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Identifying Trading Partners Under the Drug Supply Chain Security Act – Guidance for Industry – DRAFT GUIDANCE (PDF)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

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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Medicare Accounts for 16% of HME Spending — HME Business

“Another data point shows just how greatly Medicare’s importance as a revenue driver for HME has dropped. In addition to Medicare’s 16 percent share, Medicaid accounted for 15 percent of HME spending, and all other sources, such as private payer and retail sales, represented 68 percent of HME spending.”

Read The Full Source: Medicare Accounts for 16% of HME Spending — HME Business


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Training program for California HMDR Exemptee license applicants

Training program for California HMDR Exemptee license applicants

Training Affidavit For California Designated Representatives

Training affidavit for CA Designated Representative license applicants

Training affidavit for CA Designated Representative license applicants

Looking for a California Designated Representative training program?

YOU NEED A TRAINING AFFIDAVIT – If you need a training affidavit as proof of completing a training program, as part of your California Designated Representative or  CA Designated Representative-3PL license application, then keep reading.

WE CAN HELP YOU
Buy one of our courses:  Designated Representative Training Programs by SkillsPlus Intl Inc.  –  These online self-study courses are $525 per student, and they are approved by the California Board of Pharmacy. Learn more about our CA Designated Representative training programs. When you’ve successfully completed a program, simply request your copies of completed training affidavits.


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Home Medical Device Retail Exemptee Online Training Certificate – HMDR

The Home Medical Device Retailer Exemptee License Application requires proof of HMDR Exemptee training program completion.

SkillsPlus International Inc. offers an Exemptee training program (that covers topics specified by the California Dept of Public Health – Food and Drug Branch). Upon successful completion of this training course, the student will receive a certificate of completion, that is acceptable to the CDPH FDB.

Learn more about Exemptee training by SkillsPlus Intl Inc.
Buy and register now! – SkillsPlus Intl Inc. Exemptee Training Course

HMDR Exemptee Training

 


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Florida Certified Designated Representative (CDR) Required For Wholesale Distributors

Law books, gavel, scaleThe Florida Department of Business & Professional Regulation – Division of Drugs, Devices and Cosmetics answers the question, “Does my company need a permit?”  Their answer includes a helpful chart, definitions, and a link to relevant Florida statutes

Prescription drug wholesalers need to have a Florida Certified Designated Representative (CDR):

“CERTIFIED DESIGNATED REPRESENTATIVE

All prescription drug wholesale distributor and out-of-state prescription drug wholesale distributor permittees and applicants must designate in writing at least one natural person to serve as the designated representative for a given establishment.  Such person must have an active certification from the department (a “certified designated representative” or “CDR”).”

Source: Certified Designated Representative – Florida Department of Business & Professional Regulation

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FL Certified Designated Representative (CDR) online exam prep course by SkillsPlus Intl Inc. – Lots of practice exams – Practice makes perfect! – Available around-the-clock 24 x 7


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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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FAQ: Who needs an HMDR License?

High tech graphic of medical devicesQUESTION: Who needs an HMDR license from the California Department of Public Health, Food and Drug Branch (CDPH/FDB)?

ANSWER: Any person conducting an HMDR business (retail facility or warehouse) in the State of California must first obtain a license from CDPH/FDB. A separate license is required for each location. The license must be renewed each year, and the license cannot be transferred to another location, business, or business owner. {FYI: Wholesalers of medical devices are not required to obtain an HMDR license, but may be required to obtain a permit with the Board of Pharmacy if they distribute prescription (Rx) devices for wholesale purposes} http://www.pharmacy.ca.gov

Sources:


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FDA Recommends New Testing Standards for Home Use Devices | RAPS

FDA Logo for the CDRH“A final guidance document issued by the US Food and Drug Administration (FDA) aims to make medical devices used by patients in their homes safer and more reliable.

Background

In general, medical devices can be divided into two categories: Those intended to be used in professional settings by healthcare professionals, and those intended to be used in home healthcare settings by patients or caregivers.

The latter category, often referred to as “home use devices,” is associated with a unique set of concerns compared to its professional use counterparts. Because the devices are typically used frequently by those without medical training, FDA has taken an interest in making sure that they are designed appropriately for use within the home.”

Read the full article: via FDA Recommends New Testing Standards for Home Use Devices | RAPS.

Read the final FDA guidance:
Design Considerations for Devices Intended for Home Use – Guidance for Industry and Food and Drug Administration Staff (PDF)


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