Tag Archives: biologics

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.

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.

Sentry Raises Public Awareness for DEA’s National Prescription Drug Take-Back Day Initiative

As part of the U.S. Drug Enforcement Administration’s (DEA’s) National Prescription Drug Take-Back Day Initiative (NTBI), people will be able to dispose of expired, unwanted or unused prescription drugs on Saturday, October 22, 2016 from 10:00 a.m. to 2:00 p.m. at numerous collection sites around the U.S.

The DEA collected a record amount of meds during the 11th annual National Prescription Drug Take-Back Day on April 30, 2016.  According to the DEA’s May 6, 2016 press release, the DEA and over 4,200 of its state, local, and tribal law enforcement partners collected 893,498 pounds of unwanted medicines—about 447 tons—at almost 5,400 sites spread through all 50 states, beating its previous high of 390 tons in the spring of 2014 by 57 tons, or more than 114,000 pounds.

dea-take-back-day

The top five states with the largest collections, in order, were:

  1. Texas (almost 40 tons)
  2. California (32 tons)
  3. Wisconsin (31 tons)
  4. Illinois (24 tons)
  5. Massachusetts (24 tons)

“I am very proud of our state officials and residents,” said Ms. Jennifer Marcum, Sentry BioPharma Services’ chief executive officer.  Ms. Marcum continued, “Indiana’s authorities collected 29,125 pounds (14.6 tons).  That’s an enormous amount of unwanted prescription drugs and controlled substances to be safely removed from the pharmaceutical supply chain.  The statistics best illustrate how much the people of Indiana care about this important matter; no question about it.”

Marcum continued, “During the event, people can anonymously bring unwanted prescription pharmaceuticals and over-the-counter (OTC) medications to a participating drop-off site for proper drug disposal by law enforcement authorities with no questions asked.  The service is free and an ideal way to preserve the environment from pharmaceutical contamination.  This is a terrific opportunity to safely dispose of accumulated prescription drugs and medications that may have expired or are simply unwanted.”

The FDA’s Ilisa Bernstein, Pharm.D., J.D., offers a few more helpful tips when discarding drugs:

  1. Scratch out all identifying information on the prescription label to make it unreadable. This will help protect your identity and the privacy of your personal health information.
  2. Do not give your medicine to friends. Doctors prescribe medicines based on your specific symptoms and medical history. Something that works for you could harm another person.
  3. When in doubt about proper drug disposal, ask your pharmacist.

For more information about the DEA’s National Prescription Drug Take-Back Day Initiative, general public inquiries can be made by calling the DEA toll free at: 1-800-882-9539.

If you would like to learn more about Sentry’s pharmaceutical drug destruction services, please 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

FDA Removes Clinical Hold on Phase II of Juno’s “ROCKET” Trial

On Tuesday, July 12, 2016, Juno Therapeutics, a biopharmaceutical company developing cell-based cancer immunotherapies headquartered in Seattle, Washington, announced on the company’s website that the U.S. Food and Drug Administration (FDA) removed the clinical hold on the Phase II clinical trial of JCAR015 (known as the “ROCKET” trial) in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r ALL).  Under the revised protocol, the ROCKET trial will continue enrollment using JCAR015 with cyclophosphamide pre-conditioning only.

CAR-T

Earlier this month Juno received notice from the (FDA) that a clinical trial hold has been placed on the pivotal clinical trial of JCAR015.  This Phase II clinical trial, also known as the “ROCKET” trial, was being conducted in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r ALL).  As of last Friday, a total of three deaths have occurred in adult patients during clinical trials.

According to an article published by FierceBiotech on July 8, 2016, “All three deaths were in young patients, all under the age of 25, and all were due to cerebral edema.  All three of these patients were also on a preconditioning regimen of fludarabine.”

While this “living drug” may offer cancer patients a possible option where none previously existed, it is uncertain as to whether or not the class of chimeric antigen receptor T cells (CAR-T) treatments poses safety issues.  This new technology focuses on re-engaging a patient’s own immune system (T cells) via genetically engineering to recognize the antigen and kill cancerous cells.  One big question is:  Can this be done in conjunction with standard leukemia chemotherapy drugs like fludarabine and cyclophosphamide?

The removal of the clinical hold suggests that the FDA appears to satisfied with Juno’s response in addressing worrisome side effect and safety concerns resulting from the reaction between JCAR015 and the chemotherapy drug fludarabine.

