PRO Service includes current weekly industry updates and important posts gathered from the Federal Register (including guidelines, regulations, meetings and workshops announced by the FDA and other government agencies).
L I N K S : October 6, 2017
- Healthcare payers and providers seeking to enhance interoperability, patient care management, and data security are looking to blockchain technology
- 12th Pharmaceutical Cold & Supply Chain Logistics Conference to take place October 10-11, 2017
- Pharmaceutical Supply Chain Security Risk Assessment for Shipping Lanes- Transporting pharmaceutical products and production materials, throughout the manufacturing, packaging, warehousing, and distribution processes is an integral part of the Supply Chain
- Singapore’s Changi Airport announced as a pharmaceuticals air cargo hub in order to improve the local supply chain's ability to handle pharmaceutical air cargo
- Serialization In Practice: How Manufacturers Can Ensure Compliance
- Overview of the comments the Healthcare Distribution Alliance (HDA) submitted in response to the FDA’s Request For Comments in “Enhanced Drug Distribution Security Under the Drug Supply Chain Security Act; Public Meetings”
- Open-SCS Group presented its initial Packaging Serialization Standard (PSS 1.0) on September 25 at Pack Expo
- Centers for Disease Control and Prevention is experimenting with blockchain technology to store and share data faster so they can better monitor the spread of infectious diseases.
- A list of blockchain news from the month of September
- Goa FDA calls for regulation & technology upgradation of supply chain to curb counterfeiting
- Identiv, Inc. partners with Chronicled, Inc. to launch the NFC Temperature Logger- a low-cost, disposable smart sensor label that tracks and stores temperature readings for use in the cold chain industry.
- A look at some of the issues addressed by the new draft of the pharmaceutical policy released by The Department of Pharmaceuticals (DoP), under Government of India (GoI).
L I N K S : September 29, 2017
- FDA took action against more than 500 websites that sell illegal drugs to American consumers
- At Pack Expo in Las Vegas, Open Serialization Communication Standard (OPEN-SCS) Group introduces its serialization standard, Packaging Serialization Specification (PSS) 1.0
- UPS announces new technology to help healthcare companies standardize and share information for serialized pharmaceuticals in the U.S. supply chain
- The MediLedger Project demonstrates compliance with DSCSA by using blockchain technology to track and trace prescription meds
- 32nd Global GS1 Healthcare Conference to take place October 17-19, 2017. Supply chain leaders will discuss ways to improve patient safety, supply chain security and efficiency
- Tubilux selects TraceLink to achieve EU FMD compliance for its EU pharmaceutical customers
- Molecular tagging technology provides security and authentication to help pharmaceutical companies identify, target, track and trace products throughout the supply chain
- Amazon may be getting involved in the drug supply chain
L I N K S : September 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 starting Feb 9, 2019 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 : August 25, 2017
- Directors of FDA’s three medical product centers applaud the U.S. Congress for passing the FDA Reauthorization Act of 2017 (FDARA).
- The International Quality and Productivity Center released the final report of a survey they conducted to determine whether pharmaceutical manufacturers would be ready to meet DSCSA deadlines. Approximately one quarter of participants responded that they are going to miss deadlines in both the U.S and the E.U.
- The Alliance for Safe Online Pharmacies conducted a 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. This is a concern as there are roughly 33,000 illegal online pharmacies at any given time.
- 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 Drug Supply Chain Security Act.
L I N K S : August 18, 2017
- At least 17 states have enacted rules to curb the number of opioid analgesics doctors can prescribe.
- China Food and Drug Administration (CFDA) submitted its membership application to the International Council for Harmonisation, which was established to facilitate international collaboration, and has been successful in standardizing and elevating drug development practices throughout the world.
- GS1 US publishes The GTIN Adoption and Usage Model, which helps “healthcare companies improve patient safety and supply chain efficiency by better leveraging unique product identification”
- NACDS endorsed the Every Prescription Conveyed Securely Act, which requires electronic prescribing for controlled substance medications in Medicare Part D. NACDS supports the use of electronic prescriptions because they are electronically trackable, cannot be copied or altered, reduce the likelihood of fraudulent prescriptions, etc.
- Second annual blockchain conference tailored for the healthcare industry to take place September 25-26, 2017. Conference will provide insight into how blockchains are currently being used to fix problems in healthcare and what more can be done in the future.
- RXTrace red light green light article about the DSCSA verification requests. I scrolled down to the bottom to read the comments andrealized the first comment was from our very own, Bob Celeste.
- 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.