January 5, 2024

APC submits comments for Senate hearing on drug shortages

On December 5, APC submitted comments to the Senate Finance Committee for a hearing titled “Drug Shortages: Examining Supply Challenges, Impacts, and Policy Solutions from a Federal Health Program Perspective.” Our letter included four asks that would expand compounding pharmacies’ ability to alleviate drug shortages:

  1. Update the statutory definition of drug shortages to include regional shortages and input from hospitals and other health care practitioners.
  2. Codify FDA’s current guidance that states 503A pharmacies can compound drugs on FDA’s shortage list without violating rules against copying FDA approved drugs.
  3. Establish a narrow pathway, through law or policy guidance, allowing 503As to compound shortage and other drugs urgently needed for treatment of patients by practitioners when unavailable from 503B outsourcing facilities. 
  4. Provide flexibility in the manufacturing standards that apply to 503B outsourcing facilities for drugs on the FDA shortage list so they can react more quickly when shortages occur.