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:
- Update the statutory definition of drug shortages to include regional shortages and input from hospitals and other health care practitioners.
- 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.
- 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.
- 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.
