We know you’re busy,
we'll keep you plugged in.

Weekly links to top industry news and other breaking headlines.

L I N K S : 

Oct 12, 2018

• Addressing Key Challenges to Making Enterprise Blockchain Applications a Reality, by Dr. Mary Lacity

• Ensuring pharma safety goes beyond the supply chain – A look at emerging tech in packaging automation

• Aggravated? Here’s a calm intro to serialization and aggregation

• Annual CPhI Congress held in Madrid, Spain – here’s an update

• FMD: Clarifications for Wholesalers, Distributors and Logistics Firms

• Not just for pharma anymore: rfXcel extends T&T solutions to Food & Beverage

• Aggregation under the FMD

L I N K S : 

Oct 5, 2018

• FDA’s Late Recommendation on Human Readable DSCSA Product Identifier

• Chronicled launches Enterprise Protocols Laboratory to help companies interface with blockchains & smart contracts

• Reimagining the Outdated Pharmaceutical Supply Chain

• “Unblocking the Blockchain:” A conversation with GS1 about their role in the IoT

• Research shows that barcode integrity is crucial for regulatory compliance

• NITI Aayog and Oracle to fight counterfeit drugs with Blockchain

• Preparing Parallel Importers for EU-FMD Success

L I N K S : 

Sept 28, 2018

• Two major DSCSA changes for manufacturers: serialization and redefining of 3PLs

• New survey shows 60%of pharma and life science professionals using or experimenting with blockchain

• Ambrosus launches blockchain network with GS1 Digital Link Standards

• Cold Chain Association (CCA) calls for more data sharing to improve security and efficiency 

• Pharmacists should not be penalized for ‘isolated’ FMD failings

• Blockchain: Use Cases, Potential Risks and Challenges

• SIA announces THRUCOOL service for the transport of time-sensitive and temperature-controlled pharmaceutical cargo 

L I N K S : 

Sept 21, 2018

• FDA unveils two new guidance documents for the DSCSA

• 12 Common Myths about Blockchain Technology

• RxTransparent Awarded MMCAP Group Purchasing Contract for DSCSA Compliance

• How will they delay the False Medicines Directive?

• Blockchain: Closing the Supply Chain Trust Gap

• Adents launches new DispaX application for improved supply chain traceability

• Recipharm receives EMVO approval to submit serialization data to the European Hub

• IQPC publishes free online DSCSA tool: “From Serialization To Full Traceability: 2018 Outlook to Compliance”

L I N K S : 

Sept 14, 2018

• FDA opens public comments for “DSCSA Implementation: Identification of Suspect Product and Notification”

• An interview with McKesson’s Kevan MacKenzie on the biggest challenges for DSCSA preparation

• 5 Practical Use Cases Anchoring Blockchain in Healthcare

• Systech and FarmaTrust partner for pharma supply chain authenticity 

• China sets 2022 target for new drug traceability system

• RxTrace: Does the DSCSA Have A ‘Spirit’

L I N K S : 

Sept 7, 2018

• Statement from FDA Commissioner on agency’s global efforts to assure product quality and transparency

• Global contract packaging organization to launch first live blockchain tool

• GS1 News: Organisation for Economic Co-operation and Development (OECD) uses GPC for their GlobalRecals Portal

• Fears pharma sector will miss interoperability deadline, blockchain or not

• Healthcare Packaging EXPO set for October 14-17 in Chicago, IL

• rfXcel CEO explains how serialization software can unlock additional value beyond regulatory compliance

• Top 5 Blockchain Use Cases in Pharma and Healthcare you should know about

L I N K S : 

Aug 31, 2018

• DSCSA: The Time has come to Act

• Forbes: Is Blockchain the Answer to a Better Healthcare Industry?

• China’s move towards healthcare traceability

• 5 Ways Manufacturers Can Leverage Technology to Curb Counterfeiting

• Australian Logistics Council (ALC) endorses adoption of GS1 global data standards

• How Blockchain can Transform the Supply Chain

• The rise, fall and return of RFID

L I N K S : 

Aug 24, 2018

• TraceLink obtains $93M in funding for A.I. & Blockchain track & trace tools

• The countdown is on: Important considerations as the EU FMD enforcement date nears

• How Will Blockchain Impact Healthcare? Tech Leaders Weigh In.

