Tag Archives: FDA draft guidance

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  The number of Drug Supply Chain Security Act (DSCSA)-related draft guidance they expect to publish by year end remains the same, as reported by our friends at the Regulatory Affairs Professionals Society (RAPS).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 →

FDA, GS1 U.S.

FDA Speaks At GS1 Connect

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Jung_ConnieLast week, Connie Jung, RPh, PhD, Acting Associate Director for Policy and Communications, Office of Drug Security, Integrity, & Recalls, U.S. Food and Drug Administration, spoke about the Drug Supply Chain Security Act (DSCSA) at the GS1 US Connect event in Washington DC.  This was our latest opportunity to get a glimpse of what the FDA is thinking and what they are doing.  Dr. Jung spoke for about 50 minutes and then answered questions from the audience. Continue reading FDA Speaks At GS1 Connect →

FDA Guidance, UDI

FDA Considering A Delay Of A Small Part Of The UDI Rule

1622-468x60_AprilFor the second time this week, the FDA posted something related to the things I pay the most attention to.  Earlier this week it was about the DSCSA.  This time it was a draft guidance for comment on a proposed delay in enforcement of a small part of the Unique Device Identification (UDI) final rule.  I’ve seen a lot of mentions around the internet about this new FDA posting but none of them really explain it very well (including the FDA).  I’d like to take a stab.

Way back in around 1970 the FDA created a numbering system for drugs and one for devices.  The one for drugs Continue reading FDA Considering A Delay Of A Small Part Of The UDI Rule →

FDA Guidance

FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1

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?????????????????In a direct response to concerns expressed by the Healthcare Distribution Management Association (HDMA) and others (see “HDMA Expresses Concerns About Industry Readiness for DSCSA” and “Will The DSCSA Cause Drug Shortages After January 1?”), the FDA posted new guidance that states their intention to postpone enforcement of just the requirements for manufacturers, wholesale distributors and repackagers to provide and capture Transaction Information (TI), Transaction History (TH) and Transaction Statements (TS).  That requirement was to Continue reading FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1 →

FDA Guidance

FDA’s DSCSA Guidance in 2014

iStock_000025908089SmallerWhen Congress penned the Drug Supply Chain Security Act (DSCSA) last year it laid out specific dates and subjects for which it expected the FDA to publish guidance on.  So far in 2014, the FDA has kept up with that schedule by holding a public meeting, publishing multiple draft guidances and setting up a website to collect information from wholesale distributors and third-party logistics providers.

The public meeting was held on May 8th and 9th to collect ideas for the standards that FDA should support for the interoperable exchange of transaction data in paper and electronic form, starting with manufacturers, repackagers and wholesale distributors on January 1, 2015 and dispensers on July 1, 2015 (see “The 2014 FDA DSCSA Workshop“).  During the workshop, the attendees raised Continue reading FDA’s DSCSA Guidance in 2014 →

FDA Guidance

FDA Posts Guidance For Wholesale Distributor and 3PL Annual Reporting

Annual Reporting Draft GuidanceThe FDA posted new draft guidance for pharma wholesale distributors and third-party logistics providers to follow to meet their obligation to register their licensing information annually.  The new requirement is from the Drug Supply Chain Security Act (DSCSA) that was enacted last year (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law“).  The draft guidance explains who, what, when and how companies must report.  The FDA will make the data reported available to the public through a web site at some point in the future.

The information the FDA will collect as part of the report from both wholesale distributors and 3PLs include facility location and contact information, a unique facility identifier, license information for each State–including expiration dates–and any significant disciplinary action Continue reading FDA Posts Guidance For Wholesale Distributor and 3PL Annual Reporting →

Suspect Product

The FDA’s Draft Guidance on Suspect Product, and Farewell Columbus

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Suspect Product Draft GuidanceThe FDA published the draft guidance on the identification of suspect product and notification of suspect and illegitimate product on June 11 as mandated by Congress in the Drug Supply Chain Security Act (DSCSA).  The document provides helpful suggestions for those who wish to reduce the risk that they will unknowingly acquire illegitimate product through increased vigilance.  The suggestions are based on the experience the FDA has gained in their investigations over the years of many situations where companies have been duped by criminals into purchasing drugs that turned out to be counterfeit, diverted, stolen, adulterated, or otherwise unfit for consumption.  No legitimate company wants to be a party to buying, selling or dispensing to patients that kind of product, so Continue reading The FDA’s Draft Guidance on Suspect Product, and Farewell Columbus →