Tag Archives: FDAAA

Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance? Part 2

QuestionBottle.Part 2Part 1 of this essay provided a wealth of hyperlinks into the Code of Federal Regulations (CFR) and FDA guidance documents with content related to placing the National Drug Code in human- and machine-readable form onto drug packages prior to November 27, 2017 (see “Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance?  Part 1”).  In Part 2, we will look at how the Drug Supply Chain Security Act (DSCSA) will change, or add-to, the requirements found in those earlier specifications.  And finally, we will be able to answer the question in the essay title.

HOW THE DSCSA CHANGES THE NDC AND BARCODE REQUIREMENTS FOR DRUG PACKAGES

First of all, the DSCSA does not change anything Continue reading Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance? Part 2

Sponsored: The Many Faces Of The FDA

MultiFacesWhy is there such a wide gap between the actions of the UDI face of the FDA and the DSCSA face?

The U.S. Food and Drug Administration (FDA) is an agency of the U.S. government that falls under the Department of Health and Human Services, which is under the leadership of the current Presidential Administration through a cabinet seat.  But it is also a concept, and the concept has been conceived, modified, adjusted, influenced and expanded—especially expanded—by many thousands of members of Congress that have served from 1906 to 2016.  It started as a nearly powerless monitoring agency in 1906 with the passage of the Federal Food and Drugs Act.  But in the aftermath of a number of widely-reported incidents of harm and deaths caused by cosmetics and medicines, the Congress passed the original Food, Drug and Cosmetics Act (FD&C) in 1938 and President Franklin D. Roosevelt signed it into law.

Right from the beginning you had an agency with at least three faces:  foods, drugs and cosmetics.  Continue reading Sponsored: The Many Faces Of The FDA

FDA Chooses DUNS For Unique Facility Identifier

The DUNS NumberLast week the FDA published draft, non-binding guidance for their recommended unique facility identifier (UFI) for use in registering foreign and domestic drug  establishments.  Last year, Congress passed the FDA Safety and Innovation Act (FDASIA) to address safety concerns induced by inspection gaps of facilities outside the United States and other issues (see “The Supply Chain Provisions Of The FDA Safety & Innovation Act”).  In that law, Congress required the FDA to come up with some way of uniquely identifying all foreign and domestic facilities that are involved in the manufacture and importation of drugs.  This new guidance is the response. Continue reading FDA Chooses DUNS For Unique Facility Identifier

The Supply Chain Provisions Of The FDA Safety & Innovation Act

Secretary of Health and Human Services Kathleen Sebelius, President Barack Obama, Representative Nancy Pelosi
Secretary of Health and Human Services Kathleen Sebelius, President Barack Obama, Representative Nancy Pelosi

Last fall the U.S. Congress passed the Food and Drug Administration Safety and Innovation Act, or FDASIA, and the bill was signed into law by President Obama.  The purpose of the legislation was primarily to re-authorize user fees that are paid by manufacturers of drugs, medical devices and biologics, but the law also contains quite a few other things.  Readers of RxTrace will recall that the well-organized attempt to add a nationwide track & trace requirement to the bill failed (see “PDUFA Will Not Include RxTEC”), but a number of very significant supply chain security elements did make it into the law under the title “Title VII—Drug Supply Chain” (see the full text of the law here).  A closer look at these provisions is long overdue. Continue reading The Supply Chain Provisions Of The FDA Safety & Innovation Act

FDA Aligns with GS1 SGTIN For SNDC

Last Friday, the FDA published the long awaited guidance on their Standardized Numeric Identifier (SNI) for prescription drug packages.  This was right on time since the FDA Amendments Act  of 2007 gave the agency 30 months to develop a standard for SNI and they published, almost to the day, 30 months later.  Well done.

The published guidance is not radically different from the draft guidance that the agency published under the same name in January of 2009.  In fact, in my view, the only really important difference is how the Continue reading FDA Aligns with GS1 SGTIN For SNDC