(1)(a) A person may not dispense medicinal drugs unless licensed as a pharmacist or otherwise authorized under this chapter to do so, except that a practitioner authorized by law to prescribe drugs may dispense such drugs to her or his patients in the regular course of her or his practice in compliance with this section.
(b) A practitioner registered under this section may not dispense a controlled substance listed in Schedule II or Schedule III as provided in s. 893.03. This paragraph does not apply to:
1. The dispensing of complimentary packages of medicinal drugs which are labeled as a drug sample or complimentary drug as defined in s. 499.028 to the practitioner’s own patients in the regular course of her or his practice without the payment of a fee or remuneration of any kind, whether direct or indirect, as provided in subsection (4).
2. The dispensing of controlled substances in the health care system of the Department of Corrections.
3. The dispensing of a controlled substance listed in Schedule II or Schedule III in connection with the performance of a surgical procedure.
a. For an opioid drug listed as a Schedule II controlled substance in s. 893.03 or 21 U.S.C. s. 812:
(I) For the treatment of acute pain, the amount dispensed pursuant to this subparagraph may not exceed a 3-day supply, or a 7-day supply if the criteria in s. 456.44(5)(a) are met.
(II) For the treatment of pain other than acute pain, a practitioner must indicate “NONACUTE PAIN” on a prescription.
(III) For the treatment of pain related to a traumatic injury with an Injury Severity Score of 9 or greater, a practitioner must concurrently prescribe an emergency opioid antagonist, as defined in s. 381.887(1).
b. For a controlled substance listed in Schedule III, the amount dispensed pursuant to this subparagraph may not exceed a 14-day supply.
c. The exception in this subparagraph does not allow for the dispensing of a controlled substance listed in Schedule II or Schedule III more than 14 days after the performance of the surgical procedure.
d. For purposes of this subparagraph, the term “surgical procedure” means any procedure in any setting which involves, or reasonably should involve:
(I) Perioperative medication and sedation that allows the patient to tolerate unpleasant procedures while maintaining adequate cardiorespiratory function and the ability to respond purposefully to verbal or tactile stimulation and makes intra- and postoperative monitoring necessary; or
(II) The use of general anesthesia or major conduction anesthesia and preoperative sedation.
4. The dispensing of a controlled substance listed in Schedule II or Schedule III pursuant to an approved clinical trial. For purposes of this subparagraph, the term “approved clinical trial” means a clinical research study or clinical investigation that, in whole or in part, is state or federally funded or is conducted under an investigational new drug application that is reviewed by the United States Food and Drug Administration.
5. The dispensing of methadone in a facility licensed under s. 397.427 where medication-assisted treatment for opiate addiction is provided.
6. The dispensing of a controlled substance listed in Schedule II or Schedule III to a patient of a facility licensed under part IV of chapter 400.
7. The dispensing of controlled substances listed in Schedule II or Schedule III which have been approved by the United States Food and Drug Administration for the purpose of treating opiate addictions, including, but not limited to, buprenorphine and buprenorphine combination products, by a practitioner authorized under 21 U.S.C. s. 823, as amended, to the practitioner’s own patients for the medication-assisted treatment of opiate addiction.
(2) A practitioner who dispenses medicinal drugs for human consumption for fee or remuneration of any kind, whether direct or indirect, must:
(a) Register with her or his professional licensing board as a dispensing practitioner and pay a fee not to exceed $100 at the time of such registration and upon each renewal of her or his license. Each appropriate board shall establish such fee by rule.
(b) Comply with and be subject to all laws and rules applicable to pharmacists and pharmacies, including, but not limited to, this chapter and chapters 499 and 893 and all federal laws and federal regulations.
(c) Before dispensing any drug, give the patient a written prescription and orally or in writing advise the patient that the prescription may be filled in the practitioner’s office or at any pharmacy.
(d)1. Before dispensing a controlled substance to a person not known to the dispenser, require the person purchasing, receiving, or otherwise acquiring the controlled substance to present valid photographic identification or other verification of his or her identity. If the person does not have proper identification, the dispenser may verify the validity of the prescription and the identity of the patient with the prescriber or his or her authorized agent. Verification of health plan eligibility through a real-time inquiry or adjudication system is considered to be proper identification.
2. This paragraph does not apply in an institutional setting or to a long-term care facility, including, but not limited to, an assisted living facility or a hospital to which patients are admitted.
3. As used in this paragraph, the term “proper identification” means an identification that is issued by a state or the Federal Government containing the person’s photograph, printed name, and signature or a document considered acceptable under 8 C.F.R. s. 274a.2(b)(1)(v)(A) and (B).
(3) The registration of any practitioner who has been found by her or his respective board to have dispensed medicinal drugs in violation of this chapter shall be subject to suspension or revocation.
(4) A practitioner who confines her or his activities to the dispensing of complimentary packages of medicinal drugs to the practitioner’s own patients in the regular course of her or his practice, without the payment of fee or remuneration of any kind, whether direct or indirect, and who herself or himself dispenses such drugs is not required to register pursuant to this section. The practitioner must dispense such drugs in the manufacturer’s labeled package with the practitioner’s name, patient’s name, and date dispensed, or, if such drugs are not dispensed in the manufacturer’s labeled package, they must be dispensed in a container which bears the following information:
(a) Practitioner’s name;
(b) Patient’s name;
(c) Date dispensed;
(d) Name and strength of drug; and
(e) Directions for use.
(5) This chapter and the rules adopted thereunder do not prohibit a veterinarian licensed under chapter 474 from administering a compounded drug to a patient, as defined in s. 474.202, or dispensing a compounded drug to the patient’s owner or caretaker. This subsection does not affect the regulation of the practice of pharmacy as set forth in this chapter.
History.—ss. 20, 27, ch. 86-256; s. 1, ch. 88-159; s. 59, ch. 91-137; s. 6, ch. 91-156; s. 4, ch. 91-429; s. 95, ch. 92-149; s. 248, ch. 97-103; s. 11, ch. 2010-211; s. 15, ch. 2011-141; s. 1, ch. 2015-127; s. 21, ch. 2016-105; s. 25, ch. 2016-230; s. 7, ch. 2018-13.
