Tag Archives: TI

DSCSA

DSCSA: Historic Change To Commerce

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Back in 2010 I posted an RxTrace essay called “California Pedigree Law:  Historic Change To Commerce” that pointed out the significant change that was then scheduled to occur once the California law was to go into full effect in 2016.  Of course, that state law was preempted by the Drug Supply Chain Security Act (DSCSA) back in 2013 so we never actually experience that change.  But what about the DSCSA?  Will it change the way commerce happens in a historic way?  Let’s take a look.

Continue reading DSCSA: Historic Change To Commerce →
Dispensers, DSCSA

FDA Limits Ongoing Dispenser Enforcement Discretion To First Responders

iStock_000022846474_smallerBack in October the FDA announced the extended use of enforcement discretion to temporarily set aside the data exchange provisions of the Drug Supply Chain Security Act (DSCSA) for dispensers until March 1, 2016 (see “FDA Extends Dispenser Delay in DSCSA Enforcement“).  That was itself an additional four month extension to the four month enforcement discretion they originally announced on June 30 (see “FDA Publishes New Guidance Delaying Dispenser 3T Requirements Until November 1, 2015“).  Many dispensers were hoping for another extension in these last few days of February.  It turns out, the enforcement discretion will be extended until further notice, but apparently mostly just for first responders. Continue reading FDA Limits Ongoing Dispenser Enforcement Discretion To First Responders →

DSCSA

Pay No Attention To The Enforcement Delay Unless You Are A Dispenser

iStock_000037865140_smallerAs I reported last Thursday, the FDA published new revised guidance that extends their enforcement delay of the Drug Supply Chain Security Act (DSCSA) data exchange requirements for dispensers by an additional 4 months (see “FDA Extends Dispenser Delay in DSCSA Enforcement“).  What does this mean for drug manufacturers, wholesale distributors and repackagers? Continue reading Pay No Attention To The Enforcement Delay Unless You Are A Dispenser →

DSCSA

Again, Should You Off-Load Your DSCSA Obligations To Your Contract Partners?

??????????????????????I spent my holiday weekend having fun with my family and I hope you did the same.  Instead of spending my holiday writing a new RxTrace essay I am re-running one of my better essays, originally posted on October 6, 2014.  If you missed it then, or even if you read it then, it is worth another read.  See if you agree:

Manufacturers who make use of third-party contract manufacturers, contract packagers and/or third-party logistics providers (3PLs) may wish to off-load their 2015 and 2017 obligations under the U.S. Drug Supply Chain Security Act (DSCSA) to those contract organizations.  These obligations include Continue reading Again, Should You Off-Load Your DSCSA Obligations To Your Contract Partners? →

Dispensers, DSCSA

Dispensers Make Last Minute Appeal for Delay in DSCSA Deadline

Less than a week before the July 1, 2015 Drug Supply Chain Security Act (DSCSA) deadline for dispensers to begin receiving, storing a being able to retrieve Transaction Information (TI),Transaction History (TH) and a Transaction Statement (TS) for every incoming shipment of prescription drugs, a group of pharmacy associations have asked the FDA for enforcement discretion for an unspecified time to avoid “…the possible outcome of disruptions to the supply chain”.  Continue reading Dispensers Make Last Minute Appeal for Delay in DSCSA Deadline →

DSCSA

3PL Operation Under The DSCSA

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Another type of business affected by the U.S. Drug Supply Chain Security Act (DSCSA) is the third party logistics provider (3PL) business.

I wrote an RxTrace essay about the impact of the California pedigree law on 3PLs back in 2013 (see “3PL Operation Under California ePedigree“).  This is an update of that essay to address the impacts of the new DSCSA on 3PLs since the California pedigree law is now obsolete.

There are a number of important differences between wholesale distributors and 3PLs as defined in the DSCSA. Continue reading 3PL Operation Under The DSCSA →

DSCSA

Vendor Managed Inventory Under the DSCSA

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At the counterI wrote this essay on Vendor Managed Inventory (VMI) back in 2013 which was aimed at what would likely happen to VMI under the California pedigree law (see “Vendor Managed Inventory Under California ePedigree”).  But even though that law is now obsolete (see “The California Pedigree Law Is Now Officially Inoperative“), surprise, some of the same issues crop up when VMI is performed under the DSCSA.  So I converted the original essay to speak to VMI under the DSCSA.  I think you will agree, it is still pertinent…

One of the complexities of the modern pharmaceutical supply chain occurs when a pharmaceutical dispensing organization “outsources” the management of their on-premises inventory to their supplier, or “vendor”.  This is known as Vendor Managed Inventory, or VMI.  There are several Continue reading Vendor Managed Inventory Under the DSCSA →

Data Exchange

Will EPCIS Event Exchange Replace EDI ASNs for DSCSA Someday?

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SteadyState.2015.to.2023The use of Electronic Data Interchange (EDI) Advance Ship Notices (ASNs) in the U.S. pharmaceutical supply chain has expanded over the last year, due entirely to its recognition by the FDA as a valid method for passing the Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) as required by the Drug Supply Chain Security Act (DSCSA).  The Healthcare Distribution Management Association (HDMA) has encouraged that expansion by publishing a “how-to” guide for meeting the requirements of the DSCSA using an ASN (see “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again”).

Although not everything has worked out Continue reading Will EPCIS Event Exchange Replace EDI ASNs for DSCSA Someday? →