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Are you a pharmacy with 25 or fewer full-time employees? If so, contact FDA today to delay upcoming DSCSA requirements for small business dispensers.

The Issue:

The Drug Supply Chain Security Act (DSCSA)–known as the “track-and-trace” law—outlines steps for implementing certain requirements for enhanced drug distribution security. The goal is to create an electronic, interoperable exchange of information that identifies and traces certain prescription drugs down to the package level as they move through the supply chain to protect consumers from counterfeit, stolen, contaminated, or otherwise harmful drugs. DSCSA requires pharmacies, referred to as “dispensers,” to have systems and processes to comply with the law’s requirements.

Track and Trace letters on blocks

A number of DSCSA requirements for dispensers are already in effect; however, compliance with additional requirements for electronic, enhanced drug distribution security goes into effect on November 27, 2023. DSCSA requires FDA to assess the impact of the requirements on small dispensers, defined as those with 25 or fewer full-time employees, in order to ensure that the requirements do not impose undue economic hardship for small businesses. If so, FDA is to determine timelines for compliance or alternative ways for small business dispensers to comply.

The Problem:

FDA has not conducted the necessary small business assessment or sought public input on the assessment. Based on the deadlines laid out in the DSCSA, there will not be adequate time for affected dispensers to implement the requirements or alternative methods for compliance. Because FDA knows the steps that they are required to take will not be completed with adequate time for small business to implement the requirements by November 27, 2023, FDA should tell small business dispensers ASAP that they will have more time so these businesses can focus on essential patient care and not waste precious time, personnel, and financial resources.

The Ask:

APhA submitted a request to FDA to exercise enforcement discretion and give dispensers with 25 or fewer full-time employees more time to comply with the DSCSA requirements that go into effect November 27, 2023. APhA is now urging dispensers with 25 or fewer full-time employees to also tell FDA to exercise enforcement discretion and give them more time to comply with the DSCSA requirements that go into effect November 27, 2023. Tell FDA to delay!

How do I contact FDA?


  1. Download the following draft template letter and modify with your contact information to submit to the official record and send directly to FDA staff.
  2. Copy text  Download 

  3. Email a copy to drugtrackandtrace@fda.hhs.gov and cc Heather Boyd, Director, Health Policy at hboyd@aphanet.org.
  4. Click on the following link at www.regulations.gov to submit comments and complete the required information.

    Visit Regulations.gov  

  5. Copy and Paste the letter text into the “Comment” box.
  6. Choose the “Individual” (box), Click “I’m not a robot” and Click “Submit Comment.”