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rfxcel Responds to Unprecedented Cold Chain Requirements and Logistics Challenges as COVID-19 Vaccine Distribution Nears

Reno, Nevada, Dec. 2, 2020. rfxcel, the global leader in digital supply chain traceability solutions, continues to address cold chain and logistical challenges it anticipates will arise from the first widespread distribution of COVID-19 vaccines. The company has been preparing for a “vaccine surge” since the pandemic began to ensure it can respond to customer and industry needs when distribution begins to exert pressure on supply chains.

“The pandemic has revealed shortcomings in every supply chain, and we’ve seen increased competition for resources,” said rfxcel CEO and Co-Founder Glenn Abood. “We’ve worked with our global customers in pharma/life sciences, food and beverage, consumer goods, and government to keep their operations responsive and nimble. Now, we’re prepared to address additional stresses distribution of COVID-19 vaccines could create as the call for ‘all hands on deck’ commences and already scarce resources are redirected for the effort.”

rfxcel has provided traceability solutions since 2003. Its rfxcel Traceability System comprises discrete solutions that work in concert to harmonize, optimize, automate, and monitor supply chain operations, including serialization, compliance, environmental monitoring, raw materials traceability, and data analytics.

The company’s Integrated Monitoring (rIM) solution uses Internet of Things (IoT) technology to monitor the environmental condition of products in real time as they move through supply chains on land, sea, and air. rIM communicates with small IoT-enabled devices embedded with products and sends updates and alerts about more than a dozen environmental conditions, such as temperature, location, humidity, light, and shock. It can alert users about route diversions and ensure logistics providers remain in compliance with delivery agreements.

rfxcel has also developed Accurate Immunization Management (AIM), an automated, cloud-based solution that tracks the dispensing of vaccines. It seamlessly integrates with critical healthcare applications such as Electronic Health Records (EHRs) and Immunization Information Systems (IIS). It empowers healthcare practitioners to view patients’ immunization records in real time, manage accurate administering, monitor inventory, and safely dispense the right vaccines to the right patient at the right time. Because it is automated, users can be up and running with virtually no training, ensuring quick implementation in mission-critical locations.

“We want to provide foolproof traceability,” Abood said. “Today, it’s more important than ever to be able to question, examine, and control every part of the supply chain, which is what our rfxcel Traceability System platform provides with solutions such as rIM and AIM.”

For more information about rfxcel’s Traceability System, rIM, AIM, and other solutions, contact Herb Wong, vice president of marketing and strategic initiatives, at hwong@rfxcel.com or 925-824-0300.

About rfxcel

Founded in 2003, rfxcel provides leading-edge software solutions to help companies build and manage their digital supply chain, lower costs, and protect their products and brand reputations. Blue-chip organizations in the life sciences (pharmaceuticals and medical devices), food and beverage, worldwide government, and consumer goods industries trust rfxcel’s signature Traceability System (rTS) to power end-to-end supply chain solutions in key areas such as track and trace, environmental monitoring, regulatory compliance, serialization, and visibility. The company is headquartered in the United States and has offices in the United Kingdom, the EU, Latin America, Russia, India, Japan, the Middle East, and the Asia-Pacific region.

FDA DSCSA Guidance Update: Transaction and Distribution Activities During COVID-19 Emergency

On April 30, the U.S. Food and Drug Administration (FDA) issued guidance for “flexibility” pertaining to certain transaction and wholesale distribution activities under the Drug Supply Chain Security Act (DSCSA). This was a direct response to the COVID-19 public health emergency. Here’s what the FDA DSCSA guidance says.

Legal Basis for the FDA DSCSA Guidance

Public health emergencies in the United States are provided for under Section 319 of the Public Health Service Act (PHS Act). When an emergency is declared, two statutory provisions in the Federal Food, Drug, and Cosmetic Act (FD&C Act) are automatically triggered:

    1. The exemption of certain product distribution activities from the definition of transaction under the FD&C Act section 581(24)
    2. The exclusion of certain product distribution activities from the definition of wholesale distribution under the FD&C Act section 503(e)(4)

What the FDA DSCSA Guidance Says

The transaction exemption and wholesale distribution exclusion provisions mean that two DSCSA requirements do not apply to some distribution activities during the COVID-19 public health emergency:

1. Distribution of “covered COVID-19 products” to address the public health emergency. The transaction exemption and wholesale distribution exclusion apply to the following:

    • The distribution of prescription drug products that have been issued an Emergency Use Authorization (EAU) by the FDA. To date, this includes hydroxychloroquine sulfate, chloroquine phosphate, and, as of today, May 1, remdesivir. An EAU designation does not mean the FDA has approved a drug for a specific use; to date, the FDA has not approved any product to treat COVID-19.
    • FDA-approved products to diagnose, cure, mitigate, treat, or prevent COVID-19. According to the FDA website, this includes in vitro diagnostic products; high complexity molecular-based laboratory developed tests; personal protective equipment and related devices; ventilators and other medical devices; and therapeutics.

