As 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
A 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
The FDA published draft guidance earlier this week that might seem a little confusing. The full title is “The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers. Guidance for Industry”. Because it is in “draft” form, it is published only to encourage people to submit comments about it. (See also, “The Differences Between The DSCSA, FDA Rules and Guidance”.)
You should not treat it as real guidance until it is published in final form sometime in the future (if ever—many draft guidances are left handing in the breeze and never finalized). As with all draft guidances, this one comes with a docket to provide the ability for people to leave comments to help the FDA figure out how to improve it before it becomes final.
The draft covers all of the topics that were contained in the Drug Supply Chain Security Act (DSCSA) Section Continue reading The New Draft Guidance On The Effect of Section 585 of the FD&C Imposed By The DSCSA
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?
It 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 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
Last 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
On November 27, 2013 President Barack Obama signed the Drug Quality and Security Act of 2013 (DQSA) into law (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law“). That act has many provisions, but one is to preempt all existing and future state pharmaceutical serialization and pedigree laws like those that previously existed in California and Florida. Because of the preemption language contained within the DQSA, the information contained within many previous RxTrace essays is now obsolete. Some essays are entirely obsolete and some are only partially obsolete. This is because many of these essays contain ideas and discussion about topics that will also apply to the new federal law in almost the same way that they applied to the California and/or other state laws that are now inoperative. In those cases, the ideas and discussion are not obsolete, only their application to the state law(s) is now obsolete.
To address this issue I have Continue reading Preemption: What Does It Mean?