Tag Archives: FDA Guidance

DSCSA

Breaking: FDA Official Offers Advice In Absence Of DSCSA Waiver Guidance

FDA official, Connie Jung PhD, Senior Advisor for Policy, spoke at the International Society of Pharmaceutical Engineering (ISPE) Serialization Workshops event yesterday to provide background on the Drug Supply Chain Security Act (DSCSA).  I used the opportunity to ask her a number of questions regarding some of the things I based my prediction in Monday’s essay that the FDA will announce a delay in the DSCSA in the next three weeks (see “FDA Tea Leaves: Are They About To Delay The November Deadline?”).  The timing was perfect, and when I registered for the event, I didn’t even know the FDA was on the agenda.

Here’s the backstory. Continue reading Breaking: FDA Official Offers Advice In Absence Of DSCSA Waiver Guidance →

DSCSA, FDA Guidance

InBrief: Why The DSCSA Will Be Enforced Even Without FDA Guidance

New Regulations comic
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As you are already well aware, the FDA is long overdue to publish four different guidance documents covering various aspects of the Drug Supply Chain Security Act (DSCSA), as mandated by Congress (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”).  At least two of those guidance documents would affect how companies should expect to comply with the serialization deadline on November 27, 2017. 

If the FDA doesn’t publish on or before that date, does that mean you don’t need to comply on time?  Can you just sit back and wait for the FDA to post those guidance documents someday?  I don’t think so.  Here’s why. Continue reading InBrief: Why The DSCSA Will Be Enforced Even Without FDA Guidance →

DSCSA

In Absence Of FDA Guidance, Follow PDSA Recommendations

PDSA LogoThe Pharmaceutical Distribution Security Alliance (PDSA) is a coalition of companies and organizations dedicated to the safety and integrity of the U.S. pharmaceutical supply chain.  When the Drug Supply Chain Security Act (DSCSA) went into effect on November 27, 2013 the PDSA began to serve as a voice for its members in communications with the U.S. FDA.  Their preferred way of communication is through formal letters signed by their legal advisor, Vince Ventimiglia.  PDSA letters to the FDA are really interesting because they do an excellent job of providing recommendations for the FDA to consider as they prepared to publish the four guidance documents that were due back on November 27, 2015.  The FDA has still not published those documents.  Continue reading In Absence Of FDA Guidance, Follow PDSA Recommendations →

FDA

One Immediate Impact of President Trump On The FDA

Most RxTrace subscribers are aware that the FDA is way overdue to publish four guidance documents mandated by the Drug Supply Chain Security Act (DSCSA) (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?” and “Is The FDA Intentionally Delaying Publication Of The Overdue DSCSA Guidance?” for a list of the missing documents).  Two of those four documents could impact how some drug manufacturers deal with the November 27, 2017 deadline for full serialization of prescription drug products, depending on what the FDA says in them. 

Every day since the original due date of those documents (November 27, 2015) I have Continue reading One Immediate Impact of President Trump On The FDA →

HDA

HDA’s 2016 Serialization Readiness Survey

Because of all the major news and developments over the last six months, it has taken me way too long to fully cover the Healthcare Distribution Alliance’s (HDA’s) 2016 Serialization Readiness Survey of drug manufacturers.  In my defense, I did cover it partially in my report of the HDA 2016 Traceability Seminar (see “HDA Delivers Home Run To Record-Breaking Audience”), but the other news from that event seemed to overshadow the survey results.  The HDA survey executive summary was so well done, and the results so important that it deserves closer scrutiny.  So here is my coverage, better late than never. Continue reading HDA’s 2016 Serialization Readiness Survey →

FDA Guidance

FDA Finalizes Guidance On Suspect Product

suspect-product-final-guidanceHere we are, waiting for the FDA to publish new draft guidance related to the Drug Supply Chain Security Act (DSCSA) after a deadline that passed more than a year ago, and what do we get?  A final version of a guidance document that was originally published in draft form two and a half years ago:  “Identification of Suspect Product and Notification”.  Well, OK, thanks. 

I have to say, this is important guidance.  In fact, it is probably the most important DSCSA guidance that the FDA has published yet, whether in draft or final forms.  And, unfortunately, Continue reading FDA Finalizes Guidance On Suspect Product →

EDDS

5 Myths About The DSCSA In 2023

istock_67972853_smallerThere are a number of misconceptions floating around the industry right now about what will happen in November of 2023, when the Enhanced Drug Distribution Security (EDDS) phase mandated by the Drug Supply Chain Security Act (DSCSA) begins.  It is surprising where you hear some of these, but they are all based on mis-reads of the DSCSA law itself.  I’ll explain the myths, and then I will try to provide extracts from the DSCSA that expose them as myths. Continue reading 5 Myths About The DSCSA In 2023 →

FDA Guidance

Is The FDA Intentionally Delaying Publication Of The Overdue DSCSA Guidance?

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Last week I wrote about the recent FDA DSCSA Public Meeting where the FDA asked for reports on the progress of the industry toward meeting the November 27, 2017 serialization requirements contained in the Drug Supply Chain Security Act (DSCSA) (see “FDA Forfeits Opportunity To Guide Industry”).  In that essay I expressed a view that the FDA has squandered too much of the time necessary for the industry to meet whatever guidance they might offer about grandfathering and exceptions for products that are too small to accommodate a DSCSA product identifier.  These guidance documents are now 11 months late.

What if the delay in publishing these guidance documents is intentional? Continue reading Is The FDA Intentionally Delaying Publication Of The Overdue DSCSA Guidance? →