FDA Clarifies DSCSA Entities And Trading Partners

Entities & Trading Partners Defined Under The DSCSA

“The Food and Drug Administration (FDA or the Agency) is issuing this guidance to assist industry and State and local governments in understanding how to categorize the entities in the drug supply chain in accordance with the Drug Supply Chain Security Act (DSCSA). DSCSA establishes product tracing requirements for certain trading partners in the drug supply chain, including manufacturers, repackagers, wholesale distributors, and dispensers. DSCSA also requires that trading partners of manufacturers, wholesale distributors, dispensers, and repackagers must meet the applicable requirements for being “authorized trading partners.” DSCSA also requires FDA to issue regulations that establish Federal standards for the licensing of wholesale drug distributors (WDDs) and third-party logistics providers (3PLs). The Agency is currently drafting these regulations. This guidance, when finalized, will explain FDA’s current thinking on how licensing and certain other requirements apply to entities that may be considered trading partners in the drug supply chain.

This guidance is intended to (1) assist industry and State and local governments in understanding the applicability of DSCSA requirements to the various types of entities that take part in the distribution of prescription drugs in the United States, and (2) help clarify for industry whether they are engaged in activities that require licensure and annual reporting, as well as other requirements related to being an authorized trading partner in the drug supply chain. The guidance does not address all requirements described in DSCSA, but is limited to describing the activities that would determine what type of trading partner an entity may be and the applicable requirements under DSCSA.”

Source:
Identifying Trading Partners Under the Drug Supply Chain Security Act – Guidance for Industry – DRAFT GUIDANCE (PDF)


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GS1 US Workshop Series Offers Pharmaceutical Industry Professionals DSCSA Implementation Assistance | Healthcare Packaging

“Specifically, how to mark pharmaceutical products with a National Drug Code (NDC), serial number, lot number, and expiration date in both machine-readable and human-readable format will be covered, as will the use of GS1 identifiers, application identifiers, and data carriers.”

Read the full article (Source): GS1 US Workshop Series Offers Pharmaceutical Industry Professionals DSCSA Implementation Assistance | Healthcare Packaging


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Training affidavit for CA Designated Representative license applicants

Training affidavit for CA Designated Representative license applicants

How drugs intended for patients ended up in the hands of illegal users: ‘No one was doing their job’ – The Washington Post

“For 10 years, the government waged a behind-the-scenes war against pharmaceutical companies that hardly anyone knows: wholesale distributors of prescription narcotics that ship drugs from manufacturers to consumers.”

Read the full article:  Source: How drugs intended for patients ended up in the hands of illegal users: ‘No one was doing their job’ – The Washington Post


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Designated Representative and Exemptee Training

Training for Designated Representative and Exemptee license applicants

The Forwarder Awakens: Amazon receives NVOCC | Air Cargo World

“Many in the industry had speculated that Amazon was making the investments in logistics networking merely to avoid future delays in shipping goods during peak season, as the e-tailer had experienced before with integrator such as FedEx and UPS. But the NVOCC license suggests that Amazon is interested in becoming a permanent player in the 3PL market.”

Read the full article: Source: The Forwarder Awakens: Amazon receives NVOCC | Air Cargo World


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2015 DR 3PL Tr

 

FDA Releases First Wholesaler and 3PL Facility Licensure Data to the Public | The National Law Review

FDA letters on building blocks

“Users either can query the database when searching for a particular company here or download the entire data set as an Excel file from this page.  Although technically the law only requires a public wholesale distributor database, FDA determined that making the 3PL information public as well served the law’s goals, and it stated in a December 2014 policy document that: “The ultimate goal is for the public database to serve as a single repository of licensing and facility information for wholesale drug distributors and 3PLs conducting business in the United States.””

Read the full article: Source: FDA Releases First Wholesaler and 3PL Facility Licensure Data to the Public | The National Law Review


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3PL Acquisitions Expected to Increase – Pharmaceutical Processing

Map of the USA by states

“They attributed the increase to growing pressure to expand services, increase geographic footprints and drive scale in specific markets. Consolidating firms will need to weather significant industry restructuring and navigate brand confusion in some markets, the report said.

This year, meanwhile, respondents expected those large 2014 deals to lead to defensive acquisitions by other firms.”

Read the full article: Source: Third-Party Logistics Acquisitions Expected to Increase – Pharmaceutical Processing


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Do Not Let Your Firm be the Headline for a Supply Chain Systems Failure | Supply Chain Matters

Graphic of data representation

“Many years ago, I worked for a very insightful CIO who mastered communications to senior executive management. Often, when he received pressure regarding systems maintenance budgets associated with mission critical business systems such as order fulfillment, he would use an analogy of flying on a jet aircraft.  “Do you expect the pilots to upgrade or change an engine while flying at 30,000 feet.” Of course not, and that is why diligent and timely maintenance and backup plans exist.”

Read Bob Ferrari’s full article – Source: Do Not Let Your Firm be the Headline for a Supply Chain Systems Failure | Supply Chain Matters


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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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