Tag Archives: exemptions

HDA Responds To FDA Waivers, Exceptions, Exemptions Draft Guidance

Unlike the implication of this drawing, FDA does hear and care about submitted comments.

The Healthcare Distribution Alliance (HDA) recently posted their response to the latest draft Drug Supply Chain Security Act (DSCSA) guidance published by the FDA.  That draft guidance explains how, when and why companies in the US pharma supply chain can apply for waivers, exemptions and exceptions to provisions in the DSCSA (see “FDA Draft Guidance: How To Apply For A Waiver, Exception or Exemption”).  As usual, the HDA took close to the full sixty day comment period to respond.  The comment period closed last Monday. Continue reading HDA Responds To FDA Waivers, Exceptions, Exemptions Draft Guidance

FDA Draft Guidance: How To Apply For A Waiver, Exception or Exemption

Last week the FDA finally published their draft guidance for submitting a waiver, exception or exemption from certain Drug Supply Chain Security Act (DSCSA) requirements.  Originally, the latest possible date FDA could delay publishing this particular guidance was May 31, 2017.  That is, 180 days before the manufacturer’s serialization and verification requirement was due to go into effect on November 27, 2017.  Once that date passed without publishing this draft, they were forced to delay the start of the serialization/verification deadline, as they did in late June last year (see “FDA Tea Leaves: Are They About To Delay The November Deadline?” and “FDA Delays Enforcement of DSCSA November Deadline: What It Means”).  That bought the FDA another year to publish, with the new publication deadline for the guidance being May 31, 2018, which they have now met (see “FDA To Publish Key Draft Guidance Tomorrow”). Continue reading FDA Draft Guidance: How To Apply For A Waiver, Exception or Exemption

FDA To Publish Key Draft Guidance Tomorrow

This morning the FDA announced their intention to publish the long overdue draft guidance on Drug Supply Chain Security Act waivers, exceptions and exemptions tomorrow.  The timing of the publication of this particular draft guidance is critical to the FDA holding their current enforcement deadline for serialization and verification for manufacturers and repackagers.  In fact, if they had failed to meet their late May deadline for publication of this particular draft guidance Continue reading FDA To Publish Key Draft Guidance Tomorrow

FDA’s New DSCSA Grandfathering Guidance

I have now read the FDA’s new draft Grandfathering Policy that was published on Monday (see “FDA Publishes DSCSA Grandfathering Guidance Exactly 2 Years Late”) and for the life of me, I can’t figure out why it took two extra years beyond the due date to get it out. Back in September of 2015 I posted an essay that analyzed the options they had in front of them (see “Will Manufacturers Be Able To Grandfather Products In Their DC And 3PL?”). All they really had to do was chose from a short list of events that could trigger the drug’s transition into the pharmaceutical distribution supply chain at the time of the effective date. They had the following options: Continue reading FDA’s New DSCSA Grandfathering Guidance

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

FDA Tea Leaves: Are They About To Delay The November Deadline?

Drawing of tea leaves to be read
Can you read these?

I don’t have any hard evidence, but there are some interesting things out there that just might point to a coming delay in the Drug Supply Chain Security Act (DSCSA) November 27, 2017 deadline for drug manufacturer serialization and electronic transaction data exchange.  Let’s call them “tea leaves”, and let me attempt to “read” them.  They might turn out to be meaningless, so don’t take any action based on such speculation.  And if you know something more, or interpret something differently, leave a message.

During the Cold War the U.S. government and the press attempted to figure out what was going on in the Soviet Union by paying attention to who was standing next to whom during military parades.  Our exercise might see a little like that. Continue reading FDA Tea Leaves: Are They About To Delay The November Deadline?

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

DSCSA: Kit, Repack, Combo Product, or Just A ‘Collection’?…Again

iStock_000069076997_smallerI am writing this from Mumbai India where I am scheduled to speak at the Systech Uniquity Conference, but I will be home by the time you read this.  I just won’t have time to publish a new essay this week due to the incredibly long flights I need to get home.  So, here is a re-posting of a great essay from May 9, 2016.

 

DSCSA: Kit, Repack, Combo Product, or Just A ‘Collection’?

Medical convenience kits are exempt from the Drug Supply Chain Security Act (DSCSA).  But be careful.  Continue reading DSCSA: Kit, Repack, Combo Product, or Just A ‘Collection’?…Again