long term readers of RxTrace know, I did not believe EPCIS would ever be usable to meet the now obsolete California Pedigree law (see “The California Pedigree Law Is Now Officially Inoperative”), or any other State pedigree laws, and I do not believe it will be widely used to meet the Federal DSCSA before maybe 2021 or 2022, but I do believe it will take center-stage for meeting the long-term requirements of the DSCSA.

In 2023 the DSCSA transitions into Continue reading The GS1 Healthcare US Guidance For DSCSA, Vsn 1.1

Will The FDA Delay The DSCSA?

Dirty Harry.Do you Feel Lucky
Do you feel lucky?

More and more people are asking if the FDA will delay the January 1, 2015 requirements of the Drug Supply Chain Security Act (DSCSA).  On that day, drug manufacturers, repackagers and wholesale distributors must begin exchanging Transaction Information (TI), Transaction History (TH) and Transaction Statements (TS), (dispensers join them next July) and the FDA is not even due to publish guidance on how to do that until November 27 (see “The Flaw That Must Be Addressed in H.R. 3204, The Drug Quality and Security Act“).  While they have said they hope to publish that guidance earlier than that date, it still won’t give companies much time to prepare.  So, will they delay it? Continue reading Will The FDA Delay The DSCSA?

InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2014

RxTrace.com Serialization Estimate 2014.zoomIt is time for the RxTrace look at the estimated rise in the percentage of drugs in the U.S. supply chain that are serialized.  Every year we take a look at this topic while longingly wishing that someone would perform a real study and publish the numbers.  However, it may not make much difference from here on out because it will be impossible for drugs without serial numbers to exist in the U.S. supply chain in just a few years.  So let’s take a look. Continue reading InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2014

The California Pedigree Law Is Now Officially Inoperative

bop_brandThe California Board of Pharmacy made it official late this afternoon.  As required by Section 4034.1 of the California Business and Professions Code (CB&PC), the Board posted a public notice late yesterday indicating that sections 4034, 4163, 4163.1, 4163.2, 4163.4, and 4163.5 of the CB&PC became inoperative due to the enactment of the Federal Drug Quality and Security Act (DQSA) on November 27, 2013 (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law“).  These specific sections of the CB&PC comprise what has been referred to in the industry as “the California Pedigree Law”.

The public notice was mandated by California law within 90 days of federal preemption because Continue reading The California Pedigree Law Is Now Officially Inoperative

How the DQSA Will–And Won’t–Protect The Supply Chain, Part 2

Superhero right to leftLast week I published an overly long essay about how the supply chain provisions of the new U.S. Federal DQSA will and won’t protect the pharma supply chain.  Believe it or not, I had more to say on the subject, but because that essay was already too long, I withheld my additional thoughts until now.  Part 1 took another look at a number of supply chain crimes that have occurred over the last 5 to 6 years and attempted to determine how the new Drug Supply Chain Security Act (DSCSA) that is contained within the DQSA will add new protections that will or won’t help prevent crimes like them in the future.

In this Part 2 essay I want to look at the issue in a different way.  I’d like to compare the approach that Continue reading How the DQSA Will–And Won’t–Protect The Supply Chain, Part 2

Correction: Your Drug or Biologic Combination Product Is Probably NOT Exempt From The DQSA

CorrectionLast month I published an essay that analyzed the exemption language related to combination products contained in the old California pedigree law and in H.R. 3204, which was later signed into law as the Drug Quality and Security Act (DQSA) (see “Drug-Device Combo Products Under State And Federal Pedigree Laws”).  In that essay I showed how these exemptions were very similar because both were based on the existing definition of a “combination product” from 21 CFR 3.2(e).  My assessment of the effect of the wording in the old California pedigree law is still valid, in my opinion, but I now believe my analysis of the language in H.R. 3204 was incorrect.  Here is why. Continue reading Correction: Your Drug or Biologic Combination Product Is Probably NOT Exempt From The DQSA