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 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.
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.
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.
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!
Additional DSCSA Resources:
April X, 2023
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
RE: Request for Enforcement Discretion for DSCSA Small Business Dispensers
Dear Food and Drug Administration staff:
As a pharmacy with 25 or fewer full-time employees, I request that FDA announce that you will exercise enforcement discretion for the DSCSA requirements that will go into effect in November 2023 for small business dispensers. My pharmacy will need additional time to implement any alternative methods for compliance that FDA has not yet identified for small business dispensers. It will be very difficult for my pharmacy to set up compliant systems and processes without further direction and guidance from FDA.
As you know, pharmacists and pharmacies have been busy during the pandemic, with testing, immunizing, and treatments for COVID-19. In addition, there is added focus on the tripledemic we are experiencing this season with respiratory viruses, in addition to drug shortages, and financial and staffing challenges. As a small business, our resources are very limited, and our time must be spent efficiently. Until there is greater certainty for how to comply with these new requirements, many dispensers in the same situation as me are reluctant to invest already limited resources or consider what they will do to meet the requirements, including whether they will rely on their wholesalers for implementation.
I urge FDA to delay the November 27, 2023 effective date for small business dispensers and issue guidance on enforcement discretion for the appropriate sections of this law as soon possible. This will enable my pharmacy to focus on what is most important for us as frontline healthcare professionals --- providing patients with the essential care they need during multiple public health challenges and beyond.
Thank you for your consideration of this request.
[Insert pharmacist name and contact information]