Florida checks
Florida permits for compounded injections
Compounded medicine is made to order. Sterile means free of living germs. For injections, ask about the sterile-work permit as well as the pharmacy’s main permit.
A permit for making germ-free medicines
In Florida, making sterile medicine generally needs an extra pharmacy permit.
It is called a Special Sterile Compounding Permit.
It has its own number, separate from the main pharmacy permit.
A pharmacy may skip this extra permit only if all its sterile medicine meets the ‘immediate-use’ exception. This means medicine prepared for prompt use under the required pharmacy standards.
Ask for the extra permit number when shots are being sent to you. If the pharmacy claims an exception, ask how its work meets the immediate-use standards.
When it comes from another state
A registered pharmacy outside Florida needs another permit to send sterile compounded medicine here.
That is Florida’s nonresident sterile compounding permit.
The same rule covers outsourcing facilities, which make batches of sterile medicine.
For a first application, Florida requires an inspection report from the past six months. For renewal, the report must be from the past year.
Without that report, Florida’s health department must inspect the place or accept a report from an approved inspector or FDA.
FDA is the US medicine review agency.
What else to ask
Registering with FDA puts the batch-making facility in FDA’s records. It does not mean FDA approves the facility or its made-to-order products.
Poor compounding can leave germs in medicine. It can also leave an incorrect amount of the active ingredient, the part responsible for the medicine’s effect.
Ask for the permit number that covers sterile work. Ask how to reach the pharmacist about the medicine you receive.