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DSCSA, FDA

FDA Official Will not extend the 2023 deadline

August 18, 2021 Christian Souza

Deadline will not be extended

As reported by the Regulatory Focus, the FDA will not delay the interoperability deadline for the DSCSA 2023 deadline. You can for sure group the saleable returns requirements as well. The US Food and Drug Administration is working “full tilt” towards implementing requirements calling for manufacturers and trading partners to have a full interoperable electronic track and trace system in place by 2023.

Continue reading FDA Official Will not extend the 2023 deadline →

DSCSA, FDA

The FDA’s New Guidance for 2021 Explained

August 10, 2021 Christian Souza

As the premier regulatory body for ingestible products in the United States, the FDA (Food and Drug Administration) is responsible for safeguarding public health through safety measures, guidance, and regulations. The importance of the FDA’s job cannot be stressed enough, and in the current global health crisis we find ourselves in, this responsibility is even more critical.

The FDA’s annual guidance schedule is often more aspirational than strictly practical, but it does a good job in providing useful insights into what areas the FDA’s CDER (Center for Drug Evaluation and Research) has given priority for that particular year.

You can find updated lists for the FDA’s guidance for 2021 here. In this article, we’ll focus on the guidance as it relates to the DSCSA (Drug Supply Chain Security Act).

Continue reading The FDA’s New Guidance for 2021 Explained →

FDA, FSMA

FDA’s Food Safety Modernization Act (FSMA), Explained

May 24, 2021 Christian Souza

One of the most important things for a country to safeguard is the health and safety of its residents. Hazards don’t always arrive in plain sight and are most often hidden in things we trust and consume on a daily basis. The biggest example of this is the food we eat.

Food has the ability to nourish us and provide us with the energy to thrive in our existence, but it can also severely damage our health if not mandated properly. This is the main reason why the FDA’s Food Safety Modernization Act (FSMA) was enacted in 2011 by President Obama.

The specifics of the act are complicated, and the nature of the subject matter requires extensive regulations to be upheld. In this article, we’ll give you an overview of everything worth knowing about the FSMA guidelines. We’ll show you the importance of food regulation standards, we’ll get into each aspect of the FSMA in more detail and we’ll end with what’s changed for 2021.

Continue reading FDA’s Food Safety Modernization Act (FSMA), Explained →

DSCSA, HDA, PDG

2 Organizations You Need to Join to Get Ready for the DSCSA Phase II

April 19, 2021 Christian Souza

If you are a pharmaceutical company serious about meeting the requirements of Phase II of the DSCSA, there are two organizations you must join.

The first is the Partnership for DSCSA Governance, or the PDG. It is an organization formed by manufacturers, wholesalers, dispensers, and solution providers that are working to solve the interoperability requirements for the DSCSA for 2023. The PDG is a 501(c)(6) nonprofit business association requiring a yearly membership fee to join.

The other is the Healthcare Distribution Alliance, or HDA, which is a long-running organization that represents many members of the pharma supply chain in a quest to advocate for public policy that supports patient access to medical products through safe, efficient, and effective distribution. The HDA also requires a yearly membership fee.

Today’s post will look at both organizations, profile what they do, and then let you know why joining them is crucial for getting the most out of the DSCSA.

Continue reading 2 Organizations You Need to Join to Get Ready for the DSCSA Phase II →

CBD, Hemp, Marijuana

Does the DSCSA Affect How the Medical Marijuana Industry Is Regulated?

March 8, 2021 Christian Souza

The Drug Supply Chain Security Act was enacted in 2013 to put protocols into place for the serialization and traceability of pharmaceuticals that move through the drug supply chain – from manufacturer through to the distributors until they reach the hands of the patient. The goal being to ensure the safety and purity of each medication.

With medical marijuana being legalized in more states, this brings up the important question of if and how medical use marijuana should be handled under the guidelines of the DSCSA. Currently, the only states where medical marijuana is prohibited for all uses are Nebraska, Idaho and South Dakota. For the rest of the country, there are circumstances in which marijuana can be legally dispensed and consumed with a doctor’s prescription. Obviously, there’s the need for strict regulations, but the process for putting these regulations into place remains a little cloudy.

Continue reading Does the DSCSA Affect How the Medical Marijuana Industry Is Regulated? →

DSCSA, EPCIS

EPCIS GUIDE for your organization

February 23, 2021 Christian Souza

*NOTE – We are including a Free Trading Partner Integration template for you to download at the end of this article.

The 2023 DSCSA requirement looms in the near future and pharma companies are frantically working together to create and implement the technological goals that create the interoperable system by November 27, 2023. To achieve the three areas of interoperability as defined by the PDSA—exchange, verification, and tracing—these companies must also land on a common informational framework.

In other words, to create a system that allows for the DSCSA vision of “fully interoperable, electronic tracing of products at the package level,” the industry needs to pick a common standard and use it throughout pharma. I discuss the challenges in my previous article: Drug Supply Chain Security Act, Phase II: Here’s what you MUST know.

