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Identifying Trading Partners Under the Drug Supply Chain Security Act – Guidance for Industry – DRAFT GUIDANCE (PDF)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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RK Logistics Group Earns CA Board of Pharmacy Certification – PR Newswire

“for its Fremont, CA headquarters facility where it provides full-spectrum supply chain support solutions in the Tri-Valley and San Jose for hi-tech, pharmaceutical and biomedical devices firms”

Source: RK Logistics Group Earns CA Board of Pharmacy Certification – PR Newswire


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Self-Assessment Forms – California State Board of Pharmacy

Self-Assessment Forms – CA St Board of Pharmacy

 

“The assessment shall be performed before July 1 of every odd-numbered year. The self-assessment forms must remain on-site at the facility. Only submit the form to the board if requested by board staff.  The board is in the process of updating the Self-Assessment forms through a formal rulemaking.  The updates include references to statutory and regulatory changes that occurred between 2014 and 2016.  The last time the forms were formally updated was 2014.Current regulation requires a pharmacy or wholesaler to complete the 2014 version of the Self-Assessment form.  Please be advised, however, the board will accept completion of either the 2014 version OR the 2016 version.  The latter version is likely to be a more helpful assessment to the pharmacy or wholesaler completing it.”

Source: Self-Assessment Forms – California State Board of Pharmacy


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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

Flying pharma: how the industry handles medical cargo – Airport Technology

“Over 50% of all temperature excursions occur while products are in the hands of airlines and airports, according to IATA, which renders the products worthless or even dangerous for patients.”

Read the full article: Source: Flying pharma: how the industry handles medical cargo – Airport Technology

If you’re in the business of handling or coordinating the transport of pharmaceuticals, then the article above might be of some interest to you.


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Training for Designated Representative 3PL license applicants

Training for Designated Representative 3PL 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

Your 2017 Marketing Plan | HomeCare Magazine

“A successful marketing plan is based on what you did in 2016—what worked and what didn’t—and what you want to make sure you do again. If you don’t think about each of these items, you may be doomed for failure—you don’t want to be responsible for helping your competition have their best year in 2017. Plan now, and make the success all yours!”

It’s hard to believe that the year is coming to an end.  It means it’s time to get a jump on planning for the new year.  This article is full of great thought provoking ideas and tips on how to move your marketing efforts to a higher level.  Full of great advice!

Read the full article:  Source: Your 2017 Marketing Plan | HomeCare Magazine


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Designated Representative and Exemptee Training

Training Certification Class for Designated Representative and Exemptee license applicants