Rx-360

An International Pharmaceutical Supply Chain Consortium

Rx-360’s mission is to protect patient safety by sharing information and developing processes to improve the integrity of the health care supply chain and the quality of materials within the supply chain.

Rx ALERT

Falsified packs of cancer drug Votrient found in Germany

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News

Rx-360 CEO, Mark Paxton, Featured in the World Korean Medical Journal

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News

Rx-360 Agrees to Participate in DSCSA & Blockchain VirtualPilot Study

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Rx ALERT

Pharmaceutical Annual Cargo Theft Report

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Rx ALERT

Longshore Union Calls for East Coast Port Shutdown

By Marex  2017-02-23 14:01:00 The International Longshoremen’s Association (ILA) is calling for a shutdown at ports along the eastern seaboard and Gulf...

24 February 2017
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Rx ALERT

Pharmaceutical Annual Cargo Theft Report

Report provided by the Transported Asset Protection Association TAPA Americas collects, records, analyzes and reports on cargo theft data for...

20 February 2017
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Rx ALERT

Falsified packs of cancer drug Votrient found in Germany

Securing Industry 18FEB2017 – Axicorp GmbH has discovered another falsified medicine in the legitimate supply chain in Germany, this time...

18 February 2017
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Rx REPORT

Industry News Headlines

Drug-peddling brothers from Lithuania ran international counterfeit medicinescam from Oxford … Oxford Mail Enforcement officers raided the house and storage...

15 February 2017
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Rx REPORT

An Analysis of FDA FY2016 Drug GMP Warning Letters

Barb Unger, of Unger Consulting Inc., has written a superb article that makes sense of all the complicated and obscure...

6 February 2017
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Rx REPORT

Securing Medical Product Quality Through the Supply Chain

We are very pleased to inform you that the USP is announcing the availability of a CoE Pilot Program on...

6 February 2017
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Rx REPORT

FDA Final Repackaging Guidance

FDA has recently issued a final guidance for industry entitled “Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing...

3 February 2017
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Rx REPORT

Could Blockchain Technology Be Used For DSCSA Compliance?

If your email inbox is anything like mine it has recently been swamped with articles and webinar notices about the...

2 February 2017
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Rx REPORT

96% of Websites Selling Prescription Drugs Found to Be Operating Illegally

As of December 31, 2016, the National Association of Boards of Pharmacy has reviewed over 11,000 websites selling prescription medicine...

25 January 2017
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Rx REPORT

Strict vetting can help fight counterfeit drugs

The World Health Organization (WHO) estimates that about 10 per cent of global pharmaceutical supply is counterfeit and substandard. The...

23 January 2017
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Annual Reporting by Prescription Drug Wholesale Distributors: Questions and Answers

On January 10, 2017, FDA issued draft guidance addressing questions and clarifying FDA’s expectations for annual reporting to FDA by...

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Summary

US GAO Report on FDA’s Drug Inspection Program

In 2008 and 2010, GAO examined FDA’s foreign drug inspection program and recommended it conduct more foreign inspections.  In another...

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Summary

Supplier-Led Working Group Charter

The Rx-360 Supplier-Led Working Group (SLWG) was formed in 2013 as an initiative through which supplier members can share perspectives...

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Summary

Data Integrity Working Group Charter

The Data Integrity Working Group of Rx-360 focuses on an area that has been the subject of US FDA enforcement...

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Webinar

Webinar: Cargo Theft in Pharmaceutical Industry: What does it really cost?

Webinar Purpose To present the outcomes of the white paper. Busy professionals do not have time to research the true...

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Summary

FDA Issues Final Guidance on Quality Agreements

FDA has issued final guidance for industry entitled ‘‘Contract Manufacturing Arrangements for Drugs: Quality Agreements.’’ This guidance describes FDA’s current...

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Summary

FDA Public Notification of Emerging Postmarket Medical Device Signals

FDA has issued final guidance describing CDRH’s policy for notifying the public about medical device “emerging signals.”  This guidance describes the...

