March 2020 - rfxcel.com
EnglishFrenchGermanItalianPortugueseRussianSpanish

COVID-19 and the Retail Food & Beverage Supply Chain: Industry Update

March 31, 2020: Chances are your life isn’t the same as it was just two or three weeks ago. In the time of COVID-19, you might be self-quarantining. Your local government may have closed your neighborhood playgrounds and parks. Or maybe your governor has issued a stay-at-home order.

There’s also a very good chance that many of your favorite restaurants and bars are closed. In fact, all the “non-essential” or “non-life-sustaining” businesses in your community might be shut down.

One thing hasn’t changed, however: You can still go to the grocery store. You may have to wait in a line, standing on lengths of tape or spray-painted lines spaced at the proper social distance (six feet). Your store may limit how many people are allowed inside at one time. It may have set up special hours for senior citizens to shop.

But your grocery store is still open. This means the food and beverage supply chain continues to operate during the COVID-19 pandemic. Let’s take a look at a few things you should be aware of today.

1. The Basics: What is the CDC saying about grocery stores and COVID-19?

The Centers for Disease Control and Prevention (CDC) doesn’t have specific guidance for grocery stores; instead, it provides “Interim Guidance for Businesses and Employers to Plan and Respond to Coronavirus Disease 2019 (COVID-19).” It clearly states that businesses and employers can prevent and slow the spread of COVID-19.

The CDC’s key recommendations are summarized below. See the full details here, and visit the CDC website regularly to get the latest news about COVID-19 and recommendations for staying safe.

Reduce transmission among employees

    • Actively encourage sick employees to stay home.
    • Identify where and how workers might be exposed to COVID-19 at work.
    • Separate sick employees.
    • Educate employees about how they can reduce the spread of COVID-19.

Maintain healthy business operations

    • Identify a workplace coordinator who will be responsible for COVID-19 issues and their impact at the workplace.
    • Implement flexible sick leave and supportive policies and practices.
    • Assess your essential functions and the reliance that others and the community have on your services or products.
    • Determine how you will operate if absenteeism spikes (e.g., from employees getting sick or having to stay home to care for family members or to watch children).
    • Establish policies and practices for social distancing.
    • If you have more than one business location, give local managers the authority to take appropriate actions outlined in their COVID-19 response plan based on local conditions.

Maintain a healthy work environment

    • Consider improving the engineering controls using the building ventilation system (e.g., increase ventilation rates and the percentage of outdoor air that circulates into the system).
    • Support respiratory etiquette and hand hygiene for employees, customers, and worksite visitors.
    • Perform routine environmental cleaning.
    • Perform enhanced cleaning and disinfection after people suspected/confirmed to have COVID-19 have been in your place of business.

2. What are industry associations saying about COVID-19?

Grocery workers are being hailed as heroes and front-line fighters; they are the penultimate link the retail food supply chain, the people who literally hand products to consumers. Here is what some industry associations in the United States are saying about COVID-19.

The National Grocer’s Association provides best practices for its members. These follow the CDC guidance, but also have grocery-specific recommendations, such as:

    • Assigning employees to regularly sanitize shopping carts and other high-traffic or high-touch areas
    • Increasing or adding hand sanitizing stations around stores for customers and employees
    • Changing store hours to encourage shopping at times with fewer people
    • Scheduling specific hours of operation for vulnerable populations to shop without other customers

The Food Industry Association provides extensive resources about COVID-19. Visit its “Key Resources” page here. It also offers two excellent publications for download: Guidance for the Food Industry: Coronavirus Outbreak: I. Best Practices and Planning for the Immediate Situation (March 17, 2020) and Guidance for the Food Industry: Coronavirus Outbreak II. Short-Term Best Practices (March 26, 2020). Both offer guidance and information about the food supply chain, including:

