Tag Archives: GMP

Sentry team to participate in the 2019 Susan G. Komen Race for the Cure ®

This Saturday, April 27th, 2019 several Sentry BioPharma Services team members will be proudly participating in the 2019 Komen Central Indiana Race for the Cure ®. 

Over the years this event has raised more than $2 billion dollars to help fund research, education, screening and treatment.  This event is unique in that 100% of the net proceeds are invested in the Komen mission.  25% of all funds go towards research to learn about the biology of breast cancer, advance new screening technologies, develop better treatment protocols and combat metastatic disease.  The remaining 75% is invested in locally through a community grants program.  Last year $697,047 was invested in 9 local breast health programs and provide 40,000 services within a 41-county service area in Indiana.

Our team realizes that fundraising is critical to helping breast cancer patients living right here in central Indiana.  These sobering statistics from the Central Indiana Susan G. Komen website help to bring that need even more into focus.

  • 1 in 8 women in the U.S. will be diagnosed with breast cancer in her lifetime.
  • Every 19 seconds, somewhere in the world, a case of breast cancer is diagnosed.
  • Every 60 seconds, somewhere in the world, someone dies from breast cancer.
  • Every 13 minutes, one woman in the U.S will lose her life to breast cancer.
  • At the current rate, 13 million breast cancer deaths will occur around the world in the next 25 years.

Sentry is determined to take action and this event is our chance to support the Komen organization in its efforts to end breast cancer forever. 

For more info on how you can help please visit the Susan G. Komen® website.

CDC Report: First cases of Candida auris reported in U.S.

On Friday, November 4, 2016 the U.S. Centers for Disease Control and Prevention (CDC) announced the first cases of Candida auris were reported in the United States (U.S.).candida_strain

A strain of Candida auris cultured in a petri dish at CDC.
Photo Credit: Shawn Lockhart, CDC

Thirteen cases of Candida auris (C. auris), a serious and sometimes fatal fungal infection that is emerging globally, have been identified in the United States, according to the CDC. Seven of the cases occurred between May 2013 and August 2016 and are described today in CDC’s Morbidity and Mortality Weekly Report (MMWR). The other six cases were identified after the period covered by the report and are still under investigation.

The following map displays where Candida auris cases have been identified in the United States as of November 4, 2016.

candida

Source of map: https://www.cdc.gov/fungal/diseases/candidiasis/candida-auris.html

The report is the first to describe U.S. cases of C. auris infection. C. auris is often resistant to antifungal drugs and tends to occur in hospitalized patients. In June 2016, CDC issued a clinical alert describing the global emergence of C. auris and requesting that laboratories report C. auris cases and send patient samples to state and local health departments and CDC. Since then, CDC has been investigating reports of C. auris with several state and local health departments. The agency expects to continue to investigate possible cases as awareness of the emerging infection increases.

“We need to act now to better understand, contain and stop the spread of this drug-resistant fungus,” said CDC Director Tom Frieden, M.D., M.P.H. “This is an emerging threat, and we need to protect vulnerable patients and others.”

Among the seven cases detailed in the report, patients with C. auris were reported in four states: New York, Illinois, Maryland and New Jersey. All of the patients had serious underlying medical conditions and had been hospitalized an average of 18 days when C. auris was identified. Four of the patients died; it is unclear whether the deaths were associated with C. auris infection or underlying health conditions.

In two instances, two patients had been treated in the same hospital or long-term-care facility and had nearly identical fungal strains. These findings suggest that C. auris could be spread in healthcare settings.

Six of the seven cases were identified through retrospective review of hospital and reference laboratory records. Identifying C. auris requires specialized laboratory methods because it can easily be misidentified as another type of Candida infection, in which case patients may not receive appropriate treatment. Most of the patient samples in the current report were initially misidentified as another species of Candida.

Most of the C. auris strains from U.S. patients (71 percent) showed some drug resistance, making treatment more difficult. Samples of C. auris strains from other countries have been found to be resistant to all three major classes of antifungal medications. However, none of the U.S. strains in this report were resistant to all three antifungal drug classes. Based on laboratory testing, the U.S. strains were found to be related to strains from South Asia and South America. However, none of the patients travelled to or had any direct links to those regions. Most patients likely acquired the infections locally.

