Monthly Archives: May 2018

DSCSA

HDA Urges FDA To Withdraw Draft Guidance ‘In Its Entirety’

In a lengthy comment submission to the FDA’s recent publication of draft guidance on Standardization of Data & Documentation Practices for Product Tracing (see “DSCSA Guidance: Standardization of Data & Documentation Practices for Product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This is the first time I can remember HDA considering a draft guidance to be so bad that they called for its withdrawal in its entirety.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  They feel that the guidance it contains is Continue reading HDA Urges FDA To Withdraw Draft Guidance ‘In Its Entirety’ →

DSCSA

FDA Draft Guidance: How To Apply For A Waiver, Exception or Exemption

Last week the FDA finally published their draft guidance for submitting a waiver, exception or exemption from certain Drug Supply Chain Security Act (DSCSA) requirements.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the new publication deadline for the guidance being May 31, 2018, which they have now met (see “FDA To Publish Key Draft Guidance Tomorrow”). Continue reading FDA Draft Guidance: How To Apply For A Waiver, Exception or Exemption →

DSCSA

FDA To Publish Key Draft Guidance Tomorrow

This morning the FDA announced their intention to publish the long overdue draft guidance on Drug Supply Chain Security Act waivers, exceptions and exemptions tomorrow.  The timing of the publication of this particular draft guidance is critical to the FDA holding their current enforcement deadline for serialization and verification for manufacturers and repackagers.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

Blockchain, DSCSA

An Open Letter To Blockchain Vendors: Please Pay More Attention

2 Comments

Dear Blockchain Vendors,

It was good to see all of you at last week’s Drug Supply Chain Security Act (DSCSA) and Blockchain proof of concepts pilots review held by the Center For Supply Chain Studies (C4SCS) in Rockville, MD.  I hope your travel home was uneventful.  Let me say right at the top, I was in the audience representing Systech International.  My co-worker, Joe Lipari partnered with Dwight deVere of RxTransparent as the Green Team.  RxTrace is independent of Systech International.  That said, as the author of RxTrace, I have some helpful advice for you. Continue reading An Open Letter To Blockchain Vendors: Please Pay More Attention →