    • Evaluate receiving and delivery practices to minimize human-to-human contact. For example, limit the sharing of pens or equipment.
    • Work with suppliers to identify local manufacturers and producers of essential products.
    • Coordinate with buying departments or retail customers; learn about their plans to “bulk up” on core items so facilities can be secured for emergency storage.
    • Increase volumes in-demand items such as pasta, sauces, canned foods, instant noodles, frozen meals/foods, cleaning detergents, alcohol, hand sanitizer, and paper products.
    • Offer to collect from suppliers where stock is available; agree on basic commercial terms to cover costs.
    • Accept deliveries when they’re available from suppliers and prioritize inbound bookings.
    • Relax on-time performance metrics.

The American Beverage Association is one of 60 signatories to a letter advocating for a national public framework in which food, beverage, and consumer packaged goods manufacturers and their transporters are exempt from bans and curfews. It called for “uniformity and consistent policies,” noting that food, beverage, and other packaged goods manufacturing facilities have been exempted from bans and curfews in some states but not others. These groups say a uniform national policy will “ensure continuous delivery of essential services.”

Furthermore, on March 18, the association sent a letter directly to President Trump “advocating for common-sense actions to help our industry operate and deliver products during this challenging time.” These include (quoted verbatim):

    • Exempting employees involved in the manufacture, distribution, delivery, and stocking of food and beverage items from federal, state, or local restrictions to ensure continuous delivery of essential services.
    • Putting forth an executive action to lift truck weight limits, historically governed by state law, to facilitate meeting the critical need of delivering essential goods in response to COVID-19.
    • Clarifying ambiguity surrounding the Federal Motor Carrier Safety Administration’s (FMCSA) hours of service guidance. Specifically, requesting the FMCSA clarify in writing that the restocking of grocery store shelves by delivery drivers is included in what constitutes direct assistance for supporting emergency relief efforts.

3. What is the U.S. Food and Drug Administration (FDA) saying about COVID-19 and the food supply chain?

The FDA released its latest statement concerning the food supply chain on March 28. In it, the agency said it was “working around the clock to make sure that Americans have access to safe food and medical products.” Here are the key statements concerning the food supply:

    • Retail supply chains remain strong.
    • The FDA is working with food manufacturers and grocery stores to identify shortages in the human and animal food supply chain. It is in contact with industry and trade associations about supply chain issues.
    • There are “no widespread disruptions reported in the [human and animal food] supply chain.”
    • “Empty grocery shelves” resulted from “unprecedented demand,” not shortcomings in the ability to produce, process, and deliver goods.

On March 26, the FDA released “Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency: Guidance for Industry” (Docket No. FDA-2020-D-1108). It states the FDA’s “current intent … in certain circumstances related to the impact of the coronavirus outbreak (COVID-19).” It contains nonbinding recommendations, not a legal pronouncements; companies “can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.”

The document address regulations in three areas

    1. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
    2. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
    3. Foreign Supplier Verification Programs for Importers of Food for Humans and Animals

Final Thoughts

The situation is changing every hour, every day. Like all responsible companies, rfxcel is monitoring the spread and affects of COVID-19. Foremost in our minds is the well-being of our employees and their families and our customers and their employees and families.

As for the F&B supply chain, we have powerful solutions to help keep things moving. The latest version of our signature rfxcel Traceability System (rTS) is the most complete and flexible raw materials and finished goods traceability solution for F&B. And our rfxcel MobileTraceability app can track any batch, movement, and handler at any location, putting the power of a digital supply chain at your fingertips. Learn more about these and our other solutions for F&B here.

And we want our customers to know we are open and operating at full capacity. Our supply chain solutions are designed to keep working under extraordinary circumstances. If you have any questions or concerns, contact your rfxcel account and project managers.