“It appears that C. auris arrived in the United States only in the past few years,” said Tom Chiller, M.D., M.P.H., chief of CDC’s Mycotic Diseases Branch. “We’re working hard with partners to better understand this fungus and how it spreads so we can improve infection control recommendations and help protect people.”

CDC recommends that healthcare professionals implement strict Standard and Contact Precautions to control the spread of C. auris. Facilities should conduct thorough daily and after-discharge cleaning of rooms of C. auris patients with an EPA-registered disinfectant active against fungi. Any cases of C. auris should be reported to CDC and state and local health departments. CDC can assist in identifying this particular type of Candida if needed.

In 2013, CDC issued a report describing antibiotic resistance threats in the United States that needed prompt action, including Candida infections. CDC’s Antibiotic Resistance Laboratory Network is providing additional lab support in four regional laboratories to test fungal susceptibility of Candida species and identify emerging resistance. CDC is also expanding tracking of this fungus through the Emerging Infections Program. Information gathered through these networks plays a key role in tracking resistance and informing policies and interventions.

The challenge of emerging antibiotic resistant threats like C. auris highlights the need for urgent, coordinated federal, state, local, and international public health response and the importance of CDC’s AR Solutions Initiative. The timely investments in the AR Solutions Initiative empower CDC to rapidly detect, investigate, and respond to emerging threats, like C. auris; prevent resistant infections from occurring and spreading across healthcare settings and the community; and innovate, supporting development of new diagnostics and drugs to test, treat, prevent infections, and save lives.

For more information about how Sentry can implement a custom solution to meet your unique pharmaceutical 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.

For more information: https://www.cdc.gov/fungal/diseases/candidiasis/candida-auris.html

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.

pills2

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

Sentry Successfully Launches New Website

Sentry BioPharma Services is very excited to announce the launch of our newly designed website. The site’s homepage fully embraces Sentry’s brand while showcasing an elegant design while providing intuitive navigation. The newly streamlined menus highlight Sentry’s main services from vaccine distribution and GMP pharmaceutical storage to custom solutions such as biopharmaceutical labeling and packaging, controlled substance distribution and our foreign trade zone (FTZ) offering.

One of the most noticeable changes is the full integration our company logo, the Sentry molecule.  Each atom organizes Sentry’s services into five main categories:  temperature, packaging, distribution, clinical trials and custom solutions all of which are held together by Sentry’s stringent quality standards and GMP storage and drug distribution expertise. The ”Learn More” buttons under each service category allow customers easy access to relevant details regarding Sentry’s biorepository and drug distribution capabilities to include controlled substance importation and exportation, API storage, clinical trial labeling and packaging.

“With the changing ways in which information is viewed on the Internet, we wanted to provide a consistent experience across many types of devices.  Our new website is designed using “Responsive Web Design“.  This provides an optimal viewing experience across a wide range of devices, from computer monitors, to tablets and phones.” – Mike Wilson, Information Technology Manager

“As a biopharmaceutical leader, it’s important for us to make information regarding solutions, services and trends easily accessible for our current and prospective clients. We endeavor to provide our clients with the most accurate, up-to-date information and share our knowledge and expertise in the field of temperature- sensitive product management.” – Tim Mitchell, President

“Sentry is a biopharmaceutical contract service provider which maintains an exceptional quality record and provides superior customer service. Our new site is an extension of that service and we are excited to have a platform the effectively reflects our dedication to providing outstanding quality to our clients in every facet of our business and throughout the pharmaceutical supply chain.” – Jennifer Marcum, Chief Executive Officer

For more information about how Sentry can help optimize your solutions for biopharmaceutical product storage, drug distribution, clinical trial packaging and commercial fulfillment, contact Sentry via email or by phone at 1-866-757-7400.