Gary Lerner, the president at Gateway Checker Corporation, explained what it would take to make this happen. In short: “Capturing and exchanging information at this level of specificity requires a common information framework.”

Continue reading EPCIS GUIDE for your organization →

COVID-19, DSCSA, FDA

Impact of COVID-19 on DSCSA Implementation

February 9, 2021 Christian Souza2 Comments

Before the pandemic struck, the pharma industry was working feverishly to implement and enforce all the requirements of the DSCSA, especially the Phase II requirements scheduled for November of 2023. When COVID-19 dramatically changed the business landscape, the implementation became even more of an uphill battle, with both time and the pandemic acting as a cause of concern.

In today’s post, we will look at COVID-19 and its impact on the DSCSA: from the FDA loosening some of the guidelines to the different areas of the DSCSA that are being impacted the most. If we can understand the relationship between these two, we can have a better grasp of realistic understandings and the best course of action moving forward.

Continue reading Impact of COVID-19 on DSCSA Implementation →

DSCSA, FDA, Saleable Returns Verification

Why the FDA Extended The Saleable Returns Verification from 2020 to 2023

February 4, 2021 Christian Souza2 Comments

In 2020, most things did not go as planned. Considering the overwhelming impact of the worldwide pandemic, the pharmaceutical industry was far from immune to last year’s instability.

One of the major changes came with the Saleable Returns Verification’s extension. Despite being originally scheduled for a 2020 enactment, the FDA recently announced their plan to extend, yet again, the Saleable Returns Verification enforcement until 2023.

What does this really mean? Well the FDA won’t enforce it. So should you not care? It’s not that simple.

Legal liability

Remember, the law is the law. So the Saleable Returns Verifcation did become a requirement of the law this past November 27th 2020.

Continue reading Why the FDA Extended The Saleable Returns Verification from 2020 to 2023 →