Please keep an eye out for further updates via email and on our website, and contact us if you have any questions, We are here to help and answer your questions.

rfxcel Announces Accurate Immunization Management Solution to Aid in the Fight Against COVID-19

Reno, Nevada, March 23, 2020. rfxcel, the longest-tenured track and trace solutions provider in the life sciences industry, today announced the launch of Accurate Immunization Management (AIM), an automated, cloud-based solution that tracks the dispensing of vaccines in the supply chain and seamlessly integrates with critical healthcare applications such as Electronic Health Records (EHRs) and Immunization Information Systems (IIS).

“AIM ensures that the right patient gets the right vaccine at the right time,” rfxcel CEO Glenn Abood said. “It can track any vaccine, including potential vaccines for COVID-19, in any supply chain, monitor inventory, and facilitate safe, timely delivery to any location. At a time when the world is depending on supply chains to function at peak performance, AIM is a tool to get vaccines properly delivered and dispensed.”

Abood, who founded rfxcel in 2003 with Chief Strategy Officer Jack Tarkoff, emphasized that AIM utilizes a configurable rules engine and automated inventory reordering to ensure that vaccines are always on hand and are delivered as intended.

“We designed AIM to be compliant, fast, and flexible in any country,” Abood said, adding that it will comply with laws in the European Union, China, Russia, Asia, India, and the Middle East. “It will never run counter to what regulations tell us we need to do to safeguard people and the worldwide vaccine supply chain,” he said.

The announcement of AIM comes as rfxcel is marking its 17th year of developing leading-edge supply chain software solutions. Last month, it released the latest version of its rfxcel Traceability System (rTS) software platform. rTS 7.0 continues the award-winning legacy of the company’s signature full-stack solution, enabling true end-to-end supply chain traceability, environmental monitoring, and analytics from anywhere in the world. Highlights of 2019 included conducting major pharma pilots for the FDA and the Brazilian government, enhancing its powerful Integrated Monitoring (rIM) solution, launching a MobileTraceability solution, tripling the size of its team in Russia, increasing its presence in the Middle East, and entering the consumer goods industry.

“We’ve been working on AIM for a while and have successfully tested it with some of our major customers,” Abood said. “We’ve been excited about releasing it, but we couldn’t imagine the timing would coincide with COVID-19 and a ‘new normal’ for businesses everywhere. In these new circumstances, and with the situation changing hour to hour, we think AIM will strengthen rfxcel’s commitment to being a responsible and proactive member of the global business community.”

Abood concluded by saying that rfxcel was operating at full capacity and was in constant contact with its employees and customers. “We are keeping supply chains moving in critical industries, including pharmaceuticals, food and beverage, worldwide government, and consumer goods,” he said.

To learn more about rfxcel’s Accurate Immunization Management solution and the company’s other track and trace and environmental monitoring solutions for the life sciences industry, contact Vice President of Marketing Herb Wong and visit rfxcel.com.

 

Herb Wong, VP of Marketing

hwong@rfxcel.com

925-824-0300

 

About rfxcel

Founded in 2003, rfxcel provides leading-edge software solutions to help companies manage every aspect of their supply chains, 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 traceability, environmental monitoring, regulatory compliance, serialization, and visibility. The company is headquartered in the United States and has offices in the EU, Britain, Latin America, Russia, the Middle East, India, Japan, and the Asia-Pacific region.

What Dispensers Need to Know About the DSCSA in 2020

Between 2015 and 2019, manufacturers, repackagers, wholesale distributors, and dispensers (i.e., pharmacies in hospitals, clinics, supermarkets, or elsewhere) have had to meet different compliance requirements of the Drug Supply Chain Security Act (DSCSA). Now, in 2020, another deadline is looming for dispensers: On November 27, they must be able to authenticate and verify the drugs they sell to consumers.

The DSCSA was enacted on November 27, 2013, as a means to secure the U.S. supply of medications. Phased rollout of regulations began in January 2015 and is scheduled to conclude on November 27, 2023. In a nutshell, the law mandates product serialization and traceability to stop harmful drugs from entering the supply chain, spot them if they do get in, and facilitate rapid response if any are detected.

