Establishes rules for the sale, transfer, and distribution of compounded drugs in Florida.

This bill creates section 465.1903 in Florida Statutes to define "bulk drug substance" or "active pharmaceutical ingredient" and outlines requirements for the sale, transfer, and distribution of compounded drugs. It mandates that the bulk drug substance must be reviewed as part of a new drug application approved by the FDA, accompanied by a valid certificate of analysis, and verified to be free of impurities. It also requires quality control testing before use and proof that the manufacturing facility is registered with the FDA.

Establishes rules for the sale, transfer, and distribution of compounded drugs in Florida.

This bill creates section 465.1903 in Florida Statutes to define "bulk drug substance" or "active pharmaceutical ingredient" and outlines requirements for the sale, transfer, and distribution of compounded drugs. It mandates that the bulk drug substance must be reviewed as part of a new drug application approved by the FDA, accompanied by a valid certificate of analysis, and verified to be free of impurities. It also requires quality control testing before use and proof that the manufacturing facility is registered with the FDA.