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▼2021 (9) ▼Aug(2)FDA Official Will not extend the 2023 deadlineThe FDA’s New Guidance for 2021 Explained ►May(1)FDA’s Food Safety Modernization Act (FSMA), Explained ►Apr(1)2 Organizations You Need to Join to Get Ready for the DSCSA Phase II ►Mar(1)Does the DSCSA Affect How the Medical Marijuana Industry Is Regulated? ►Feb(3)EPCIS GUIDE for your organizationImpact of COVID-19 on DSCSA ImplementationWhy the FDA Extended The Saleable Returns Verification from 2020 to 2023 ►Jan(1)Drug Supply Chain Security Act, Phase II: Here’s what you MUST know ►2020 (11) ►Nov(1)The Future of RxTrace Has Arrived ►May(1)FDA Provides Guidance on DSCSA Exemptions for Covid-19 PHE ►Apr(1)DSCSA Exemption For Public Health Emergencies ►Feb(4)2021 UDI Conference Has Been RescheduledACTION REQUIRED: RxTrace Subscriber UpdateWHO Publishes Draft Policy Brief for Medicines Traceability RegulationsWhat Happens To The FMD In the UK After Brexit Day? Seriously, Does Anyone Know? ►Jan(4)How The DSCSA Is Designed To WorkThe HHS Importation Proposed RuleThe Partnership for DSCSA Governance Is Up and Running2020: The View Ahead ►2019 (49) ►Dec(3)China Sets Aggressive Date for Vaccine TraceabilityJapan Moves To Mandate Barcodes For Drug TraceabilityDSCSA: Industry Moves Forward ►Nov(3)Brazil Moves to Formalize A Phased Rollout, Starting Next OctoberDSCSA: Will 2020 Be FDA's Year To Leap Forward?Russia: Rationality Makes An Appearance at the 11th Hour. Will It Matter? ►Oct(4)2019 GS1 US Barcode Assessment, ExtrapolatedChina Inches Closer To Another Pharma Serialization MandateNext Week's HDA Traceability SeminarFDA Inaction On Fixing The NDC Indicates Why They Should Get Out Of The Numbering Business ►Sep(4)No Surprise: DSCSA Verification DelayPharma Counterfeiter Strategies In a Track & Trace WorldRussia Officially Cuts Length of Crypto-code in HalfGS1 US Publishes New DSCSA VRS Implementation Guide ►Aug(4)DSCSA Uniqueness: SNI vs SGTIN...AgainCan GS1 Hold Onto Drug Identification Worldwide?PDSA Releases Prospectus To Prospective Governance Group MembersCan Trump/Azar/Sharpless Eliminate Parts of the DSCSA to Enable Importation? ►Jul(4)DSCSA Schedule Assessment, July 2019EMVO Calls For Enforcement Of FMD/DRChina Commits To The Digital Future In Healthcare, Including Pharma TraceabilityBarcodes 45, RxTrace 10 ►Jun(4)Here We Go Again. Florida Flirts With Opening Door To CounterfeitsIs The FDA About To Delay Enforcement Of The Wholesaler's 2019 Mandate?Meet The Latest GS1 Key: The Global Model Number (GMN)China: NMPA Drug Traceability Guidance ►May(3)Brazil: The Anvisa 2019 Pilot ReportDSCSA: Historic Change To CommercePDSA Brainstorms Vision For DSCSA Governance Organization With Stakeholders ►Apr(5)An Aggregation 'Discussion'Global Regulators Recommend Track & Trace Interoperability FeaturesGlobal Differences In Expiration Date EncodingBlockchain And Track & Trace ModelsPDSA's Proposal for Governance of DSCSA Phase II Interoperability ►Mar(5)A Serious DSCSA Governance Organizational Proposal Emerges From PDSAThe New GS1 Digital Link StandardRussia: CRPT Posts Test Methodology For Crypto CodeDSCSA: What Wholesalers WantDSCSA: Interoperable Data Exchange In 2023 ►Feb(5)Barcoding Regulation For India's Domestic Drug SupplyFDA Hammer Comes Down On McKesson For DSCSA ViolationsHDA Makes A Strong Case For 'Reframing' Of FDA's Draft Guidance On DSCSA Verification SystemsFDA Announces Start Of DSCSA Voluntary Piloting ProgramMost Companies Will Do DSCSA Verification Wrong ►Jan(5)GS1's Messaging Standard For Verification Of Product IdentifiersFMD: Denmark Moves To Solve FMD DilemmaMixed Signals From RussiaEPCIS ExplainedMy Comments Regarding The New NDC Format ►2018 (59) ►Dec(3)More Details On The Russian Crypto-CodeGS1 Blockchain Discussion Group Kickoff MeetingFDA Gets Comments On Their Draft Q&A on DSCSA Product Identifiers ►Nov(4)FMD: Your Initial Upload To The EU HubHow To Accept Manual Entry Of Drug Unique IdentifiersFDA New NDC Format Public MeetingAn Open Letter To The FDA: New NDC Format Public Meeting ►Oct(6)DSCSA: Verification Systems Draft GuidanceDSCSA Uniqueness: SNI vs SGTIN2018 HDA Traceability Seminar RecapMcKesson's DSCSA 483 ExplainedAggregation Under the FMDFDA's Late Recommendation On Human Readable ►Sep(5)FDA Posts Two Final DSCSA Guidances And A Draft Product Identifier Q&A DocumentFrom Serialization to Full Traceability: 2018 Outlook On ComplianceHow Will They Delay The FMD?IQPC: The Biggest Challenges Preparing For The DSCSADoes the DSCSA Have A 'Spirit' ►Aug(4)China Posts New Draft Pharma Serialization GuidelinesEMVO Admits, 'Insufficient Randomisation' Warnings Can Be IgnoredFDA Seeks Input On The Future Format of the