Unitrans Life Sciences Logistics Newsletter | Edition 1 | March 10, 2015
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In Edition 1:
Coldchain Comments
Industry, Carrier and Service updates
Security Update: PCSC
Compliance Corner: PARP II and customs updates

Links of the Week

PCSC-Pharma

CBP

Unitrans

Coldchain Comments

Effective coldchain management of temperature sensitive products is fraught with challenges. In his latest book, Coldchain Chronicles, Kevin O'Donnell, expert in pharmaceutical cold chain management, illustrates these challenges through a collection of stories aimed at improving cold chain practices and stewardship.

In practice here at Unitrans, we note the following cold chain management essentials:

• Breadth and depth of service / Network alignment
• Carrier and route risk assessment
• Qualification and Validation processes
• Packaging, Handling and Equipment alignment
• Consistent, recurrent training
• Monitoring and Communications
• Multi-partner SOP Development

 


Industry, Carrier and Service updates:


AIRFREIGHT: Fuel costs across the airline industry represent a large portion of overall expenses - accounting for 30% of an airline's operating expenses. Even as the cost of oil has plummeted in recent months, many carrier fuel surcharges have not budged. What's up with that?

Effective February 17, 2015, Delta Airlines will no longer require CSafe AcuTemp RKN containers to be built onto pallets for carriage on Delta aircraft.  The changes will allow C Safe's active containers to be processed as true shipper loaded units (SLU). Therefore, there will no longer be a requirement to lose an entire pallet space for an odd numbers of containers.

IAG (the carrier resulting from the BA and IB joint venture) continues to expand their Constant Climate (Active Container) network. They recently added Stockholm, Guayaquil and Quito to the Constant Climate destination network. This brings their total joint network for active containers (Envirotainer™ and C-Safe™ units) to 99 destinations across 6 continents.

SEAFREIGHT: A new labor contract announced Feb. 20 will allow normal cargo operations to resume at 29 West Coast ports.  The tentative agreement between the Pacific Maritime Association, representing shipping lines and terminal operators, and the International Longshore and Warehouse Union, representing about 20,000 dockworkers, resulted in a new five-year contract after nearly ten months of negotiations  and pressure from federal labor mediation officials in the last few weeks.  Even with operations recovering as union members return to work, it could be months before the existing backlog is cleared.  The agreement still must be ratified by both sides in a process that could take another 30 days. Read More 

Mark Edwards, former Global Freight Manager, Actavis, presents at the 14th annual Cool Chain & Controlled Room Temperature Logistics Europe, discussing the advantages of seafreight: sustainability, cost containment, reduced handling, improved temperature stability and security.  Caveat: high value shipments vs. carrier liability limitations and large shipment volumes required to make worth the effort. View Video  

TRUCKING:  A solution to the driver shortage?

The Federal Motor Carrier Safety Administration has concluded that a Pilot Program has successfully demonstrated that Mexican motor carriers can and do operate throughout the United States at a safety level equivalent to U.S and Canada-domiciled motor carriers and consistent with the high safety standards that FMCSA imposes on all motor carriers authorized to operate in the United States. Recommending the extension of cross-border  long haul operating authority to pilot participants.

CRST announces acquisition of Pegasus Transportation, a leading provider of regional truckload services, with a focus on Life Sciences, high-security and temperature sensitive requirements. More Info

MEDTECH: Amazon entering the Med Tech industry? Read More


Security update from PCSC:


We want to take this opportunity to inform you of a highly important initiative of the Pharmaceutical Cargo Security Coalition – that of formally registering each of your products trademark and/or copyright. This initiative is being advanced in co-operation with CBP’s Pharmaceutical Center of Excellence & Expertise (this was discussed with Tony Orosz of US Customs at the PCSC Conference on Feb. 10 and 11, 2015).

There are several advantages to registering product trademarks if you haven’t already.  The costs associated are minimal when compared to the benefits. Following is a partial list of some of the advantages:

  • Makes intellectual property rights information available at ports of entry to help CBP personnel with infringement determination/detection of counterfeit merchandise
  • Prevents (or at the very least minimizes) the importation of infringing foreign goods
  • Strengthens CBP’s enforcement posture when regulations say “may” vs. “shall” seize
  • It affords those who register visibility to the violators information
  • Such a registration provides legal presumption that you are the owner of a valid trademark and that you have exclusive rights to use that trademark. Such a registration provides the right to sue in federal court
  • A federal registration is a tool to counter “cyber squatters” (those that might register your trademark in their domain). A registration allows for the valid rights owner to request a Cease & Desist Letter that the infringing domain be terminated – or at the very least a hold be placed on the infringing domain

The recording fee for copyrights is less than $200. The recording fee for trademarks is also less than $200 per International Class of goods. This process is recommended by CBP for all manufactured products – not just exclusively pharmaceuticals.

