465.003 Definitions.—As used in this chapter, the term:
(1) “Acute and postacute hospital care at home” means acute and postacute health care services provided in a clinically qualified patient’s permanent residence, as defined in s. 196.012(17), through a program approved by the Centers for Medicare and Medicaid Services and the Agency for Health Care Administration.
(2) “Administration” means the obtaining and giving of a single dose of medicinal drugs by a legally authorized person to a patient for her or his consumption.
(3) “Automated pharmacy system” means a mechanical system that delivers prescription drugs received from a Florida licensed pharmacy and maintains related transaction information.
(4) “Board” means the Board of Pharmacy.
(5) “Central distribution facility” means a facility under common control with a hospital holding a Class III institutional pharmacy permit that may dispense, distribute, compound, or fill prescriptions for medicinal drugs; prepare prepackaged drug products; and conduct other pharmaceutical services.
(6) “Centralized prescription filling” means the filling of a prescription by one pharmacy upon request by another pharmacy to fill or refill the prescription. The term includes the performance by one pharmacy for another pharmacy of other pharmacy duties such as drug utilization review, therapeutic drug utilization review, claims adjudication, and the obtaining of refill authorizations.
(7) “Common control” means the power to direct or cause the direction of the management and policies of a person or an organization, whether by ownership of stock, voting rights, contract, or otherwise.
(8) “Compounded sterile product” means a drug that is intended for parenteral administration, an ophthalmic or oral inhalation drug in aqueous format, or a drug or product that is required to be sterile under federal or state law or rule, which is produced through compounding, but is not approved by the United States Food and Drug Administration.
(9) “Compounding” means combining, mixing, or altering the ingredients of one or more drugs or products to create another drug or product.
(10) “Consultant pharmacist” means a pharmacist licensed by the department and certified as a consultant pharmacist pursuant to s. 465.0125.
(11) “Data communication device” means an electronic device that receives electronic information from one source and transmits or routes it to another, including, but not limited to, any such bridge, router, switch, or gateway.
(12) “Department” means the Department of Health.
(13) “Dispense” means the transfer of possession of one or more doses of a medicinal drug by a pharmacist to the ultimate consumer or her or his agent. As an element of dispensing, the pharmacist shall, prior to the actual physical transfer, interpret and assess the prescription order for potential adverse reactions, interactions, and dosage regimen she or he deems appropriate in the exercise of her or his professional judgment, and the pharmacist shall certify that the medicinal drug called for by the prescription is ready for transfer. The pharmacist shall also provide counseling on proper drug usage, either orally or in writing, if in the exercise of her or his professional judgment counseling is necessary. The actual sales transaction and delivery of such drug shall not be considered dispensing. The administration shall not be considered dispensing.
(14) “Institutional formulary system” means a method whereby the medical staff evaluates, appraises, and selects those medicinal drugs or proprietary preparations which in the medical staff’s clinical judgment are most useful in patient care, and which are available for dispensing by a practicing pharmacist in a Class II or Class III institutional pharmacy.
(15) “Medicinal drugs” or “drugs” means those substances or preparations commonly known as “prescription” or “legend” drugs which are required by federal or state law to be dispensed only on a prescription, but shall not include patents or proprietary preparations as hereafter defined.
(16) “Nuclear pharmacist” means a pharmacist licensed by the department and certified as a nuclear pharmacist pursuant to s. 465.0126.
(17) “Outsourcing facility” means a single physical location registered as an outsourcing facility under the federal Drug Quality and Security Act, Pub. L. No. 113-54, at which sterile compounding of a drug or product is conducted.
(18) “Patent or proprietary preparation” means a medicine in its unbroken, original package which is sold to the public by, or under the authority of, the manufacturer or primary distributor thereof and which is not misbranded under the provisions of the Florida Drug and Cosmetic Act.
(19) “Pharmacist” means any person licensed pursuant to this chapter to practice the profession of pharmacy.
(20)(a) “Pharmacy” includes a community pharmacy, an institutional pharmacy, a nuclear pharmacy, a special pharmacy, and an Internet pharmacy.
