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The American Society for Pharmacy Law (ASPL) is an organization of attorneys, pharmacists, pharmacist-attorneys and students of pharmacy or law who are interested in the law as it applies to pharmacy, pharmacists, wholesalers, manufacturers, state and federal government and other interested parties.

ASPL is a non-profit which encourages diversity & inclusion with the Society, regardless of differing backgrounds, perspectives, experiences, orientations, origins, and practice settings. The Society embraces participation and diversity as it leads to advancing our purpose: 

  • Furthering knowledge in the law related to pharmacists, pharmacies, the provision of pharmaceutical care, the manufacturing and distribution of drugs, and other food, drug, and medical device policy issues;
  • Communicating accurate legal educational information; and
  • Providing educational opportunities for pharmacists, attorneys, and others who are interested in pharmacy law

Latest News

October 15, 2024

FDA issues DSCSA exemption for certain dispensers with 26 or more FTEs

The Food and Drug Administration is issuing an exemption for pharmacies and other small dispensers to be exempt from certain DSCSA interoperable system requirements until Nov. 27, 2025, to prevent disruptions of patient access to their medications.

This exemption applies to any product transacted by “eligible trading partners,” which are trading partners who have successfully completed or made documented efforts to complete data connections with their immediate trading partners, but still face challenges exchanging data. Trading partners who utilize these exemptions do not need to notify FDA.

Additionally, FDA is still allowing pharmacies and other small dispensers (a corporate entity that owns the dispenser and has 25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians) to be exempt from certain DSCSA interoperable system requirements until Nov. 27, 2026.

Trading partners that don’t qualify for the exemptions above and are unable to meet the interoperability requirements granted in the exemptions by Nov. 27, 2024, may request a waiver, exception, or exemption from those requirements.

[Waivers and Exemptions Beyond the Stabilization Period. FDA 9 Oct 2024; DSCSA Exemptions from Certain Requirements Under Section 582 of the FD&C Act for Small Business Dispensers (revised with clarifying edits to June 12, 2024, letter). FDA 12 July 2024.]