WASHINGTON, DC – Today, The American Pharmacists Association launched a campaign to help small businesses/dispensers with upcoming DSCSA requirements.
APhA is urging pharmacies to join them in calling for FDA to postpone the upcoming DSCSA requirements for small business dispensers to allow for more time to comply with the Drug Supply Chain Security Act (DSCSA) requirements that go into effect on November 27, 2023.
Several DSCSA requirements for pharmacies, referred to as “dispensers,” in the DSCSA are already in effect. Last month, APhA submitted a request to FDA to exercise enforcement discretion and give pharmacies/dispensers with 25 or fewer full-time employees additional time to comply with the DSCSA requirements for electronic, enhanced drug distribution security that will go into effect on November 27, 2023.
“Implementing the upcoming DSCSA requirements is a critical issue for small pharmacies employing 25 or fewer people. FDA has not started the feasibility study that’s required to evaluate the impact on small pharmacies, so it is unclear what they will need to do. These are small businesses like any other, a key component of the local economy and a critical part of underserved health care infrastructure. FDA needs to hear from small business pharmacies that they will need more time to comply with these upcoming DSCSA requirements,” said Ilisa BG Bernstein, PharmD, JD, FAPhA, interim executive vice president and CEO of APhA.