Tag Archives: pharmaceutical supply chain management

Sentry representatives attend DCAT week

Sentry BioPharma Services is pleased to announce delegates from Sentry’s Business Development team will be in New York City attending the Drug, Chemical & Associated Technologies Association (DCAT) Week March 19th -22nd. The four-day conference brings together key sourcing, procurement and business development stakeholders within the industry’s top life science organizations.  The Sentry team’s focus will be to connect with current clients and prospective pharmaceutical development and manufacturing companies requiring first-in-class temperature-sensitive product management and global distribution support.

President Tim Mitchell and Business Development Manager Alex Mitchell are looking forward to discussing Sentry’s GMP pharmaceutical storage expertise and expanded service offerings coming throughout 2018 and 2019. They along with representatives from our marketing team will be sharing information regarding Sentry’s services to include:

  • Six validated storage environments
    • +15°C to +30°C
    • +2°C to +8°C
    • -15°C to -25°C
    • -33°C to -43°C
    • -40°C to -60°C
    • -70°C to -90°C
    • Custom Temperature Solutions from 0°C to -90°C
  • Controlled Substance Storage and Security
  • Secondary Labeling and Packaging
  • Foreign Trade Zone Import/Export Support
  • Government, Seasonal/Pandemic, Vaccine and Bio-defense Stockpile and Distribution Support

API Sampling and Dispensing

  • Commercial Fulfillment

Schedule a strategic meeting with the Business Development team to learn how Sentry can optimize GMP solutions for your clinical and commercial project needs.

FDA’s Know Your Source: Protecting Patients from Unsafe Drugs

Beware of Rogue Wholesale Drug Distributors

Wholesale drug distributors are a link between manufacturers and health care professionals. Their role is to ensure prescription medications are delivered safely and efficiently to thousands of health care practitioners and pharmacies nationwide every day.

While the U.S. health care supply chain is one of the most secure and sophisticated in the world, there is a growing network of rogue wholesale drug distributors selling potentially unsafe drugs in the U.S. market.

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Reduce the Chance of a Potentially Unsafe Drug Reaching Your Patients

In order to protect your patients from unsafe or ineffective drugs, the FDA urges health care professionals to verify that their supplier is licensed by the state. Drugs from rogue wholesale drug distributors may harm your patients and expose them to unknown risks or side effects.  The FDA advises health care providers to know the source for prescription drugs.

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Verify that Your Wholesale Drug Distributor is Licensed in Your State

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http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/ucm281446.htm

For more information about Sentry’s pharmaceutical licensing, registration and international compliance program, contact Sentry via email or by phone at 1-866-757-7400.

For more information: http://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm389121.htm

DoD | Human Trials Begin for Army-Developed Zika Vaccine

By Cheryl Pellerin, DoD News, Defense Media Activity / Published Nov. 8, 2016

A clinical trial began yesterday at the Walter Reed Army Institute of Research, where 75 participating healthy adults were vaccinated with a Zika virus vaccine that the institute’s scientists developed earlier this year, Walter Reed officials announced today.zika

Laboratory-confirmed Zika virus disease cases reported to ArboNET by state or territory as of Nov. 2, 2016. ArboNET is a national surveillance system for arthropod-borne virus diseases in the United States, such as those from ticks and mosquitoes.

The Phase 1 trial will test the safety and immunogenicity — the ability of the vaccine to trigger an immune response in the body — of the purified, inactivated Zika virus vaccine called ZPIV. The vaccine is being tested at WRAIR’s Clinical Trial Center in Silver Spring, Maryland.

“The Army has moved efficiently from recognizing Zika virus as a threat, producing ZPIV for use in animals and demonstrating its effectiveness in mice and monkeys, producing ZPIV for human testing, and now initiating clinical trials to establish its safety and build the case for subsequent efficacy trials,” Army Col. (Dr.) Nelson Michael, director of WRAIR’s Military HIV Research Program, or MHRP, and Zika program co-lead, said in a statement.

Efficacy refers to the vaccine’s ability to demonstrate a health effect when tested in a clinical trial.  “All of this,” he added, “was done in 10 months.”

Dr. Kayvon Modjarrad, Zika program co-lead and associate director for emerging infectious disease threats at WRAIR’s MHRP, said the Army was able to move so quickly in developing, manufacturing and testing a Zika vaccine “because of its extensive experience with this vaccine platform and longstanding investments in the understanding and mitigation of flaviviruses like yellow fever, dating back to the founding of WRAIR.”

