Showing posts with label DQSA. Show all posts
Showing posts with label DQSA. Show all posts

Sunday, May 17, 2015

Is Your Pharmacy Ready for Drug Supply Chain Integrity? | The National Law Review

Read the full article: Is Your Pharmacy Ready for Drug Supply Chain Integrity? | The National Law Review:

"Beginning July 1, 2015, most pharmacies in the U.S. will be required to have systems in place to receive transaction information regarding the prescription drugs they purchase from suppliers.  The requirement stems from a 2013 federal law called the Drug Supply Chain Security Act (DSCSA), enacted as one component of the Drug Quality and Security Act."

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Wednesday, December 17, 2014

FDA > DSCSA > Are you ready for the Drug Supply Chain Security Act?

Sign-up for a Board-approved California Designated Representative course now:
 - Wholesaler Training Course
 - 3PL Training Course
 - Reverse Distributor Training Course


"There are new requirements under the Drug Supply Chain Security Act (DSCSA) for manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers (trading partners). Some requirements began in November 2014 and several key requirements begin at various stages in 2015. The new requirements, development of standards, and the system for product tracing will continue to be phased in over the next nine years. FDA will continue working with trading partners and other stakeholders to effectively implement the new requirements."

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For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):


Thursday, October 16, 2014

FDA Announces Availability of Draft Guidance Regarding Licensure Standards Under Title II of the DQSA - News - National Association of Boards of Pharmacy® (NABP®)

Read the full article: FDA Announces Availability of Draft Guidance Regarding Licensure Standards Under Title II of the DQSA - News - National Association of Boards of Pharmacy® (NABP®):

"FDA is issuing this document, “The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers,” (PDF) to help stakeholders understand the immediate effects of the law and to clarify section 585’s effect on state product tracing requirements, and on standards, requirements, and regulations related to licensing wholesale distributors and/or third-party logistics providers (3PLs)."

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     California (earn a training completion certificate):


Thursday, September 18, 2014

Free Download - Applying GS1 Standards to U.S. Pharmaceutical Supply Chain Business Processes to support DSCSA - GS1 US

Updated June 1, 2025

The original link got outdated and broke.

You might also be interested in:

GS1 US DSCSA Implementation Suite


-----  original post follows below  ------

Request to download the free guide: Implementation Guideline - Applying GS1 Standards to US Pharma Supply Chain Business Processes to support DSCSA - GS1 US:

"This guideline offers pharmaceutical industry stakeholders best practices for meeting immediate lot-level management deadlines, and sets the foundation for serialized item-level traceability. Release 1.1 of the GS1 Healthcare US Implementation Guideline, “Applying GS1 Standards to U.S. Pharmaceutical Supply Chain Business Processes to support DSCSA”, will help companies comply with early term, mid term and later requirements defined in the 2013 DSCSA law."

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California Designated Representative Training Courses (wholesaler, third-party logistics provider, 3PL) - Approved by the California State Board of Pharmacy
California Designated Representative Training Courses (wholesaler, third-party logistics provider, 3PL) - Approved by the California State Board of Pharmacy - Earns a training affidavit

- - -

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):


Friday, September 5, 2014

The Drug Supply Chain Security Act Explained (eBook) - RxTrace

Updated September 12, 2016

The link in the original post below didn't age well.  You might also be interested in:

The Drug Supply Chain Security Act Explained: Second Edition, Plus Explanations Of Key FDA DSCSA Guidances - by Dirk Rodgers





- -  original post follows below  - -

Learn more & purchase this eBook: The Drug Supply Chain Security Act Explained - RxTrace:

"The Drug Supply Chain Security Act (DSCSA), which is Title II of the DQSA, is the most complex pharma track and trace law ever enacted.  Its many layers of complicated rules and regulations provide challenges that companies will need to untangle.  But now, Dirk Rodgers explains it all.

"The Drug Supply Chain Security Act Explained" is a clear, section-by-section explanation of the Drug Supply Chain Security Act (DSCSA), with important implications for companies in the U.S. supply chain, by writer and founder of RxTrace.com, Dirk Rodgers, an expert in healthcare supply chain technologies.

"The Drug Supply Chain Security Act Explained" will guide readers through the process of complying with the DSCSA.  It includes thousands of hyperlinks to the definitions of terms and other sections within the DSCSA as well as to the original DSCSA text. It also includes pages of references to external material.  An abbreviated version of the Table of Contents is below."