1. The term “community pharmacy” includes every location where medicinal drugs are compounded, dispensed, stored, or sold or where prescriptions are filled or dispensed on an outpatient basis.
2. The term “institutional pharmacy” includes every location in a hospital, clinic, nursing home, dispensary, sanitarium, extended care facility, or other facility, hereinafter referred to as “health care institutions,” where medicinal drugs are compounded, dispensed, stored, or sold.
3. The term “nuclear pharmacy” includes every location where radioactive drugs and chemicals within the classification of medicinal drugs are compounded, dispensed, stored, or sold. The term “nuclear pharmacy” does not include hospitals licensed under chapter 395 or the nuclear medicine facilities of such hospitals.
4. The term “special pharmacy” includes every location where medicinal drugs are compounded, dispensed, stored, or sold if such locations are not otherwise defined in this subsection.
5. The term “Internet pharmacy” includes locations not otherwise licensed or issued a permit under this chapter, within or outside this state, which use the Internet to communicate with or obtain information from consumers in this state and use such communication or information to fill or refill prescriptions or to dispense, distribute, or otherwise engage in the practice of pharmacy in this state. Any act described in this definition constitutes the practice of the profession of pharmacy.
(b) The pharmacy department of any permittee shall be considered closed whenever a Florida licensed pharmacist is not present and on duty. The term “not present and on duty” shall not be construed to prevent a pharmacist from exiting the prescription department for the purposes of consulting or responding to inquiries or providing assistance to patients or customers, attending to personal hygiene needs, or performing any other function for which the pharmacist is responsible, provided that such activities are conducted in a manner consistent with the pharmacist’s responsibility to provide pharmacy services.
(21) “Pharmacy intern” means a person who is currently registered in, and attending, a duly accredited college or school of pharmacy, or who is a graduate of such a school or college of pharmacy, and who is duly and properly registered with the department as provided for under its rules.
(22) “Practice of the profession of pharmacy” includes compounding, dispensing, and consulting concerning contents, therapeutic values, and uses of any medicinal drug; consulting concerning therapeutic values and interactions of patent or proprietary preparations, whether pursuant to prescriptions or in the absence and entirely independent of such prescriptions or orders; and conducting other pharmaceutical services. For purposes of this subsection, the term “other pharmaceutical services” means monitoring the patient’s drug therapy and assisting the patient in the management of his or her drug therapy, and includes reviewing, and making recommendations regarding, the patient’s drug therapy and health care status in communication with the patient’s prescribing health care provider as licensed under chapter 458, chapter 459, chapter 461, or chapter 466, or a similar statutory provision in another jurisdiction, or such provider’s agent or such other persons as specifically authorized by the patient; and initiating, modifying, or discontinuing drug therapy for a chronic health condition under a collaborative pharmacy practice agreement. This subsection may not be interpreted to permit an alteration of a prescriber’s directions, the diagnosis or treatment of any disease, the initiation of any drug therapy, the practice of medicine, or the practice of osteopathic medicine, unless otherwise permitted by law or specifically authorized by s. 465.1865 or s. 465.1895. The term “practice of the profession of pharmacy” also includes any other act, service, operation, research, or transaction incidental to, or forming a part of, any of the foregoing acts, requiring, involving, or employing the science or art of any branch of the pharmaceutical profession, study, or training, and shall expressly permit a pharmacist to transmit information from persons authorized to prescribe medicinal drugs to their patients. The practice of the profession of pharmacy also includes the administration of vaccines to adults pursuant to s. 465.189; the testing or screening for and treatment of minor, nonchronic health conditions pursuant to s. 465.1895; and the preparation of prepackaged drug products in facilities holding Class III institutional pharmacy permits. The term also includes the ordering and evaluating of any laboratory or clinical testing; conducting patient assessments; and modifying, discontinuing, or administering medicinal drugs pursuant to s. 465.0125 by a consultant pharmacist.
