Tag Archives: FDA

Here comes drug importation – Pharmaceutical Commerce

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According to the article:

“The Trump Administration wants to start a drug-importation program from Canada for both small-molecule and biologic products. The program would be a “time-limited Section 804 importation program” (SIP), with the SIP program sponsored by “a pharmacist, a wholesaler, or another State or non-federal governmental entity” and subject to FDA review. Additional language in the notice of proposed rulemaking (NPRM) gives guidance on how manufacturers themselves could set up reimportation. The NPRM is available in draft form today (Dec. 18), and is expected to be published officially in the Federal Register on Dec. 23.”

Read the source article:  Here comes drug importation – Pharmaceutical Commerce

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

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““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

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

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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

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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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FDA Steps in to Regulate Microneedling Devices | RAPS

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“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)

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

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“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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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

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Related articles

New Draft Guidance Clarifies UDI Exceptions for Convenience Kits – FDA Law Blog

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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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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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