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.

Why serialization is vital for pharmaceutical product integrity in the cold chain

Read entire article at the Cold Chain View blog.

More than ever before, drug security is an important issue in ensuring the integrity of medicines and vaccines reaching patients. The industry needs to demonstrate that we care for patients, and are putting all necessary measures in place to ensure that medicines are safe to be taken.

That means knowing the entire journey of a medicine through the supply chain, and having fully automated documentation about the conditions on its journey. One of the ways in which this can be addressed in the cold supply chain is through serialization. A key driver for implementing serialization will be global compliance requirements coming into play. The USA introduced the Drug Supply Chain Security Act at the end of 2013, which will require the availability of information at individual package level about where a drug has been in the supply chain.

‘The Smallest Individual Saleable Unit’ In The DSCSA - RxTrace

Drawing from the GS1 Healthcare GTIN Allocation Rules document showing how to assign GTINs in multi-pack scenarios. Click image to enlarge.

The U.S. Drug Supply Chain Security Act (DSCSA) requires manufacturers and repackagers to place DSCSA-specific “product identifiers” on all drug packages and homogeneous cases by November 27, 2017 (2018 for repackagers).  These product identifiers must include a Standardized Numeric Identifier (SNI), which is composed of the drugs National Drug Code (NDC) and a unique serial number (for more on DSCSA “product identifiers”, see “The DSCSA Product Identifier On Drug Packages“, for more on the SNI, see “FDA Aligns with GS1 SGTIN For SNDC“, and for more on the NDC, see “Anatomy Of The National Drug Code“).

3PL Operation Under The DSCSA - RxTrace.com paper

Photo from Wikipedia

Dirk Rodgers has written another great article covering the impact on 3PLs when considering the DSCSA - Read the full article on RxTrace.com

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.

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 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])

5th Traceability and the Drug Quality and Security Act - ExL Events

5th Traceability and the Drug Quality and Security Act - An ExL Event

5th Traceability and the Drug Quality and Security Act– 5th Traceability and the Drug Quality and Security Act

Join us in Morristown, New Jersey at the 5th Traceability and the Drug Quality and Security Act conference to learn from leading supply chain experts about they have managed to provide business value through serialization and pedigree beyond regulatory compliance. Make sure you have everything in place to be able to respond to FDA inquiries within 48 hours to avoid high fines and work effectively together with your wholesalers and dispensers. This interactive forum discusses best practices for track and trace and lessons learned from implementing an integrated global supply chain security program that improves transparency, secures your supply chain and protects your brand, all while leveraging business benefits.

California Board of Pharmacy Issues Licensing Guidance for 3PLs

The California Board of Pharmacy issued guidance this week outlining the process for obtaining the licensing as third-party logistics providers or non-resident third-party logistics providers in the state. This requirement extends to all 3PLs that ship pharmaceuticals to or from California.
Prior to the Drug Supply Chain Security Act (DSCSA), 3PLs were required to obtain licensing as a wholesaler—now 3PLs and wholesalers are separate entities under California law.
Read the full story at IWLA

Pharma Serialization Update - April

Bill Fletcher highlights a few key deadlines looming for Pharma Serialization:

1. The FDA enforcement discretion not to enforce the transaction document aspects of the Drug Supply Chain Security Act (DSCSA) ends May 1. Companies who may have chosen to spend more time working out kinks in their transaction document (TD) may be running out of time.  
2. There is controversy with the way shipper cases are tracked in Brazil.
3. Companies selling into Brazil will now need to collect traceability data from 3 LOTs by December of this year. 
4. Chinese traceability is fully effective this December.  
5. New requirements in India for primary packages are creating very onerous designs on manufacturers
6. EU delegated acts for Falsified Medicines is expected in the next couple of months. Encoding will include GTIN, country reimbursement code, LOT expiration date and serial number in human readable and encoded in a GS1 DataMatrix symbol

Bill Fletcher - Pharma-Logic

Real-World Serialization: How Good is Your Game Plan?

Real-World Serialization: How Good is Your Game Plan? Understanding Global Requirements and ROI - INTERPHEX 2015 - Presented By Bill Fletcher - Date: April 21st at 11:15 am on the Pharma Tech Stage at the end of the 1200 row if you are attending.

Using SAP Event Management to ensure cold chain compliance

Serialization is a buzz right now, and for good reason as the DQSA kicks in to "low" gear. Pharma companies can no longer procrastinate and need to start the long process of imbdessing serialization in to all phases of their supply chain. The fun part is that they need to become compliant to satisfy the regulatory need but also need to ensure that their supply chain operates as efficiently in order to remain financially viable as a business. That is no easy task. I do digress a little from the topic I want to write about in this article although it is relevant to compliance.

FDA Issues Guidance for Track-and-Trace of Pharmaceuticals, TwoImportant Takeaways for 3PLs by Jan. 1

The U.S. Food and Drug Administration issued guidance for the Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, and Prescription Drugs. The document establishes initial standards for the interoperable exchange of product tracing information (transaction history (TH), transaction statement (TS), transaction information (TI) in paper or electronic format. #1: Track […]


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