• Systech asserts leadership position in blockchain solutions for the pharma supply chain

• EMVO admits ‘Insufficient Randomisation’ warnings can be ignored

• SAP pilots blockchain-based supply chain tracker

• Experts discuss how successful track & trace technology can drive the industry

L I N K S : 

Aug 17, 2018

• Amazon, Alphabet, Microsoft and others make health data pledge

• HDA Traceability Seminar to feature FDA Update, Discussions on DSCSA Milestones

• AIM Global announces new blockchain workgroup

• GS1 announces new global standard “GS1 Digital Link” that enables coding and identification of specific product batches

• Amazon’s leader of global healthcare discusses the company’s endeavors in healthcare industry

• FDA seeks input on the future format of the National Drug Code

L I N K S : 

Aug 10, 2018

• New HDA Research Foundation Report analyzes Reverse Distribution of pharma products

• Blockchain and IoT platform, Ambrosus, releases new platform to improve food and pharma supply chain transparency

• 94 supply chain players sign on to Maersk, IBM blockchain initiative

• TraceLink joins Irish Medicines Verification Organization (IMVO) serialization pilot for pharmacies and clinics

• Aggregation: The Achilles’ Heel of Pharma Supply Chain Operation Under A Serialization Regulation

L I N K S : 

Aug 3, 2018

• Blockchain Health Summit Comes to Washington, DC.

• FDA announces “Quality Metrics Feedback” and “Quality Metrics Site Visit” drug quality programs

• Supply Chain Wizard to host “Digital Age Pharma CMO Summit” in Princeton, NJ on Oct. 25th

• Microsoft software architect explains importance of blockchain in the pharma industry at Adent’s recent “Serialization Innovation Summit”

• HDA News: Statement on FDA work group to examine prescription drug importation

• New from RxTrace: “Personalized Medicines in a Serialized World”

• rfXcel’s VRS (Verification Router Service) pilot open to all supply chain partners

• Cold chain technologies are transforming logistics – IoT, big data and analytics all part of the growing trend

L I N K S : 

July 27, 2018

• Russian Federation’s “serialization pilot report” should be taken with a grain of salt

• FDA’s new stance on drug imports creates alarm across pharma industry

• Blockchain Gains Traction in the Food Supply Chain

• Manufacturer Participation in Saleable Returns Verification and Master Data

• How blockchain can help fight counterfeit drugs in India

• 6 questions and 1 answer about blockchain in logistics

• How to Engage a Contract Packer: As the EU FMD draws closer, a lack of readiness persists

• Overview: HHS Blockchain projects in healthcare industry

L I N K S : 

July 20, 2018

• Scientific American: “U.S. Health Care Companies Begin Exploring Blockchain Technologies”

• HDA Responds to FDA Waivers, Exceptions, Exemptions Draft Guidance

• Using blockchain to solve the EU’s need to establish an immutable, unhackable, secure repository system

• TraceLink unveils its Product Information Manager, designed to leverage serialized product information across the supply chain

• “Serialized Drug Verification – 60 Million Reasons Why Manufacturers Need to Act Now”

• FOCUS: GCC pharmaceutical logistics in the Middle East

• How blockchain can revamp the manufacturing industry

L I N K S : 

July 13, 2018

• AAM and HDA weigh in on the FDA’s most recent DSCSA draft guidance

• Virtual Strategy: Cryptowerk Helps Businesses Fight Fraud with Blockchains

• What marketing authorization holders should know about EU FMD

• Serialization: Scaling Down for the Final Stretch

• RxTrace shares newly published material from HDA and C4SCS

• An inside look at the Adents Serialization Innovation Summit

• Blockchain in medicine is just around the corner, new research says

L I N K S : 

July 6, 2018

• HDA gives update on its Verification Router Service (VRS)

• “Year 9”: RxTrace’s recap of the last 12 months of the DSCSA

• 2018 Cold Chain Global Forum kicks off on September 24th in Philadelphia, PA

• Pharma’s “Serialization Sprint” to implementation

• Big Data and IoT are allowing companies to gain new levels of visibility

• Blockchain's potential role in securing the healthcare industry

• New safety regulations complicate drug labeling

• Uncertain Certification: Do CEIV-Pharma standards really help

L I N K S : 

June 29, 2018

• Amazon to buy PillPack, signaling big changes signals big changes for the pharma supply chain

• Merck turns to blockchain to tackle counterfeit drugs

• To Aggregate or Not to Aggregate?