For the complete list of benefits and a “how to” guide on the registration process, Click Here.

*Courtesy of Chuck Forsaith, Chairman, Pharmaceutical Cargo Security Coalition www.pcscpharma.com

Compliance Corner: PARP II initiative*


Compliance Corner:  PARP II initiative* The Pharmaceutical Agriculture Release Program II (PARP II) is an initiative developed by U.S. CBP and USDA to promote efficient facilitation of pharmaceutical imports to the U.S.  The original PARP I has been changed to add criteria that may allow pharmaceutical imports (within certain criteria – see requirements below) with animal by-product to be a part of the program.

I.       GENERAL INFORMATION:

The Pharmaceutical Agriculture Release Program (PARP) is a Pilot Project that was implemented based on an agreement between U.S. Customs and Border Protection (CBP) at the port of Philadelphia and United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS). This agreement is limited in scope and will only apply to imported pharmaceutical products that are arriving at the Port of Philadelphia. The PARP Project expedites importation of pharmaceutical products into the United States.  

Pharmaceutical products that have been reviewed and authorized for inclusion in PARP II by CBP and APHIS will be listed on the APHIS Intranet.  The benefits to the customer for inclusion on the listing will result in substantially fewer holds placed by CBP. It is estimated that only 1 out of 45 shipments will be held by CBP for an intensive agriculture review.  The PARP II Program promotes efficient facilitation of pharmaceutical imports by spending less time and resources inspecting products of little agricultural concern.

This agreement and program standards do not relieve the importer of their obligation to comply with entry requirements for other agencies with jurisdiction over these pharmaceutical products.
The foundation discussion for the proposal of PARP began on May 23, 2011.

II.          REQUIREMENTS:

Pharmaceutical products requiring USDA, APHIS, VS import permits are not eligible for PARP II Project participation. Pharmaceutical products eligible for PARP II are listed below.

All APHIS guidelines and CBP local guidelines must be adhered to.

  1. The product must have a history of documentation attesting to absence of animal derived ingredients. Exception: FDA approved/ licensed human pharmaceutical(s) &/or human vaccine(s) in final dosage form and human pharmaceuticals containing dried milk used as a fixative, excipient or binder
  2. The product must not be regulated or capable of being derived from an animal source.
    Exception: Reference must be noted on worksheet: Merck Index, Wikipedia (online URL) or FDA documentation (online URL) (Note: This information covers not the intended use but the source(s) of the ingredients.)
  3. The product name must be manifested in CBP’s Automated Targeting System (ATS).
  4. The importer must not have any non-compliance issues (APHIS or CBP).
  5. The label should have identified all components that are present in the product.
  6. If chemically synthesized, the product must not contain nor be derived from any animal or cell culture derived products (as per Guideline to Importation 1105).
  7. If the human pharmaceutical or human vaccine contains an animal derived component, the human pharmaceutical or human vaccine must be FDA approved, licensed and in final dosage form (as per Guideline to Importation 1100)
  8. If the product contains only dry milk or a dried milk product; then dry milk or dried milk product must be only used as a fixative or binding agent in a mixture of other ingredients.

III.                APPLICATION INFORMATION:

Information that must be supplied by the requestor, for each product (send one file with all the information for one drug) per application.

  1. Importer(s) name & Importer(s) of Record (IOR)
  2. Shipper name/address
  3. Pharmaceutical/chemical name
  4. Expected shipment volume per year
  5. Shipping labels, product labels, permits and any other related shipment information (Scans are permitted)
  6. If the product contains gelatin, identify the plant &/or animal species of  the gelatin
  7. FDA registration (ANDA# or NDA# or IND#)
  8. Final form of product
  9. Ingredients list
  10. CT-PAT and or ISA participant
  11. List any bindings agents/fixatives

Once you have compiled the information requested above, forward the package to the CBP Agriculture Air Cargo general mailbox at BPAIAIRPHILA@CBP.DHS.GOV  and Hal Fingerman HAL.S.FINGERMAN@CBP.DHS.GOV.  
The subject line should read “PARP II Application with the Pharmaceutical and company (applicant) names and date applied.

*FOR FURTHER INFORMATION, ASSISTANCE OR QUESTIONS, PLEASE CONTACT: HAL.S.FINGERMAN@CBP.DHS.GOV

Customs Operations Update: According to various sources, Customs Operations would be slowed if DHS Appropriations Bill Fails. Should DHS funding run out following a six month extension, normal cargo processing, including import and entry work will continue, however, work related to audits, classification rulings, issuance of customs brokerage licenses and other key projects and functions would be suspended. Read More

Questions?  Comments? Ideas? We’d love to hear from you @ dave.janzow@unitrans-us.com

 

 

 


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