I was on an industry call a few weeks ago when someone from a technology vendor suggested that the industry should take some particular action because, it was aligned with “the spirit of the Drug Supply Chain Security Act (DSCSA)”. That got me to thinking… Continue reading Does the DSCSA Have A ‘Spirit’
As I mentioned last week, the FDA published two new draft DSCSA guidance documents on the day of the recent FDA DSCSA Public Meeting (see “FDA DSCSA Public Meeting #3: A Difference?”). Let’s take a closer look at what’s in them and their significance to companies facing the Drug Supply Chain Security Act (DSCSA). I’ll cover one of the two in this essay and cover the other document in the next essay. Continue reading DSCSA Guidance: Definitions of Suspect and Illegitimate Product for Verification Obligations
China once had one of the most aggressive pharma serialization mandates of any market. Their compliance timeline began in 2007 with a list of “essential drugs” and ended in January of this year when, effectively, all drug packages were required to carry a unique serial number. Shortly after that milestone the government suspended that requirement, pending a new regulation. Since that time the China Food and Drug Administration (CFDA) has posted several documents related to their new plans (see “China Adds Traceability Requirement To CFDA Drug Quality Management Specification”). Last month a new notice from the CFDA Continue reading China’s Retreat From Pharma Serialization: Will This Become A Global Trend?
The 2014 Partnership for Safe Medicines (PSM) Interchange event was held on September 18 in Washington DC. This was the fifth year of the event and every year it gets better. That’s why RxTrace has been a media sponsor of the event for the last four years. This year, I found every speaker to be compelling. Next year I am elevating this event to my “highly recommended” short list.
Attendance at the event has grown each year and this time they reached the capacity of the venue and were forced to cut off registrations some time before the day of the event. A number of RxTrace readers were present at the this year’s event but more ought to attend going forward.
The PSM interchange is a different kind of event. It’s not a “how to” event. Over the years, the speaker lineup has included State and Federal pharma regulators, criminal justice professionals (investigators and prosecutors), academics, politicians, pharmaceutical industry associations, medical professionals and occasionally, victims of counterfeit drugs. The audience includes all of the above, plus Continue reading The Partnership For Safe Medicines Interchange 2014
Are you a pharmaceutical manufacturer who is acting as a wholesale distributor, as defined by the U.S. Drug Supply Chain Security Act (DSCSA), for some of your products? This might occur if you are buying pre-packaged drugs from the New Drug Application (NDA)-holder or Abbreviated New Drug Application (ANDA)-holder and offering them for sale to U.S. wholesale distributors. If you cannot justifiably fit into the DSCSA definitions of either a “co-licensed partner”, or an “exclusive distributor” for those drugs, you might as well remove them from your catalog because the “Big-3” wholesale distributors—AmerisourceBergen, Cardinal Health and McKesson—probably will not be willing to buy them anymore as of next January.
That’s because the DSCSA, which begins to take effect at that time, will most likely consider you as a Continue reading DSCSA: Special Privileges For The “Big-3” Wholesale Distributors, Part 1
- GS1 Serial Number Considerations
- Properties of Randomization
- Threat Analysis (this essay)
- Algorithmic Approach
- Other Approaches to Randomization
This week Ken introduces the concept of threat analysis. – Dirk. Continue reading Randomization—An Interview with Ken Traub—Part 3: Threat Analysis
This is the third in a series of essays about data exchange components required by the Drug Supply Chain Security Act (DSCSA) beginning next January. The previous essays in this series include DSCSA Transaction Information (TI) and DSCSA Transaction History (TH). The DSCSA, which is Title II of the Drug Quality and Security Act (DQSA), defines Transaction Statement (TS) this way:
“(27) TRANSACTION STATEMENT.—
The ‘transaction statement’ is a statement, in paper or electronic form, that the entity transferring ownership in a transaction—
Let’s take a brief pause from our in-the-moment work on meeting today’s healthcare supply chain security needs and consider what the supply chain will look like in the future. Because of regulations and laws enacted in 2012 and 2013 in the U.S., and expected in 2014 in the E.U., we know more today about how healthcare supply chain security will work In 2024 than looking forward in any previous 10 year period. In the last two years the U.S. and the E.U. have enacted legislation and introduced regulations that will have a profound impact on the security of these major supply chains in ten years. These include:
- In the U.S.:
- In the E.U.: