FDA Draft Guidance: How To Apply For A Waiver, Exception or Exemption

Last week the FDA finally published their draft guidance for submitting a waiver, exception or exemption from certain Drug Supply Chain Security Act (DSCSA) requirements.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the new publication deadline for the guidance being May 31, 2018, which they have now met (see “FDA To Publish Key Draft Guidance Tomorrow”).

So now that we have it, companies wishing to apply for a waiver, exception or exemption from the DSCSA serialization requirement should do so quickly.  The process will almost certainly take more time that you would like before you find out if the FDA grants your request…or denies it.  The process starts with the submission of your application.  The FDA has not provided a form, but the draft guidance includes a list of elements that all applications must include.  See the original draft guidance for the full details, but here is a summarized list:

  1. Applicant contact info;
  2. Identity of the trading partner(s) to be covered;
  3. Description of the activities and/or products for which the waiver, exception, or exemption is sought;
  4. The requested effective period (see below);
  5. The DSCSA requirement(s) to which the proposed waiver, exception or exemption would apply;
  6. A detailed statement of the reasons why FDA should grant the proposed waiver, exception or exemption, including any supporting documents.

For #3, include the specific National Drug Code(s) (NDCs) for the prescription drug product you are seeking the action on.  If your application is not for a specific drug but for certain “activities” covered by the DSCSA, make sure you are very clear about the extent of those activities (see “Anatomy Of The National Drug Code“).  For clarity when supplying #5 in this list, I recommend that you include the specific section number of the DSCSA text.

Exactly how you should submit your application to the FDA is determined by which part of the FDA regulates your product.  FDA provided the table below in an appendix of the draft guidance:

Click image to enlarge

When the FDA receives your application, they will send you an acknowledgement.  If you don’t receive one within a reasonable period of time, you might want to follow-up with another message.

As part of their evaluation, FDA might reach out to the contact person listed on the application if they need any additional documentation or clarification.  Of, if the application is too weak, they may simply deny the application and you will have to start over.

Please note that FDA expects to limit the duration of the waivers, exceptions or exemptions they grant, so you might want to propose a reasonable time limit yourself in item #4 of your application.  In some cases, they may set the time limit to “until further notice”, but only in “extraordinary circumstances”.  If your application is approved, FDA expects you to notify them of any material change in the circumstances that were the basis of your original request, even if the time period granted has not yet expired.

For some exceptions and exemptions, FDA intends to use the authority granted to it under the DSCSA to initiate the review process on its own.  These will include any issue that affects a broad segment(s) of industry and/or multiple trading partners, impacts many activities, or involves numerous products.  For example, the draft guidance says that they already intend…

“…to only establish exceptions […] on [FDA’s] own initiative where it is assessed that the excepted product(s) is packaged in a container that is too small or otherwise unable to accommodate a label with sufficient space to bear the information required for compliance with the section 582 requirements relating to product identifiers.  Similarly, FDA intends to only establish exemptions […] on its own initiative where it determines that the exemption is appropriate to maintain public health or is otherwise appropriate.”

So it appears that companies will not need to submit applications related to a single product for size issues, at least, since the FDA intends to issue an exception/exemption of that type for all products.  If/when it does so FDA will make an announcement on their website, or otherwise notify those affected by the action (see also “Is Your Drug Too Small For The Mandated 2D Barcode?”).  However, be aware that any exception or exemption established by FDA “…may be limited in duration or valid until further notice from FDA.”  Obviously these will be big news so I will watch for them and write about them here in RxTrace.

FDA will review all waivers, exceptions and exemptions granted “until further notice” every two years to determine if it is appropriate to continue granting them.  They will either renew those for another two years, or terminate them.  If the action under review was originally granted to an applicant, FDA may reach out to that applicant for help in assessing the current situation.  If termination is necessary, FDA will provide written notice to the recipient of the waiver, exception or exemption.  For FDA-initiated exceptions and exemptions, they will announce the termination in an appropriate way and in a reasonable time before the specified termination date.

An applicant for a waiver, exception or exemption that is granted with a time limit may submit a renewal request for consideration by the FDA as the time limit approaches.  These applications should include a detailed statement justifying the continuance, and the desired length of time for the extension.  Renewal requests for FDA-initiated exceptions and exemptions will not be accepted.  If you need an extension for one of those they expect you to submit your own individual application for an exception or exemption for just your products and your circumstances.


On Friday, FDA also published a notice in the Federal Register about their DSCSA pilots program.  The full title is “Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Pilot Project Program Under the Drug Supply Chain Security Act”.  The document contains several types of information related to their ongoing preparations for the pilot program FDA announced in 2016 and updated in 2017 (see “FDA Announces New DSCSA Pilot Program and Public Meeting Series”).

Over the last 18 months, FDA received 27 responses to their original request for comments on their pilots program.  In one section of this new notice FDA respond to just four comments received from stakeholders from that original comment period.

The main purpose of the notice is to seek the approval of the White House Office of Management and Budget (OMB) to participate in industry pilots of this type.  The notice gives no indication of when FDA-linked DSCSA piloting would begin or end, except that they will not begin until OMB approval is obtained.  The notice itself includes a 60-day comment period that ends on June 11, 2018.