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Training for CA Designated Representative & Designated Representative-3PL license applicants


- - -

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Wednesday, July 23, 2014

HDMA Revises 856 Advance Ship Notice Documentation

Read the full article: HDMA revises 856 Advance Ship Notice documentation:

"That HDMA has come out twice with updates is a testament to the urgency of getting data-forwarding practices in order among US drug distributors: come January, distributors will need to be able to verify shipments (at the lot level) to pharmacies and other customers. This is the legislated mandate from Congress when it passed the Drug Quality and Security Act (of which DSCSA is a part); FDA is on call to Congress to issue guidelines for drug tracking by late November."

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For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

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     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):


Monday, May 5, 2014

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

Updated November 29, 2019

You might also be interested in:
Drug Supply Chain Security Act Law and Policies - FDA.org

- - -  the original post follows below  - - -

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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The largest selection of Board-approved California Designated Representative online training classes for wholesalers, 3PL, reverse distributors. Earns a training affidavit.
The largest selection of Board-approved California Designated Representative online training classes for wholesalers, 3PL, reverse distributors. Earns a training affidavit.



For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Thursday, January 16, 2014

What Are The FDA's CGMPs? Ramifications for Compounding Outsourcing Facilities

Updated February 4, 2026

Some of the links in the original post broke.

You might also be interested in:
---  the original post follows below  ---

On November 27, 2013, President Obama signed the Drug Quality and Security Act (DQSA), legislation that contains important provisions relating to the oversight of compounding of human drugs. In the new law, a compounder can become an “outsourcing facility.” Outsourcing facilities must comply with CGMP requirements. (Source:  FDA.gov - Compounding Quality Act - Title I of the Drug Quality and Security Act of 2013)

The FDA (Food and Drug Administration) puts forth the cGMP regulations (current good manufacturing practice). The CGMPs are also commonly referred to as:
  • GMP - good manufacturing practice, or
  • CGMPR (current good manufacturing practices regulations)
If you're unfamiliar with the FDA cGMPs, then consider taking this online course:
21 CFR 211: Pure, Safe, and Effective - an introduction to the FDA cGMPs

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For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Monday, January 13, 2014

Don’t Skip The DQSA Definition of Terms Section - RxTrace

Follow the link below, and heed Dirk Rodgers/RxTrace advice. Here's a sampling of glossary terms that might interest you:  dispenser, distribution, exclusive distributor, repackager, 3PL provider, wholesale distributor.

Don’t Skip The DQSA Definition of Terms Section - RxTrace:

"Section 581, Definitions, is a special glossary of terms whose definitions only apply within the text of the law.  So if you read the other sections and you assume the dictionary or the everyday definition of certain terms, you will miss the full meaning of those sections."

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For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Wednesday, December 4, 2013

Full-line distributor sales topped $300 billion in 2012 - DQSA lot/item level tracking stats

Full-line distributor sales topped $300 billion in 2012, representing 91% of pharma sales - Pharmaceutical Commerce:

"The Factbook contains operational details often of high interest to vendors serving wholesalers’ infrastructure needs. One particular number to call out: two out of three HDMA members are already tracking lot-level barcodes through their systems for at least some of their products. Lot-level tracking is now the centerpiece of the Drug Quality and Security Act, which will mandate such tracking over the next four years. Data on item-level tracking (the next stage in DQSA) is occurring, but at significantly lower percentages."

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The Exemptee Institute

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Thursday, November 28, 2013

Obama signs Drug Quality and Security Act into law - SecuringIndustry.com


SecuringIndustry.com - Obama signs Drug Quality and Security Act into law:

"President Obama has signed H.R. 3204 into law, setting the wheels in motion for the FDA to develop a national track-and-trace system to secure the pharmaceutical supply chain.

The aim of the Drug Quality and Security Act (DQSA) is to "minimise opportunities for contamination, adulteration, diversion, or counterfeiting," whilst also clarifying the FDA's authority to regulate compounding pharmacies, according to the White House."

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CA Designated Representative online web-based training certification by SkillsPlus Intl Inc.
FL Designated Representative online e-Learning exam preparation by SkillsPlus Intl Inc.
The Designated Representative Institute

CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc.
The Exemptee Institute

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Monday, November 18, 2013

Breaking news: US Senate clears track-and-trace bill - SecuringIndustry.com

SecuringIndustry.com - Breaking news: US Senate clears track-and-trace bill:

"The US Senate passed H.R. 3204 by unanimous voice vote today, bringing a national track-and-trace system for medicines and new laws governing compounding pharmacies to the brink of fruition.

With the House having given its blessing to H.R. 3204- also known as the Drug Quality and Security Act (DQSA) - at the end of September, all that remains now is for the bill to be passed to President Obama for signature."

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CA Designated Representative online web-based training certification by SkillsPlus Intl Inc.
FL Designated Representative online e-Learning exam preparation by SkillsPlus Intl Inc.
The Designated Representative Institute

CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc.
The Exemptee Institute

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