Tag Archives: FDA Guidance

HDA Makes A Strong Case For ‘Reframing’ Of FDA’s Draft Guidance On DSCSA Verification Systems

Last October the FDA published a draft guidance called “Verification Systems Under the Drug Supply Chain Security Act (DSCSA) for Certain Prescription Drugs” (see “DSCSA: Verification Systems Draft Guidance”).  Near the end of the comment period in December, the Healthcare Distribution Alliance (HDA) submitted comments containing proposed changes.  Like other comments submitted by the HDA for other FDA DSCSA guidance, these are well worth reading.  Once again, the HDA demonstrates their thorough understanding of the DSCSA and their ability to clearly and crisply explain where the FDA’s draft language fails to reflect the language in the original law. 

Continue reading HDA Makes A Strong Case For ‘Reframing’ Of FDA’s Draft Guidance On DSCSA Verification Systems

DSCSA: Verification Systems Draft Guidance

Verification is an important part of the operation of the Drug Supply Chain Security Act (DSCSA), and from my observation, it isn’t understood very well.  People new to the DSCSA always think “verification” means something beyond what the actual definition is in the law.  Late last week the FDA published new draft guidance describing their current thinking about the “verification systems” that members of the supply chain are required by the DSCSA to have in place.  It’s an important draft because I suspect not many companies have “verification systems” that have the kind of capabilities spelled out by the FDA.  Of course, as usual, it’s only a draft, not for implementation but for comment only.  You have until December 24, 2018 to submit comments for consideration by the FDA as they someday make this guidance final. Continue reading DSCSA: Verification Systems Draft Guidance

Will Manufacturers Be Able To Grandfather Products In Their DC And 3PL? Again

Grandfather clockThis week I am posting one of my favorite essays from last fall because at this moment, I am in the middle of moving my home and office from one side of the Chicago metro area to the other to be closer to our kids.  Also at this moment, the FDA is almost eight months late in publishing the grandfathering guidance that was mandated by the DSCSA.  Here it is again.

Regulations often make use of a concept known as “grandfathering” to soften a given deadline so that it is easier for companies to meet.  When allowed, grandfathering allows Continue reading Will Manufacturers Be Able To Grandfather Products In Their DC And 3PL? Again

HDMA Responds To FDA Pilots RFC

iStock_000023623347_SmallerA few months ago the FDA opened two “dockets”, or Requests for Comments (RFC) to collect ideas and experiences about technology pilots related to the Drug Supply Chain Security Act (DSCSA).  The first docket was associated with the FDA Public Meeting held on April 5 and 6 (see “The 2016 FDA Pilots Workshop”).  The second docket was opened shortly after the Public Meeting to continue collecting the same kind of information from anyone who had already conducted their own pilots or was planning future pilots.  Both dockets are now closed so here is a look at the responses. Continue reading HDMA Responds To FDA Pilots RFC

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 Announces OMB Approval Of One DSCSA Draft Guidance

omb-logoIt’s funny.  Here we are waiting for the FDA to publish four new Drug Supply Chain Security Act (DSCSA) guidance documents (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?“), when an unexpected notice is published about an older draft DSCSA guidance document.  When I first looked at the title of the notice I had to read it four times before I could get myself to believe what I was seeing.

That’s right, this morning the FDA Continue reading FDA Announces OMB Approval Of One DSCSA Draft Guidance

Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?

Happy Martin Luther King Day!

Congress set the calendar for many different kinds of requirements when it adopted the Drug Supply Chain Security Act, signed by the President back on November 27, 2013.  One of those dates was last November 27, 2015, two years after enactment, when the FDA was required to publish four new draft guidances.  So far, none of them have appeared (see “FDA DSCSA Deadline Passes Quietly”).  Continue reading Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?

FDA DSCSA Deadline Passes Quietly

Last Friday was the deadline for the FDA to publish four new guidance documents under the Drug Supply Chain Security Act (DSCSA) (see “Decoding The FDA’s DSCSA Timeline”).  The deadline was established by the U.S. Congress when they enacted the legislation and it was signed by President Obama on November 27, 2013 (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”).  But time spent by the FDA to meet their obligations under the DSCSA is “unfunded”.  That is, Congress did not provide any specific additional money to pay for the FDA’s new obligations under the DSCSA.  It is an unfunded mandate.

Fortunately the FDA is Continue reading FDA DSCSA Deadline Passes Quietly