• Combining Big Data and Blockchain to support a new pharma ecosystem

• Why the DSCSA may make mergers & acquisitions more complex, risky and costly

• RxTrace on the DSCSA: Why FDA will not mandate Blockchain, EPCIS or any other specific technology

• Why blockchain and the IoT are positioned to improve the healthcare supply chain

L I N K S : 

June 15, 2018

• Five ways track-and-trace systems cut costs, mitigate risk and improve supplier control, quality and scale

• Blockchain is more than just the technology behind bitcoin

• Serialization regulations could enhance drug recall procedures for pharmaceutical companies

• How IoT and blockchain can increase security along the cold chain

• A Conversation with Blockchain Thought Leader David Houlding, Microsoft Principal Healthcare Program Manager

• Supply Chain Visibility for Increased Quality and Efficiency

• Blockchain is the technology of the logistics industry in the future, says COSCO e-Logistics CTO

L I N K S : 

June 8, 2018

• WSJ: Under Pressure to Tighten Supply Chain, Drug Companies Look to Blockchain

• Meeting the EU Serialization Deadline: Some SMEs are struggling

• Blockchain is digitalizing trust by using decentralized database

• Health sector gives blockchain glowing prognosis

• TraceLink offers customers EMVO Approval for data submission to EU Hub

• The Blockchain Healthcare Revolution is in Progress

• ATA speakers: The future of supply chains and why blockchain is a team sport

L I N K S : 

June 1, 2018

• GS1 Summer Talk: “8 reasons why standardization in healthcare really works differently”

• HDA Urges FDA To Withdraw Draft Guidance ‘In Its Entirety’

• McKesson & AmerisourceBergen release snapshot of “DSCSA Phase 2”

• What the future holds for pharma packaging as the DSCSA and FMD take effect

• Deloitte Study: “Businesses ignoring blockchain will fall behind”

• Are you ready for serialization? Three industry experts weigh in.

• HDA supports Senate bills to enforce drug distributor data sharing

• Opinion: Why aggregation is worth the consideration

• Using serialization as driver for operational improvement beyond regulatory compliance

• Manufacturing and Blockchain: Prime Time Is Yet to Come

L I N K S : 

May 18, 2018

• FedEx CIO Says Blockchain a ‘Game Changer’ for Supply Chain Visibility

• The pursuit of visibility into pharmaceutical supply chains

• How the IoT can help to achieve efficient & advanced temp monitoring, control and response

• An inside look: Healthcare on the Blockchain, Day 2: Private vs. Public Blockchains

• What Does Blockchain have to do with Omnichannel Retailing?

• FDA Draft Guidance: How to apply for a waiver, exception or exemption

• Six blockchain observations from HLTH’s recent “Future of Healthcare” event

L I N K S : 

May 11, 2018

• FDA publishes its long-awaited DSCSA waiver guidance

• Blockchain continues to baffle pharma supply chains

• Read FDA’s “Waivers, Exceptions/ Exemptions from Requirements of Section 582 of the Federal Food, Drug & Cosmetic Act”

• New from ASME: Manufacturers investigating promise of blockchain to streamline operations

• Dept. of Homeland Security holds hearing on “Leveraging Blockchain Technology to Improve Supply Chain Management and Combat Counterfeit Goods”

• Separating fact from fiction to better understand the value of blockchain

• (Opinion) Blockchain Will Revolutionize the Medical Industry – Here’s How

L I N K S : 

May 4, 2018

• HDA urges the FDA…please re-read the DSCSA

• Is Your Supply Chain Stuck in the Bermuda Triangle?

• OPINION: Blockchain can help mitigate investment risk for the pharmaceutical industry

• Disparity danger: Feeling ready vs. actually being ready for serialization

• ABSTRACT: Leveraging Blockchain Technology to Enhance Supply Chain Management in Healthcare

• How to ensure end-to-end visibility in pharmaceutical supply chains

• Pharma manufacturers excited about future of blockchain’s potential to verify goods moving through the supply chain

L I N K S : 

April 27, 2018

• FDA to hold May 8th webinar, "Protecting Patients: Pharmacists Requirements under the DSCSA”

• DSCSA progress report: five years in and one extension later, the pharma industry is adapting

• Intel’s Dir. Of Healthcare Privacy & Security (and current C4SCS Study Team member) discusses enterprise-adoption of blockchain

• INDUSTRY UPDATE: Innovation in pharma packaging

• The importance of supply chain visibility to identify inefficiencies, monitor suppliers, ensure compliance and eliminate fraud

