Previously, the drug was marked as available but stayed on the shortage list.
It is now considered resolved.
Traditional pharmacies have 60 days, and outsourcing facilities have 90 days to transition patients to an FDA-approved drug.
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TheASHP liststill marks both semaglutide and tirzepatide injections as being in shortage.
The agency may soon determine the shortage is resolved and remove the drug from the list entirely.
Patients may experience variability at a particular pharmacy location regardless of whether a drug is in shortage.
The FDA usually updates its drug shortage list based on reports from pharmaceutical companies about their supply.
There are two types of compounding pharmacies: 503A and 503B.
503A compounding pharmacies work like traditional pharmacies.
503B outsourcing facilities operate on a large scale, creating compounded drugs to distribute to traditional pharmacies.
Days after the lawsuit was filed, the FDA said it would reconsider the status change.
The GLP-1 Drug Shortage Is Not Like Others
Drug shortages are not uncommon in the U.S.
There are nearly 300 drugs in shortage currently, most of which are older generic drugs.
ASHP publishes a drug shortage list independent of the FDA.
If the shortage is confirmed, it is listed on the ASHP website.
Ganio said that most drug shortages are because of disruptions in supply.
The tirzepatide and semaglutide shortages are different because they are demand-driven.
There is no good metric to understand demand.
There are data repositories to track insurance claims for FDA-approved drug prescriptions.
But insurance plans usually dont reimburse for compounded drugs.
Theyve got a prescription now that can no longer be filled, Brunner said.
An interruption of that therapy could have health consequences for those patients.
Several telehealth companiesuse that price difference to market their compounded tirzepatide and semaglutide to consumers.
Many insurance policies dont cover the cost of tirzepatide and semaglutide.
But compounders ability to do that has a shelf life, Brunner said.
Food and Drug Administration.FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize.
Food and Drug Administration.Compounding inspections and oversight frequently asked questions.
