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Description:
IMPORTANT: New Legislation in Florida Effectively Stops GLP-1 Compounding.

SB860 directly undermines the FDA’s decisions related to GLP-1 compounding. It only targets weight loss medication and leaves other compounding untouched.

Here is how.

1. Prohibits compounding of weight loss medications unless the entity provides documentation certifying:
2. Requires an identical API to the FDA approved version
3. API must be manufactured according to the same manufacturing process as specified on the label of the FDA approved drug.
4. API must have a certificate of analysis that ALSO provides informational material on the safety and effectiveness of the drugs compounded using the API. (It is unclear how this is possible given it’s in conflict with compounded medication not being FDA approved.)
5. CoA must also include information on impurities, including identifying every impurity.

6. API must be manufactured in a facility that:
- Was FDA inspected in the last 2 years
- Has GCMP compliance.
- Inspection resulted in “Voluntary Action Indicated” or “No Action Indicated” classification.

This undermines the work the FDA did creating the greenlist for GLP-1 API manufacturers. It also ignores that in 2024 the FDA reported a backlog of 2,000 inspections it was behind on. This was all before the significant layoffs at the FDA this year.

Enforcement:
$1,000 fine per prescription
Potential revocation of licenses

This law takes immediate effect giving no path for compounding pharmacies in Florida to comply.