The Food and Drug Administration and Drug Enforcement Agency could help prevent drug shortages by making some COVID-19 flexibilities permanent, group purchasing organization Premier Inc. said in a statement Thursday.
Premier told the FDA it should allow 503B compounding pharmacies to make drugs that aren't on the agency's drug shortage list to respond to "short-term or regional shortages or demand surges for certain dosage strengths and/or packaging sizes" after the public health emergency ends.
"This waiver proved particularly helpful during the pandemic, as it allowed 503B compounders to quickly and seamlessly fill capacity gaps and alleviate spot shortages before they became severe enough to spread nationwide and make it onto the FDA drug shortage list," Premier said.
The group purchaser also suggested the FDA should stop requiring hospital compounding to take place within one mile of a facility, arguing that a time-based standard makes more sense. According to Premier, the change would allow hospitals to combine pharmacy services and run more efficiently by conserving personal protective equipment, maximizing pharmacy staff and reducing medication errors.
DEA should scrap its controlled substance quota system, Premier said. Instead of basing quotas on weight, it should base quotas on dosage form and differentiate "between injectables and solid oral dosage forms," the group purchasing organization said. Those changes could better align drug control policy with how drugs are manufactured and distributed.
The COVID-19 pandemic created a natural experiment for regulatory relief and reform. Now providers, insurers, suppliers and other industry stakeholders want to make some of those changes permanent, including telehealth expansion and expanded scopes of practice.
Only 503B pharmacies can manufacture pharmacy products for medical offices, clinics and hospitals.