FDA Enforcement Delay of Wholesale Distributor Verification Requirement for Saleable Returns – LSPediA

“The US FDA published a compliance policy final guidance document on September 23, 2019, announcing a one-year enforcement discretion for the Wholesale Distributor Verification Requirement for Saleable Returned Drug Product.

If you’re a wholesaler or a manufacturer rushing to meet the November 2019 deadline, this guidance is significant. But before you breathe a sigh of relief, you need to read the entire guidance document and the entirety this LSPediA article.”

Read the full source article:  FDA Enforcement Delay of Wholesale Distributor Verification Requirement for Saleable Returns – LSPediA

View the FDA final guidance document:  Wholesale Distributor Verification Requirement for Saleable Returned Drug Product — Compliance Policy – Guidance for Industry (PDF)


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The Growing Trend of PBM Track-And-Trace Audits – Frier Levitt

The Growing Trend of PBM Track-And-Trace Audits – Frier Levitt

“Pharmacies are being asked [to] provide transaction history, transaction information, and transaction statement, and to maintain such records for not less than six years after the transaction.”

“Pharmacies are expected to ensure that wholesalers provide the aforementioned information at the time of purchase or be in a position to provide this information at the time of a request. Such requests are being made despite pharmacies having purchased from duly, licensed, and verifiable wholesalers.”

Read the full source article:  The Growing Trend of PBM Track-And-Trace Audits – Frier Levitt


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How DSCSA Changes the Licensing Landscape | Pharmaceutical Executive


California Designated Representative Training Course for 3PL (approved by the California State Board of Pharmacy)


The impact of new 3PL licensing

The big license aftershock following the DSCSA earthquake came when the FDA redefined the parameters of 3PL companies. Before the passage of DSCSA, 3PL companies could be licensed as a wholesaler. Now, that’s no longer the case.”

Read the entire article to learn how the DSCSA impacts third-party logistics providers (3PLs).

Read the complete article (source): How DSCSA Changes the Licensing Landscape | Pharmaceutical Executive


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TraceLink Bags $93M, Plans A.I. & Blockchain Tools for Drug Tracking – Xconomy

“Another area of interest for TraceLink is blockchains, the online, distributed ledger systems that power cryptocurrencies such as Bitcoin. TraceLink is developing blockchain-based software to help the pharma industry meet certain track and trace requirements in the U.S. Drug Supply Chain Security Act, Dahod says. He says the company will release more details about the project by the end of the year.”

Read the full source article: Xconomy: TraceLink Bags $93M, Plans A.I. & Blockchain Tools for Drug Tracking


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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

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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NEW: 2015-16 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors – Drug Channels

Graphic of different kinds of medicines

“This year’s report—our sixth edition—has been updated, revised, reorganized, and expanded. It contains the latest industry and financial data, along with detailed information about the strategies and market positions of the largest public companies: AmerisourceBergen, McKesson, and Cardinal Health. It also includes many new elements.”

Read the full article: Source: Drug Channels: NEW: 2015-16 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors


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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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