National Drug CodeAggregation: The Achilles’ Heel of Pharma Supply Chain Operation Under A Serialization Regulation ►Jul(5)Personalized Medicines In A Serialized WorldNew Direction For Pharma Serialization In The Russian FederationHDA Responds To FDA Waivers, Exceptions, Exemptions Draft GuidanceNewly Published Material From HDA and C4SCSRxTrace: Year Nine ►Jun(4)DSCSA Makes M&A More Complex/Risky/CostlyDSCSA: Why FDA Will Not Mandate Blockchain, EPCIS Or Any Other Specific TechnologySimple, Standard, Low Cost Product Master Data Synchronization for DSCSAImportant New Blockchain Study Launched ►May(4)HDA Urges FDA To Withdraw Draft Guidance 'In Its Entirety'FDA Draft Guidance: How To Apply For A Waiver, Exception or ExemptionFDA To Publish Key Draft Guidance TomorrowAn Open Letter To Blockchain Vendors: Please Pay More Attention ►Apr(6)HDA Urges FDA...Please Re-Read The DSCSAData Ownership In The Track And Trace Cloud, Reprised And UpdatedWhat's So Hard About Unique Identifier Verification?I Receive My First Serialized Drug From My Pharmacy: Is It Right?Extracting Value Beyond Compliance From SerializationDSCSA: OIG Report Exposes Likely Enforcement Approach ►Mar(6)The 2 Most Helpful Requirements In The DSCSANewly Updated Global Serialization Regulation MapDSCSA Guidance: Standardization of Data & Documentation Practices for Product TracingInterview With Four Pharma Supply Chain Thought LeadersDSCSA Guidance: Definitions of Suspect and Illegitimate Product for Verification ObligationsFDA DSCSA Public Meeting #3: A Difference? ►Feb(6)The Most Head-Scratching Section Of The FMDHuman Readable Text ControversyFMD, One Year OutUnique Device Identification Questions Answered HereDispenser Perspectives On The DSCSA: An IQPC InterviewWholesalers Find Troubling Results In DSCSA Barcode Assessment ►Jan(6)Blockchain Will Not Be Used For DSCSA Data ExchangeHDA Questions FDA's Authority To Mandate A Centralized System For the EDDSAnti-counterfeiting Successes and Failures Around the World3 DSCSA Requirements You Can Totally IgnoreEDDS: The New Data Exchange Requirements2018: The Year of FDA DSCSA Public Meetings ►2017 (69) ►Dec(4)A US Medicines Verification Organization (USMVO)? AgainEuropean Medical Device and In Vitro Diagnostic Medical Device Regulations ConferenceFDA DSCSA Public Meeting #2, Still A GulfHDA Guidelines For Bar Coding In The Pharmaceutical Supply Chain ►Nov(6)FDA's New DSCSA Grandfathering GuidanceFDA Publishes DSCSA Grandfathering Guidance Exactly 2 Years LateHDA's 2017 Manufacturer Serialization Readiness Survey ResultsFDA Speaks About DSCSA At HDAHDA Traceability Seminar: RxTrace Future Topic List ExplodesWhat The TraceLink v HDA Lawsuit Teaches Us About The Value of Supply Chain Master Data ►Oct(8)The Fall Global GS1 Healthcare ConferenceTracelink vs. HDABio/Pharma Serialization and Traceability Summit 2017Opioid Epidemic: Root Cause ExposedFDA DSCSA Public Meeting Q&AA US Medicines Verification Organization (USMVO)?Why Aren't Health Insurance Companies Interested In Pharma Traceability in the US?HDA Schools FDA On DSCSA ►Sep(5)OPEN-SCS Announces Major MilestoneDoes Interoperability Change In 2023?Don't Miss These Back-To-Back Pharma Serialization and Tracing EventsThe FMD Product CodeDSCSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure, Again ►Aug(5)FDA DSCSA Public Meeting #1 Exposes Gulf In GoalsIdentifying Trading Partners Under the DSCSAHow Long Until You Are Fully Serialized?DSCSA Verification and Suspect ProductDSCSA Red Light Green Light: Verification Responses ►Jul(6)DSCSA Serialization Delay Eclipses GrandfatheringWhat Should FDA Pilot?FDA Announces New DSCSA Pilot Program and Public Meeting SeriesDSCSA Cascading DelaysDSCSA and RxTrace: The Song Remains The SameFDA Delays Enforcement of DSCSA November Deadline: What It Means ►Jun(5)Blockchain Reigns At GS1 Connect 2017Two-For-One FDA Guidance DocsSerial Number BondingFDA Delays UDI and FSMA: What About DSCSA?New Must-Read DSCSA Resource ►May(5)Brazil Publishes RDC-157 To Regulate 2017 3-Lot PilotThank You Peggy Staver!Breaking: FDA Official Offers Advice In Absence Of DSCSA Waiver GuidanceFDA Tea Leaves: Are They About To Delay The November Deadline?Is Your Drug Too Small For The Mandated 2D Barcode? ►Apr(5)Will Manufacturers Have Trouble Verifying Some Drugs Next Year?InBrief: Why The DSCSA Will Be Enforced Even Without FDA GuidanceIn Absence Of FDA Guidance, Follow PDSA RecommendationsKen Traub (1963 - 2017)Can Anyone Buy Non-Serialized Drugs After 11-27-2019? ►Mar(9)How To Properly Define GTINs For Your NDCsDSCSA Serialization: What Wholesalers ExpectMy Handshake With GermanyPharma Serial Number Randomization Under The Falsified Medicines DirectivePharma TraceabilityThe