FL HB 1037

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Description

Outsourcing Facilities; Requires outsourcing facilities apply to DOH, using form prescribed by Board of Pharmacy, to obtain permit before engaging in specified activities; requires department to issue outsourcing facility permits to applicants board certifies as meeting certain criteria; requires that initial application for permit include specified documentation; requires board to review such documentation & consider certain actions of applicant outsourcing facility; prohibits department from issuing permit to outsourcing facility; provides that certain outsourcing facilities are only required to obtain outsourcing facility permit; requires outsourcing facilities to obtain additional applicable permits if they engage in certain activities; provides applicability; provides that outsourcing facilities holding valid outsourcing permit issued before specified date are deemed to be in compliance with certain permitting requirements; authorizes such facilities to continue operating under such permit until certain condition occurs; requires board & department to rely on & recognize certain federal inspection reports as satisfying state inspection requirements for purposes of initial permitting & subsequent renewals; authorizes department to conduct inspections; provides that board is sole state regulatory authority responsible for permitting, oversight, & discipline of outsourcing facilities; exempts permitted outsourcing facilities from separate licensure or permitting requirements under Florida Drug & Cosmetic Act for engaging in specified activities; requires board to adopt rules; exempts permitted outsourcing facilities from applicability of Florida Drug & Cosmetic Act.