• Data Ownership in the track & trace cloud

• DEEP DIVE: Five useful articles that examine the pharma supply chain’s current biggest challenges

• Fighting fake drugs with blockchain

L I N K S : 

April 20, 2018

• Xtalks to host “Understanding the Impact of Blockchain on Pharmaceutical Serialization and Track & Trace Requirements” webinar

• Amazon shelves plan to sell drugs to hospitals – Insiders explain why

• Controlant CEO discusses how automation is revolutionizing the Cold Chain

• Five industry experts weigh in on the key ingredients for a successful pharma track & trace system

• Regulators from US, Europe and Japan working toward creating consistent drug specifications

• Data, Security, Insurance: How Blockchain is disrupting the healthcare industry

• What’s So hard about Unique Identifier Verification?

• How manufacturers can unlock the benefits of transitioning to a Digital Supply Network (DSN)

• Dubai launches “Middle East Pharma Cold Chain Congress”

L I N K S : 

April 13, 2018

• Too Little or Too Late? Perspectives on FDA's New Serialization Guidances

• FDA/IMSN to host Summit for international drug regulators in June 2018

• How Blockchain Can Improve the Pharma Manufacturing Supply Chain

• TraceLink announces EU FMD Express for smaller pharmaceutical companies

• Indian think tank, NITI Aayog, backs blockchain for medicine security

• Best blockchain uses and barriers the healthcare industry must address as it moves to adopt the technology

• Seven steps to successfully comply with EU’s new FMD regulations

L I N K S : 

April 6, 2018

• (FULL REPORT PDF) HHS Office of Inspector General: “Drug Supply Chain Security: Dispensers Received Most Tracing Information”

• RxTrace Analysis: OIG’s DSCSA Report exposes likely enforcement approach

• PharmaTech presents Keynote Series “The Industrial Internet of Things, Blockchain & Smart Contracts” at April 2018 INTERPHEX

• Complying with EU’s FMD: Some key challenges and practical questions for wholesalers and logistics providers

• SAP releases its long-awaited Study: “Blockchain: A Study Rooted in Reality”

• Alliance for Safe Online Pharmacies launches “ASOP Canada” to protect Canadians from illegal online sales of unsafe medicines

• Leveraging blockchain to simplify and transform healthcare for payers, providers and patients

L I N K S : 

Mar. 30, 2018

• New report from HHS Inspector General reveals that pharmacies received most required tracing info

• What is blockchain and what can it do for pharmaceutical supply chains?

• HDA’s three main takeaways from FDA’s most recent DSCSA public meeting

• TraceLink publishes full analysis from Global Drug Supply, Safety and Traceability Report

• DSCSA Unit-Level Serialization: The Clock Is Ticking

• Fact or Fallacy: Is Blockchain a Panacea for Healthcare’s IT Issues?

L I N K S : 

Mar. 23, 2018

• The importance of supply chain visibility for avoiding disruptions in the pharma supply chain

• 5 good reasons to blockchain your supply chain

• Pharma manufacturers gear up for next-gen drugs, new regulations

• A closer look at FDA’s recent draft guidance: “Standardization of Data & Documentation Practices for Product Tracing”

• Using GS1 standards and blockchain technology for added supply chain transparency

• 3 useful ways to apply blockchain to healthcare: EHRs, Pharma Supply Chain and Clinical Trials

• What do pharmaceutical GMP inspectors really want to see?

• IQPC releases is updated global pharma serialization regulation map for 2018

• DHL, Imperial and Authentag embrace blockchain ledger technology

L I N K S : 

Mar. 16, 2018

• FDA Releases “DSCSA Draft Guidance on Standardization of Data and Documentation Practices for Product Tracing”

• Chronicled publishes “The MediLedger Project” report demonstrating the use of blockchain platform for track & trace

• Standardized bar code formats will introduce new efficiencies throughout the supply chain

• Lower costs, fewer opportunities and a smaller carbon footprint making ocean transport more attractive for pharma

• DHL and Accenture launch collaborative blockchain project to couple track & trace with product verification

• IQPC talks to four top pharma execs about the future of serialization and track & trace

• Can blockchain succeed where EHRs have failed?

L I N K S : 

Mar. 9, 2018

• FDA’s releases new DSCSA guidance for the standardization of transferring transaction information through the supply chain

• Health insurer, Cigna, to purchase Express Scripts

• Overview FDA’s Public Meeting #3 – what was different about this one?