DoD Zika Response

WRAIR officials say this study is part of the Defense Department response to the ongoing Zika outbreak in North and South America and Southeast Asia.

For service members, there are concerns about infection during deployment and travel, but also in the continental United States, where most military installations are concentrated in southern states. There, climate conditions and mosquito populations favor Zika transmission, WRAIR officials say.mosquito

Zika virus is transmitted to people primarily through the bite of an infected Aedes species mosquito — Aedes aegypti, shown here, and Aedes albopictus. The same mosquitoes spread dengue and chikungunya viruses. The mosquitoes typically lay eggs in and near standing water in things like buckets, bowls, animal dishes, flower pots and vases. They prefer to bite people and live indoors and outdoors near people. Mosquitoes that spread chikungunya, dengue, and Zika are aggressive daytime biters, but they can also bite at night. Mosquitoes become infected when they feed on a person already infected with the virus. Infected mosquitoes can then spread the virus to other people through bites. CDC photo by James Gathany

As of Nov. 2, according to the Centers for Disease Control and Prevention, 149 cases of Zika infection were confirmed in the military health system, including four pregnant service members and one pregnant family member.

Zika infection during pregnancy, CDC says, can cause a birth defect of the brain called microcephaly and other severe fetal brain defects.

Other problems have been detected among fetuses and infants infected with Zika virus before birth, such as defects of the eye, hearing deficits and impaired growth. And reports have increased about Guillain-Barré syndrome, an uncommon sickness of the nervous system, in areas affected by Zika, CDC says.

But even Zika infections without symptoms “can lead to severe birth defects and neurological complications,” Zika study principal investigator Army Maj. (Dr.) Leyi Lin said, adding, “A safe and effective Zika vaccine that prevents infection in those at risk is a global public-health priority.”

Zika and Other Flaviviruses

Flaviviruses like Zika are found mainly in mosquitoes and ticks and cause widespread morbidity and mortality worldwide. Other mosquito-transmitted viruses that are members of the flavivirus genus include yellow fever, or YF, dengue fever, Japanese encephalitis, or JE, and West Nile viruses, according to the CDC web page.

“We want to assess the safety and immune response of the ZPIV vaccine in JE and yellow fever YF vaccine recipients because these vaccines may alter the response to the ZPIV vaccine,” Lin said.

“Uniquely,” he added, “illness as a result of natural infection from JE, YF or Zika could be more severe when prior flavivirus infection or vaccination exists. Our study assesses co-vaccination to learn how to reduce risk when protecting against circulating flaviviruses.”

This is important for service members who are vaccinated against other flaviviruses and then stationed in or deployed to areas where Zika is becoming endemic, WRAIR scientists say.

Zika Vaccine Platform

WRAIR’s inactivated flavivirus vaccine platform was the same technology the institute used to create its Japanese encephalitis vaccine, licensed in 2009.

An earlier preclinical study found that rhesus monkeys vaccinated with ZPIV developed a strong immune response and were protected against two strains of Zika virus.

The National Institute of Allergy and Infectious Diseases, or NIAID, part of the National Institutes of Health, helped identify the viral strain used in the ZPIV vaccine, supported the preclinical safety testing and is sponsoring the conduct of this trial.

WRAIR, NIAID and the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority, or BARDA, have established a joint research collaboration agreement to support the vaccine’s development.

The Pilot Bioproduction Facility at WRAIR manufactured the ZPIV vaccine being used in Phase 1 clinical studies, and the Army recently signed a cooperative research and development agreement to transfer the ZPIV technology to Sanofi Pasteur to explore larger-scale manufacturing and advanced development. BARDA recently awarded a six-year contract to Sanofi Pasteur to further develop this vaccine to licensure, according to the WRAIR release.

Other ZPIV Trials

WRAIR’s ZPIV candidate also will soon be part of an NIH trial that began in August. The NIH vaccine contains DNA that instructs volunteers’ cells to make certain Zika proteins that then illicit an immune response. As part of that study, WRAIR’s ZPIV vaccine will be given to volunteers as a booster after they receive the NIH DNA vaccine, WRAIR officials say.