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Summary

EC Publications on Investigational Medicinal Products

December 9, 2015 The European Commission has recently published four (4) new public consultations on Investigational Medicinal Products (IMPs), which...

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Summary

EU GMP Annex 16: Certification by a Qualified Person and Batch Release

December 9, 2015 On October 12, 2015, EMA published GMP Annex 16, Certification by a Qualified Person and Batch Release.  Annex...

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Summary

MHRA announced it signed a Memorandum of Understanding (MOU) with its counterpart body in India

December 17, 2015 On October 5, 2015, the MHRA announced it signed a Memorandum of Understanding (MOU) with its counterpart...

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Audit Reports

Audit Report

Asahi Kasei Medical Co., Ltd. JA – 801

Audit #: JA - 801
Region: Oita-shi
Material: Basic Chemicals/Raw Materials
Company: Asahi Kasei Medical Co., Ltd
Location: Planova Oita Plant 2111-2 Oaza Sato, Oita-shi, Oita 870-0396, Japan
Date: 17 November 2016
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Audit Report

Asahi Kasei Medical Co., Ltd. JA – 800

Audit #: JA - 800
Region: Nobeoka-shi Miyazaki
Material: Basic Chemicals/Raw Materials
Company: Asahi Kasei Medical Co., Ltd
Location: Planova Plant 6-4158 Asahi-machi, Nobeoka-shi Miyazaki 882-0847, Japan
Date: 15-16 November 2016
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Audit Report

Nuova OMPI JA – 579

Audit #: JA - 579
Region: Padova
Material: Packaging
Company: Nuova OMPI
Location: Via Molinella, 17 35017 Piombino Dese, Padova, Italy
Date: 30-31 March 2015
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Audit Report

Nipro Glass JA – 606

Audit #: JA - 606
Region: Virginia
Material: Packaging
Company: Nipro Glass
Location: 194 Duckworth Drive, Chase City, Virginia 23924
Date: 19-20 May 2015
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Audit Report

NAMSA, Sterilization Products Division JA – 525

Audit #: JA - 525
Region: Ohio
Material: Basic Chemicals/Raw Materials
Company: NAMSA, Sterilization Products Division
Location: 6750 Wales Road Northwood, Ohio 43619
Date: 26 May 2015
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Audit Report

Morton Salt JA – 551

Audit #: JA - 551
Region: Ohio
Material: API/Excipients
Company: Morton Salt
Location: 151 South Industrial Avenue Rittman, Ohio 44270
Date: 11 August 2015
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Audit Report

Mingtai Chemical Co. Ltd JA – 707

Audit #: JA - 707
Region: Taoyuan Hsien
Material: API/Excipients
Company: Mingtai Chemical Co. Ltd
Location: 1142, Shin Hsing Rd., Bah-Der City, Taoyuan Hsien, Taiwan, ROC
Date: 19-20 November 2015
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Audit Report

Medistri SA JA – 579

Audit #: JA - 579
Region: Domdidier
Material: Packaging
Company: Medistri SA
Location: 96 Route de l’industrie, 1564 Domdidier Switzerland
Date: 9 April 2015
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Audit Report

Mallinckrodt Pharmaceuticals JA – 531

Audit #: JA - 531
Region: Greenville
Material: API/Excipients
Company: Mallinckrodt Pharmaceuticals
Location: DaOnne Pustelnik 100 Louis Latzer Drive Greenville, IL 62246
Date: 14 May 2015
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Audit Report

M and H Plastics JA – 722

Audit #: JA - 722
Region: Suffolk
Material: Packaging
Company: M and H Plastics
Location: Beccles, Suffolk NR34 8TS United Kingdom
Date: 13-14 October 2015
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Latest News

News

Pharma Logistics Week – Exclusive Discount

22 February 2017
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News

Rx-360 CEO, Mark Paxton, Featured in the World Korean Medical Journal

17 February 2017
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