• Upcoming FMD regulations and Brexit could lead to supply chain bottlenecks

• Are you gambling with 2D data codes?

• Logistics Viewpoints: “The benefits of blockchain are obvious, but of course the chain is only as good as the participants…”

• IoT firm deploys blockchain to transform pharmaceutical shipments

• An interview with CEO of Optel Group India about mission to deliver affordable & globally compliant track & trace solutions to India

• DHL publishes on the digitalization of the supply chain and notes 95% of companies are yet to realize full benefits

L I N K S : 

Mar. 2, 2018

• FDA releases draft guidance: Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the DSCSA

• FDA releases draft guidance: Standardization of Data and Documentation Practices for Product Tracing

• Is blockchain a one-trick pony?

• Top 5 cool chain innovations making a difference in supply chain quality

• House Judiciary holds hearing on proposed CVS Health-Aetna merger

• Time and Temperature-Controlled Transport: Supply Chain Challenges & Solutions

• Why a Data Health Check May Be the Best Medicine for Pharmaceutical Regulatory Compliance

• A look at Version 9 of the FMD’s “Safety Features for Medicinal Products for Human Use, Questions and Answers”

L I N K S : 

Feb. 23, 2018

• HDA update: “Transitioning to Traceability — and a Verification Router Service”

• Fake Medicines Continue to Threaten Consumers – EU Member States have an Obligation to Act

• Just 6.6% of meds have DSCSA-compliant 2D barcodes

• WHO issues “Global Surveillance & Monitoring System for Substandard and Falsified Medical Products” report

• The Human Readable text controversy

• Center for Supply Chain Studies enters Phase 2 of DSCSA & Blockchain Study

• Blockchain for pharma is here to stay

• One-year countdown to Falsified Medicines Directive – is the UK ready?

• HDA calls for “Universal” Suspicious Orders Database to enhance efforts against diversion, misuse

• Albertsons to acquire Rite Aid

• Discussion topics for FDA’s February 28, 2018 Public Meeting #3

L I N K S : 

Feb. 16, 2018

• NABP publishes 2018 Internet Drug Outlet Identification Program Progress Report

• Walgreens considers acquisition of AmerisourceBergen

• Pharma Security World’s 2018 anti-counterfeiting conference to be held in London, England on March 20-21

• Some companies may be facing uphill battle as final adoption of EU FMD deadline approaches

• HDA announces availability of API Certification Program for Origin

• Pharma leaders call for the use of GS1 standards in clinical research to achieve consistency in product identification

• Fueling pharma industry’s growth: How overall reliability will improve

• Pharmapack Europe offers industry insights and innovations that are reimagining the capabilities of packaging and drug delivery

L I N K S : 

Feb. 9, 2018

• TraceLink to dismiss litigation against Healthcare Distribution Alliance (HDA)

• Gov. Kasich proposes tightening Ohio’s rules on drug distribution

• Health effort by Amazon, others aims to succeed where others have failed

• Researchers developing new technologies as counterfeit drugs continue to plague the supply chain

• Pharma & biotech companies innovate on ways of transporting highly sensitive products to keep up with
  new industry challenges and diverse markets

• A look into Pharmapack 2018 from the show floor

• How blockchain can reduce waste for pharmaceutical companies

• securPharm calls for big push on EU Falsified Medicines Directive

• GS1 releases guidance on using NTIN in EPCIS visibility events

• Wholesalers Find Troubling Results In DSCSA Barcode Assessment

L I N K S : 

Feb. 2, 2018

• Amazon, Berkshire Hathaway, and JPMorgan Chase & Co. to partner on employee healthcare

• Why most small players may not survive China’s pharmaceutical industry consolidation

• Here Amazon's healthcare moves that led up to the JPMorgan Chase-Berkshire Hathaway deal

• Paving the way for the DSCSA: FDA and industry officials met publicly to discuss standards and obstacles

• A look at 3D printing, drones, the Amazon effect and emerging technologies in the pharmaceutical supply chain

• IEEE to host “Blockchain for Clinical Trials Forum” at Orlando Science Center

L I N K S : 

Jan. 26, 2018

• FDA issues 2018 Compounding Policy Priorities Plan

• New York Times: Fed up with drug companies, hospitals decide to start their own