Three more Phase 1 trials using ZPIV are scheduled to begin this year, the WRAIR release noted:

— St. Louis University researchers, through the NIAID-funded Vaccine and Treatment Evaluation Units network, will examine the optimal dose of the vaccine to be used in larger studies.

— Beth Israel Deaconess Medical Center and Harvard Medical School researchers will evaluate the safety and immune response from a compressed vaccine schedule.

— The Ambulatory Center for Medical Research, part of Ponce Health Sciences University in Puerto Rico, will examine the vaccine’s safety and immune response in participants who have already been naturally exposed to Zika or dengue viruses.

The WRAIR trial that began yesterday is sponsored by NIAID and funded by the Army and the Defense Department.

For more information about how Sentry’s proven vaccine management system can protect your vaccine throughout the global supply chain, contact Sentry via email or by phone at 1-866-757-7400.

For more information: http://www.defense.gov/DesktopModules/ArticleCS/Print.aspx?PortalId=1&ModuleId=753&Article=999584

Sentry’s New Vaccine Storage Campaign

Sentry BioPharma Services is proud to announce its new vaccine storage and distribution services campaign. Sentry’s decade long commitment to protect product integrity  married with its state-of-the-art facility provides the life sciences industry with a unique level of quality, regulatory and operational advantages that strengthen the vaccine supply chain. Sentry’s vaccine program advantages include:

Proven Track Record of Compliant Vaccine Storage, Rotation And Vaccine Drug Distribution

vaccinecampaignSentry’s long and unblemished regulatory inspection history is a reflection of its superior approach to standard operating procedures and temperature sensitive product management.

Large Scale Repository and Tracking Capabilities Through Advanced Inventory Management Systems

Live 24/7 real-time inventory tracking ensures full visibility of inventory throughout an organization and accurate tracking compliant with GMP storage regulations 21 CFR Parts 210 and 211. High-touch communication with the Sentry Operations and Quality Teams provides proper distribution of vaccines for routine fulfillment or pandemic response.

Advanced Building Management Systems That Monitor And Control Temperature Of Storage Environments

Sentry’s validated cold chain storage environments minimize time-out-of-refrigeration (TOR) risks, helping to reduce or eliminate waste attributable to deficient storage methods. The facility’s multi-tiered security structure and flexible storage options help fulfill requirements for specific seasonal or stockpile campaigns.

Trusted By Hospitals, Government Healthcare Agencies, And Manufacturers To Protect Vaccine Products And Stockpile

Over its ten years as a contract service organization, Sentry has been a trusted partner to hospitals, vaccine manufacturers and government healthcare organizations concerned with drug product integrity, vaccine storage security, risk management and timely vaccine distribution.

For more information about how Sentry’s temperature sensitive product management expertise can help you optimize your seasonal vaccine stockpile requirements, contact Sentry via email or by phone at 1-866-757-7400.

New CDC Study: Influenza Vaccination Reduces Risk of Hospitalization by More Than Half Among Seniors

Influenza season is upon us, so now is an appropriate time to remind ourselves to line up for our flu shots.  Sentry BioPharma Services provides vaccine product management services to a wide group of clients from the US Federal and State government agencies to vaccine manufacturers, with an emphasis on timely delivery of vital vaccines globally.

Recently, the US Center for Disease Control (CDC) published a study on the beneficial effects of influenza vaccines on older populations within the USA.  We have provided an overview of the study below for your review and consideration.shutterstock_351328199

August 2, 2016—A new CDC study published today in the journal Clinical Infectious Diseases (CID) provides more evidence on the benefits of flu vaccination among older adults. The study looked at flu-associated hospitalizations among people 50 and older during the 2010-2011 flu season and found that people who had received a flu vaccine reduced their risk of flu-associated hospitalization by half.

People 65 and older are at high risk of serious flu complications and account for the majority of flu hospitalizations and deaths each year. The CID study “Case-control study of vaccine effectiveness in preventing laboratory-confirmed influenza hospitalizations in older adults, United States, 2010-11,” cites data from three recent influenza seasons, during which an estimated 115,000 to 630,000 hospitalizations and 5,000 to 27,000 deaths occurred. It’s estimated that people 65 and older accounted for between 54 percent and 71 percent of hospitalizations and between 71 percent and 85 percent of deaths.

