FL H0877

Creates s. 465.1903, F.S., regulating the sale, transfer, and distribution of compounded drugs made under federal Section 503A, requiring bulk drug substances to meet USP/National Formulary standards, be FDA-approved components, or appear on the FDA's approved list

Requires compounders to verify bulk drug substances are pharmaceutical grade, accompanied by valid certificates of analysis identifying impurities and country of manufacture, and to conduct quality control testing before use

Manufacturing facilities must be FDA-registered and have undergone FDA inspection within the previous 2 years with a classification of "Voluntary Action Indicated" or "No Action Indicated"

Violations subject to $1,000 fine per dose of illegally compounded drug sold and potential revocation of pharmacy or facility license

Records related to bulk drug substance acquisition, examination, and testing must be maintained for at least 2 years after expiration of the last drug lot and furnished to the Board of Pharmacy within 1 business day upon request