Tag Archives: FDA draft guidance

HDA Urges FDA To Withdraw Draft Guidance ‘In Its Entirety’

In a lengthy comment submission to the FDA’s recent publication of draft guidance on Standardization of Data & Documentation Practices for Product Tracing (see “DSCSA Guidance: Standardization of Data & Documentation Practices for Product Tracing”), the Healthcare Distribution Alliance (HDA) called on the FDA to move on and focus on requirements for deadlines in the future, not those in the past.  HDA’s comments on this guidance was the most strongly-worded submission of any they have made yet related to the Drug Supply Chain Security Act (DSCSA).

This is the first time I can remember HDA considering a draft guidance to be so bad that they called for its withdrawal in its entirety.  They are not even asking the agency to re-write it.  They feel that the guidance it contains is Continue reading HDA Urges FDA To Withdraw Draft Guidance ‘In Its Entirety’

FDA Draft Guidance: How To Apply For A Waiver, Exception or Exemption

Last week the FDA finally published their draft guidance for submitting a waiver, exception or exemption from certain Drug Supply Chain Security Act (DSCSA) requirements.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with the new publication deadline for the guidance being May 31, 2018, which they have now met (see “FDA To Publish Key Draft Guidance Tomorrow”). Continue reading FDA Draft Guidance: How To Apply For A Waiver, Exception or Exemption

FDA To Publish Key Draft Guidance Tomorrow

This morning the FDA announced their intention to publish the long overdue draft guidance on Drug Supply Chain Security Act waivers, exceptions and exemptions tomorrow.  The timing of the publication of this particular draft guidance is critical to the FDA holding their current enforcement deadline for serialization and verification for manufacturers and repackagers.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

DSCSA Guidance: Standardization of Data & Documentation Practices for Product Tracing

The second—and longer—draft guidance document the FDA published on the day of the third DSCSA public meeting is a “catch-all” (see also “DSCSA Guidance: Definitions of Suspect and Illegitimate Product for Verification Obligations” and “FDA DSCSA Public Meeting #3: A Difference?”).  It contains lots of diverse recommendations, all related to the standardization of data contained in the DSCSA transaction information (TI), transaction history (TH), and transaction statement (TS).  This draft guidance applies to every member of the supply chain, including drug manufacturers, CMOs, 3PLs, wholesale distributors, repackagers and dispensers of all kinds.  Everyone should read it and submit comments to the FDA when something isn’t clear enough.  Continue reading DSCSA Guidance: Standardization of Data & Documentation Practices for Product Tracing

DSCSA Guidance: Definitions of Suspect and Illegitimate Product for Verification Obligations

As I mentioned last week, the FDA published two new draft DSCSA guidance documents on the day of the recent FDA DSCSA Public Meeting (see “FDA DSCSA Public Meeting #3: A Difference?”).  Let’s take a closer look at what’s in them and their significance to companies facing the Drug Supply Chain Security Act (DSCSA).  I’ll cover one of the two in this essay and cover the other document in the next essay. Continue reading DSCSA Guidance: Definitions of Suspect and Illegitimate Product for Verification Obligations

DSCSA and RxTrace: The Song Remains The Same

Led Zeppelin:  The Song Remains The Same album coverDrug manufacturers facing the November 27, 2017 deadline for applying unique identifiers to their products should take care when interpreting the FDA’s recent draft compliance policy.  All the headlines scream (including last week’s RxTrace essay:  “FDA Delays Enforcement of DSCSA November Deadline: What It Means”) that the Drug Supply Chain Security Act (DSCSA) serialization deadline is delayed, but there are important nuances to the delay.  Don’t just read the headlines, read the whole articles.  Officially, the deadline remains the same.  Yes, the FDA will look the other way for some drugs, but for others, the deadline still appears to apply.  How do you know if your drugs are those where the deadline still applies?  Read on. Continue reading DSCSA and RxTrace: The Song Remains The Same

FDA Delays Enforcement of DSCSA November Deadline: What It Means

Business man trying to stop the clockAs you have read, the FDA has let it slip, with a draft guidance document, that they have decided not to enforce the DSCSA’s November 27, 2017 deadline for manufacturers to apply the new serialized product identifier on drug packages and verification requirements for one year, but it also contains cascading enforcement delays (see “FDA Tea Leaves: Are They About To Delay The November Deadline?”).  This is a major move by the FDA and it will have important consequences for the industry.  Let’s break it down. Continue reading FDA Delays Enforcement of DSCSA November Deadline: What It Means

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