The study, which compared 368 flu-hospitalized patients and compared them against case controls selected from the community, found that vaccinated people 50 years and older were 57 percent less likely to be hospitalized from flu than unvaccinated people. The benefits were similar by age group, including adults 75 years and older. This is a notable finding since flu effectiveness studies that have looked at how well vaccine protects against flu-related doctor’s visits have generally found that effectiveness is declines with age. This study indicates that protection against hospitalization was level among older people.

Annual influenza vaccination has been recommended for adults 65 and older in the U.S. since the 1960s and for adults 50 years and older since 2000. Since 2005, CDC has conducted annual influenza vaccine effectiveness studies to assess how well the vaccine works in preventing medically attended illness. Until recently, there have been few studies that look at how well the vaccine works in preventing more serious outcomes, like hospitalization. The CID study adds to a growing body of evidence that supports the importance of vaccination in order to prevent these more serious outcomes.

Study findings also support current U.S. recommendations for annual influenza vaccination among adults, especially among adults 65 years of age and older who are at high risk of influenza-associated complications. During 2015-2016, an estimated 66% of people 65 and older got a flu vaccine. While this is the highest vaccination rate among the public for any age group, that still leaves nearly one-third of people 65 and older unvaccinated.

Secure GMP storage and flu vaccine distribution services protect your refrigerated inventory throughout the temperature-controlled supply chain.  For more information about how Sentry’s vaccine storage and proven vaccine management system can protect your vaccine throughout the pharmaceutical global supply chain, contact Sentry via email or by phone at 1-866-757-7400.

FDA Announces Meeting on Implementing DSCSA’s Product Identification Requirements

Sentry BioPharma Services continues to strengthen its leadership position in providing high quality and secure pharmaceutical supply chain services to pharmaceutical clients and companies utilizing biotechnology to manufacture biological products and vaccines.  Therefore, we would like to draw attention to an upcoming public meeting concerning the Drug Supply Chain Security Act (DSCSA) hosted by the FDA.

fda-dscsaThe Food & Drug Administration (FDA) will be holding a public meeting to provide members of the pharmaceutical distribution supply chain and interested stakeholders an opportunity to discuss with FDA the implementation of the Drug Supply Chain Security Act’s (DSCSA’s) product identification requirements. To be held on October 14, 2016, from 9:00 a.m. to 4:00 p.m. at FDA’s White Oak Campus in Silver Spring, MD, the meeting, “Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act,” will include presentations from the public and follow-up questions from an FDA panel. The objective of the meeting is to discuss the pharmaceutical supply chain’s progress toward implementing the DSCSA’s product identification requirements, including best practices in each sector of the pharmaceutical distribution supply chain to conduct product tracing, verification, and identification.

More Background on the Drug Supply Chain Security Act (DSCSA)

Title II of the Drug Quality and Security Act of 2013

The Drug Quality and Security Act (DQSA), was signed into law by President Obama on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act, outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.

Ten years after enactment, the system will facilitate the exchange of information at the individual package level about where a drug has been in the supply chain. The new system will:

  • enable verification of the legitimacy of the drug product identifier down to the package level;
  • enhance detection and notification of illegitimate products in the drug supply chain; and
  • facilitate more efficient recalls of drug products.

Drug manufacturers, wholesale drug distributors, repackagers, and many dispensers (primarily pharmacies) will be called on to work in cooperation with FDA to develop the new system over the next 10 years.

Among key provisions implemented over the next 10 years are requirements for:

  • Product identification: Manufacturers and repackagers to put a unique product identifier on certain prescription drug packages, for example, using a bar code that can be easily read electronically.
  • Product tracing: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) in the drug supply chain to provide information about a drug and who handled it each time it is sold in the U.S. market.
  • Product verification: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to establish systems and processes to be able to verify the product identifier on certain prescription drug packages.
  • Detection and response: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to quarantine and promptly investigate a drug that has been identified as suspect, meaning that it may be counterfeit, unapproved, or potentially dangerous.
  • Notification: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to establish systems and processes to notify FDA and other stakeholders if an illegitimate drug is found.
  • Wholesaler licensing: Wholesale drug distributors to report their licensing status and contact information to FDA. This information will then be made available in a public database.
  • Third-party logistics provider licensing: Third-party logistic providers, those who provide storage and logistical operations related to drug distribution, to obtain a state or federal license.