The FDA says that companies involved in the distribution of covered COVID-19 products should “maintain the security of the supply chain as these products are distributed to address the urgent public health need.” If possible, companies should continue to fully comply with the DSCSA regulations if doing so isn’t “a barrier to timely distribution of covered COVID-19 products.”

2. Distribution of other products affected by the COVID-19 public health emergency. The transaction exemption and wholesale distribution exclusion also extend to the distribution of “other affected products in certain circumstances.” For COVID-19, these circumstances exist when:

    • The distribution activities are directly affected by the COVID-19 public health emergency.
    • The distribution activities are for emergency medical reasons, such as treating symptoms of COVID-19.

The FDA gives three examples of when the COVID-19 public health emergency could directly affect distribution of these other products:

    • Distribution to an area where product availability is limited and there is higher demand.
    • Distribution by an authorized trading partner that needs to establish a new, temporary facility for distribution.
    • Dispenser-to-dispenser transfers of products that are needed, regardless of whether there is a specific patient need.

3. There are a few other parameters for the FDA DSCSA Guidance: 

    • They apply only to products distributed to address the COVID-19 public health emergency.
    • They apply to products that were already in the supply chain when the COVID-19 public health emergency was first declared.
    • They do not apply to a drug shortage unless it is caused by the public health emergency.
    • They are in effect only as long as the COVID-19 public health emergency is in effect.

Final thoughts

For the record, the U.S. COVID-19 public health emergency first went into effect on January 27, 2020. A 90-day renewal took effect on April 26. And as we all know, it’s had a huge impact on people’s lives and the global economy.

rfxcel is committed to being part of the solution. We recently released our Accurate Immunization Management Solution (AIM), an automated, cloud-based solution that tracks the dispensing of vaccines in the supply chain — including potential COVID-19 vaccines. We’ve joined the COVID-19 Healthcare Coalition. We are open and operating at full capacity. Contact us today if you have any questions about our supply chain visibility solutions or our work during the COVID-19 public health emergency.

 

COVID-19 (Coronavirus) and the Global Supply Chain: 5 Things to Know

COVID-19 has affected a wide array of industries and their supply chains. A February 7 article in Forbes reported that 421 global companies, including 394 based in the United States, had discussed the COVID-19 outbreak in China during calls about first-quarter earnings. Their conclusion? The virus could have a negative impact on financial performance for that timeframe.

rfxcel is monitoring news about COVID-19. Below, we summarize five of the most recent developments. As we all know, the situation is changing every day — as do the key takeaways about how the virus is affecting global supply chains — so these are snapshots, not analyses, predictions, or conclusions.

We’ll continue following the situation, so check back often for updates.

1. Monday, Feb. 24: Potential U.S. Supply Chain Disruptions as More COVID-19 Cases Reported in China, Japan, and South Korea

China, Japan, and South Korea are major U.S. trading partners. Combined, these countries accounted for more than 25% of total American imports in 2019. Let’s break down the numbers from the U.S. Census Bureau to get an idea of the potential impacts on U.S. supply chains if factories in these countries were shut down for long periods.

