Tag Archives: wholesaler

The Federal Lot-Based Pedigree Before Congress

June 3, 2013 Dirk Rodgers 7 Comments

The current drafts of the nationwide pharmaceutical track and trace (Pedigree) bills on the floors of the U.S. Senate and House of Representatives both include an initial lot-based pedigree requirement that may be based on paper or electronic documentation (see “The Politics Of Federal Track & Trace Legislation”). What is a lot-based pedigree and how is it different from one based on package-level serial numbers? Let’s take a closer look at the kind of system that these bills would require. Keep in mind that the Senate bill would mandate this kind of pedigree system for the next 10 years and the House bill would make it permanent.

First of all, according to both bills, pharma manufacturers would be required to Continue reading The Federal Lot-Based Pedigree Before Congress →

California Pedigree Law

Are Your Drugs Exempt From The California Pedigree Law?

March 25, 2013 Dirk Rodgers 6 Comments

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.

The list of exemptions are covered in the California Business and Professions Code under section 4034 (g)(1) through (9) (see pages 20-21 of the “2013 Lawbook For Pharmacy”). Section 4034(g) simply states, “The following transactions are exempt from the pedigree requirement created by this section:” Continue reading Are Your Drugs Exempt From The California Pedigree Law? →

California Pedigree Law

The New Grandfathering Provisions Of The California Pedigree Law

March 4, 2013 Dirk Rodgers 1 Comment

At the February 5, 2013 meeting of the California Board of Pharmacy the Board took the final vote to proceed with filing a number of important clarifying regulations–the first since the Ridley-Thomas bill was enacted in 2008 that established the current staggered effective dates. These include the recognition of the FDA Standardized Numeric Identifier (SNI) as the “unique identifier” for use on each drug package, and definition around how supply chain companies can grandfather their existing non-serialized, non-pedigreed stock at the time the law goes into effect.

The official minutes of the meeting are not yet available but the video has been posted for a few weeks now. The pertinent action occurs in the first video of the two day meeting at approximately 2:24:00 (hours:minutes:seconds). (Don’t you just love government meetings on YouTube?) The source text of the pending regulation (which is Continue reading The New Grandfathering Provisions Of The California Pedigree Law →

Falsified Medicines

Well-Intended Report Calls For Global Track & Trace Of Pharmaceuticals

February 18, 2013 Dirk Rodgers 4 Comments

I’ve been reading the Institute of Medicine (IOM) report called “Countering the Problem of Falsified and Substandard Drugs” that was published last week. At 360 pages, it is quite literally a book, and you can buy it that way. But they also allow you to download the “Pre-publication Copy: Uncorrected Proofs” version in a 300 page PDF for free. I’m not sure why they would post uncorrected proofs rather than the final document on their site but I assume the text is in its final edited form and only the formatting might be different between the book and the PDF. I hope so anyway.

I have not yet read the whole thing so this isn’t intended to be a proper review (see the Regulatory Focus article about it). The document offers Continue reading Well-Intended Report Calls For Global Track & Trace Of Pharmaceuticals →

Counterfeit Drugs

InBrief: Illegally Imported Drugs Found To Be Counterfeit…Again

February 6, 2013 Dirk Rodgers

Yesterday the FDA alerted healthcare providers that a cancer drug illegally imported and distributed to medical practices by a licensed pharmaceutical distributor going by the names “Medical Device King” and “Pharmalogical”, and Taranis Medical, is counterfeit. The FDA alert can be found here. Once again, the drug is labeled as Altuzan, a version of bevacizumab which contains the same active ingredient as Avastin. Here is AP story about it. Here is the WSJ article about it.

Avastin was the subject of a counterfeit importation crime about a year ago, (see “How Counterfeit Avastin Penetrated the U.S. Supply Chain“).

It is illegal to import drugs that are not approved by the FDA for sale and use in the U.S., and so even if the drug had not turned out to be a counterfeit version, this would have still been a crime. It makes me wonder if the reason this case came to light was because the drug name on the package was clearly not approved here. What if the counterfeit drug had been Continue reading InBrief: Illegally Imported Drugs Found To Be Counterfeit…Again →

California Pedigree

California ePedigree Uncertainty

February 4, 2013 Dirk Rodgers

A lot of things related to ePedigree in the U.S. supply chain are cooking right now but they seem to be happening a little too slowly, so it will be interesting to see where it all ends up in the next few years. After developing the Drug Pedigree Messaging Standard (DPMS) in 2006-2007, GS1 is now taking only the initial steps toward adding network-centric ePedigree capabilities to their EPCIS and related standards. The California Board of Pharmacy says they would like to be able to accept a semi-centralized network centric approach as long as it includes all the stuff listed in their pedigree law. For nearly 18 months, GS1 U.S. has been “nearing publication” of a draft guideline—six years in the making—that is supposed to help companies who want to use EPCIS to meet the California law. Congress considered passing a Federal track & trace regulation that would have preempted the California law last year but failed from lack of agreement between the parties. Some companies are making good progress on meeting the serialization requirement but the number who have the pedigree part figured out are those who have settled on DPMS. All the while the California pedigree deadlines are rushing toward us like a bus-sized asteroid heading straight toward Earth. Not surprisingly, the asteroid is moving faster than the efforts to divert or absorb it.

I’ve written about my theory that the date of impact won’t be pushed out again, no matter what happens (for a full explanation of that theory, see “Will The California ePedigree Dates Slip Again?”).

What can be done? In my view, it’s going to be determined by Continue reading California ePedigree Uncertainty →

PDMA

How Pedigrees Protect The Drug Supply: The Case Against Cumberland Distribution

January 28, 2013 Dirk Rodgers 4 Comments

On January 17, 2013 a federal grand jury indicted three individuals in 28 counts connected with Cumberland Distribution, a pharmaceutical distribution company licensed in Tennessee, on charges of conspiracy, mail fraud, money laundering and obstruction of justice. Notably, some of the evidence used against the alleged co-conspirators are the pedigrees that they allegedly forged in an attempt to make their business look legitimate to their unsuspecting customers.

Now, as the press release about the indictment from the U.S. Department of Justice (DoJ), Middle District of Tennessee points out, “An indictment is merely an accusation and is not evidence of guilt. All defendants are presumed innocent unless and until proven guilty in a court of law.” So let’s just look at the evidence and how the DoJ is using it to build their case against the defendants in this case. From that we can see what impact pedigrees might have in other cases like this.

The charges are for activities that Continue reading How Pedigrees Protect The Drug Supply: The Case Against Cumberland Distribution →

Anti-counterfeiting, serialization

Pharma Anti-Counterfeiting and Serialization

November 19, 2012 Dirk Rodgers 1 Comment

Counterfeiting of drugs has become a favorite activity of organized criminals and it negatively impacts the citizens of every country in the world. The pharma industry is multi-national, the criminals are multi-national, the patients that are harmed are multi-national. What we need now more than ever before is a multi-national approach to fighting these crimes.

That’s why I was deeply disappointed last week to read that the World Health Organization (WHO) has barred a group of people with certain global crime fighting ideas from participating in their “member state” meeting on substandard/spurious/falsely-labelled/falsified/counterfeit medical products being held today through Wednesday in Buenos Aires, Argentina. See the Reuters article “Row flares over global fight against fake medicine” and see Roger Bate’s introduction to the group’s position “How to achieve international action on falsified and substandard medicines” and don’t miss the full PDF containing the group’s well-stated position.

The dispute is Continue reading Pharma Anti-Counterfeiting and Serialization →

RxTrace