• Center for Drug Evaluation and Research issues CY2018 Guidance agenda

• Pharma labeling and packaging industry trends to watch in 2018

• READ: HDA comments to FDA in resp0nse to Dec 5-6, 2017 DSCSA public meetings

• Oxford University to pilot new medicine verification system in readiness to comply with impending EU Falsified Medicines directive

• In strategic move to streamline its shipment handling process, Pharma.Aero adds new industry “heavyweights” to Board

• The future of pharma shipping and how the industry will keep up with the changes

L I N K S : 

Jan. 19, 2018

• PharmTech.com: Pharma Serialization Nears a Tipping Point

• IQPC to host 7th Annual Pharma Anti-Counterfeiting & Brand Protection Summit in Philadelphia, March 26-28

• As biopharm supply chains streamline, companies consolidate

• Could the blockchain be the salvation of the pharmaceutical industry?

• RxTrace: 3 DSCSA Requirements You Can Totally Ignore

• 6 Ways Cloud Computing Is Transforming Healthcare

• Environmental Risks & the Life Science Supply Chain: Lessons Learned from Hurricane Maria

• Yahoo Finance: Systech Europe announces rapid expansion of pharma serialization partners

L I N K S : 

Jan. 5, 2018

• FDA’s DSCSA Public Meeting #2 now available

• 5 trends to watch in 2018 in temp-sensitive pharmaceuticals

• IEEE’s Maria Palombini discusses potential blockchain benefits for US pharma in Blockchain Technology News

• Analysis: Time and temperature compliance makes air travel the clear choice for transporting pharmaceuticals

• Tracelink VP’s interview reveals 2017 pharma challenges, opportunities, and trends

• Blockchain & Healthcare: promising and moving quickly, though no silver bullet

• May ’18 start for Brazil medicines traceability pilot

• Carlo RW De Meijer of MIFSA shares blockchain observations & predictions for 2018

• Tracelink welcomes Center for Supply Chain Studies for Jan 9th “Blockchain & DSCSA” podcast

• 2018: The Year of FDA DSCSA Public Meetings

L I N K S : 

Dec. 22, 2017

• CanadaDrugs.com has pleaded guilty to the sale of fake pharmaceuticals, showing online pharmacies can be a consumer danger

• Is pharma overlooking aggregation? Some companies are still shying away

• Industry analysis: Future growth of RFID in the pharmaceutical market

• EPM Magazine: A review of 2017 pharma industry opportunities, challenges and trends

• Greater demand for innovative temp control packaging solutions as global shipments of temp-sensitive products increase

• 2018: Key industry trends in delivery logistics and supply chain management

• Overview of 2017 MDR & IVDR EU Conference: Focus on EU’s UDI compliance program

• Adents planning 2018 serialization conferences in Paris, Philadelphia, and Shanghai

• How blockchain, A.I. and other technology will evolve the 2018 healthcare industry

L I N K S : 

Dec. 15, 2017

• Optel Group expands pharma traceability offering with acquisition of Verify Brand

• Healthcare IT News calls blockchain “the next big thing” in the pharma supply chain

• Experts weigh in on during roundtable discussion on healthcare supply chain improvements

• New automation methods being developed & implemented as pharma supply chain evolves

• READ: An explanation of FDA’s guidance on the DSCSA ‘grandfathering’ policy

• Speculation continues around Amazon and UPS pharmacy endeavors

• RxTrace’s take on FDA’s recent DSCSA Public Meeting

• Looking ahead: Some major FDA policy goals for 2018

L I N K S : 

Dec. 8, 2017

• Peer collaborations for medicine shipments could benefit practitioners transporting temperature sensitive drugs

• Global coalition in fight against falsified medicines meets in Brussels as it welcomes the NABP as its newest partner

• CVS Health announced a $69 billion to buy Aetna

• CVS-Aetna deal is direct response to Amazon's foray into prescription drug market

• Amazon cancels Maine pharmaceutical license application

• Brexit raises concerns about future of pharma regulations, mutual medicine recognition & cross-EU drug supply chains

• Systech teams with NKP Pharma to expand Indian track & trace and wean pharma firms off serialization providers

• SAP announces “Information Collaboration Hub for Life Sciences” public cloud network

• SophiaTX unveils working blockchain for Track & Trace Proof of Concept & White Paper

• EMA and European Commission publish updated pharma guidance for UK’s withdrawal from European Union

