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Identifying Trading Partners Under the Drug Supply Chain Security Act – Guidance for Industry – DRAFT GUIDANCE (PDF)


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California Third-Party Logistics Provider License – 3PL

California 3PL Provider License – CA Board of Pharmacy

ICYMI – The California Board of Pharmacy oversees 3PL providers and their Designated Representative-3PL.

“Third-party logistics provider” means an entity that provides or coordinates warehousing or other logistics services for a dangerous drug or dangerous device in intrastate or interstate commerce on behalf of a manufacturer, wholesaler, or dispenser of the dangerous drug or dangerous device, but does not take ownership of the dangerous drug or dangerous device, nor have responsibility to direct its sale or disposition. … The Designated Representative-3PL Responsible Manager must file a separate application with the board if he or she is not already licensed as a Designated Representative-3PL in California. The application form is available by selecting the following link Designated Representative-3PL Application.

Source:  Third-Party Logistics Provider/Nonresident Third-Party Logistics Provider License – California Board of Pharmacy

You might also be interested in:  Designated Representative – 3PL License – California Board of Pharmacy


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California Designated Representative-3PL – Training Program

Earn a training affidavit. Training program for CA Designated Representative-3PL license applicants.

The California Board of Pharmacy says,

“To be licensed as a Designated Representative – 3PL in California, you must satisfy the requirements under Business and Professions Code section 4053.1. Each place of business of a third-party logistics provider shall be supervised and managed by a responsible manager. The responsible manager shall be responsible for the compliance of the place of business with state and federal laws governing third-party logistics providers and with the third-party logistics provider’s customer specifications, except where the customer’s specifications conflict with state or federal laws. The responsible manager shall maintain an active license as a designated representative-3PL with the board at all times during which he or she is designated as the responsible manager.”

A complete license application package includes submission of a training affidavit, as proof of training program completion.


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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

Trump & Sanders’ reimportation proposals a risk, AmerisourceBergen – in-Pharma Technologist

” “How a wholesaler could potentially procure drugs, whether they’re in Canada, Europe and get those back to the US and get those into the supply channel efficiently and effectively I think is quite cumbersome,” said CFO Tim Guttman. “It’s not efficient and there are risks.” VP Barbara Brungess added despite the impracticalities and legal hurdles to overturn, the primary concern is safety.”

Read the full article:  Source: Trump & Sanders’ reimportation proposals a risk, AmerisourceBergen – in-Pharma Technologist.com


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Designated Representative and Exemptee Training

Training Certification Class for Designated Representative and Exemptee license applicants

Experts warn pharma to take precautions against Thanksgiving thefts

“drug companies still need to take precautions when normal operations are disrupted Shepard said, explaining that: “Thanksgiving has the highest number of cargo thefts compared to all holidays.”

“Fridays, Saturdays and Sundays are when most cargo thefts occur and most thefts occur with parked vehicles.””

Read the full artice: Source: Experts warn pharma to take precautions against Thanksgiving thefts


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Designated Representative and Exemptee Training

Training Certification Class for Designated Representative and Exemptee 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

 

New Draft Guidance Clarifies UDI Exceptions for Convenience Kits – FDA Law Blog

Hands holding a pen, above some papers“On January 4, CDRH issued its first draft device guidance of the year. The Draft Guidance “Unique Device Identification: Convenience Kits” explains FDA’s position as to what constitutes a convenience kit for purposes of the UDI Rule.”

Read the full article: Source: FDA Law Blog: New Draft Guidance Clarifies UDI Exceptions for Convenience Kits


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Prescription drug scheme: Miami Beach prescription drug supplier pleads guilty – South Florida Business Journal

Prescription vial spilling out drug capsules

“Prescription drug diversion compromises the integrity of America’s drug supply chain,” Principal Deputy Assistant Attorney General Benjamin Mizer said in a new release. “This Miami-based supplier sold tens of millions of dollars of illegally diverted drugs, which ended up on the shelves of pharmacies and in the medicine cabinets of American consumers.”

Read the full article:  Source: Prescription drug scheme: Miami Beach prescription drug supplier pleads guilty – South Florida Business Journal


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