Tag Archives: drug

New – California Designated Representative-Reverse Distributor License

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California Designated Representative-Reverse Distributor License Created – New!

Designated Representative Reverse Distributor License – CA Board of Rx website

About California Designated Representative Reverse Distributor Training

California Senate Bill – SB 752 (Chapter 598, Statutes of 2017, Stone) Designated Representative-Reverse Distributor has been “chaptered” by the Secretary of State (enacted October 8, 2017). It includes the creation of a designated representative-reverse distributor license. At a high level:

Section 4040.5 of the Business and Professions Code is amended to read:
4040.5. “Reverse distributor” means every person who acts as an agent for pharmacies, drug wholesalers, third-party logistics providers, manufacturers, and other entities by receiving, inventorying, warehousing, and managing the disposition of outdated or nonsaleable dangerous drugs or dangerous devices.

Section 4022.6 is added to the Business and Professions Code, to read:
4022.6. “Designated representative-reverse distributor” means an individual to whom a license has been granted pursuant to Section 4053.2, who is responsible for supervision over a licensed wholesaler that only acts as a reverse distributor. A pharmacist fulfilling the duties of Section 4053.2 shall not be required to obtain a license as a designated representative-reverse distributor.

Go to DREprof.com: The Designated Representative and Exemptee Training Website

AmerisourceBergen snaps up independent wholesaler H. D. Smith for $815M | FiercePharma

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“In the face of a tough pricing market that has weighed on generic drugmakers and their distributors, wholesaling giant AmerisourceBergen has decided to go out and snarf up a bigger share. It will pay $815 million in cash for H. D. Smith, the largest independent drug distributor left in the U.S.”

Source: AmerisourceBergen snaps up independent wholesaler H. D. Smith for $815M | FiercePharma

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Amazon Has Obtained Pharmaceutical Wholesaler Licenses In 12 States – Consumerist

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“The Post-Dispatch was able to confirm through public records that Amazon has been approved as a pharmaceutical wholesaler in the states of Alabama, Arizona, Connecticut, Idaho, Louisiana, Michigan, Nevada, New Hampshire, New Jersey, North Dakota, Oregon, and Tennessee. An application in Maine is still pending.”

Source: Amazon Has Obtained Pharmaceutical Wholesaler Licenses In 12 States – Consumerist

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New ATA report takes a deep dive into the ongoing truck driver shortage – Logistics Management

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“So, what about those future numbers? You may want to cover your eyes, as they are not pretty. According to the ATA, the driver shortage is projected to hit 50,000 by the end of 2017, with the possibility, if things remain the same, that the number could exceed 174,000 by 2026.”

Source: New ATA report takes a deep dive into the ongoing truck driver shortage – Logistics Management

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California wants to pull Cardinal Health license over ‘red flags’

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“The state of California wants to revoke the wholesale license for a facility run by Cardinal Health, one of the nation’s largest pharmaceutical distributors, for failing to note a series of unusual sales of an opioid painkiller and three other tightly regulated medicines to a pharmacy.”

Source: California wants to pull Cardinal Health license over ‘red flags’

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Drug Distributor Profits Will Remain Weak, Says New Drug Channels Institute Study

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“We project that U.S. drug distribution revenues at the Big Three public wholesalers—AmerisourceBergen, Cardinal Health, and McKesson—will reach $425 billion in 2017, a 4.5% increase from the 2016 figure.” said Drug Channels Institute CEO Adam J. Fein, Ph.D., the study’s author and a widely regarded expert on pharmaceutical economics and the drug distribution system. “This is the slowest revenue growth since 2013. We also estimate that core U.S. drug distribution margins peaked in 2015 and have declined ever since.”

Source: Drug Distributor Profits Will Remain Weak, Says New Drug Channels Institute Study

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FDA Clarifies DSCSA Entities And Trading Partners

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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

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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 Training Program – New Website

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There’s a new website for California Designated Representative training

That website is intended for California Designated Representative license applicants.

Go to that new website:
Training program for California Designated Representative license applicants

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California Designated Representative Training Course for 3PL

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California Designated Representative Training Course for 3PL (approved by the California State Board of Pharmacy) – earn a training affidavit

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.

Go to DREprof.com: The Designated Representative and Exemptee Training Website