The law requires FDA to develop standards, guidance documents, and pilot programs and to conduct public meetings, in addition to other efforts necessary to support efficient and effective implementation. FDA is developing a schedule for implementing the law’s requirements.

This system will enhance the U.S. Food and Drug Administration’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers. Failure to comply with the requirements of the law can result in penalties.

The development of the system will be phased in with new requirements over a 10-year period. These requirements will include providing product and transaction information at each sale with lot level information, in paper or electronic format, and placing unique product identifiers on individual drug packages.

The FDA is soliciting either electronic or written comments related to this public meeting by November 14, 2016. To register or request to make a presentation, visit the public meeting web page.

For more information about how Sentry’s secure drug supply chain management programs can ensure drug product integrity in every phase of the pharmaceutical supply chain, contact Sentry via email or by phone at 1-866-757-7400.

Sentry Visits Biotech Clients in the Pacific Northwest to Discuss API Importation and FTZ Benefits

Sentry recently completed a week-long trip to the Pacific Northwest region to satisfy multiple requests to learn more about the company’s foreign trade zone (FTZ) service offering.  Client interest focused on importing high value active pharmaceutical ingredients (API) into Sentry’s FTZ for an indefinite storage term.

As supply chains become more intricate in our ever shrinking world, any weak link that chain can produce devastating results for temperature-sensitive biotech drug products.  “Most of us in pharma and biotech have our stories of disasters or near calamities concerning product movements globally” stated Tim Mitchell, President of Sentry.  “In light of the tremendous investment in treasury and time required to bring a new medication to market, it is critical to not allow product safety, identity, strength, purity and quality (SISPQ) to be impacted by delays which are inherent with the standard drug importation process.”

Sentry can help prevent time-out-of-temperature excursions through the utilization of its Foreign Trade Zone (FTZ), subzone 11 of zone 72 located at its facility in Indianapolis, Indiana.

What is a Foreign Trade Zone?ftza

The U.S. Foreign Trade Zone program was established by the Foreign Trade Zone Act of 1934 to “expedite and encourage foreign commerce” in the United States. Certain geographical areas, in or adjacent to Customs Ports of Entry, can obtain foreign trade zone (FTZ) status and receive commercial merchandise under the same Customs standards as if it were outside the commerce of the United States. Any merchandise, including pharmaceutical products, admitted and held in a foreign trade zone can be exempt of any Customs duties, tariffs and other ad valorem taxes. No duty or back taxes are charged on “value-added,” or foreign-sourced parts or materials incorporated into a finished product using U.S. parts and labor until the product is officially imported into the U.S. Commerce. This tariff and tax relief lowers the costs of U.S.-based organizations engaged in international trade while creating and retaining employment and capital investment opportunities that result from those operations.

Benefits to the Biopharmaceutical Industry

Pharmaceutical and biopharmaceutical companies can take advantage of Sentry’s GMP temperature-sensitive pharmaceutical storage and light manufacturing facility, which resides in a foreign trade zone.  Sentry’s FTZ allows drug product to reside within the product’s designated temperature range, (such as API, biologics, controlled substances, etc.), while awaiting clearance for importation by the U.S. Customs and Border Protection agency (CBP) and approved for distribution by the Food & Drug Administration (FDA).

During its stay in the FTZ, the biopharmaceutical product can be further labeled and secondarily packaged while greatly mitigating the numerous logistic and economic challenges encountered throughout the drug importation and development process.

Logistic Benefits 

Unlimited Storage Terms Term of pharmaceutical material storage in an FTZ is indefinite.
Eliminated U.S. Quota Restrictions Product previously subject to quota limitations is now exempt from such restrictions.
Strengthened Foreign Pharmaceutical Supply Chain Eliminate administrative and importation hold-ups at Customs and ports of entry by bringing product straight to our GMP pharmaceutical storage environments ensuring product integrity: safety, identity, strength, purity and quality (SISPQ) along the drug supply chain.
Uninterrupted Local Manufacture Prior to Importation Product can be labelled, kitted and packaged and stored in the United States until need for importation into U.S. Commerce and Customs Clearance.
Expedited Release to Market Product can be held in an FTZ until FDA approval, greatly reducing time and logistic hassle from manufacturer to end-user.

