Hello all,
On June 12, 2024, the FDA announced DSCSA exemptions for certain types of dispensers (i.e., “small dispensers”) until November 27, 2026.
PLEASE NOTE: These exemptions may not affect your facility! FDA stated that trading partners that do not qualify for the exemptions may be able to ask for a waiver if they are not able to meet the enhanced drug distribution security requirements of noted in the exemption document for DSCSA. If you’re facility wants to request an exemption, the FDA requests that you have until August 1, 2024 to do so. They have stated you can request at anytime though. Timelessness is imprtanf though.
Note….this exemption is a limited exemption. You need to evaluate the small dispenser exemption language noted at the following link: https://www.fda.gov/media/179256/download?attachment
First….let’s look at the definition of “dispenser” per DSCSA language:
SECECTION 581 of the FD&C Act DEFINITIONS.
``In this subchapter:
``(3) Dispenser.--The term `dispenser'--
``(A) means a retail pharmacy, hospital pharmacy, a group of chain pharmacies under common ownership and control that do not act as a wholesale distributor, or any other person authorized by law to dispense or administer prescription drugs, and the affiliated warehouses or distribution centers of such entities under common ownership and control that do not act as a wholesale distributor”
FDA per the exemption document noted above has defined what they view as “small” which is:
• “……a dispenser* is considered a “small dispenser” if the corporate entity that owns the dispenser has a total6 of 25 or fewer full-time employees** licensed as pharmacists or qualified as pharmacy technicians.*** We believe this definition best incorporates small pharmacy operations and those who are most in need of additional time to comply with the requirements of sections 582(g)(1) and 582(d)(4) of the FD&C Act outlined below.”
*The total number of employees as of November 27, 2024.
**For the purpose of these exemptions, we are adopting the Internal Revenue Service’s (IRS) definition of “full-time employee.” The IRS defines a full-time employee as “for a calendar month, an employee employed on average at least 30 hours of service per week, or 130 hours of service per month.” For additional information on identifying full-time employees, see https://www.irs.gov/affordable-care-act/employers/identifying-full-time-employees.
***We recognize that section 582(g) refers to “dispensers with 25 or fewer full-time employees” without limiting such employees to those who are licensed pharmacists or authorized pharmacy technicians. However, the exemptions being granted here, pursuant to section 582(a)(3), apply to a broader category of dispensers.
So, if your facility has 25 or less total full-time employees that work At least 30 hours per week or 130 hours per month and are pharmacists and/or technicians, you may fall into the exemptions noted.
If your facility qualifies for the exemption, does this mean you are “off the hook” for DSCSA compliance? Not at all! You still need to work toward full compliance. Ensure your systems are fully built. Test your systems. Personally, I would practice as if full compliance for DSCSA is required of you right now and consider that FDA or state may ask you to perform certain task such as completing an investigation of a suspect drug. Also, you will still need to do all functions for DSCSA with the exception of the noted exemptions. This would include (and not limited to):
• Purchasing only from trading partners that you have ensured are authorized.
• Document that you have completed the Authorized Trading Partner (ATP) review.
• Have an agreement in place with your supplier if the plan is for them to store your T3 information. If you are using a third-party solution, personally I would ensure that the contract or agreement with them is clear that they are maintaining the T3 info for you as well. I would assume most contracts are written in this way but just be sure it is clear.
• Only purchase items (that fall under DSCSA requirements) that have 2D barcodes.
• Reconcile/compare your products you receive vs. the data noted on the track and trace (T3) data as per the discussion noted in the following FDA Guidance Document: https://www.fda.gov/media/171666/download
• Investigate suspect products. Notice the exemption does limit all you have to do as part of the investigation such as not requiring the “verification” of the 3 items or 10%. Personally, I would still complete this process. Doing the process now helps ensure you are “testing your systems” and pushing forward to full compliance.
• Responding to request for track and trace information such as from an ambulance provider if/when they have purchased the item from you and they need to complete and investigation.
• Maintain all DSCSA records for at least 6 years.
Also, it is very helpful to have all your processes written in a document such as a procedure/SOP. Train your employees on DSCSA. Ensure the training is documented. I personally would consider doing an annual competency assessment with the employees as well.
If you are using a third-party solution and you are a small dispenser, if all things are set up properly with that companyhopefully they will help you ensure to be in full compliance before the November 27, 2026 deadline. Remember you must still complete certain task to maintain compliance beyond the third-party tools processes.
With any site, regardless of use of a third-party solution or not, you must ALWAYS be mindful of your policies/procedures/SOPs and ensure that your staff are following them! DSCSA, much like other such things as USP 797, DEA requirements, etc., MUST be maintained. There can be penalties for non-compliance.
Hopefully you find this helpful!
Jay G.
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