(1) Duly authorized agents and employees of the department may inspect in a lawful manner at all reasonable hours any pharmacy, hospital, clinic, wholesale establishment, manufacturer, physician’s office, or any other place in the state in which drugs and medical supplies are compounded, manufactured, packed, packaged, made, stored, sold, offered for sale, exposed for sale, or kept for sale for the purpose of:
(a) Determining if any provision of this chapter or any rule adopted under its authority is being violated;
(b) Securing samples or specimens of any drug or medical supply after paying or offering to pay for such sample or specimen; or
(c) Securing such other evidence as may be needed for prosecution under this chapter.
1(2) Duly authorized agents and employees of the department may inspect a nonresident pharmacy registered under s. 465.0156 or a nonresident sterile compounding permittee under s. 465.0158 pursuant to this section. The costs of such inspections shall be borne by such pharmacy or permittee.
(3) Except as permitted by this chapter, and chapters 406, 409, 456, 499, and 893, records maintained in a pharmacy relating to the filling of prescriptions and the dispensing of medicinal drugs may be furnished only to the patient for whom the drugs were dispensed, or her or his legal representative, or to the department pursuant to existing law, or, if the patient is incapacitated or unable to request such records, her or his spouse except upon the written authorization of such patient.
(a) Such records may be furnished in any civil or criminal proceeding, upon the issuance of a subpoena from a court of competent jurisdiction and proper notice to the patient or her or his legal representative by the party seeking such records.
(b) The board shall adopt rules establishing practice guidelines for pharmacies to dispose of records maintained in a pharmacy relating to the filling of prescriptions and the dispensing of medicinal drugs. Such rules must be consistent with the duty to preserve the confidentiality of such records in accordance with applicable state and federal law.
History.—ss. 1, 7, ch. 79-226; ss. 2, 3, ch. 81-318; ss. 1, 2, ch. 85-151; ss. 26, 27, ch. 86-256; s. 59, ch. 91-137; s. 6, ch. 91-156; s. 4, ch. 91-429; s. 125, ch. 94-218; s. 245, ch. 97-103; s. 127, ch. 2000-160; s. 1, ch. 2003-166; s. 4, ch. 2014-148; s. 3, ch. 2019-99.
1Note.—Section 11, ch. 2019-99, which was codified as s. 499.02851, provides in part that “[i]mplementation of sections 2 through 10 of this act is contingent upon authorization granted under federal law, rule, or approval.” If the contingency occurs, subsection (2), as amended by s. 3, ch. 2019-99, will read:
(2) Duly authorized agents and employees of the department may inspect a nonresident pharmacy registered under s. 465.0156, an international export pharmacy permittee under s. 465.0157, or a nonresident sterile compounding permittee under s. 465.0158 pursuant to this section. The costs of such inspections shall be borne by such pharmacy or permittee.