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The Florida Senate

2011 Florida Statutes

Title XXXII REGULATION OF PROFESSIONS AND OCCUPATIONS
Chapter 465 PHARMACY Entire Chapter
SECTION 0276
Dispensing practitioner.
F.S. 465.0276
1465.0276 Dispensing practitioner.—
(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 (5).
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. The amount dispensed pursuant to the subparagraph may not exceed a 14-day supply. This exception 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. For purposes of this subparagraph, the term “surgical procedure” means any procedure in any setting which involves, or reasonably should involve:
a. 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
b. 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.
(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.
(3) The department shall inspect any facility where a practitioner dispenses medicinal drugs pursuant to subsection (2) in the same manner and with the same frequency as it inspects pharmacies for the purpose of determining whether the practitioner is in compliance with all statutes and rules applicable to her or his dispensing practice.
(4) 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.
(5) 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.
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.
1Note.—Section 28, ch. 2011-141, provides that:

“(1) DISPOSITION OF CONTROLLED SUBSTANCES.—

“(a) Within 10 days after the effective date of this act, each physician licensed under chapter 458, chapter 459, chapter 461, or chapter 466, Florida Statutes, unless he or she meets one of the exceptions for physician who dispenses under s. 465.0276, Florida Statutes, shall ensure that the undispensed inventory of controlled substances listed in Schedule II or Schedule III as provided in s. 893.03, Florida Statutes, purchased under the physician’s Drug Enforcement Administration number for dispensing is:

“1. Returned in compliance with the laws and rules adopted under chapter 499, Florida Statutes, to the wholesale distributor, as defined in s. 499.003, Florida Statutes, which distributed the controlled substances to the physician; or

“2. Turned in to local law enforcement agencies and abandoned.

“(b) Wholesale distributors shall buy back the undispensed inventory of controlled substances listed in Schedule II or Schedule III as provided in s. 893.03, Florida Statutes, which are in the manufacturer’s original packing, unopened, and in date, in accordance with the established policies of the wholesale distributor or the contractual terms between the wholesale distributor and the physician concerning returns.

“(2) PUBLIC HEALTH EMERGENCY.—

“(a) The Legislature finds that:

“1. Prescription drug overdose has been declared a public health epidemic by the United States Centers for Disease Control and Prevention.

“2. Prescription drug abuse results in an average of seven deaths in this state each day.

“3. Physicians in this state purchased more than 85 percent of the oxycodone purchased by all practitioners in the United States in 2006.

“4. Physicians in this state purchased more than 93 percent of the methadone purchased by all practitioners in the United States in 2006.

“5. Some physicians in this state dispense medically unjustifiable amounts of controlled substances to addicts and to people who intend to illegally sell the drugs.

“6. Physicians in this state who have purchased large quantities of controlled substances may have significant inventory 30 days after the effective date of this act.

“7. Thirty days after the effective date of this act, the only legal method for a dispensing practitioner to sell or otherwise transfer controlled substances listed in Schedule II or Schedule III as provided in s. 893.03, Florida Statutes, purchased for dispensing, is through the abandonment procedures of subsection (1) or as authorized under s. 465.0276, Florida Statutes.

“8. It is likely that the same physicians who purchase and dispense medically unjustifiable amounts of drugs will not legally dispose of the remaining inventory.

“9. The actions of such dispensing practitioners may result in substantial injury to the public health.

“(b) Immediately upon the effective date of this act, the State Health Officer shall declare a public health emergency pursuant to s. 381.00315, Florida Statutes. Pursuant to that declaration, the Department of Health, the Attorney General, the Department of Law Enforcement, and local law enforcement agencies shall take the following actions:

“1. Within 2 days after the effective date of this act, in consultation with wholesale distributors as defined in s. 499.003, Florida Statutes, the Department of Health shall identify dispensing practitioners who purchased more than an average of 2,000 unit doses of controlled substances listed in Schedule II or Schedule III as provided in s. 893.03, Florida Statutes, per month in the previous 6 months, and shall identify the dispensing practitioners in that group who pose the greatest threat to the public health based on an assessment of:

“a. The risk of noncompliance with subsection (1).

“b. The purchase amounts.

“c. The manner of medical practice.

“d. Any other factor set by the State Health Officer.

“The Attorney General shall consult and coordinate with federal law enforcement agencies. The Department of Law Enforcement shall coordinate the efforts of local law enforcement agencies.

“2. On the 3rd day after the effective date of this act, the Department of Law Enforcement or local law enforcement agencies shall enter the business premises of the dispensing practitioners identified as posing the greatest threat to public health and quarantine any inventory of controlled substances listed in Schedule II or Schedule III as provided in s. 893.03, Florida Statutes, of such dispensing practitioners on site.

“3. The Department of Law Enforcement or local law enforcement agencies shall ensure the security of such inventory 24 hours a day until the inventory is seized as contraband or deemed to be lawfully possessed for dispensing by the physician in accordance with s. 465.0276, Florida Statutes.

“4. On the 31st day after the effective date of this act, any remaining inventory of controlled substances listed in Schedule II or Schedule III as provided in s. 893.03, Florida Statutes, purchased for dispensing by practitioners is deemed contraband under s. 893.12, Florida Statutes. The Department of Law Enforcement or local law enforcement agencies shall seize the inventory and comply with the provisions of s. 893.12, Florida Statutes, to destroy it.

“(c) In order to implement this subsection, the sum of $3 million of nonrecurring funds from the General Revenue Fund is appropriated to the Department of Law Enforcement for the 22010-2011 fiscal year. The Department of Law Enforcement shall expend the appropriation by reimbursing local law enforcement agencies for the overtime-hour costs associated with securing the quarantined controlled substance inventory as provided in paragraph (b) and activities related to investigation and prosecution of crimes related to prescribed controlled substances. If requests for reimbursement exceed the amount appropriated, the reimbursements shall be prorated by the hours of overtime per requesting agency at a maximum of one law enforcement officer per quarantine site.

“(3) REPEAL.—This section expires January 1, 2013.”

2Note.—The reference to the 2010-2011 fiscal year appropriation was erroneous; the apparent intent was to reference the 2011-2012 fiscal year as appropriations cannot be made for past fiscal years.