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

January 12, 2025

FDA Releases Guidance for 503A and 503B Compounding

FDA released revised guidance governing what pharmacies can compound. Under the guidance, 503A compounding pharmacies can continue to compound substances that are the active ingredient in an FDA-approved drug, have a U.S. Pharmacopeia monograph, or are placed in FDA’s “Category 1” list of proposed bulk drugs that do not pose a significant safety risk but have not yet been placed on the 503A bulks list. (The Category 1 list is also known as “Substances Nominated for the Bulks List Currently Under Evaluation.”)  503A compounding pharmacies, however, would not be able to compound substances without monographs, like peptides, until a review is conducted.

Under separate revised guidance, 503B outsourcing facilities can only compound drugs on the Category 1 of the 503B bulks list, or FDA-approved drugs in shortage.

[Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry; Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act FDA January 2025.]