Wednesday, May 21, 2014

The Differences Between The DSCSA, FDA Rules and Guidance - RxTrace

More great stuff that's clear and easy to understand from Dirk Rodgers. Follow the link below to read his full post.

The Differences Between The DSCSA, FDA Rules and Guidance - RxTrace:

"From reading the responses to the FDA docket requesting public feedback on standards for interoperable information exchange, I think it is time to review the difference between laws, FDA Rules and FDA guidance, like those stemming from the Drug Supply Chain Security Act (DSCSA).  It appears that some people might be confusing these a little."

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Monday, May 12, 2014

The 2014 FDA DSCSA Workshop - RxTrace

Dirk Rodgers reports. Follow the link below to see his entire post and observations:

The 2014 FDA DSCSA Workshop - RxTrace:

"The U.S. FDA held their first industry workshop focusing on the new Federal Drug Supply Chain Security Act (DSCSA) last Thursday and Friday at FDA Headquarters in Silver Spring, MD.  The goal of the workshop was to help the FDA collect ideas and preferences from industry stakeholders and technology providers for meeting the January 1, 2015 DSCSA requirement to exchange Transaction Information (TI), Transaction History (TH) and Transaction Statements (TS).  The FDA must publish a draft guidance document on the same topic before November 27, 2014, so this workshop, plus the responses to the recent docket, will help them write that draft."

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Monday, May 5, 2014

Implementing Pharmaceutical Serialization and Traceability Perspectives and Investments - The Pew Charitable Trusts

Implementing Pharmaceutical Serialization and Traceability Perspectives and Investments: - The Pew Charitable Trusts

"The Pew Charitable Trusts’ drug safety project and Booz Allen Hamilton conducted a qualitative assessment in 2013 of stakeholder perspectives on serialization and traceability systems across the U.S. pharmaceutical distribution supply chain. The analysis in the report Implementing a Pharmaceutical Serialization and Traceability System in the United States: Stakeholder Perspectives and Investments offers a high-level snapshot of industry expectations, system preferences, and anticipated investments that can inform implementation of DQSA. "

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Read The Report:  Implementing a Pharmaceutical Serialization and Traceability System in the United States: Stakeholder Perspectives and Investments (PDF)

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California HMDR Licensing Program Home Page - CA Dept of Public Health

California Home Medical Device Retailer (HMDR) Licensing Program

HMDR Licensing Program Home Page - CDPH:

"This program licenses California [Home Medical Device Retailer] HMDR facilities and registers Out-of-State HMDR facilities. In-State HMDR facilities supply prescription medical devices or durable medical equipment for use in the home to treat acute or chronic illnesses or injuries. Out-of-State HMDR facilities must supply prescription medical devices in order to qualify for the registration. The HMDR program also licenses exemptees that are required to be on staff in lieu of a pharmacist at facilities selling prescription medical devices as described under California and Federal medical device laws."

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Thursday, May 1, 2014

Cardinal Health Profit Falls 8.7% - Wall Street Journal - WSJ.com

Cardinal Health Profit Falls 8.7% - Wall Street Journal - WSJ.com:

"Cardinal Health Inc. said its fiscal third-quarter earnings fell 8.7% as the drug wholesaler’s results were hurt by the expiration of its contract with Walgreen Co.

Cardinal Health was dealt a blow last year when Walgreen and European drug giant Alliance Boots GmbH agreed to get their branded and generic pharmaceutical products from rival AmerisourceBergen Corp.

Drug wholesalers have been forming ventures and collaborations with other health-care related companies in an effort to increase their bargaining power with pharmaceutical companies and expand internationally."

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