Let’s take a quick look at how the DSCSA has affected dispensers to date — and what’s coming up in November.

Are You a Dispenser?

As we noted above, dispensers are pharmacies. However, to make sure we’re all on the same page (and that you know if the law applies to you), here’s how the DSCSA defines “dispenser”:

    • A retail pharmacy, hospital pharmacy, a group of chain pharmacies under common ownership and control that do not act as a wholesale distributor, or any other person authorized by law to dispense or administer prescription drugs, and the affiliated warehouses or distribution centers of such entities under common ownership and control that do not act as a wholesale distributor.
    • Does not include a person who dispenses only products to be used in animals.

The First DSCSA Deadline for Dispensers

The first important deadline for dispensers was July 1, 2015, when they had to begin exchanging “T3” information about every drug they bought and who handled it each time it changed ownership in the United States. (Manufacturers, repackagers, and wholesale distributors had to do this starting January 1, 2015). For every transaction, they’re required to exchange “product tracing information” that includes three things:

1. Transaction Information (TI) about a product:

    • Proprietary or established name or names
    • Strength and dosage form
    • National Drug Code number
    • Container size
    • Number of containers
    • Lot number (certain wholesale distributor transactions were excluded from this requirement)
    • Transaction date
    • Shipment date (if more than 24 hours after the transaction date)
    • Transfer of ownership (the name and addresses of the business/person from whom and to whom ownership is being transferred)

2. Transaction History (TH): An electronic statement with the TI for every transaction going back to the manufacturer

3. Transaction Statement (TS): An electronic statement confirming the entity transferring ownership:

    • Is authorized as required under DSCSA
    • Received the product from a person that is authorized as required under DSCSA
    • Received TI and a TS from the prior owner of the product, as required under the law
    • Did not knowingly ship a suspect or illegitimate product
    • Had systems and processes in place to comply with verification requirements under the law
    • Did not knowingly provide false TI or alter the transaction history.

2016-2019 Milestones

There were three key requirements for dispensers between 2016 and 2019:

1. They must confirm their trading partners are licensed or registered.

2. They must receive, store, and provide product tracing documentation.

    • Accept only prescription drugs with proper T3 information.
    • Store the T3 information for six years.
    • Generate and provide all T3 information when they sell a prescription drug to a trading partner.

3. They must investigate and properly handle suspect and illegitimate drugs

    • This includes drugs that may be counterfeit, diverted, stolen, intentionally adulterated, or unfit for distribution.
    • Quarantine and investigate suspect drugs to determine if they are fake. If they are determined to be fake, dispensers should work with the manufacturer and take specific action to ensure they do not reach patients/consumers. Pharmacies must also notify the FDA and relevant trading partners (i.e., those they bought the drug from and those they sold it to) about the compromised drug.

Preparing for November 2020

The next phase of DSCSA implementation for dispensers concerns authenticating and verifying drugs. They will have to have processes in place to authenticate and verify all the medicines they buy before selling them to consumers. (Wholesale distributors have been required to do this since November 2019.) This boils down to two key requirements:

1. Dispensers may buy and sell only products encoded with product identifiers (PIs).

    • A PI is a standardized graphic with three elements: the product’s standardized numerical identifier (SNI), which comprises the National Drug Code plus a unique alphanumeric serial number); a lot number; and an expiration date. PIs must be in human- and machine-readable formats.

2. Verify every product at the package level, including the SNI.

    • The FDA defines a package as “the smallest unit placed into interstate commerce by the manufacturer or the repackager that is intended by that manufacturer or repackager, as applicable, for individual sale to the pharmacy or other dispenser of the drug product.”

