Tag Archives: pedigree laws

The New Draft Guidance On The Effect of Section 585 of the FD&C Imposed By The DSCSA

Regulations.govThe FDA published draft guidance earlier this week that might seem a little confusing.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all of the topics that were contained in the Drug Supply Chain Security Act (DSCSA) Section Continue reading The New Draft Guidance On The Effect of Section 585 of the FD&C Imposed By The DSCSA

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

DQSA: Getting To Electronic Transaction Data Exchange

Files transfer.While we wait for President Obama to sign the Drug Quality and Security Act of 2013 (DQSA, a.k.a. H.R. 3204) we can be confident it will become law in the next week or so.  This President has been presented with over 740 bills so far in his Presidency and he has signed all but two.  He has 10 days to sign the bill or it becomes law anyway but there might be some delay in the process between passage by the Senate and when the President is presented with the bill.

My interest in the DQSA of 2013 is only the Drug Supply Chain Security Act (DSCS) which is Title II within the overall bill.  I’m going to keep referring to it as the DQSA of 2013 but be aware that I probably won’t ever write about the compounding part, Title I.  If that is what brought you here, sorry, look elsewhere.

It is not law yet, but we can now be 100% sure it will be very soon.  Even before the bill was Continue reading DQSA: Getting To Electronic Transaction Data Exchange

U.S. Senate Passes H.R. 3204 With A Voice Vote

flag-usThe U.S. Senate has passed H.R. 3204, the Drug Quality and Security Act (DQSA) with a voice vote, sending the important legislation to the desk of President Barack Obama.  The President is expected to sign it happily.  In an email to members, John M. Gray, President and CEO of the Healthcare Distribution Management Association (HDMA) stated:

“Today the U.S. Senate passed the Drug Quality and Security Act (H.R. 3204). We expect it will be quickly signed into law by the President. This is the culmination of nearly 10 years of effort by HDMA members to preempt all state laws relating to drug pedigrees and track-and-trace systems, to further enhance the security and safety of our nation’s drug supply chain. Since 2004, HDMA has Continue reading U.S. Senate Passes H.R. 3204 With A Voice Vote

All Eyes On The U.S. Senate Tonight

U.S. Capitol building, Senate wing. The flag above the wing indicates that the Senate is in session.
U.S. Capitol building, Senate wing. The flag above the wing indicates that the Senate is in session.  Photo by Dirk.  Click to enlarge.

The effort to enact a nationwide pharmaceutical serialization law that would preempt all state laws has been going on for four or five years now, and this evening could be the culmination of all of those efforts.  The U.S. Senate calendar for today makes the passage of H.R. 3204, the Drug Quality and Security Act a top priority.  It finally looks like it is going to happen.

The official Senate calendar for today includes the following as the first order of business:

“                         CALENDAR OF BUSINESS

Monday, November 18, 2013

SENATE CONVENES AT 2:00 P.M.

PENDING BUSINESS

H.R. 3204 (ORDER NO. 236)

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. Continue reading All Eyes On The U.S. Senate Tonight

Drug-Device Combo Products Under State And Federal Pedigree Laws

Metered dose inhaler drug-device combination product
Metered dose inhaler drug-device combination product

Important Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.Both the California ePedigree law and the potential federal pedigree law that currently exists within the womb that is H.R. 3204 contain an exemption for drug-device combination products.  This is an expanding category of products so this exemption is worthy of a closer look.

The drug-device combo product exemption language included in the California Business and Professions Code, 4034(g)(9), is almost identical to the language in H.R. 3204, 581(24)(B)(xii).  There is a reason for that.  They are both based on part of the FDA’s definition for a drug-device combination product, found in 21 CFR 3.2 (e). Continue reading Drug-Device Combo Products Under State And Federal Pedigree Laws

How Smooth Will Industry Deployment of the ePedigree Laws Be? Take a Good Look At Healthcare.gov

healthcare.gov initial screenWhen either the California ePedigree law or the federal law go into full effect, how smooth will that rollout be?  While there are big differences between those implementations and the deployment of Healthcare.gov, the U.S. federal government’s new health insurance exchange website that is part of the Patient Protection and Healthcare Affordable Care Act (often referred to as the ACA, or “Obamacare”), I think the troubles it is experiencing may be an example of how the ePedigree system will work on initial rollout.  That’s right, I’m predicting a nightmare, especially if it’s the California law that rolls out. Continue reading How Smooth Will Industry Deployment of the ePedigree Laws Be? Take a Good Look At Healthcare.gov

Will Generic Drug Manufacturers Serialize Their Drugs In Time?

Get Ready
Get Ready

Important Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.The one thing all pharmaceutical manufacturers can count on, regardless of whether or not the U.S. Congress passes a new track and trace regulation in this or future sessions, is that unit-level serialization will be a necessity on drug packages sold into the U.S. market within the next few years.  We have all been paying close attention to the draft legislation that has been moving through the two houses of Congress for several months now, but there is no doubt that unit-level serialization will be required whether something passes at the federal level or not.  The only questions are, exactly which year will it be required and what else will be required?

We know that Continue reading Will Generic Drug Manufacturers Serialize Their Drugs In Time?