Clinical Trial of Chikungunya Vaccine

Safeguarding the health of clinical trial participants and the progression of trial results demands strict adherence to protocols.  Sentry BioPharma Services specializes in vaccine drug product storage, labeling, kitting and effective distribution for clinical trials worldwide.   Please see the following article concerning the National Institute of Health’s (NIH) phase 2 clinical trial of Chikungunya Vaccine which is now open and seeking patients.

NIH-Sponsored Clinical Trial of Chikungunya Vaccine Opens

This digitally-colorized transmission electron micrograph (TEM) depicts numerous chikungunya virus particles, which are composed of a central dense core that is surrounded by a viral envelope.
Credit: CDC
TEM

An experimental vaccine to protect against the mosquito-borne illness chikungunya is being tested in a Phase 2 trial sponsored by the National Institutes of Health. Results from an initial trial of the vaccine, which was developed by scientists at the NIH National Institute of Allergy and Infectious Diseases (NIAID), were reported in 2014. In that study, all 25 vaccine recipients developed robust immune responses and no safety concerns were noted. The new trial is designed to enroll 400 healthy adult volunteers aged 18 to 60 years old at six sites in the Caribbean. It will continue to gather data on the candidate vaccine’s safety and ability to elicit immune responses, including antibodies.
The hallmark symptoms of chikungunya are severe joint pain accompanied by fever and headache. The pain typically eases after about a week but can persist for months or years in some cases. There are no specific treatments for chikungunya infection and no vaccine to prevent it.
Since its appearance in the Western Hemisphere in late 2013, cases of chikungunya have skyrocketed. So far in 2015, more than 621,000 suspected and confirmed cases have been reported throughout the Americas.
“The recent re-emergence of chikungunya virus in this hemisphere has rapidly become a significant health burden,” said NIAID Director Anthony S. Fauci, M.D.  “Our chikungunya vaccine development efforts are part of a broader research effort to prevent, diagnose, treat and ultimately control this painful illness, which can strike anyone unlucky enough to be bitten by an infected mosquito.”
The experimental vaccine, developed by investigators at NIAID’s Vaccine Research Center, uses virus-like particles (VLPs) instead of either inactivated or weakened whole virus. VLP vaccines can stimulate immune responses comparable to those resulting from naturally acquired immunity following infection and, because virus is not needed to produce VLP vaccines, they do not need to be prepared in high-level biocontainment facilities.
Eligible volunteers will be randomly assigned to enroll into one of two groups of 200 people each. Study participants will receive either two doses of the candidate vaccine spaced 28 days apart or two doses of an inactive placebo. Blood samples will be drawn at multiple time points following the injections to assess whether the candidate vaccine prompted the production of antibodies to chikungunya virus.

Additional details about the trial can be found at ClinicalTrials.gov  using the identifier NCT02562482.

References:

L-J Chang et al. Chikungunya virus-like particle vaccine elicits neutralizing antibodies in healthy adults in a phase I dose escalation clinical trial. The Lancet DOI: 10.1016/S0140-6736(14)61185-5 (2014).

NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

Strict adherence to clinical material management protocols, in combination with proven GMP storage, secondary packaging, distribution, and shipping expertise allow Sentry to provide a variety of flexible services to our clinical trial outsourcing clients.

For more information about how Sentry can integrate your requirements into a scalable, secure, value-added clinical trial logistics solution, contact Sentry via email or by phone at 1-866-757-7400.

HPV (Human Papillomavirus) Vaccine – Gardasil®-9: What You Need to Know

Secure vaccine storage and distribution services protect your inventory throughout the supply chain. Sentry BioPharma Services ensures proper vaccine storage, rotation, accurate tracking and proper distribution of vaccines for routine fulfillment or pandemic response. Standard operating procedures (SOPs) and validated cold chain storage environments minimize time-out-of-refrigeration (TOR) risks, helping to reduce or eliminate waste attributable to inadequate storage methods.  Sentry provides the following vaccine information statement updated recently by the Centers For Disease Control and Prevention (CDC) concerning the human papillomavirus.

