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FL H7077

Bill

Status

Passed

6/13/2014

Primary Sponsor

Health and Human Services Committee

Click for details

Origin

House of Representatives

2014 Regular Session

AI Summary

  • Nonresident pharmacies and outsourcing facilities must obtain a nonresident sterile compounding permit from the Board of Pharmacy to ship, mail, deliver, or dispense compounded sterile products into Florida, with applications requiring a nonrefundable fee and biennial renewal
  • Applicants must submit proof of registration, sterile compounding policies compliant with USP Chapter 797 standards, a current inspection report, and written attestations from an owner/officer and pharmacist in charge confirming compliance with Florida's sterile compounding laws
  • Nonresident pharmacies already shipping compounded sterile products into Florida as of the effective date must obtain a permit by February 28, 2015; those registering on or after October 1, 2014, may not ship such products until both nonresident pharmacy registration and the sterile compounding permit are issued
  • The Board of Pharmacy may deny, revoke, or suspend a nonresident pharmacy's registration or permit, or impose fines or reprimands, for conduct causing or potentially causing serious bodily injury to humans or nonhuman animals, without first referring the matter to the pharmacy's home state
  • The Department of Health is authorized to inspect nonresident pharmacies and sterile compounding permittees, with all inspection costs borne by the pharmacy or permittee; the act took effect October 1, 2014

Legislative Description

Nonresident Sterile Compounding Permits

Last Action

Chapter No. 2014-148

6/13/2014

Committee Referrals

Health Policy4/22/2014
Health And Human Services3/24/2014
Health Care Appropriations Subcommittee3/11/2014

Full Bill Text

No bill text available