Tag Archives: FDA

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? →

FDA

FDA Forfeits Opportunity To Guide Industry

fda-building-2016-10-14-16-38-20I hope you were able to attend last Friday’s FDA DSCSA Public Meeting at FDA’s White Oak, Maryland campus (see “FDA To Hold DSCSA Public Meeting”).  If you missed it, make sure you listen in on the recording that the FDA will provide on the event webpage.  You can also submit written comments through that page as well.  The event was called “Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act (DSCSA)” and it consisted of very brief introductory comments by the FDA followed by presentations made by attendees who applied for a speaking slot.  Presentations covering progress toward the November 27, 2017 DSCSA serialization requirements were made by: Continue reading FDA Forfeits Opportunity To Guide Industry →

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 →

GS1

Product Identification And National Registration Codes

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iStock_000090544423_smallerThere is a long-running tug-of-war going on between GS1 and national governments around the world over how exactly to identify medical products, whether devices or pharmaceuticals.  National governments regulate those products to maximize the health of their citizens and so they take a natural interest in how they are identified.  They want to eliminate all ambiguity between products within their market.  They need to be able to tightly grant market authorization, revoke it and oversee recalls when warranted.  To do that effectively, they need a way of clearly and concisely referencing a given product.  That same way of referencing the product should also be used for patient education and for healthcare professional prescribing.  Bad things happen when mistakes are made in the identification of healthcare products.

GS1 offers a global standard way of identifying Continue reading Product Identification And National Registration Codes →

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 →