Friends

HPV (Human Papillomavirus) Vaccine – Gardasil®-9: What You Need to Know

1. Why get vaccinated?

Gardasil-9 prevents human papillomavirus (HPV) types that cause many cancers, including:

  • cervical cancer in females,
  • vaginal and vulvar cancers in females,
  • anal cancer in females and males,
  • throat cancer in females and males, and
  • penile cancer in males.

In addition, Gardasil-9 prevents HPV types that cause genital warts in both females and males.

In the U.S., about 12,000 women get cervical cancer every year, and about 4,000 women die from it. Gardasil-9 can prevent most of these cases of cervical cancer.

Vaccination is not a substitute for cervical cancer screening. This vaccine does not protect against all HPV types that can cause cervical cancer.  Women should still get regular Pap tests.

HPV infection usually comes from sexual contact, and most people will become infected at some point in their life. About 14 million Americans, including teens, get infected every year.  Most infections will go away and not cause serious problems. But thousands of women and men get cancer and diseases from HPV.

2. HPV vaccine

Gardasil-9 is an FDA-approved HPV vaccine. It is recommended for both males and females. It is routinely given at 11 or 12 years of age, but it may be given beginning at age 9 years through age 26 years.

Three doses of Gardasil-9 are recommended with the second dose given 1-2 months after the first dose and the third dose given 6 months after the first dose.

3. Some people should not get this vaccine:

  • Anyone who has had a severe, life-threatening allergic reaction to a dose of HPV vaccine should not get another dose.
  • Anyone who has a severe (life threatening) allergy to any component of HPV vaccine should not get the vaccine.
  • Tell your doctor if you have any severe allergies that you know of, including a severe allergy to yeast.
  • HPV vaccine is not recommended for pregnant women. If you learn that you were pregnant when you were vaccinated, there is no reason to expect any problems for you or your baby. Any woman who learns she was pregnant when she got Gardasil-9 vaccine is encouraged to contact the manufacturer’s registry for HPV vaccination during pregnancy at 1-800-986-8999. Women who are breastfeeding may be vaccinated.
  • If you have a mild illness, such as a cold, you can probably get the vaccine today. If you are moderately or severely ill, you should probably wait until you recover. Your doctor can advise you.

4. Risks of a vaccine reaction

With any medicine, including vaccines, there is a chance of side effects. These are usually mild and go away on their own, but serious reactions are also possible.

Most people who get HPV vaccine do not have any serious problems with it.

Mild or moderate problems following Gardasil-9:

  • Reactions in the arm where the shot was given:
  • Soreness (about 9 people in 10)
  • Redness or swelling (about 1 person in 3)
  • Fever:
  • Mild (100°F) (about 1 person in 10)
  • Moderate (102°F) (about 1 person in 65)
  • Other problems:
  • Headache (about 1 person in 3)

Problems that could happen after any injected vaccine:

  • People sometimes faint after a medical procedure, including vaccination. Sitting or lying down for about 15 minutes can help prevent fainting, and injuries caused by a fall. Tell your doctor if you feel dizzy, or have vision changes or ringing in the ears.
  • Some people get severe pain in the shoulder and have difficulty moving the arm where a shot was given. This happens very rarely.
  • Any medication can cause a severe allergic reaction. Such reactions from a vaccine are very rare, estimated at about 1 in a million doses, and would happen within a few minutes to a few hours after the vaccination.

As with any medicine, there is a very remote chance of a vaccine causing a serious injury or death.

The safety of vaccines is always being monitored.  For more information, visit: www.cdc.gov/vaccinesafety/.

5. What if there is a serious reaction?

What should I look for?

Look for anything that concerns you, such as signs of a severe allergic reaction, very high fever, or unusual behavior.

Signs of a severe allergic reaction can include hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, and weakness. These would usually start a few minutes to a few hours after the vaccination.

What should I do?

If you think it is a severe allergic reaction or other emergency that can’t wait, call 9-1-1 or get to the nearest hospital. Otherwise, call your doctor.

Afterward, the reaction should be reported to the “Vaccine Adverse Event Reporting System” (VAERS). Your doctor should file this report, or you can do it yourself through the VAERS web site at www.vaers.hhs.gov, or by calling 1-800-822-7967.  VAERS does not give medical advice.

