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

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

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“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


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New Draft Guidance Clarifies UDI Exceptions for Convenience Kits – FDA Law Blog

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 The Draft Guidance “Unique Device Identification: Convenience Kits” explains FDA’s position as to what constitutes a convenience kit for purposes of the UDI Rule.”

Read the full article: Source: FDA Law Blog: New Draft Guidance Clarifies UDI Exceptions for Convenience Kits


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

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“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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FDA’s Patient Preference Initiative: … | FDA Voice

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


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With One Day Remaining Before July 1 Compliance Date, FDA Exercises Enforcement Discretion of DSCSA’s Product-Tracing Requirements for Dispensers – FDA Law Blog

“Only one day before the product-tracing provisions of the Drug Supply Chain Security Act (“DSCSA”) were set to take effect for dispensers, FDA issued a Guidance Document for immediate implementation that signals FDA’s intention to delay any use of enforcement for failure to comply with the DSCSA’s two major product-tracing requirements for dispensers until November 1, 2015.”

Gavel, law books, and a scaleRead the full article via: Source: FDA Law Blog: With One Day Remaining Before July 1 Compliance Date, FDA Exercises Enforcement Discretion of DSCSA’s Product-Tracing Requirements for Dispensers

You might also be interested in the FDA guidance:

DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy Guidance for Industry – FDA (PDF)


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Wholesale Distributor & Third-Party Logistics Providers Reporting – FDA Requirement

A green lizard in front of a laptop PC keyboard“The Federal Food, Drug, and Cosmetic Act as amended by the DSCSA, requires third-party logistics providers to begin reporting this information annually to FDA on November 27, 2014, while wholesale distributors are required to begin on January 1, 2015.

FDA has issued a draft guidance, “DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers” that addresses what information and how wholesale distributors and third-party logistics providers should report to the FDA.”

Read the full explanation: via Drug Supply Chain Security Act > Wholesale Distributor and Third-Party Logistics Providers Reporting (on FDA.gov).


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Compound Pharmacies Complain FDA is Compounding Their Problems – Pharmalot – WSJ

Tops of injectable medication vials“The stepped-up oversight was hastened by a new law that bolstered FDA authority. But compounders say the get-tough approach is a double-edged sword. Hospitals, doctors and patients may eventually have more confidence in compounded’ medicines, but in the meantime costs and red tape have increased. And a new batch of proposed guidelines issued by the FDA last week has set off another round of anguish.

The FDA maintains the guidelines are “critical to protecting public health.” But Scott Karolchyk of QmedRx, a compounder based in Maitland, Florida, argues “the FDA is trying to punish success. If these [guidelines] go into effect, a lot of pharmacies face onerous restrictions. And limiting good compounding pharmacies only hurts patients and their access to medications.””

Read the full article: via Compound Pharmacies Complain FDA is Compounding Their Problems – Pharmalot – WSJ.

You might also be interested in:  FDA issues new draft documents related to compounding of human drugs


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FDA Announces Exercise of Enforcement Discretion on Imminent Track and Trace Requirements – FDA Law Blog

Wooden gavel sitting on law books“On December 24th, in response to industry requests, FDA issued a guidance document indicating that it will not enforce product tracing requirements of the Drug Supply Chain Security Act (“DSCSA”) prior to May 2015. The guidance, states in relevant part:” . . .

Read the full article: via FDA Law Blog: In Keeping With the Spirit of the Season, FDA Announces Exercise of Enforcement Discretion on Imminent Track and Trace Requirements.

Read the FDA guidance: DSCSA Implementation: Product Tracing Requirements — Compliance Policy – FDA Guidance for Industry (PDF)


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FDA > Are you ready for the Drug Supply Chain Security Act?

FDA logo in blueBecome familiar with the law 

There are new requirements under the Drug Supply Chain Security Act (DSCSA) for manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers (trading partners). Some requirements began in November 2014 and several key requirements begin at various stages in 2015. The new requirements, development of standards, and the system for product tracing will continue to be phased in over the next nine years. FDA will continue working with trading partners and other stakeholders to effectively implement the new requirements.

Read the full article: via Drug Supply Chain Security Act > Are you ready for the Drug Supply Chain Security Act?.


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