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FL S0662
Bill
Status
1/16/2014
Primary Sponsor
Appropriations
Click for details
AI Summary
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Requires registered nonresident pharmacies and outsourcing facilities to obtain a nonresident sterile compounding permit to ship, mail, deliver, or dispense compounded sterile products into Florida, effective October 1, 2014.
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Nonresident pharmacies already registered must obtain a permit by February 28, 2015, while those registering on or after October 1, 2014 must obtain a permit before shipping any compounded sterile products into the state.
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Applicants must submit proof of registration, written attestations regarding compliance with Florida's sterile compounding standards, current inspection reports (within 6 months for initial permit, 1 year for renewal), and existing compounding policies and procedures.
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Authorizes the Florida Department of Health to inspect nonresident pharmacies and permittees, with all inspection costs borne by the facility being inspected; permits the board to deny, revoke, or suspend permits for violations of Florida compounding standards or other regulatory violations.
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Defines key terms including "compounding," "outsourcing facility," and "compounded sterile product"; expands penalty provisions to include injury to nonhuman animals and subjects nonresident pharmacies to healthcare fraud provisions.
Legislative Description
Nonresident Sterile Compounding Permits
Last Action
Laid on Table, companion bill(s) passed, see CS/HB 7077 (Ch. 2014-148)
4/29/2014