Phase I of the JCAR015 study had a “complete response rate” (i.e., detectable cancer did not appear present after treatment), this cancer treatment offers much promise and hope to individuals and families battling this devastating and too often fatal disease.

For more information about how Sentry can implement a custom solution to provide GMP storage for clinical trial materials and/or meet your unique biopharmaceutical supply chain challenges, contact Sentry via email or by phone at 1-866-757-7400, for a complimentary, no obligation phone call with one of Sentry’s problem-solving experts.

Consultants Day at Vetter Development Services

Sentry BioPharma Services was pleased to be invited to speak at Vetter Development Services, Consultant Day which took place in Chicago, IL on June 22, 2016.

The theme for the conference was “Your Molecule’s Journey”.  The objective of the conference was to inform pharmaceutical consultants of the unified service offerings of Sentry and Vetter (see diagram below).  The combined services take a molecule after discovery from formulation to end patient.  Alongside Vetter’s and Sentry’s presentations were talks by CMC Biologics on drug discovery and development and by FedEx Custom Critical on issues surrounding drug distribution and delivery worldwide.

Sentry Vetter Brochure P2

Vetter Development Services, Inc., located in Skokie, Illinois, is a premier contract development and manufacturing organization (CDMO).  Vetter is a global leader in the fill & finish contract manufacturing of aseptically prefilled syringe systems, cartridges, and vials. It is a family-owned, independent company with facilities both in Germany and the US, as well as offices in Singapore and Japan. Vetter’s focus is on providing state-of-the-art biopharmaceutical manufacturing, from early clinical development and scale-up to commercial filling and packaging of parenteral drugs. They provide support every step of the way, guiding your drug product through development, regulatory approval, launch, and life cycle management. Vetter offers biotech and pharmaceutical companies a foundation of experience spanning more than 35 years including dozens of product approvals for novel pharmaceutical and biotech compounds.

Mr. Tim J. Mitchell, President of Sentry BioPharma Services, presented a talk entitled:  “Protecting Product Integrity Throughout the Supply Chain”.  Mr. Mitchell had this to say about the meeting, “Through our many years of experience at Sentry we have encountered numerous issues arising from the supply chain of drug products.  I shared several stories and this example highlights the key points of my talk.”

A few years ago a large multinational pharmaceutical company (“LMP”), which is a Sentry client today, contacted Sentry concerning the +2°C to +8°C GMP storage and distribution of a sizable quantity of a new commercial vaccine which was to be imported from Europe.  We were told that LMP would handle all pharmaceutical cold chain logistics activities and we should be ready to receive the product on a certain date.  The receipt date came and went with no vaccine delivery.

The vaccine was held up in customs at O’Hare International Airport, the port of entry.  Ten days go by and finally the product arrives at Sentry.  There was concern about the vaccine strength, identity, safety, purity and quality (SISPQ) because the LMP knew that the temperature data loggers would have stopped working days earlier.  However, this issue became moot.

The pharmaceutical company ultimately had hired “Bob’s Trucking” to pick up the vaccine at O’Hare and delivery it to Sentry.  The shipping manifest called for a refrigerated truck with a temperature set point of +5°C.  Unfortunately, Bob was unclear on the differences between Centigrade and Fahrenheit so he placed the shipment in a reefer truck with a temperature set point of +5°F.

“It is a dismal situation for a company to devote the significant resources to develop and manufacture an expensive medication which can save lives and have it all ruined by avoidable mistakes during the last miles of the pharmaceutical supply chain to patients,” Mr. Mitchell pointed out.

“The scenario above is too common today regardless of present day technical advancements.  Sentry’s foreign trade zone (FTZ) could have provided a different and much better outcome for the vaccine distribution process.  Instead of clearing customs at the airport, the vaccine could have been sent directly to Sentry and placed in its validated +2°C to +8°C GMP storage environment.  While at Sentry, the product could have cleared customs and obtained FDA approval.  Once this was accomplished the vaccine would have entered U.S. commerce and could have been distributed to hospitals, clinics and ultimately to patients.”

Sentry BioPharma Services is a contract service organization (CSO) which supports the life science industry by offering GMP temperature-controlled storage, global drug distribution, FDA-compliant labeling and packaging services and importation support utilizing Sentry’s Foreign Trade Zone (FTZ).  Drug development and commercialization require continuous temperature monitoring and control.  Sentry’s diverse offerings protect product integrity throughout the pharmaceutical supply chain.  Sentry’s validated software, GMP storage and drug distribution facility, industry expertise and stringent quality standards support this objective throughout manufacturing, packaging, storage and distribution.