Economic Benefits 

Duty Deferral or Duty Aversion  Import, admit and hold product without paying U.S. Customs duties.
Zero Inventory Taxes All materials held in an FTZ are exempt from state, county and local ad valorem taxes.
Country of Origin Marking and Labeling Country-of-origin labels are non-required on product admitted to an FTZ freeing companies from this expense.

Sentry BioPharma Services’ pharmaceutical supply chain management expertise and FTZ status across all storage environments ensures product integrity and project management flexibility.

For more information about how Sentry’s Foreign Trade Zone can help you optimize your medical and pharmaceutical import/export process, contact Sentry via email or by phone at 1-866-757-7400.

Sentry’s Controlled Substance Program Strengthens the Reliable and Secure Pharmaceutical Drug Supply Chain

Regulatory oversight shapes every dimension of controlled substances: licensing, registration, storage, security, use, inventory and controlled drug disposal. Finding a Drug Enforcement Administration (DEA) licensed partner to store, distribute and manage returns and destruction of Schedule III-V controlled substances while maintaining regulatory and quality standards required for a secure pharmaceutical supply chain can be a challenge. Sentry BioPharma Services provides seamless product management required to safeguard controlled substances which are brought into Sentry’s custody and care.

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Features & Benefits of Sentry’s Controlled Substance Program

DEA Regulation Secure Storage – Inspected and approved by the Drug Enforcement Administration  in 2014, Sentry’s state-of-the-art controlled substance capacity provides secure and reliable storage to support your pharmaceutical supply chain needs.

Controlled Substance Importation/Exportation – Sentry’s controlled substance importation and controlled substance exportation capabilities provide pharmaceutical organizations unique flexibility in the drug supply chain. This coupled with Sentry’s high quality standards affords pharmaceutical companies a competitive advantage throughout the drug development process.

Redundant Systems and Extensive Security Measures Product safety, identity, strength, purity and quality (SISPQ) remain intact.  Sentry features which support this agenda include:

  • Auxiliary power feeds and back-up systems
  • Continuous (24/7) security monitoring
  • Foreign Trade Zone (FTZ) status which allows controlled substances to be internationally shipped directly to Sentry where DEA, Customs & Border Patrol (CBP) and FDA clearances can be obtained within the security provided by Sentry’s GMP facility
  • Physical plant security
  • Redundant HVAC systems
  • Secure data and document programs

Pharmaceutical Labeling and Packaging – Sentry’s light pharmaceutical manufacturing capabilities help streamline clinical trial distribution and commercial drug distribution with one stop shop GMP labeling and GMP secondary packaging.

Drug Product Return and Drug Disposal Services – Sentry completes the controlled substance supply chain with a full-service approach to product guardianship.  Our drug product return and drug destruction program ensures project integrity, reliable inventory tracking and public safety from development to launch.

For more information about how Sentry can provide controlled substance supply chain solutions for your project, contact Sentry via email or by phone at 1-866-757-7400.

Features & Benefits of a Pharmaceutical Foreign Trade Zone

What is a Foreign Trade Zone?

The U.S. Foreign Trade Zone program was established by the Foreign Trade Zone Act of 1934 to “expedite and encourage foreign commerce” in the United States. Certain geographical areas, in or adjacent to Customs Ports of Entry, can obtain foreign-trade zone (FTZ) status and receive commercial merchandise under the same Customs standards as if it were outside the commerce of the United States. Any merchandise, including pharmaceutical products, admitted and held in a foreign trade zone can be exempt of any Customs duties, tariffs and other ad valorem taxes. No duty or back taxes are charged on “value-added,” or foreign-sourced parts or materials incorporated into a finished product using U.S. parts and labor until the product is officially imported into the U.S. Commerce. This tariff and tax relief lowers the costs of U.S.-based organizations engaged in international trade while creating and retaining employment and capital investment opportunities that result from those operations.

Benefits to the Biopharmaceutical Industryshutterstock_367703690

Pharmaceutical and biopharmaceutical companies can take advantage of Sentry’s GMP temperature-sensitive pharmaceutical storage and light manufacturing facility, which  resides in a foreign trade zone.  Sentry’s zone allows drug product to reside within the product’s designated temperature range, (such as API, biologics, controlled substances, etc.), while awaiting clearance for importation by the CBP and approved for distribution by the Food & Drug Administration (FDA).