• HDA releases, “88th Edition HDA Factbook: The Facts, Figures and Trends in Healthcare”

• DEA’s “Faux Pharmacy” illicit opioid trafficking operation targets 26 pharmacies in three states

• TraceLink unveils FutureLink conference to address supply chain compliance and the future of digital drug supply

• Updated “HDA Guidelines for Bar Coding in the Pharmaceutical Supply Chain” now available

L I N K S : 

Dec. 1, 2017

• FDA: Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier

• Former FDA Official explains issues with counterfeit drugs in the pharmaceutical supply chain

• December ’17 Cold Chain Distribution Conference releases highly anticipated Attendee List

• Industry insiders share insights on upcoming Feb 2019 EU Falsified Medicines Directive

• DSCSA deadline sets one-year alarm call for enforcement

• New GS1 US Technology Produces Test Cards to Support Effective Barcode Verification Processes

• Blockchain & The Pharma Supply Chain — Beyond DSCSA Compliance

• RxTrace: An explanation of the FDA’s new DSCSA Grandfathering Policy

• Coming up: Next FDA DSCSA public meeting on December 5-6, 2017

L I N K S : 

Nov. 17, 2017

• “Can Blockchain Protect us from Counterfeit Drugs?” An overview from IEEE’s “Cutting to the Trace with Blockchain” workshop

• 123 countries participated in Pangea X to fight counterfeits, resulting in 1,058 investigations

• Amazon claims it won’t store or ship drugs, but will use pharmacy licenses sell medical devices and supplies

• Some industry professional’s thoughts on key pharmaceutical trends heading into 2018

• Blockchain in healthcare potential for EHRs, interoperability, security, precision medicine, and a patient-driven healthcare system

• CEVA Logistics opens 132,000-sq ft. facility in U.K. to push deeper into the pharma logistics industry

• Live from HDA Traceability: Most-asked question of the day suggests a need for future guidance

• A summary of FDA’s presentation on the DSCSA and FDA’s vision for 2023 at HDA Traceability Seminar

L I N K S : 

Nov. 3, 2017

• As of Nov 1, 2017, FDA recognizes drug manufacturing inspection data from eight European regulatory authorities

• Pharma CEOs welcome Amazon into pharmaceutical distribution, hoping for improvements in technology and efficiency

• Supply Chain Wizard launches new suite of digital supply chain products to optimize growth, service and efficiency

• A Blockchain solution to address India’s Pharma Industry supply chain concerns

• FIATA signs MoU with GS1 to advance transport & logistics solutions for customers

• “Rethinking FRESH” – Advancements and areas for improvement in the cold chain industry

• RxTrace: An overview of the info shared at the Global GS1 Healthcare Conference 2017

• IEEE's survey sees opportunity for blockchain to address supply chain optimization, compliance & security issues

• Convergence of blockchain and artificial intelligence could reduce pharma supply chain issues

• In mission to eliminate falsified drugs, Pakistan moving ahead with plans to introduce 2D barcodes

L I N K S : 

Oct. 20, 2017

• Does the US need its own version of a USMVO to reach DSCSA deadlines?

• Number of online pharmacies selling illegal meds is growing, many recently warned by the FDA

• IEEE to release study to exploring if blockchain meets DSCSA serialization guidelines for manufacturers, distributors & dispensaries

• EBN Online: “5 major advantages that result from the use of blockchain technology in the supply chain”

• Blockchain technology could introduce higher levels of security and confidence in supply chain transactions

• IQPC’s Traceability Forum Interactive event to directly follow the FDA’s DSCSA December workshop

• MedCity News: “Blockchain, IoT, and the healthcare industry: What you need to know.”

• Some highlights from the 2017 IQPC Global Cold Chain Forum

L I N K S : 

Oct. 6, 2017

• Healthcare payers and providers looking to blockchain technology

• 12th Pharmaceutical Cold & Supply Chain Logistics Conference to take place October 10-11, 2017

• READ: Pharmaceutical Supply Chain Security Risk Assessment for Shipping Lanes

• Singapore’s Changi Airport announced as a pharmaceuticals air cargo hub

• Serialization In Practice: How Manufacturers Can Ensure Compliance

• Overview of HDA's comments to FDA's “Enhanced Drug Distribution Security Under the DSCSA; Public Meetings”

• Open-SCS Group presented its initial Packaging Serialization Standard (PSS 1.0) on September 25 at Pack Expo

• CDC experimenting with blockchain to store & share data to better monitor the spread of infectious diseases.