(23) “Prescription” includes any order for drugs or medicinal supplies written or transmitted by any means of communication by a duly licensed practitioner authorized by the laws of the state to prescribe such drugs or medicinal supplies and intended to be dispensed by a pharmacist. The term also includes an orally transmitted order by the lawfully designated agent of such practitioner. The term also includes an order written or transmitted by a practitioner licensed to practice in a jurisdiction other than this state, but only if the pharmacist called upon to dispense such order determines, in the exercise of her or his professional judgment, that the order is valid and necessary for the treatment of a chronic or recurrent illness. The term “prescription” also includes a pharmacist’s order for a product selected from the formulary created pursuant to s. 465.186. Prescriptions may be retained in written form or the pharmacist may cause them to be recorded in a data processing system, provided that such order can be produced in printed form upon lawful request.
Cited 13 times | Published | Florida 2nd District Court of Appeal | 2005 WL 291948
...Florida law specifically recognizes the practice of prescribing medicine by telephone, including the telephonic issuing of prescriptions by a physician's staff. Included in the statutory definition of prescription is "an orally transmitted order by the lawfully designated agent of [the prescribing] practitioner." § 465.003(14)....
Cited 13 times | Published | Florida 2nd District Court of Appeal | 2008 WL 899280
...tionalized setting such as a nursing home. § 465.0125(1), Fla. Stat. (2001). The Pharmacy Act defines a "Consultant Pharmacist" as a pharmacist licensed by the Department of Health and "certified as a consultant pharmacist pursuant to s. 465.0125." § 465.003(3), Fla....
...st's responsibilities. Such laboratory and clinical testing may be ordered only with regard to patients residing in a nursing home facility, and then only when authorized by the medical director of the nursing home facility. § 465.0125(1). Further, section 465.003(13) mandates that "nothing in this subsection may be interpreted to permit an alteration of a prescriber's directions, the diagnosis or treatment of any disease, the initiation of any drug therapy, the practice of medicine, or the pra...
...macist's role beyond that of an administrative advisor. Again, the Pharmacy Act specifically restricts a pharmacist from altering a prescriber's directions, diagnosing or treating any disease, initiating any drug therapy, or practicing medicine. See § 465.003(13), Fla....
...The court did not describe what those circumstances might be. We are unable to distinguish the facts in McLeod or Pysz from the instant case. The appellant argued that a 1986 amendment to the definition of "dispense" in the Florida Pharmacy Act, codified at section 465.003(5), Florida Statutes (Supp.1986), [2] created a duty and private cause of action and that McLeod is no longer applicable....
...The pharmacist shall also provide counseling on proper drug usage, either orally or in writing, if in the exercise of his professional judgment counseling is necessary. Id. The interpretation of this language is apparently of first impression in this state; therefore, we must determine whether section 465.003(5) in the pharmaceutical regulatory statute creates a cause of action....
...reate a private remedy against a qualifying agent. Id. Likewise, the legislative history in the instant case is devoid of any indication that the Legislature intended to create a private cause of action under these circumstances, and the language of section 465.003(5) was adopted within the regulatory scheme for pharmacists....
Cited 6 times | Published | Florida 2nd District Court of Appeal | 2007 WL 2713539
...tion 499.003(25). That statute, in turn, defines "legend drug" as "any drug, including, but not limited to, finished dosage forms, or active ingredients subject to, defined by, or described by s. 503(b) of the Federal Food, Drug, and Cosmetic Act or s. 465.003(8), s. 499.007(12), or s. 499.0122(1)(b) or (c)." Of those listed statutes, section 465.003(8), Florida Statutes (2004), provides the simplest definition: "legend drugs" are drugs that are "required by federal or state law to be dispensed only on a prescription." Section 893.04(1) states that a pharmacist may dispense a "con...
...definitional subsection to which it refers, section 499.003(25), address topics other than criminal drug possession or drug trafficking. For example, *842 the State dismisses the possibility that the statute we discussed in the preceding paragraph, section 465.003(8), could have any bearing here because chapter 465 deals with the regulation of pharmacists....
Cited 6 times | Published | Florida 4th District Court of Appeal | 2005 WL 1278930
...Although the Florida pharmaceutical regulatory statutes and administrative codes do not create a private cause of action against pharmacists, see Johnson v. Walgreen Co., 675 So.2d 1036, 1038 (Fla. 1st DCA 1996), they do describe the duties of Florida pharmacists. According to § 465.003(6), Fla....