During its stay in the FTZ, the biopharmaceutical  product can be further labeled and secondarily packaged  while greatly mitigating the numerous logistic and economic challenges encountered throughout the  drug importation and development process.

Logistic Benefits 

Unlimited Storage Terms Term of pharmaceutical material storage in an FTZ is indefinite.
Eliminated U.S. Quota Restrictions Product previously subject to quota limitations is now exempt from such restrictions.
Strengthened Foreign Pharmaceutical Supply Chain Eliminate administrative and importation hold-ups at Customs and ports of entry by bringing product straight to our GMP pharmaceutical storage environments ensuring product integrity: safety, identity, strength, purity and quality (SISPQ) along the drug supply chain.
Uninterrupted Local Manufacture Prior to Importation Product can be labelled, kitted and packaged and stored in the United States until need for importation into U.S. Commerce and Customs Clearance.
Expedited Release to Market Product can be held in an FTZ until FDA approval, greatly reducing time and logistic hassle from manufacturer to end-user.

Economic Benefits 

Duty Deferral or Duty Aversion  Import, admit and hold product without paying U.S. Customs duties.
Zero Inventory Taxes All materials held in an FTZ are exempt from state, county and local ad valorem taxes.
Country of Origin Marking and Labeling Country-of-origin labels are non-required on product admitted to an FTZ freeing companies from this expense.

Sentry BioPharma Services’ pharmaceutical supply chain management expertise and FTZ status across all storage environments ensures product integrity and project management flexibility.

For more information about how Sentry’s Foreign Trade Zone can help you optimize your medical and pharmaceutical import/export process, contact Sentry via email or by phone at 1-866-757-7400.

Read more about the Greater Indianapolis Foreign Trade Zone: inzone.org

Operation Silver Snake Sets CBP Field Operations Seizure Record in San Juan, Puerto Rico

Last month, the U.S. Customs and Border Protection (CBP) San Juan Field Operations announced that approximately 268 seizures were made of counterfeit products, valued at $2.4 million, which were illegally imported into Puerto Rico via international mail.  This is a record number of counterfeits seized by CBP in Puerto Rico during a single week.

A wide range of counterfeited products was seized during the week-long enforcement effort, called Operation Silver Snake, to include: consumer products, apparel, footwear, textiles, pharmaceuticals, and more.

CBP Operation SS (1)

International Mail packages are inspected by CBP to verify compliance with US laws

This is the second iteration of a week-long operation carried out in San Juan this year by the Mobile Intellectual Property Enforcement Team (MIPET), with the support of CBP’s Centers of Excellence and Expertise (CEEs), IPR-National Targeting & Analysis Group (NTAG), Homeland Security Investigations (HSI), and United States Postal Inspection Service (USPIS).

“Our dedicated CBP officers, Import Specialist, International Trade Specialists and Seized Property Specialists were key ingredients to this successful enforcement effort to protect the U.S. economy and consumers from counterfeit products,” said Edward Ryan, Assistant Director of Trade for Puerto Rico and the US Virgin Islands. “We are looking forward to conducting follow-up operations with our partners to further protect legitimate businesses and consumers from intellectual property thieves, said Ryan.

Various international mail packages inspected by CBP officers at the San Juan International Mail Branch revealed products that infringed intellectual property rights.  The products were shipped from vendors in China.

CBP protects businesses and consumers every day through an aggressive intellectual property rights (IPR) enforcement program.  CBP targets and seizes imports of counterfeit and pirated goods, and enforces exclusion orders on patent-infringing and other IPR goods.

CBP Operation SS (2)

CBP Officers label counterfeit products seized during the operation.

To effectively enforce intellectual property rights, CBP relies heavily on the cooperation of the owners of these rights. If your intellectual property is registered with the Patent and Trademark Office, the Copyright Office or the subject of a United States International Trade Commission exclusion order, you will want to inform CBP.

Information about counterfeit merchandise being illegally imported into the United States can be submitted to the CBP using an on-line tool called E-Allegation.  The e-Allegation provides a means for the public to anonymously report to CBP any suspected violations of trade laws or regulations related to the importation of goods into the U.S.

For more information about how Sentry’s import/export team can add value to your international supply chain, contact Sentry via email or by phone at 1-866-757-7400.

Source: https://www.cbp.gov/newsroom/local-media-release/2016-07-20-000000/cbp-stops-millions-unsafe-counterfeits