Several national pharmacy associations are asking the FDA to offer a blanket exemption, waiver or exception from the Drug Supply Chain Security Act.
The law aims to improve tracking of packaged therapies and increase the FDA's authority to regulate compounded medications.
In an Aug. 30 letter to the FDA, eight major national pharmacy associations said many pharmacies are only receiving 20% to 40% of necessary electronic product code information services data from distributors.
Enforcement of the DSCSA, which was passed in 2013, has been delayed multiple times already.
A secure drug distribution requirement was originally supposed to go into effect November 2023, but two months before the deadline, the agency delayed enforcement of some policies until November 2024. Pharmacies with 25 or fewer full-time employees have until Nov. 27, 2026, to be in compliance, the FDA said June 12.
"Pharmacy compliance with DSCSA is fully dependent on the compliance of upstream trading partners," the Aug. 30 letter said. "In cases where manufacturers supply partial or no data, the DSCSA provides pharmacies limited recourse beyond rejecting shipments. … [C]onsidering the scope of the missing data, we are concerned that this could potentially jeopardize patient care."
The organizations represent more than 40,000 retail pharmacies and more than 100,000 pharmacists, student pharmacists and pharmacy technicians.
They are the American Association of Colleges of Pharmacy, the American College of Clinical Pharmacy, the American Pharmacists Association, the American Society of Consultant Pharmacists, the American Society of Health-System Pharmacists, the National Association of Chain Drug Stores, the National Alliance of State Pharmacy Associations and the National Community Pharmacists Association.