Final Thoughts

We know: It can be confusing. That’s why you have to work with a supply chain solution provider that knows the DSCSA inside and out and can help you navigate the deadlines and unexpected changes or delays.

rfxcel has the DSCSA in its DNA. The solutions in our signature platform have DSCSA compliance built in. Our supply chain experts will, ahem, dispense their knowledge when you need it. They will advise, guide, and support you as you grow your business while safeguarding your customers. Contact us today to learn more about how we can help you with the DSCSA and your other supply chain needs.

Quick News: Russia Changes 2020 Serialization Deadlines for Footwear

Leap Year brought significant change to the timetable for footwear serialization in Russia. Announced February 29, Government Resolution No. 860 gave companies a few extra months to comply with the regulations: Key deadlines were pushed back from March 1 to  July 1.

Here’s what happens with footwear serialization on July 1

Starting on July 1:

  • Production and import of unlabeled shoes is prohibited.
  • Wholesale and retail sale of unlabeled footwear is prohibited.
  • Transfer of information about production, importation, and wholesale and retail sales to Russia’s National Track and Trace Digital System (Chestny ZNAK) becomes mandatory.

We discussed Russia’s labeling requirements for footwear in a previous blog post. Read it here.

Two other changes in 2020

Resolution No. 860 also stipulated changes to deadlines concerning unlabeled footwear:

  • Unlabeled footwear purchased before July 1 may be imported until August 1. (The original dates were March 1 and April 1, respectively.)
  •  Companies may label shoes made or acquired before July 1 until September 1, but only if they can document the date of manufacture or purchase. (The original dates were July 1 and September 1, respectively.)

And that’s that. Short and sweet — but significant in that companies who were not prepared have gained some much-needed time to ensure they’re in compliance.

Why you should choose rfxcel for Russian compliance, no matter what industry you’re in

rfxcel is the undisputed leader in Russia compliance. We’ve prepared for Chestny ZNAK since 2018. We’re one of the few providers with active implementations in the country. We’ve tripled our workforce in Russia over the last year. Our team in Moscow provides our clients, which include major global consumer goods and pharmaceutical companies, the quickest time to market while fully automating their compliance reporting.

No matter how far along you are in your preparations to meet Chestny ZNAK requirements, we are who you need to talk to — even if you’re already working with another provider. Our powerful software ensures companies in any industry will remain compliant with Russia’s complex regulations while mastering their supply chains with end-to-end traceability and rich, actionable data mined right down to the unit level.

Email us today at russia@rfxcel.com to schedule a conversation with one of our supply chain experts in Moscow. We think you’ll be impressed when you learn more about our capabilities in Russia.

And be sure to read “Russia 2020: A Guide to Consumer Goods Supply Chain Compliance,” an easy-to-understand white paper that explains the fundamentals of the Russian legislation and puts it all in context.

Brazil Serialization Timeline: Milestones and Requirements

The Brazilian Health Regulatory Agency (ANVISA) is implementing a comprehensive nationwide serialization solution. Pharmaceutical companies manufacturing in or importing into Brazil are required to follow the regulations set forth in the National Medicine Control System (SNCM). The regulations are scheduled to go into effect in May 2022.

At its core, SNCM is a modernization scheme: Every supply chain actor must be able to capture, store, and exchange data electronically. All products will be required to have a GS1 Data Matrix barcode that houses a Global Trade Item Number (GTIN), an ANVISA Medicine Registry Number, a unique serial number, an expiration date, and a lot/batch number. These internationally accepted measures will enable Brazil to protect its almost 190 million citizens against common problems in the drug supply chain, such as counterfeit pharmaceuticals and cargo theft.

ANVISA also aims to prepare Brazil’s pharma industry to meet global standards. By doing so, when Brazilian companies decide to export to developed countries, they will have no issues complying with local regulations because they follow global standards.

Let’s look back at the most important SNCM deadlines so far and what to expect between now and 2022.

December 28, 2016

ANVISA signs the SNCM into law (Law No. 13.410). It establishes the serialization requirements and timelines for the entire Brazil pharmaceutical supply chain.

