Brazil Suspends Pharma Serialization And Tracing Requirements | RxTrace

"Last week, Brazil’s pharma industry regulatory agency, the National Agency of Sanitary Surveillance (ANVISA), announced that they were “suspending” at least part of RDC-54/2013, the declaration that mandated drug serialization and tracing, until further notice.  Thank you to all who forwarded the link to the official announcement.  I was able to translate and read it on Thursday, and I submitted a comment on my own last essay, “Pharma Serialization Deadlines In Flux“, to include the link.  Apparently shortly after that essay was published, ANVISA  publicly announced the suspension." Dirk Rodgers - Read the full article from Dirk here.

FDA Looking For Consulting Org To Run DSCSA Pilots - RxTrace.com

Dirk Rodgers of RxTrace.com writes about an RFP the FDA issued last month that is due August 13th... Check it out, in full, on RxTrace.com...
Last week the FDA quietly posted a Request For Proposal (RFP) on the FedBizOpps.gov government bidding site for a consulting organization to design and implement a program of pilot projects that explore and evaluate methods to enhance the safety and security of the pharma supply chain.  The scope of work is:

“Development and implementation of a program for the pilot projects will include, but is not limited to: development of the program structure, determination of the scope of the pilot projects and what issues should be covered, ensuring the pilot project design fulfills the requirement of the DSCSA, development of an enrollment process for potential participants, development of timing and schedule, development of monitoring and reporting schedule, development of pilot project metrics and evaluation plan; and development of a communication plan. The pilot project(s) developed under the DSCSA need to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain, through

1. utilization of the product identifier for tracing of a product throughout the supply chain and may include verification of product identifier, including the use of aggregation and inference;

2. improvement of the technical capabilities of each sector and subsector to comply with systems and processes needed to utilize the product identifiers to enhance tracing of a product; and

3. identification of system attributes that are necessary to implement the requirements established under the DSCSA.”

The RFP was posted on July 31, 2015 and responses must be submitted by midnight on August 13, 2015.  As part of developing the program, the contractor will also help the FDA run a public workshop and docket to collect ideas and comments that will help guide the design of the pilots.  The “period of performance” is eight months from date of the award.
Check out the full article at RxTrace.com...

RxTrace.com: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2015

Dirk Rodgers of rxtrace.com writes "It’s August and that means it is time to check in on the progress toward full serialization of drugs in the U.S. supply chain.  This is an annual look I’ve been doing for five years now.  For my previous essays, see:

• “Estimated Rise In Serialized Drugs In The U.S. Supply Chain”;
• “Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2011“;
• “InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2012“;
• “InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2013“;
• “InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2014”.

In each essay I produced a graph of my own personal estimate of the likely rise in the percentage of drugs that I thought would result, based on the deadlines that were in place at the time.  Of course, things changed last year because the Drug Supply Chain Security Act had preempted the California Pedigree law the previous November, so last year I made a new estimate that took into consideration the DSCSA dates.

Vendor Managed Inventory Under the DSCSA - RxTrace.com

Dirk Rodgers of RxTrace.com writes another interesting article around Vendor Managed Inventory and the impact of DSCSA on it.

The ANVISA Unique Medicine Identifier (IUM) on Drug Packages - Dirk Rodgers

Last week Dirk wrote about the DSCSA Product Identifier on Drug Packages in the United States.  Last month he wrote about shipping container/transport package identification under the Brazil National Medicine Control System (SNCM) (see “ANVISA And The SSCC Controversy”).  In this article Dirk takes a look at drug package identifiers under the SNCM as regulated by the National Agency of Sanitary Surveillance (ANVISA).  Dirk is a member of the GS1 Healthcare group - Contact GS1 Healthcare for more information.

An excerpt from Dirk's article:

"Under the SNCM, manufacturers must apply a Unique Medicine Identifier (IUM) to all drug packages imported or sold into the Brazilian supply chain and trace them through the supply chain by December 11, 2016.  By December 11 of 2015, manufacturers must apply the IUM to the packages of at least three lots of drugs and trace them to the dispensing points.  And you thought compliance with the DSCSA was going to be hard to achieve!

The DSCSA Product Identifier On Drug Packages - Dirk Rodgers

According to the Drug Supply Chain Security Act (DSCSA), manufacturers must apply a new “Product Identifier” on all of their prescription drug products by November 27, 2017 (Repackagers by that date in 2018).  The DSCSA Product Identifier is defined this way:

“PRODUCT IDENTIFIER.—
The term ‘product identifier’ means a standardized graphic that includes, in both human-readable form and on a machine-readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the standardized numerical identifier, lot number, and expiration date of the product.”  (Section 581[14])

Identification Of Pharma Cases In The U.S. - Dirk Rodgers

Article from Dirk Rodgers - "Last week I discussed controversy over the use of GS1’s Serial Shipping Container Code (SSCC) in the Brazil pharma supply chain to meet regulatory requirements imposed by ANVISA. But there are different controversies, or at least potential confusion, in the U.S. pharma supply chain surrounding case labels, and some of those are relate to the SSCC and its use. 

A case product identification label is the label a manufacturer usually places on each homogeneous case at case-packing time to identify what is inside the corrugated box. A “homogenous case” is a case that contains units from a single NDC and all units are from a single packaging lot. The product identification label should not be confused with a shipping/logistics label, which, if it exists, is applied at the time of shipment and contains information about the destination.

Typically, cases that are shipped from a higher-volume manufacturer to a larger wholesale distributor will be placed onto a pallet. The pallet often has cases of multiple products, and even different homogeneous cases of the same product can contain different lot numbers. You can sometimes even find a Non-homogeneous case mixed in with the homogeneous cases. Further, cases on the same pallet can actually be fulfilling different purchase orders submitted by the buyer. All of these variations complicate the job of the receiving clerk." - Read full article at RxTrace.com