Tag Archives: pharmaceutical drug distribution

Sentry Opens New Qualified Shipping Lane to Puerto Rico

Sentry BioPharma Services announced the successful opening of a qualified shipping lane for pharmaceutical drug product between its facility in Indianapolis, Indiana and San Juan, Puerto Rico.

On August 17th, 2016 a dry ice shipment of drug product was delivered to San Juan, PR, 00926 via FedEx International Priority Service.  The -80º Celsius product arrived next day in San Juan within the qualified temperature range.

Background.  As pharmaceutical cold chain management has become a more critical component in the global biopharmaceutical supply chain, regulatory agencies and industry associations have been launched solely to develop standards for compliance in this market.  Achieving regulatory compliance was a much simpler task in traditional supply chain models of the past. Now, due to an increasingly complex set of social, scientific and political pressures, industry mandates and international regulations have become significantly more stringent. Each country has its own body of rules and guidelines governing the shipment and handling of pharmaceutical and biological products. A qualified pharmaceutical cold chain management and 3PL partner must demonstrate compliance with international guidelines.

In addition to mandates prescribed by external regulatory agencies, the industry has begun to develop its own body of industry-accepted standards for biopharmaceutical distribution and handling. Several prominent groups have been formed throughout the world to discuss regional challenges and issues; collaborate on problem-solving; examine emerging trends; and define industry best practices. A pharmaceutical cold chain management partner should be familiar with the standards being developed by leading international pharmaceutical discussion groups. 

Ship-To 08-17-16

Custom Pharmaceutical Product Management, Distribution and Patient Support

Sentry provides scalable clinical trial and commercial pharmaceutical drug distribution globally. As with all programs, Sentry maintains regulatory compliance and transparency in fulfilling orders placed by clinics, hospitals, pharmaceutical distributors and other licensed recipients.

Clinical and Commercial Drug Distribution Support

  • 24/7 order receipt
  • Client ERP integration possible
  • Destructions program
  • Returns program
  • Single point of contact
  • Transparent business support

Sentry, as a cold chain logistics partner can provide immediate access to its state-of-the-art GMP storage facility that has been designed to meet the unique requirements of temperature-sensitive drug products. It offers: validated, temperature controlled storage and temperature-monitoring equipment; redundant power, cooling and environmental monitoring systems; redundant data storage capabilities; and sophisticated data security systems.

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

Sentry Attends CBP’s International Trade Meeting for Q2-2016

Several members of Sentry BioPharma Services’ compliance team voluntarily attended the Q2-2016 international trade meeting hosted by the U.S. Customs and Border Protection (CBP) on Wednesday, June 8, 2016 at the Indianapolis International Airport (IND).   James Moore presently serves as Port Director for Indianapolis, Indiana and opened the meeting by welcoming guests and reviewing the agenda.

The three main topics were discussed during the event:international

H.R. Bill 644 was passed by the 114th Congress on February 24, 2016.  Section 101 of the bill states, “This bill directs the U.S. Customs and Border Protection (CBP) to ensure that CBP partnership programs, such as the Customs-Trade Partnership Against Terrorism, provide trade benefits to importers, exporters, and certain other private sector entities that meet program requirements.”

Port Director Moore reinforced the CBP’s position by saying, the CBP port in Indianapolis, Indianapolis will make every effort to protect your brand and run as smoothly as possible.

Director Moore commented, “The U.S. Customs and Border Protection (CBP) enforces Intellectual Property Rights (IPR), most visibly by seizing products that infringe IPR such as trade­marks, copyrights, and patents. The theft of intel­lectual property and trade in fake goods threaten America’s economic vitality and national security, and the American people’s health and safety. Trade in these illicit goods funds criminal activities and orga­nized crime.

To protect both private industry and consumers, CBP has made IPR enforcement a priority trade issue. CBP has developed a multi-layered, strategic approach to IPR enforcement. In addition to seizing goods at U.S. borders, the strategy includes expanding the border through post-import audits of companies that have been caught bringing fake goods into the United States, collaboration with our trading part­ners, and partnering with industry and other federal agencies to enhance these efforts. CBP also issues civil fines and, where appropriate, refers cases to other law enforcement agencies for criminal investigation.

CBP uses technology to increase interdiction of fake goods, facilitate partnerships with industry, and enhance enforcement efforts through the sharing of information and intelligence. CBP is refining its risk modeling technology to more accurately identify sus­pected shipments of counterfeit and pirated goods for inspection.

Rights holders can use our web-based tool, e-Recordation, to record their trademarks and copyrights with CBP. Recordation makes information on protected rights available to CBP offices through­out the United States.

Our online trade violation reporting system, e-Allegations, makes it easier for the private sector to notify CBP of possible IPR violations and other trade violations.

In IPR audits, an innovative enforcement practice, CBP audits the business records of companies at high risk for importing counterfeits, issues penalties for infringing goods uncovered in the audits, and works with companies to improve their internal controls.

CBP is a partner at the interagency National Intellectual Property Rights Coordination Center (IPR Center). The IPR Center is designed to leverage the resources and authorities of partner agencies for criminal enforcement of IPR.”