September 2017–August 2018: Pilot Phase

In the first phase of the SNCM, regulations were completed/finalized, a management committee was formed to oversee implementation, and preparations began for the next phase (evaluation). ANVISA selected industry stakeholders (e.g., importers, distributors, and retailers) to disseminate data about at least three batches of medicines in a pilot.

September 2018–May 2019: Evaluation Phase

This included analysis, correction, and validation tasks to further streamline the pharma compliance process. The management committee assessed results from the experimental phase and the next phase (implementation) was defined.

April 2019–April 2022: Implementation Phase

Serialization requirements are rolled out and finalized. ANVISA will monitor and evaluate results and work to correct any problems. The key serialization deadlines are listed below. Public discussions concerning the deadlines below have ended, and there might be changes. ANVISA hasn’t made any announcements yet; we’ll keep you updated about its decisions.

  • October 2020: Pharma stakeholders must serialize 25% of their products
  • April 2021: Pharma stakeholders must serialize 50% of their product
  • September 2021: Pharma stakeholders must serialize 75% of their product
  • April 2022: Pharma stakeholders must serialize 100% of their product

Final thoughts: rfxcel Brazil serialization solutions

rfxcel has fine-tuned its traceability software to help manufacturers operating in the Brazilian market achieve SNCM compliance, and we are prioritizing assisting Brazilian companies to prepare for all the deadlines between now and May 2022. Our entire team of supply chain experts is here to help you be ready. If you have questions or concerns about the SNCM regulations, email Commercial Director for Latin America Vinicius “Vinnie” Bagnarolli or contact us here.

The Latest About China’s Pharma Regulatory Requirements

China’s pharma regulations can be confusing. However, the Chinese National Medical Products Administration (NMPA) published a set of documents last year that clarified the country’s new serialization code. Released on April 28, 2019, the documents cover regulations for pharma ranging from coding requirements to guidelines for event reporting.

These documents are a valuable resource to help understand China’s complicated regulations. For example, they state that manufacturing authorization holders must build a traceability system, which they can create themselves or through a third party. In order to trade at an item level, issuing agencies must create a serial number generation strategy to ensure one-of-a-kind traceability codes.

Let’s discuss a few critical points of the regulatory requirements for pharma in China.

Chinese Pharma Reporting

Previous Chinese pharma regulations had strict reporting guidelines. Under the new regulations, pharma companies are not required to request or receive serial numbers from a central or state-controlled source as long as the number schemes are compliant with set standards. This allows manufacturers more control over which software solutions they can use.

Companies must also exchange all the information they generate and report with their supply chain partners — who, in turn, must also report their own data to the government.

Chinese Pharmaceutical Coding Requirements

The NMPA advises that China’s drug traceability strategy should incorporate current and future manufacturing and production needs. For coding, China requires a drug traceability code, a drug identification code, and a product identification code.

The drug traceability code will identify a sales package at the unit level. The code is a combination of numbers, letters, and symbols. To be compliant, the code must include 20 characters (seven of these are the drug identification code) and adhere to ISO standards.

The drug identification code identifies the license holder, generic drug name, manufacturer, formulation, dosage form, specifications, and package specifications. The product identification code contains manufacturing data.

Chinese Printing Requirements

All printed information must be readable by the human eye. But China’s regulatory requirements do establish some guidelines for machine-readable data. Companies can choose from a 2D matrix/RFID tag or a linear bar code. This data must include:

  • Batch and serial number
  • Production date
  • Pharmaceutical form
  • Information about the manufacturing authorization holder
  • Expiry date

rfxcel Global Pharma Compliance Software Solutions

rfxcel has been developing innovative supply chain solutions and helping pharma companies with serialization, compliance, and traceability since 2003. We’re experts in global compliance and are here to answer your questions about regulations in any country, including China. To learn more about how you can stay compliant, no matter where you do business, contact us today!