To learn more about how Sentry BioPharma Services can protect your products’ integrity throughout the pharmaceutical supply chain, please, contact Sentry via email or by phone at 1-866-757-7400.

Sentry Goes Purple in June for Alzheimer’s & Brain Awareness Month

Sentry is going purple! On Friday, June 24, 2016 Sentry BioPharma Services invites employees to wear the color purple in recognition of Alzheimer’s and brain awareness month.

SBS-Approved-Logo-High-Res-With-Trademark__03.10.11Orange-Purple

Alzheimer’s disease is the sixth leading cause of death in the United States; it kills more citizens annually than prostate and breast cancer combined. Worst of all, there presently is no cure for Alzheimer’s disease. Researchers possess great hope that there will be treatments that can stop or slow Alzheimer’s in the near future.

The National Institute on Aging (NIA), one of the 27 Institutes and Centers of the National Institutes of Health (NIH), leads a broad scientific effort to understand the nature of aging and to extend the healthy, active years of life. NIA is the primary Federal agency supporting and conducting Alzheimer’s disease research. For more information about Alzheimer’s disease, please watch the video below.

Several medications are approved by the U.S. Food and Drug Administration to treat symptoms of Alzheimer’s. Donepezil (Aricept®), rivastigmine (Exelon®), and galantamine (Razadyne®) are used to treat mild to moderate Alzheimer’s (donepezil can be used for severe Alzheimer’s as well). Memantine (Namenda®), is used to treat moderate to severe Alzheimer’s.

These drugs work by regulating neurotransmitters, the brain chemicals that transmit messages between neurons. They may help maintain thinking, memory, and communication skills and help with certain behavioral problems. However, these drugs don’t change the underlying disease process. They are effective for some but not all people and may help only for a limited amount of time.

For more information about how Sentry can implement a custom solution to meet your unique GMP storage and pharmaceutical cold chain challenges, contact Sentry via email or by phone at 1-866-757-7400, for a complimentary, no obligation phone call with one of Sentry’s problem-solving experts.

WHO’s World Blood Donor Day 2016: Blood Connects Us All

The World Health Organization (WHO) has declared Tuesday, June 14, 2016 as World Blood Donor Day.  The theme is “Blood Connects Us All”.

shutterstock_419643730  wallpaper-girl

In May 2005, at the Fifty-Eighth Session of the World Health Assembly, 192 Member States of the WHO adopted resolution WHA58.13 to establish World Blood Donor Day as an annual event, to be celebrated each year on 14 June.

According to the WHO, “The safest blood donors are voluntary, non-remunerated blood donors from low-risk populations. In the key global fact and figures of 2011 (Fact sheet number 279), in 62 countries, national blood supplies are based on 100% or almost 100% (more than 99.9%) voluntary unpaid blood donations. Forty countries collect less than 25% of their blood supplies from voluntary unpaid blood donors. The primary goal of the WHO is for all countries to obtain all blood supplies from voluntary unpaid donors by 2020 in accordance with World Health Assembly resolution 28.72, which was adopted in 1975.”

Ms. Jennifer Marcum, Sentry BioPharma Services’ CEO, acknowledges the significance of the international event by scheduling an appointment to donate whole blood at the American Red Cross on June 17, 2016.  Ms. Marcum offers, “The National Institutes of Health (NIH) says approximately five million Americans require blood transfusions every year.  The need is continuous.  To this day blood cannot be manufactured on an industrial scale.  There is some research being done at The University of Edinburgh to create blood type O red blood cells using pluripotent stem cells, but a true biological blood substitute has not been commercially approved by the FDA.   So, in the absence of a safe and effective blood surrogate, we donate.  A blood donation not only forges a bond between human beings, but it also creates links to our local and global community.  It is the one common denominator among us all.”

Ms. Marcum continues, “Protecting the integrity of the entire blood cold chain should be an integral part of the global blood distribution system.”  The WHO says, “Deviations from specified temperature ranges and conditions during storage and transportation of blood and blood products can seriously affect the viability of the constituents of blood, thus leading to reduced clinical benefits. It can also increase the risk of bacterial proliferation in blood components during storage and may cause potentially life-threatening transfusion reactions, such as septic shock and even death.”

