Tag Archives: FDA

At Least 2.5 Million Home Health Patients Using Medical Equipment Vulnerable to Natural Disasters – HomeHealthCareNews

Posted on by

““Health care trends suggest that 2.5 million number is just going to continue to grow as more people opt to age in place,” Marriele Mango, lead author of the study and resilient power fellowship program associate for Clean Energy Group, told HHCN. “In the end, energy security just isn’t there for them in the way that it is in a nursing home, assisted living home or a hospital.”

In the event of a natural disaster, lack of energy security can be fatal.”

Read the full source article:  At Least 2.5 Million Home Health Patients Using Medical Equipment Vulnerable to Natural Disasters – HomeHealthCareNews.com

You might also be interested in:   FDA – Hurricane Checklist – Medical Devices

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

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

Posted on by

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

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

How DSCSA Changes the Licensing Landscape | Pharmaceutical Executive

Posted on by

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

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

FDA Steps in to Regulate Microneedling Devices | RAPS

Posted on by

“The US Food and Drug Administration (FDA) on Thursday issued a draft guidance detailing when it considers “microneedling” products to be medical devices and subject to regulation.”

Read the full article – Source: FDA Steps in to Regulate Microneedling Devices | RAPS

Read the guidance:  Regulatory Considerations for Microneedling Devices – FDA (PDF)

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

FDA Clarifies DSCSA Entities And Trading Partners

Posted on by

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)

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

GS1 US Workshop Series Offers Pharmaceutical Industry Professionals DSCSA Implementation Assistance | Healthcare Packaging

Posted on by

“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

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

Training affidavit for CA Designated Representative license applicants

Training affidavit for CA Designated Representative license applicants

Refurbished Medical Devices: FDA Wants to Hear More From Industry | RAPS

Posted on by

FDA logo

“The US Food and Drug Administration (FDA) on Thursday announced that it’s seeking more information on medical devices that are refurbished, reconditioned, rebuilt, remarketed, remanufactured, serviced or repaired in order to investigate a number of potential safety issues.”

Read the full article:  Source: Refurbished Medical Devices: FDA Wants to Hear More From Industry | RAPS

Read the proposed rule:
Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Request for Comments

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

Exemptee Training Available 24 x 7

Related articles

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

Posted on by

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

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

FDA Releases First Wholesaler and 3PL Facility Licensure Data to the Public | The National Law Review

Posted on by

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

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

FDA’s Patient Preference Initiative: … | FDA Voice

Posted on by

A mix of people with thought bubbles over themThis should interest HME professionals:

“Last week we announced FDA’s first-ever Patient Engagement Advisory Committee, which will provide advice to the FDA Commissioner on complex issues relating to medical devices, the regulation of devices, and their use by patients. We thought it would be good to step back and fill you in about our Patient Preference Initiative.”

Read the full blog post: Source: FDA’s Patient Preference Initiative: The Need for Evolving Tools and Policies | FDA Voice

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

Related articles