Russia Serialization Pilot GuidelineThe Season For Label RedesignDawn of HDA's Origin, The Key to DSCSA ComplianceBrand Protection: The 'No Brainer' Value, Beyond Compliance ►Feb(6)One Immediate Impact of President Trump On The FDAANVISA Reveals Draft Serialization Regulation and Asks For CommentsRxTrace to Sponsor the 2017 UDI Conference – June 7 & 8 in Baltimore, MD!HDA's 2016 Serialization Readiness SurveyRussia Begins Its Pharma Supply Chain PilotMonitor Your Product. Manage Your Brand. ►Jan(5)The Intrigue Contained In The New China Drug CodeSerializing Product Groupings Under Global RegulationsFirst Meeting of the HDA Verification Router Service Task ForceDSCSA: Saleable Returns VerificationBrazil Gets Rational With Their New Pharma Traceability Law ►2016 (63) ►Dec(4)NDC Nearing Its End, Afflicted by 'Identifier Failure'FDA Finalizes Guidance On Suspect ProductWill Global Serialization Mandates Result In Less Counterfeiting?Could Blockchain Technology Be Used For DSCSA Compliance? ►Nov(5)Drug Samples Under Global Serialization and Tracing RegulationsThe New GS1 US DSCSA Implementation Guidance SuiteHDA Delivers Home Run To Record-Breaking AudienceWill President Trump Eliminate The DSCSA?5 Myths About The DSCSA In 2023 ►Oct(6)China's Retreat From Pharma Serialization: Will This Become A Global Trend?Is The FDA Intentionally Delaying Publication Of The Overdue DSCSA Guidance?FDA Forfeits Opportunity To Guide IndustryInterview With Two Pharma Supply Chain Thought LeadersDSCSA: Kit, Repack, Combo Product, or Just A ‘Collection’?...AgainThe Open Serialization Communication Standard (Open-SCS) ►Sep(5)Brazil Officially Suspends All Remaining Serialization Deadlines Of RDC-54FDA Posts DSCSA-Specific Information Sharing Agreement Template For State AgenciesFDA To Hold DSCSA Public MeetingSerialization Mistake #1: Printing On Your OutsertProposed Pharma Serialization Regulation Progresses in Brazil ►Aug(5)The HDA Bar Code Quick Start Guide For Meeting The DSCSA And Other FDA RegulationsProduct Identification And National Registration CodesFDA Plans Busy Second Half of 2016 With Six DSCSA Draft Guidances ExpectedWho Will Enforce The DSCSA 2017 Serialization Mandate?China Adds Traceability Requirement To CFDA Drug Quality Management Specification ►Jul(4)Decommissioning Under the FMD/EUDRWill Manufacturers Be Able To Grandfather Products In Their DC And 3PL? Again#BlackLivesMatter Explained By A White GuySeven ►Jun(4)How Brexit Might Impact The Pharma Supply ChainHow Will The DSCSA Serialization Mandate Be Enforced After 2017?DSCSA: Label Artwork HeartachesFDA Speaks At GS1 Connect ►May(6)How RxTrace Became The Target Of A CounterfeiterHDMA Responds To FDA Pilots RFCMore Concerns With The FMD/EUDR Big Bang StartDSCSA: Kit, Repack, Combo Product, or Just A 'Collection'?Important HDMA Webinar On Barcoding for DSCSAIs A GS1 GTIN Really Usable As An NDC For DSCSA Compliance? Part 2 ►Apr(6)Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance? Part 1GLN: The Lowly Identifier That Could Kill The Use Of EPCIS For Pharma Regulatory ComplianceDSCSA Serialization Update: Where We are Now and How to Prepare for What’s NextInBrief: Pharma Supply Chain Leaders, Stop Throwing Interoperability Under The BusThe 2016 FDA Pilots WorkshopAn Open Letter To The FDA, RE: Please Fix The National Drug Code Soon ►Mar(5)Tracking Serialization: 2016 Pharma Trace Market TrendsEU FMD: Aggregation Is Not Mandated, But It Will Be NecessaryThe 2016 RxTrace U.S. Pharma Traceability Survey, Sponsored by Frequentz, Final ReportHDMA DMC Serves Sizzling Steak With A Small Side Of Snake OilDrug Verification: EU Vs US ►Feb(9)FDA Limits Ongoing Dispenser Enforcement Discretion To First RespondersThe Many Faces Of The FDAMeeting U.S. and E.U. Drug Serialization Requirements With A Single SolutionFDA To Hold DSCSA Pilots WorkshopThe E.C. 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The 2015 RxTrace U.S. Pharma Traceability Survey, Sponsored by FrequentzHDMA Expresses Concerns About Industry Readiness for DSCSAThe Coming Transition To Serialized Data ►Nov(5)FDA Publishes Draft Guidance For DSCSA Data ExchangeThe DSCSA, the NDC, Inventory Management, GS1 GTINs...and TurkeysWill The DSCSA Cause Drug Shortages After January 1?Global Traceability Data Exchange: Troubled Waters AheadWho Is A DSCSA Repackager? ►Oct(5)The GS1 Healthcare US Guidance For DSCSA, Vsn 1.1The Partnership For Safe Medicines Interchange 2014Will GS1's EPCIS Be Used Widely For DSCSA Data Exchange?The New Draft Guidance On The Effect of Section 585 of the FD&C Imposed By The DSCSAShould You Off-Load Your DSCSA Obligations To Your Contract Partners? ►Sep(7)Will The FDA Delay The DSCSA?Everything You Need To Know About UDI