6. The National Vaccine Injury Compensation Program

The National Vaccine Injury Compensation Program (VICP) is a federal program that was created to compensate people who may have been injured by certain vaccines.

Persons who believe they may have been injured by a vaccine can learn about the program and about filing a claim by calling 1-800-338-2382 or visiting the VICP website at www.hrsa.gov/vaccinecompensation. There is a time limit to file a claim for compensation.

7. How can I learn more?

  • Ask your health care provider. He or she can give you the vaccine package insert or suggest other sources of information.
  • Call your local or state health department.
  • Contact the Centers for Disease Control and Prevention (CDC):
  • Call 1-800-232-4636 (1-800-CDC-INFO) or

Visit CDC’s website at www.cdc.gov/hpv 

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.

 

Global Drug Supply Disruptions

Sentry BioPharma Services is a leading service provider for pharmaceutical companies needing to diversify their critical drug safety stocks, thereby reducing their risk of drug shortages brought on by unforeseen calamities.

“In the aftermath of the devastating earthquake and tsunami on March 11, 2011, our company entered into numerous agreements with Japanese pharmaceutical manufacturers,” stated Tim Mitchell, Sentry’s President.  “In support of their risk mitigation programs, companies divided their critical drug supplies between their facilities and Sentry’s central Indiana U.S. GMP facility”.

Earthquake

April 2016 Earthquake area: Traced from a report of The Geospatial Information Authority of Japan. 

The article below is provided for information purposes. 

Japan Today AFP

Plants shut down after quake, fueling economic fears

Apr. 16, 2016 – 06:10AM JST

TOKYO —

Some of Japan’s biggest firms including Sony and Toyota shut down operations in southern Japan Friday after the region’s deadly earthquake…

Read more…

Sentry provides GMP validated temperature product management and global distribution of high value drug products, from API to finished vaccines.  Sentry’s validated temperatures range from +15°C to -90°C with multiple temperature set points in between.

To learn more about how Sentry can help your company lower product loss risks contact Sentry via email or by phone at 1-866-757-7400.

Sentry Helps the DEA to Raise Public Awareness about the 11th 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, April 30, 2016 from 10:00 a.m. to 2:00 p.m. at numerous collection sites around the U.S.

“The DEA’s program is designed to focus national attention on the proper disposal of prescription drugs and controlled substances,” said Ms. Jennifer Marcum, Sentry BioPharma Services’ chief executive officer.  Marcum continued, “During the event, people can bring their 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 not only free and anonymous, but also an ideal way to preserve the environment from unwanted pharmaceutical contamination.  This is a terrific opportunity for those who missed the previous events, or who have subsequently accumulated unwanted, unused prescription drugs, to safely dispose of those medications.”

Americans that participated in the DEA’s tenth annual National Prescription Drug Take-Back Day on September 26, 2015, turned in more than 350 tons of unwanted or expired medications for safe and proper drug disposal at more than 5,000 take-back collections sites available in all 50 states and U.S. territories.  When the results of the ten prior Take-Back Days are combined, the DEA, and its state, local, and tribal law-enforcement and community partners have removed 5,525,021 pounds of drugs from circulation.

“The numbers are shocking—approximately 46,000 Americans die each year from drug-related deaths.  More than half of those are from heroin and prescription opioids,” said Acting DEA Administrator Chuck Rosenberg.  “With four out of five new heroin users starting with prescription medications, I know our take-back program makes a real difference.”  The NTBI addresses a crucial public safety and public health issue.  According to the 2014 National Survey on Drug Use and Health, 6.5 million Americans abused controlled prescription drugs.  That same study showed that a majority of abused prescription drugs are obtained from family and friends, including from the home medicine cabinet.  The DEA’s NTBI events are also a significant piece of the White House Office of National Drug Control Policy’s prescription drug abuse prevention strategy.

Sentry BioPharma Services will also continue its support of the DEA’s efforts by helping to raise public awareness of this important initiative.  For more information about the drug disposal program, general public inquiries can be made by calling the DEA toll free at: 1-800-882-9539.