Learn more about Customs and Border Protection and the Indianapolis port at https://www.cbp.gov/contact/ports/indianapolis.

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.

DEA’s 2016 Controlled Substance Distributor Conference

Sentry BioPharma Services attended the Controlled Substance Distributor Conference, hosted by the Drug Enforcement Administration (DEA), Office of Diversion Control, in Indianapolis, Indiana on May 10 – 11, 2016. The topics presented include prescription drug and chemical trends, ARCOS/record keeping, drug disposal and effective controls against drug diversion.

Jennifer Marcum, Sentry’s CEO, says, “Overall, the controlled substance distributors’ conference was informative with much emphasis being placed on the addiction epidemic, controlled substance trends and the emergence of illegal pain management clinics.”  Ms. Marcum continued, “The DEA is very clear about compliance with 21 CFR 1306.04(a).  The DEA wants to enable practitioners to issue prescriptions for legitimate medical purposes.  The DEA expects all members of the pharmaceutical supply chain to manufacture according to GMPs, to tightly control inventory and to maintain accurate records.”

James A. Arnold, Acting Chief Liaison & Policy Section, addressed the opioid prescription problem, the public health epidemic and the impact on society.

OPIOID PROBLEM

Between 2000 and 2014, there has been a 137% increase in unintentional deaths due to a prescription overdose.  28,647 deaths involved an opioid in 2014.  The number of deaths per year exceeds that of motor vehicle accidents.  Opioid addiction and abuse is a very serious situation in the U.S.   Heroin, an illegal highly addictive analgesic drug derived from morphine, usage and death rates skyrocketed in 2015.  However, heroin is only part of the problem.  More and more people are getting hooked on prescription painkillers, laced illicit drugs and lethal drug cocktails like the “Holy Trinity” consisting of hydrocodone, carisoprodol and alprazolam.  Heroin mixed with fentanyl creates a deadly drug combo that is 100 times more potent than morphine.  Just one-fourth of 1 mg of fentanyl is enough to be potentially fatal.  Read more about the DEA’s 2015 Drugs of Abuse Report: https://www.dea.gov/pr/multimedia-library/publications/drug_of_abuse.pdf

PUBLIC HEALTH EPIDEMIC & TRENDS

An opioid and prescription drug abuse epidemic is sweeping the U.S., impacting all segments of society. Opioid-related hospitalizations and infections from contaminated needles have caused the total opioid-related healthcare costs to rise significantly.  Read the DEA’s Drug Fact Sheet for the latest information on substances:  https://www.dea.gov/druginfo/factsheets.shtml

IMPACT ON SOCIETY

The Federal Bureau of Investigation (FBI) and DEA have an effective enforcement program for arresting people and attacking the supply of the opiates.  But to reduce the demand for the drugs, the FBI and DEA are collaboratively deploying outreach programs to educate the public about what lies in wait for somebody who experiments opioids. 

To help increase awareness about this epidemic and to help educate young people on the dangers of addiction, the FBI and DEA have released the documentary Chasing the Dragon: The Life of an Opiate Addict, a compilation of heart-wrenching first-person accounts by addicts, and family members of addicts, about their experiences.

For more information about how Sentry can meet safety and regulatory demands for pharmaceutical packaging, GMP storage, drug distribution and controlled substance disposal, contact Sentry via email or by phone at 1-866-757-7400.

Sentry BioPharma Services Implements Technology Upgrade with State-of-the Art Systems

Sentry BioPharma Services admits one of the most exciting and frustrating aspects of information technology is the speed with which change occurs. New hardware and software products emerge with attractive features that make it easier for users to perform their jobs.

This becomes even more challenging when upgrade activities must comply with GAMP5 and 21 CFR Part 11 for GMP systems. The pharmaceutical and biotechnology industries mandate change control and software validation to prove control, avoid a breach and maintain data integrity. This is a very intentional process.

Information technology comprises:

  • Client software
  • Computer systems
  • Network devices (routers, switches, network printers)
  • Network infrastructure (cabling, internet connection)
  • Peripherals (monitors, scanners, local printers)
  • Security devices (firewalls, biometric and smart card readers, IDS appliances)
  • Server hardware
  • Server software
  • Software packages

In 2012, Sentry BioPharma Services planned a multi-year technology upgrade program which commenced with an upgrade of user’s work stations, business servers and moved into upgrading the company’s non-GMP enterprise resource planning (ERP) system to optimize efficiencies. In the past two years, Sentry successfully upgraded and validated the building management system (BMS).

“Sentry’s information technology program is important to all of our pharmaceutical and biotech clients,” says Jennifer Marcum, CEO. She continues, “The U.S. Department of Homeland Security (DHS) warns of sophisticated cyber attackers and nation-states planning to exploit vulnerabilities to steal information and corrupt systems. The ‘bad guys’ are developing capabilities to disrupt, destroy, or threaten the delivery of essential services globally. We must be vigilant in maintaining awareness and managing the risks to thwart their plans whenever possible.”

Sentry’s technology upgrade program even includes upgrading the company’s website with mobile-friendly enhancements designed to improve prospective and existing client’s Web experience. The new website “Go Live” date is presently scheduled for the end of March, 2016.

https://www.dhs.gov/topic/cybersecurity