In One Neat PackagePharma Serialization: Going Totally Global SoonGS1 Healthcare US Publishes Updated Guidance For DSCSAWho Is A DSCSA Dispenser?The HDMA Supply Chain Product Transaction Scenarios For DSCSAIs Your Drug Exempt From The Federal Drug Supply Chain Security Act? Revisited ►Aug(5)Pharma Supply Chain Companies Organize To Establish Global Traceability Data Exchange Architecture2014 Fall Conference Season PreviewFDA Posts Small Entity Compliance Guide For UDI and GUDIDThe Case Against RFID In PharmaInBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2014 ►Jul(7)DSCSA: Special Privileges For The “Big-3″ Wholesale Distributors, Part 3DSCSA: Special Privileges For The “Big-3″ Wholesale Distributors, Part 2HDMA Has Updated Their EDI ASN Guidance For DSCSA, AgainDSCSA: Special Privileges For The "Big-3" Wholesale Distributors, Part 1DSCSA: A Closer Look At The Six-Year Record-Keeping Requirement2014 RxTrace Reader SurveyFive Years of Pharma Supply Chain Analysis ►Jun(5)DSCSA: Congress Should Have Mandated RandomizationThe FDA's Draft Guidance on Suspect Product, and Farewell ColumbusProduct Identifier Authentication (PIA)The Aggregation Hoax and PIAOne Goal: End Cancer. ►May(6)U.S. Pharma Supply Chain Complexity--RevisitedGS1 Ratifies Updated Versions of EPCIS and CBVThe Differences Between The DSCSA, FDA Rules and GuidanceRequesting an Extension/Exception to the U.S. FDA UDI RulesThe 2014 FDA DSCSA WorkshopUDI Deadline For Class III Medical Devices Quickly Approaching ►Apr(9)Just Released - The HDMA EDI ASN Guidance For DSCSARandomization—An Interview with Ken Traub—Part 5: Other ApproachesRandomization—An Interview with Ken Traub—Part 4: The Algorithmic ApproachRandomization—An Interview with Ken Traub—Part 3: Threat AnalysisRandomization—An Interview with Ken Traub—Part 2: Properties of RandomizationRandomization—An Interview with Ken Traub—Part 1: GS1 Serial Number ConsiderationsBringing UDI and the Global UDI Database to LifeDSCSA: Many Questions, Few AnswersIs Your Drug Exempt From The Federal Drug Supply Chain Security Act? ►Mar(5)DSCSA: Transaction StatementDSCSA: Transaction HistoryDSCSA: Transaction InformationThe Drug Supply Chain Security Act ExplainedThe Future of Healthcare Supply Chain Security ►Feb(6)Decoding The FDA's DSCSA TimelineDQSA: How Should Transaction Data Be Exchanged?DQSA: Dancing Around The Returns ProblemThe California Pedigree Law Is Now Officially InoperativeDoes The DQSA Require Manufacturers To Provide Aggregation Data? Survey Says...DQSA: Did The Authors Get The Timeline Right? ►Jan(5)How the DQSA Will--And Won't--Protect The Supply Chain, Part 2How the DQSA Will--And Won't--Protect The Supply Chain, Part 1Transatlantic AlignmentDon't Skip The DQSA Definition of Terms SectionDetecting Drug Diversion With Data Analytics--An RxTrace Interview With Analytics Expert Kosta Tzavaras ►2013 (83) ►Dec(7)This Is Not JournalismRest Up, 2014 Will Be Very BusyCorrection: Your Drug or Biologic Combination Product Is Probably NOT Exempt From The DQSAWill The FDA Eliminate The Linear Barcode On Drugs?FDA: Ready, Set, Hike!Announcing The 2014 RxTrace U.S. Pharma Traceability SurveyPreemption: What Does It Mean? ►Nov(8)It's Official, President Obama Signs H.R. 3204, DQSA, Into LawDQSA: The U.S. Pharma Supply Chain Must Organize, Or Risk FailureDQSA: Will U.S. Pharma Distributors Mandate Aggregation Data In Phase 1?DQSA: Getting To Electronic Transaction Data ExchangeU.S. Senate Passes H.R. 3204 With A Voice VoteAll Eyes On The U.S. Senate TonightDrug-Device Combo Products Under State And Federal Pedigree LawsThe Flaw That Must Be Addressed in H.R. 3204, The Drug Quality and Security Act ►Oct(6)How Smooth Will Industry Deployment of the ePedigree Laws Be? Take a Good Look At Healthcare.govInBrief: Comments on H.R. 3204 by FDA's Dr. Ilisa Bernstein at PSM Interchange 13Eli Lilly: "Serialization Needs Standardization"Dr Ilisa Bernstein of FDA CDER Office of Compliance To Keynote PSM InterchangeWill Use Of EPCIS Force Everyone To Use GS1 Identifiers?California, Congress and The Choices We Are Forced To Face ►Sep(7)Waiting For The Senate To Act On A Track & Trace Bill, AgainInBrief: Important New Bicameral Draft Of A Pharma Supply Chain Security BillUDI And The Approaching End Of The NDCInBrief: FDA Publishes Final UDI RuleInBrief: California Proposes Breakthrough ePedigree Regulation On Drop ShipmentsWhat The UDI Date Format Says About FDA's DirectionFDA Chooses DUNS For Unique Facility Identifier ►Aug(6)Working With CMOs Under California ePedigree3PL Operation Under California ePedigreeInBrief: 'The Smallest Package Or Immediate Container' In CaliforniaVendor Managed Inventory Under California ePedigreeInBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2013Federal Pedigree: Caught In A Web Of Politics ►Jul(7)Senators Propose Amendments To S. 959Still Waiting For The SenateSummer Writing: Steve Jobs, Bill Gates and MeInBrief: CBO Estimates S. 959 Would Exceed Unfunded Mandate Threshold For Private Entities In At Least One YearFall Conference Season PreviewWill Generic Drug Manufacturers Serialize Their Drugs In Time?Four Years Of RxTrace ►Jun(8)Hey California Board of Pharmacy: Your Time Is Running Out!The California ePedigree Timeline Vs. The Senate Bill TimelineSummer NewsFalling Between The Cracks Of The California Pedigree LawShould Pharmacies Decommission EPCs Upon Dispense?InBrief: The Pharma Track & Trace Bill Has Passed the U.S. House Of RepresentativesInBrief: CBO Estimates H.R. 1919 Would Exceed Unfunded Mandate Threshold For Private EntitiesThe Federal Lot-Based Pedigree Before Congress ►May(8)The Politics Of Federal Track & Trace LegislationWould A U.S. Federal Pedigree Law Require A New UFA?InBrief: A Track & Trace bill Has Made It To The Senate FloorRanbaxy, FDA, FDASIA and Indian Pharma CredibilityInBrief: A Track And Trace Bill Has Made It To The House FloorAn Industry Protection Bill Concealed Under The Veil Of Patient ProtectionHouse Subcommittee To Markup Track & Trace Draft Today And TomorrowCalifornia Responds To The Senate Pharma Track & Trace Discussion Draft ►Apr(8)The House Hearing on 'Securing Our Nation's Prescription Drug Supply Chain'California's Draft Regulation on InspectionsCalifornia's Draft Inference RegulationThe New Pharma Track & Trace Discussion Draft In The SenateDraft Regulations On Certifications Within California ePedigreesThe Board of Pharmacy Must Respond To Ideas For Making EPCIS WorkInBrief: Can ePedigree Be Deferred Until Mid-2016?Q&A With Virginia Herold, Executive Officer, California Board Of Pharmacy ►Mar(4)Are Your Drugs Exempt From The California Pedigree Law?The Best Laid Plans...The New GS1 Healthcare US Track & Trace GuidanceThe New Grandfathering Provisions Of The California Pedigree Law ►Feb(7)E-Pedigree Vendor SelectionNew RxTrace Column in Healthcare Packaging MagazineWell-Intended Report Calls For Global Track & Trace Of PharmaceuticalsThe Supply Chain Provisions Of The FDA Safety & Innovation ActInBrief: Illegally Imported Drugs Found To Be Counterfeit...AgainCalifornia ePedigree UncertaintyInBrief: Pharma Supply Chain Community Calls For Solutions To Security Problems ►Jan(7)InBrief: FDA Again Says It Plans To Publish Track & Trace Guidance By Year EndHow Pedigrees Protect The Drug Supply: The Case Against Cumberland DistributionHow Should Inference Work?Celebrating Martin Luther King Jr.Walgreens, Automation, And Erasing DisabilitiesData Ownership In The Track & Trace Cloud"The Shadows Of Things That MAY BE, Only" : EPCIS and California Compliance ►2012 (60) ►Dec(4)California Board of Pharmacy Clarifies Use Of GS1 EPCISRobert J. "Bob" Bergantino (1960-2012)How To Make The Semi-Centralized Track & Trace Model A RealityCan HIBCC Withstand The GS1 Tide In Medical Device Identification? ►Nov(6)The Different Goals of Anti-Counterfeiting Technologies and SerializationInBrief: Pharma Supply Chain Criminals Get Justice, Part 2Pharma Anti-Counterfeiting and SerializationThe Significance of the Abbott, McKesson and VA PilotWill The California ePedigree Dates Slip Again?More Thoughts On The Congressional Discussion Draft ►Oct(7)Congressional Legislation Development: Mad Libs Edition!The Congressional Draft Proposal to Improve Drug Distribution SecurityWe Should Be Ashamed Of The U.S. Approach To Pharma RecallsHow To Maximize The ROI Of Attending A ConferenceCould It Be The Cloud? More Thoughts On IBM's Divestiture Of Its EPCIS And E-Pedigree SuiteIBM Divests EPCIS and ePedigree SuiteInBrief: RFID and Barcode Interoperability ►Sep(4)InBrief: Pharma Supply Chain Criminals Get JusticeShould GS1 Continue Developing ePedigree Standards?FDA Proposed UDI: The GUDID DatabaseInBrief: California Board of Pharmacy Webcasts ►Aug(6)FDA Proposed UDI: AIDC RequirementsFDA Proposed UDI: A Revolution In Number AssignmentA Quick Note About The UDI Conference September 18 & 19, 2012Pelotonia 2012...180 Miles!Standards and Guidance For U.S. Pharma Supply Chain TechnologyInBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2012 ►Jul(5)Return Of Two ClassicsWho Will Decide Which Pedigree Model You Will Invest In?The Good News About Cancer TreatmentsAnnouncing, Dirk Rodgers Consulting, LLCThree Years of Heat and Light ►Jun(4)Summer WritingPDUFA Will Not Include RxTECSome People Actually WANT To Buy Counterfeit DrugsThe Preemption Provisions Built Into The California Pedigree Law ►May(4)Before You Sign Up For GDSN, Get Your Data In Order