Tag Archives: DSCSA

Kits

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 →

DSCSA

FDA Posts DSCSA-Specific Information Sharing Agreement Template For State Agencies

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istock_19522725_smallerWhile I was preparing a DSCSA resource list to be handed out at the Systech Uniquity event in Mumbai next week I stumbled across a document that the FDA recently posted on their website.  It is a template for a DSCSA-specific information sharing agreement that is aimed at state agencies, like state boards of pharmacy and probably state’s attorneys’ offices and state bureaus of investigation, etc.  The DSCSA contains several clauses that imply data sharing between the FDA and “…appropriate Federal or State official[s]”. 

The problem is, the data that would likely need to be shared Continue reading FDA Posts DSCSA-Specific Information Sharing Agreement Template For State Agencies →

FDA

FDA To Hold DSCSA Public Meeting

2016-04-05 14.11.09.reducedThe FDA is almost 10 months behind in the release of guidance documents for the Drug Supply Chain Security Act (DSCSA) as scheduled by Congress (see “FDA DSCSA Deadline Passes Quietly”, “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”, “FDA Speaks At GS1 Connect”, and “FDA Plans Busy Second Half of 2016 With Six DSCSA Draft Guidances Expected”).  So far this year the FDA has held one public meeting to collect public and stakeholder input on the pilot that the law mandates (see “FDA To Hold DSCSA Pilots Workshop”, and “The 2016 FDA Pilots Workshop”).  The DSCSA requires the FDA to hold at least five public meetings “…to enhance the safety and security of the pharmaceutical distribution supply chain and provide for comment.”

This morning, the FDA announced Continue reading FDA To Hold DSCSA Public Meeting →

serialization

Serialization Mistake #1: Printing On Your Outsert

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istock_83993805_smallerThere are lots of mistakes a company can make when designing their solution to comply with pharma serialization and tracing regulations.  One of these is to print the unique identifier on the outsert attached to their packaging.  An “outsert” is a tightly folded piece of paper that contains very detailed prescribing information intended to inform medical professionals who prescribe, dispense and/or administer the drug.  It contains Continue reading Serialization Mistake #1: Printing On Your Outsert →

Barcodes, HDA

The HDA Bar Code Quick Start Guide For Meeting The DSCSA And Other FDA Regulations

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HDA logoThe Healthcare Distribution Alliance (HDA) (formerly HDMA) published their highly anticipated “Guidelines for Bar Coding in the Pharmaceutical Supply Chain, Quick Start Guide” a few weeks ago.  Do yourself a favor and stop reading this essay right now, click on the link and download your copy and read it.  It is free, and it is essential reading for manufacturers and solution providers who expect to develop and deploy solutions that ship serialized units and cases of prescription drugs to U.S. wholesale distributors.  This includes solutions that Continue reading The HDA Bar Code Quick Start Guide For Meeting The DSCSA And Other FDA Regulations →

DSCSA, FDA Guidance

FDA Plans Busy Second Half of 2016 With Six DSCSA Draft Guidances Expected

FDALogoLast week the US FDA Center for Drug Evaluation and Research (CDER) published an update to their guidance agenda for calendar 2016.  Originally published in January, this is the mid-year update, when the CDER has a shorter window to think about and, presumably, can be more accurate.  What has changed since January?  The number of Drug Supply Chain Security Act (DSCSA)-related draft guidance they expect to publish by year end remains the same, as reported by our friends at the Regulatory Affairs Professionals Society (RAPS).

In fact, according to RAPS, those same six draft guidances were Continue reading FDA Plans Busy Second Half of 2016 With Six DSCSA Draft Guidances Expected →

DSCSA

Who Will Enforce The DSCSA 2017 Serialization Mandate?

Last week I listened in on a Drug Supply Chain Security Act (DSCSA) call hosted by one of the Big-3 U.S. wholesale distributors.  It was a well-run call that included several presentations and a Q&A session.  Several times the question was discussed about whether or not the wholesale distributor would accept non-serialized product in the time between November 27, 2017 and November 27, 2019. Continue reading Who Will Enforce The DSCSA 2017 Serialization Mandate? →

GTIN, NDC

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 →