Pharma Cargo Theft Takes New Spike - FiercePharma Mfg

Pharma cargo theft takes new spike - FiercePharma Manufacturing:

"the trend has turned up again. The logistics and security company reported that in 2013, full-truckload pharmaceutical thefts jumped by 50% to 33 from 22, with the average loss up 14.15% to $261,819. Total pharma thefts, including last-mile cargo theft, spiked to 83, with an average loss of $180,346 in 2013. That was up from just 36, with an average loss of $153,697, in 2012. Last-mile thefts usually involve street criminals who rip off pharmacy delivery vans."

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FDA'S Response To Cargo Thefts

The FDA wants to make sure that drugmakers do more than bolster internal operations. In a new standard operating procedure, the agency wants the pharmaceutical industry to know that there are various obligations when a theft occurs and this includes alerting regulators and the public.

FDA STAFF MANUAL GUIDES, VOLUME IV - AGENCY PROGRAM DIRECTIVESGENERAL OR MULTIDISCIPLINEFDA'S RESPONSE TO CARGO THEFTS - Effective Date: 03/23/2012

The purpose of this Standard Operating Procedure (SOP) is to provide a general procedure for determining FDA’s regulatory response when a cargo theft involving an FDA-regulated product has occurred. When followed in conjunction with the established procedures for product removal from the market, public notice, and handling medical product shortages, if applicable, the procedures described in this document will ensure that FDA’s regulatory response to cargo thefts is consistent and effective.

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IATA Perishable Cargo Regulations

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The International Air Transport Association (IATA) represents some 230 airlines comprising 93% of scheduled international air traffic.

IATA publishes The Perishable Cargo Regulations Manual: THE standard for cargo handling (buy online)

According to IATA, The Perishable Cargo Regulations (PCR) manual is the leader in temperature control and cold chain management for goods from the health care and food sectors, including pharmaceutical products and non-hazardous biological materials and includes everything you need to properly prepare, package and handle time and temperature sensitive goods quickly and efficiently.

Additional IATA resources related to perishable cargo

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IATA Perishable Cargo Regulations Take Effect

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Updated Jan 18, 2017:

The original post contains many invalid links.

You might still be interested in:
IATA Perishable Cargo Regulations
IATA Time & Temperature Sensitive Labels

= =  original post follows below  = =

Kevin O'Donnell reminds us that the new version of IATA's Perishable Cargo Regulations (PCR) take effect on July 1, 2009, in one of his recent Where Cooler Heads Prevails Blog (http://www.coolerheadsblog.com/) posts, Links to IATA's New Regulations for Time and Temperature-Sensitive Healthcare Products.

In one of his earlier posts, New IATA Regulations Take Effect July 1st, 2009, he writes, "The International Air Transport Association (IATA) will release the 9th Edition of the Perishable Cargo Regulations in June, with the content effective July 1st, 2009. Commonly referred to as Chapter 17, (Air Transport Logistics for Time- and Temperature-Sensitive Healthcare Products), it has undergone considerable revision and represents the airline's pro-active effort to improve handling processes for high-value, high-volume healthcare cargo, including requirements for implementation of a new handling label."

In a nutshell, the 9th edition of the PCR introduces new requirements for the transportation logistics of healthcare products. Amongst these are a new quality management system, training requirements and a new label (mandatory as of July 2010). These changes are the result of the collaboration by carriers with pharmaceutical associations and many other stakeholders in the supply chain, all within a major revision to Chapter 17.

Additional Resources and Materials:
The new IATA “Time and Temperature Sensitive” label and training requirements
The IATA Perishable Cargo Regulations manual

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