The WHO notes, “A break in the blood cold chain leads to wastage and discard of unsuitable blood units, which may adversely affect the supply of blood and blood products for transfusion. An effective blood cold chain is essential for the countries to implement strategies to expand safe blood transfusion services to cover wider geographic areas and achieve universal access to safe blood transfusion for all patients who need transfusion.”

Sentry BioPharma Services offers biological product storage to pharmaceutical companies, hospitals and organizations with need for validated refrigerated (+2°C to +8°C) storage and temperature-sensitive product shipping services.  For more information about how Sentry’s GMP warehouse can help protect the integrity of the blood cold chain and biological products in general, contact Sentry via email or by phone at 1-866-757-7400.

Five Benefits of a Self-Directed FTZ Audit

On Thursday, April 21, 2016, Sentry BioPharma Services completed a self-directed (voluntary) inspection of the company’s foreign trade zone (FTZ) and compliance with 15 CFR Part 400.  Randall L. Higgins, Sentry’s Senior Manager of Compliance and Validation, defines five main benefits of an independent compliance evaluation as follows:

Establishes a Professional Relationship

Sentry BioPharma Services establishes a professional relationship with an experienced and specialized service provider for several reasons.  Familiarization with Sentry’s organization, employees, facility layout, policies, procedures, daily activity and compliance history facilitates the uptake of tacit knowledge.   Clear communication channels streamline response time when trouble-shooting a problem or developing a new business opportunity.  Having an established relationship also creates a new avenue for gaining important information and insight, which is especially important as new regulations evolve.

Builds Regulatory Alignment

Tapping the knowledge and experience of a foreign trade zone expert helps a company build stringent alignment with requirements of various regulatory agencies (DEA, FDA & CBP).  Normally, the specialized consultant starts with an unbiased gap analysis to test the company’s system for robustness.  This analysis offers a realistic picture of the present state of affairs.  It also simulates the way a regulatory agency may conduct an impromptu CBP inspection.  The non-threatening environment fosters collaboration to proactively reveal unknown deficiencies and opportunities for improvement.

Drives a Competitive Advantage

Teaming up with a foreign trade zone specialist serves as a competitive advantage.  The FTZ consultant identifies operational inefficiencies and offers suggestions to improve routine and in some cases repetitive tasks.  The import/export professional advice can lead to the elimination of non-value added tasks, simplification of paperwork and the reduction of redundancies.  In some cases, the objective analysis minimizes or eliminates duties, processing fees, violations, fines and penalties.

Cooperates with Administrator of the Grant of Authority

Sentry BioPharma Services’ FTZ is part of Zone 72 and is identified as subzone 011.   Sentry’s zone is located at the Indianapolis International Airport (IND) and is not considered within the customs territory of the United States.  Sentry intends to continue participation in the Federal Foreign Trade Zone program for years to come.  By voluntarily completing an internal FTZ system audit, it demonstrates Sentry’s intent to maintain a good compliance record year-after-year with its grantee.

Cultivates New Business Opportunities

The advice of a foreign trade zone consultant typically brings solutions to pain points in the pharmaceutical supply chain.  In many cases, unique problems serve as opportunities to grow the business and expand the service offering. Clients with temperature-sensitive pharmaceutical products are often looking for ways to better control the pharmaceutical supply chain.  Protecting pharmaceutical product integrity tops the list.  Also high on the list of client needs are expediting shipping and/or customs clearance requests.   Customers benefit from the added level of drug product protection which results in time-saving and overarching risk mitigation.

Mr. Randy Higgins expands, “Sentry BioPharma Services has delivered a pristine regulatory compliance record to existing and prospective clients’ year-after-year.  By embracing self-directed and independent evaluations, Sentry protects the safety, identity, strength, purity and quality (SISPQ) of the pharmaceutical products and controlled substances moving through our GMP warehouse on a daily basis.”

Sentry’s active FTZ status and customs bond support import optimization and control of temperature-sensitive biological and pharmaceutical ingredients, materials, semi-finished and finished drug products.  For more information about how Sentry’s Foreign Trade Zone can help you optimize your medical and pharmaceutical import process, contact Sentry via email or by phone at 1-866-757-7400.

https://enforcement.trade.gov/ftzpage/grantee/regs.html

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