China: No. 3 in total trade value in 2019
    • From 2018 to 2019, China’s trade with the United States fell 15.15 percent, from $654.36 billion to $555.25 billion.
    • In 2019, exports totaled $106.63 billion and imports totaled $448.62 billion (deficit of $342 billion).
    • Top 10 exports: civilian aircraft, parts; computer chips; soybeans; motor vehicles for transporting people; machinery, parts for semiconductor manufacturing; medical instruments for surgeons, dentists, vets; oil; plasma, vaccines, blood; medical equipment for physicals; medicines in individual dosage
    • Top 10 imports: cell phones, related equipment; computers; toys, children’s bicycles, games; TVs, computer monitors; motor vehicle parts; furniture, parts; seats, excluding barber, dental; electric water, space, soil heaters; lamp and lighting parts; computer parts
Japan: No. 4 in total trade value in 2019
    • Trade totaled $218.29 billion. Exports totaled $74.65 billion and imports totaled $143.64 billion (deficit of $68.98 billion).
    • Top 10 exports: civilian aircraft, parts; petroleum gases, other gaseous hydrocarbons; medical instruments for surgeons, dentists, vets; medicines in individual dosages; corn; machinery, parts for semiconductor manufacturing; pork meat, fresh, frozen or chilled; coal, briquettes; plasma, vaccines, blood; oil
    • Top 10 imports: motor vehicles for transporting people; motor vehicle parts; machinery, parts for semiconductor manufacturing; self-propelled heavy construction machinery; defense-related aircraft, parts; printers, all types, parts; value added to a returned import; medicines in individual dosages; motor vehicle engines; aircraft engines, engine parts
South Korea: No. 6 in total trade value in 2019
    • Trade totaled $134.41 billion. Exports totaled $56.9 billion and imports totaled $77.51 billion (deficit of $20.61 billion).
    • Top 10 exports: oil; machinery, parts for semiconductor manufacturing; computer chips; petroleum gases, other gaseous hydrocarbons; civilian aircraft, parts; motor vehicles for transporting people; frozen beef; medical instruments for surgeons, dentists, vets; gasoline, other fuels; acyclic alcohols
    • Top 10 imports: motor vehicles for transporting people; motor vehicle parts; gasoline, other fuels; computer parts; cell phones, related equipment; computer chips; plasma, vaccines, blood; unrecorded media for audio; rubber tires; refrigerators, freezers

2. Monday, Feb. 24: Shanghai introduces measures to help companies resume production and mitigate impact of COVID-19 outbreak

Local authorities in Shanghai’s Pudong New Area have introduced rent reduction, rent exemption, and other policies to help companies affected by the virus. The Pudong New Area is home to the Lujiazui Finance and Trade Zone and the Shanghai Stock Exchange, as well as the Port of Shanghai, the Shanghai Pudong International Airport, and the Zhangjiang Hi-Tech Park.

The Pudong New Area State-owned Assets Supervision and Administration Commission said more than 1 billion yuan (approximately $142 million) in rent reduction and exemption would benefit about 8,000 companies in the industry, retail, commerce, and technical services sectors.

According to officials, 66 percent of industrial enterprises, 93 percent of software information service companies, and more than 85 percent of foreign trade enterprises have resumed work in this key economic area.

In the nearby Lingang Special Area of China (Shanghai) Pilot Free Trade Zone, 971 companies have resumed operation and more than 40,000 employees have returned to work. Key sectors here include integrated circuits, artificial intelligence, biomedicine, aerospace, and new energy vehicles.

3. Friday, Feb. 21: Chinese President Xi Jinping says manufacturing supply chains should get help to resume output

At the meeting of the Communist Party Politburo on February 21, the Chinese president said the country must work to both contain the spread of COVID-19 and ensure that industry can resume output and meet economic targets. These comments came as businesses question Chinese suppliers’ ability to meet demand and consider finding other places to source materials.

“Priority should be given to ensure leading companies that are important in the global supply chain restore production and supply, maintaining the stability of the supply chain,” he said to the 25-member Politburo. “It is necessary to help key export enterprises resume work and production as soon as possible.”

4. Monday, Feb. 17: China has issued 1,600+ “force majeure certificates” to protect companies from legal damages arising from the COVID-19 outbreak

The China Council for the Promotion of International Trade (CCPIT) has issued 1,615 force majeure certificates to companies in more than 30 sectors, covering a total contract value of 109.9 billion yuan (approximately $15.7 billion).

Furthermore, China’s Ministry of Commerce has instructed six trade associations in the healthcare, textile, machinery, mining and other sectors to help with legal counseling and applying for the certificates.

A certificate protects a company that does not perform or only partially performs contractual duties by proving it is being affected by circumstances that are beyond its control. The CCPIT says its certificates are recognized by governments, customs organizations, trade associations ,and enterprises in more than 200 countries and regions.

5. Tuesday, Feb. 11: Dun and Bradstreet release white paper about COVID-19’s effect on global business

Here’s what the commercial data and analytics company estimates:

    • Approximately 90% of all active businesses in China are in the regions affected by COVID-19.
    • At least 51,000 companies around the world have one or more direct or Tier 1 suppliers in the affected region; 163 of these are Fortune 1000 companies.
    • At least 5 million companies have one or more Tier 2 suppliers in the affected region; 938 of these are Fortune 1000 companies.
    • Currently, 49,000 businesses in the affected region are branches or subsidiaries of companies headquartered outside China. Nearly half of these are based in Hong Kong, 19% are in the United States, 12% in Japan, and 5% in Germany. Other countries include the United Kingdom (including the Virgin Islands), the Cayman Islands, the Netherlands, Switzerland, and France.