With One Day Remaining Before July 1 Compliance Date, FDA Exercises Enforcement Discretion of DSCSA’s Product-Tracing Requirements for Dispensers – FDA Law Blog

“Only one day before the product-tracing provisions of the Drug Supply Chain Security Act (“DSCSA”) were set to take effect for dispensers, FDA issued a Guidance Document for immediate implementation that signals FDA’s intention to delay any use of enforcement for failure to comply with the DSCSA’s two major product-tracing requirements for dispensers until November 1, 2015.”

Gavel, law books, and a scaleRead the full article via: Source: FDA Law Blog: With One Day Remaining Before July 1 Compliance Date, FDA Exercises Enforcement Discretion of DSCSA’s Product-Tracing Requirements for Dispensers

You might also be interested in the FDA guidance:

DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy Guidance for Industry – FDA (PDF)


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Wholesale Distributor & Third-Party Logistics Providers Reporting – FDA Requirement

A green lizard in front of a laptop PC keyboard“The Federal Food, Drug, and Cosmetic Act as amended by the DSCSA, requires third-party logistics providers to begin reporting this information annually to FDA on November 27, 2014, while wholesale distributors are required to begin on January 1, 2015.

FDA has issued a draft guidance, “DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers” that addresses what information and how wholesale distributors and third-party logistics providers should report to the FDA.”

Read the full explanation: via Drug Supply Chain Security Act > Wholesale Distributor and Third-Party Logistics Providers Reporting (on FDA.gov).


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FDA Announces Exercise of Enforcement Discretion on Imminent Track and Trace Requirements – FDA Law Blog

Wooden gavel sitting on law books“On December 24th, in response to industry requests, FDA issued a guidance document indicating that it will not enforce product tracing requirements of the Drug Supply Chain Security Act (“DSCSA”) prior to May 2015. The guidance, states in relevant part:” . . .

Read the full article: via FDA Law Blog: In Keeping With the Spirit of the Season, FDA Announces Exercise of Enforcement Discretion on Imminent Track and Trace Requirements.

Read the FDA guidance: DSCSA Implementation: Product Tracing Requirements — Compliance Policy – FDA Guidance for Industry (PDF)


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

FDA logo in blueBecome familiar with the law 

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.

Read the full article: via Drug Supply Chain Security Act > Are you ready for the Drug Supply Chain Security Act?.


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FDA Law Blog: FDA Speaks at Annual HDMA Track-and-Trace Conference

Workers in a warehouse“Throughout the conference, manufacturers, distributors, and other members of the drug supply chain expressed concern over the current lack of guidance from FDA regarding compliance with federal product tracing laws with only 49 days until the DSCSA is set to begin to take effect.

Dr. Connie Jung, Acting Associate Director for Policy and Communications for the Office of Drug Security, Integrity, and Recalls in FDA’s Center for Drug Evaluation and Research, Office of Compliance, once again spoke at the conference and attempted to address some of their concerns.”

Read the full report-out: via FDA Law Blog: FDA Speaks at Annual HDMA Track-and-Trace Conference.


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FDA publishes Q&A on DSCSA provisions – SecuringIndustry.com

FDA Logo in blue“The FDA has published a draft question-and-answer document to help guide the implementation of the US’s traceability system for medicines.

The guidance – which is aimed at wholesalers and third-party logistics (3PL) companies – is the latest information from the US regulatory on the Drug Supply Chain Security Act (DSCSA) and is open for comment until December 8.”

Read the full article: via SecuringIndustry.com – FDA publishes Q&A on DSCSA provisions.

View the FDA’s draft guidance: 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 – FDA Draft Guidance For Industry (PDF)


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HDMA – Issues in Distribution: Pharmaceutical Traceability and the Drug Supply Chain Security Act

President Obama signing new law“The Drug Supply Chain Security Act (DSCSA, or Title II of the Drug Quality and Security Act) was enacted on November 27, 2013. The act replaces a 50-state patchwork of pedigree requirements with one federal traceability solution for prescription medicines, and raises licensure standards across the U.S.

The law will transform how the domestic supply chain operates to the benefit of healthcare providers and pharmacists — and their patients. HDMA and the nation’s primary pharmaceutical distributors have long advocated for this national solution.

With enactment of the law:

All existing state pedigree requirements that went above and beyond the Prescription Drug Marketing Act (PDMA) of 1987 are immediately preempted. The baseline requirements of the original law will remain in place until January 1, 2015, when statutory requirements, assisted by guidances currently being developed by FDA, will go into effect.

In 2015, enhanced product tracing requirements begin, which over 10 years, will lead to the establishment of a single system of federal electronic, unit-level traceability requirements across the entire supply chain.

National distributor licensure standards also have been strengthened. Instituting strong, consistent distributor licensing standards is a critical component in ensuring that the supply chain remains safe and secure.”

Read the full article, and reference a great collection of fact sheets and educational material about this subject: via HDMA – Issues in Distribution: Pharmaceutical Traceability and the Drug Supply Chain Security Act.


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Federal government renews charges of illicit drug distribution involving FedEx – Pharmaceutical Commerce

Ordering medication by computer“It has been the contention of DEA and the Dept. of Justice for several years that companies involved in shipping and delivering controlled substances must ensure that both providers and shipment recipients are authorized (licensed) to make or receive these shipments. In “normal” distribution, a licensed manufacturer of such drugs ships them to a licensed pharmacy; paperwork follows the shipment, at least when the shipping and receiving is occurring within US borders. In the case of illicit online pharmacies (which, technically, aren’t allowed to fill prescriptions unless they are sited in the US), offshore organizations accept orders from individuals—especially via the Internet—and then look to carriers like FedEx to complete the shipment.”

Read more: via Federal government renews charges of illicit drug distribution involving FedEx.


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FDA Law Blog: And So It Begins: FDA Issues First DSCSA Guidance

The FDA just published:  Guidance for Industry – Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification (PDF)

William Koustas (FDA Law Blog) writes, “The DSCSA tasked FDA with addressing three issues in this guidance: (1) identifying scenarios that could increase the risk of suspect product entering the supply chain; (2) recommending ways trading partners can identify and determine whether product is suspect; and (3) creating a process for trading partners to terminate illegitimate product notifications.  FDC Act § 582(h)(2).  The Draft Guidance addressed each of these three issues as follows:” . . .

Read the full article: via FDA Law Blog: And So It Begins: FDA Issues First DSCSA Guidance.


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

How To Approach, Read, and Interpret the DSCSA
Another great educational snippet from Dirk Rodgers (RxTrace). Follow the link below to read his full article.

“So let’s apply that to the exchange of Transaction Information TI, Transaction History TI, and Transaction Statements TS that all U.S. pharma supply chain trading partners must do beginning on January 1 of next year (dispensers don’t have to do it until July 1 of next year) (see “DQSA: How Should Transaction Data Be Exchanged?”).  First, the DSCSA that contains this requirement is a law, which means non-exempt trading partners are obligated to follow those requirements or be exposed to penalties.

The DSCSA also obligates the FDA to take certain actions on a particular schedule (see “Decoding The FDA’s DSCSA Timeline”).  Two of those actions are the publication of guidance on identification of suspect product and termination of notifications of illegitimate product, which is due by next Monday, and the publication of draft guidance establishing standards for interoperable exchange of TI, TH and TS in paper or electronic format, which is due on or before November 27 of this year.  Both of these are guidance, which means they will contain non-binding information that represents the current thinking of the FDA on those topics.”  via The Differences Between The DSCSA, FDA Rules and Guidance.


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