• A list of blockchain news from the month of September

• Goa FDA calls for regulation & technology upgrade of supply chain to curb counterfeiting

• Identiv, Inc. partners with Chronicled, Inc. to launch the NFC Temperature Logger

• A look at some issues addressed in the new draft of Dept of Pharmaceuticals, under Government of India

L I N K S : 

Sept. 29, 2017

• FDA took action against more than 500 websites that sell illegal drugs to American consumers

• OPEN-SCS Group introduces its serialization standard, Packaging Serialization Specification (PSS) 1.0

• UPS announces technology to help healthcare cos standardize & share info for serialized pharmaceuticals in the U.S. supply chain

• MediLedger Project demonstrates compliance with DSCSA by using blockchain technology to track and trace prescription meds

• 32nd Global GS1 Healthcare Conference slated for October 17-19, 2017 to discuss patient safety, supply chain security & efficiency

• Tubilux selects TraceLink to achieve EU FMD compliance for its EU pharmaceutical customers

• Molecular tagging technology provides security & authentication to help pharmas identify, target, track and trace products

• Amazon moving into the drug supply chain arena

L I N K S : 

Sept. 14, 2017

• FDA Clarifies DSCSA Track & Trace Requirements DSCSA

• CEN chooses GS1 SSCC to identify parcels - Jan Somers TV appearance

• RxTrace: Explanation of the Unique Identifier requirements under the Falsified Medicines Directive (FMD)

• Cold chain pharmaceutical logistics challenges - addressing the gaps

• State Of Serialization: Where FDA & The Pharma Industry Currently Stand

• Blockchain considered Revolutionary Technology in pharma industry

• A look at the global anti-counterfeit packaging market in pharmaceutical industry for 2017-2021

• GS1 announces collaboration w/IBM & Microsoft to leverage GS1 Standards in enterprise blockchain applications

• 2 back-to-back pharma serialization events coming to D.C. in Dec!

• It’s time to stop talking about “anti-counterfeiting,” and move to integrated, collaborative supply chain security, experts say

• Press Release: BlockRx™ to Improve Patient Safety with the First Pharmaceutical ICO Offering

• Industry leaders participate in survey about serialization in the pharmaceutical industry - what do they think?

• Confidence is high in Indian pharma packaging industry

L I N K S : 

Aug. 25, 2017

• Directors of FDA’s three medical product centers applaud the Congress for passing FDA Reauthorization Act of 2017 (FDARA)

• IQPC released final survey report conducted to determine whether pharmaceutical manufacturers are ready for DSCSA deadlines

• Alliance for Safe Online Pharmacies conducted survey to determine consumer behavior and perceptions of online pharmacies. 95% of participants said they were not aware of the tools available to verify the safety of online pharmacies.

• LogistiVIEW presents technology at NACDS Total Store Expo that “will enable a pharmaceutical supply chain workforce to be both efficient and compliant with Drug Quality Security Act (DQSA) regulations from production facility to the pharmacy”

• FDA releases new draft guidance entitled "Identifying Trading Partners Under the Drug Supply Chain Security Act”

• Bob Celeste, director of the Center for Supply Chain Studies, and other professionals speak at the NACDS Total Store Expo

• Manufacturers are working to improve pharmaceutical labeling in order to meet the demands of the DSCSA

L I N K S : 

Aug. 18, 2017

• At least 17 states have enacted rules to curb the number of opioid analgesics doctors can prescribe.

• China Food and Drug Administration submits membership application to the International Council for Harmonisation

• GS1 US publishes The GTIN Adoption and Usage Model

• NACDS endorses "Every Prescription Conveyed Securely Act", requiring electronic prescribing for controlled substance meds

• 2nd annual blockchain conference for healthcare industry to be held September 25-26, 2017

• RXTrace red light green light article about the DSCSA verification requests

• NACDS presents “Vision 2028”- emerging technology in the future of retail and pharmacy. Expo will be held August 19-22

• Conference at Johns Hopkins suggests that while blockchain is very promising, it is still years away from being established

• Illegitimate online pharmaceuticals continue to be a problem. The Alliance for Safe Online Pharmacies conducted a survey- most participants could not differentiate between a legitimate and illegitimate online pharmacy. FDA runs Pangea program, an annual event to shut down and arrest illegitimate or outright-illegal online pharmacies, but they keep popping up.