As you are already well aware, the FDA is long overdue to publish four different guidance documents covering various aspects of the Drug Supply Chain Security Act (DSCSA), as mandated by Congress (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”). At least two of those guidance documents would affect how companies should expect to comply with the serialization deadline on November 27, 2017.
If the FDA doesn’t publish on or before that date, does that mean you don’t need to comply on time? Can you just sit back and wait for the FDA to post those guidance documents someday? I don’t think so. Here’s why.
There is an obscure, one-sentence section of the DSCSA that has the title “Self-Executing Requirements”. It states, in full:
“SELF-EXECUTING REQUIREMENTS.—Except where otherwise specified, the requirements of this section may be enforced without further regulations or guidance from the Secretary.” (DSCSA Section 582[a]).
What does this mean? I’ve been told that it means what it says, that the DSCSA Section 582 (the heart of the regulation) may be enforced without further regulations or guidance from the FDA. So even if the FDA fails to ever publish the guidance that the DSCSA mandates from them, this section says that they can still enforce the rest of the regulation. Sorry, you can’t use the missing or late guidance as an excuse for being late in your compliance.
BTW, WILL WE EVER SEE THOSE GUIDANCE DOCUMENTS?
A few months ago I noticed that the rate at which the FDA is publishing new guidance documents of any kind took a sharp dive as soon as President Trump was inaugurated (see “One Immediate Impact of President Trump On The FDA”). Now others are taking note. Ace reporter, Zachary Brennan, with the Regulatory Affairs Professional Society (RAPS) posted a new article on their website that covers the same topic and provides some extra background (see “Release of New FDA Guidance Declines Sharply Following Trump’s Inauguration”). The FDA’s publication rate fluctuates from week to week, but it remains well below pre-inauguration levels right up through last week.
Perhaps the agency is building up a supply of unpublished guidances and we will see the floodgates open as soon as the new leadership is seated and ready to move forward. Or perhaps not. We’ll have to wait a little longer to find out. But considering the DSCSA section on self-executing requirements, don’t let that stop you from being ready on November 27.