Tag Archives: controlled substances

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.

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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

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.