With A Data Quality ProgramAn Open Letter to GS1, RE: GDSN MarketingJames "Jim" Dowden (1955? - 2012)The Built-in Protections Of The U.S. Pharma Supply Chain ►Apr(5)The Serial Number Handling In Your WMS Probably Isn't Sufficient For Pharma SerializationYour GS1 Company Prefix: An Enterprise ResourceShould FDA Cede All Standards Development To GS1?InBrief: ePedigree Models and Points of FailureGS1 Standards - Betcha Can't Use Just One! ►Mar(6)InBrief: FDA To Publish Track & Trace Standard By Year EndPharma Aggregation: How Companies Are Achieving Perfection TodayCalifornia Enforcement Subcommittee Moves To Require FDA SNIWhat If RxTEC Isn't Adopted?The Abrupt Surge of Interest in Serialization and ePedigree TopicsThe Surprise Consequence of the California Pedigree Law ►Feb(4)Will the FDA Accept RFID for Drug Identification?How Counterfeit Avastin Penetrated the U.S. Supply ChainWhy NOW Is The Time To Move Away From Linear BarcodesRepackaging Drugs Under A Serialization Regulation ►Jan(5)Anatomy Of An FDA SNIDepicting An NDC Within A GTINAnatomy of a GTINUpdated HDMA Bar Code Guidance: A Must ReadAnatomy Of The National Drug Code ►2011 (25) ►Dec(1)Could This Be Your Future Track & Trace/ePedigree Exchange Solution? ►Nov(4)Should Regulations Dictate Technology?STEP #1: Raise Penalties For Drug Crimes To Reflect The Widespread Harm They Can InflictWhy GS1 EPCIS Alone Won't Work For California Pedigree, Part 2Impact of RxUSA v. HHS On Future Pedigree Legislation ►Oct(3)Inspecting An Electronic PedigreeWhy GS1 EPCIS Alone Won't Work For California Pedigree, Part 1Safe Prescription Drug Reimportation: An Oxymoron ►Sep(3)Pharmaceutical Anti-Counterfeiting, A First-Rate New ResourceDiscounts For PSM Interchange 2011 End Next WeekCalifornia Board of Pharmacy Re-awaken ►Aug(1)Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2011 ►Jul(2)Pew Prescription Project: After HeparinRxTrace: Sophomore Effort ►Jun(2)SNI's Are Not Enough In a Plateau-Based Supply Chain Security ApproachIllegitimate Drugs In The U.S. Supply Chain: Needle In A Haystack ►May(3)Plateaus of Pharma Supply Chain SecurityU.S. Pharma Supply Chain ComplexityThe Viability of Global Track & Trace Models ►Apr(2)Reliance on Trust in the U.S. Pharma Supply ChainLessons from "Drug Theft Goes Big" ►Feb(1)Attributes Of A Global Track & Trace Application ►Jan(3)GS1 Identifiers and EPC's in EDI Messages: Important New HDMA GuidanceElectronic Message Security and More on CertificationsPharma Serialization ROI ►2010 (31) ►Dec(2)Happy Holidays 2010Do We Even Need To Mandate Drug Pedigrees Anymore? ►Nov(2)Writing Is Thinking. For Example, Ken TraubThe Future of Traceability Repositories and Inventory Management Systems ►Oct(5)Certifications In A California-Compliant Drug PedigreePedigree Will Change FOB TermsPartnership For Safe Medicines Interchange 2010Terminology: Track and Trace, and PedigreeBefore You Participate in The GS1 US 2015 Readiness Program, Read This ►Sep(2)A Semi-Centralized, Semi-Distributed Pedigree System IdeaStop Claiming that 10% of Drugs Worldwide are Counterfeit ►Aug(3)Masterpiece: GS1 Tag Data Standard 1.5Yifan “Ivan” Shen (1962–2010)Estimated Rise In Serialized Drugs In The U.S. Supply Chain ►Jul(1)RxTrace, One Year Retrospective ►Jun(3)The “Normal Distribution” ConceptCalifornia Pedigree Law: Historic Change to CommerceWill The Pharma Supply Chain Be Able To Use Inference? Maybe Not! ►May(3)Inference in the Pharmaceutical Supply ChainThe Modern Pharmaceutical Wholesaler and the Approaching TransformationInnovation and the “Authenticating Wholesaler” Idea ►Apr(1)RFID is DEAD…at Unit-Level in Pharma ►Mar(3)FDA Aligns with GS1 SGTIN For SNDCSo a customer demands that you use GLN’s and GTIN’s. What next?WAR: GS1 Vs. HIBCC ►Feb(2)Supply Chain Data Synchronization and Patient SafetyWill The Pharma Supply Chain Find Any Value In GS1 Discovery Services? ►Jan(4)The Deputized Supply Chain“Why the rush for GS1 standards?”Charles “Chuck” Schramek (1945 – 2010)New Layout for RxTrace ►2009 (19) ►Dec(1)Who owns supply chain visibility data? ►Nov(4)How to Stop Pharmaceutical Cargo TheftUse of GLN and GTIN for Pedigree Regulatory CompliancePDMA Lawsuit Resolved?What are Pedigree Laws Trying to Accomplish Anyway? ►Oct(2)Pedigree Models and Supply Chain Master Data"The State of Healthcare Logistics" ►Sep(3)Master Data, Supply Chain Master Data and Instance DataWho’s Responsible for Global Supply Chain Security?The California Pedigree Law ►Aug(4)Digital SignaturesThe Legitimate and Illegitimate Supply ChainsThe Florida Pedigree LawSubscribing to RxTrace ►Jul(5)GS1Dangerous DosesThe Importance of StandardsFundamental Law of CommerceWelcome to rxTrace

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