...ry duty. The Florida Statutes and Florida Administrative Code require a pharmacist to provide patient counseling and any information that is necessary in the pharmacist's professional judgment. See Fla. Admin. Code R. 64B16-27.820(1)(d), (e) (2006); § 465.003(6), Fla....
Cited 3 times | Published | Florida 3rd District Court of Appeal
...on. Reversed. NOTES [1] A community pharmacy is defined as including every store, shop, office, etc. or other place "where medicinal drugs are compounded, dispensed, or sold or where prescriptions are filled or dispensed on an outpatient basis." See § 465.003(3)(a), Fla....
...state pharmaceutical laws are instructive. Specifically, the use of the term “lawfully obtained” in the statute can be read as authorizing possession to only those individuals who have a legally recognized reason for the possession. Pursuant to section 465.003(6), Florida Statutes (2008), pharmacies may lawfully dispense medications to a consumer or his or her agent....
...for the unique needs of an individual patient”). . See Florida Pharmacy Act, Fla. Stat. §§ 465.001 et seq. (creating the Florida Board of Pharmacy and conferring upon the Board the duty to regulate the practice of pharmacy within the state); id. § 465.003(13) (" ‘Practice of the profession of pharmacy’ includes compounding, dispensing, and consulting concerning contents, therapeutic values, and uses of any medicinal drug ....”) (emphasis added)....
...Ctr., 536 F.3d at 397 (footnotes converted to text). . See Florida Pharmacy Act, Fla. Stat. §§ 465.001 et seq. (creating the Florida Board of Pharmacy and conferring upon the Board the duty to regulate the practice of pharmacy within the state); id. § 465.003(13) (“ ‘Practice of the profession of pharmacy' includes compounding, dispensing, and consulting concerning contents, therapeutic values, and uses of any medicinal drug ....”) (emphasis added); Fla....
...also be asserted by “any individual authorized by the prescription holder to hold the medications on his or her behalf.” State v. Latona, 75 So.3d 394, 395 (Fla. 5th DCA 2011) (citing McCoy, 56 So.3d at 39 ). This extension derives from sections 465.003(6) 2 and 893.04(2)(a), 3 *176 Florida Statutes (2009), which allow pharmacists to dispense prescription drugs to a patient’s agent....
....This is one of those rare cases where ineffective assistance of trial counsel is “apparent on the face of the record.” Grant v. State, 864 So.2d 503, 505 (Fla. 4th DCA 2004) (citations omitted). However, we do not decide the case on this ground because Ramirez does not argue this basis on appeal. . See § 465.003(6), Fla....
...ate a private cause of action against pharmacists. See Badger Acquisition, 983 So.2d at 1182 ; Johnson v. Walgreen Co., 675 So.2d 1036, 1038 (Fla. 1st DCA 1996). However, they do describe the duties of Florida pharmacists. Powers, 903 So.2d at 278 . Section 465.003(6), Florida Statutes (2011), provides that [a]s an element of dispensing, the pharmacist shall, prior to the actual physical transfer, interpret and assess the prescription order for potential adverse reactions, interactions, and dosa...
...tionally vague and over-broad. Sale of prescription drug without a prescription Section 465.015(2)(c) under which appellant was convicted reads as follows: (2) It is unlawful for any person: [[Image here]] (c) To sell or dispense drugs as defined in s. 465.003(7) without first being furnished with a prescription....
...Be that as it may, section 465.015(2)(c) is quite specific and does not preclude the prosecution of a person such as appellant. However, in order to convict appellant for violating section 465.015(2)(c), the state had to prove the drug which appellant sold was among those defined in section 465.003(7), Florida Statutes (1981). Section 465.003(7) contains the following definition: (7) “Medicinal drugs” or “drugs” means those substances or preparations commonly known as prescription or legend drugs which are required by federal or state law to be dispensed only on a...
...a person who is currently registered in, and attending, a
duly accredited college or school of pharmacy, or who is a
graduate of such a school or college of pharmacy, and who
is duly and properly registered with the department as
provided for under its rules.
§ 465.003(21), Fla....
...§§ 465.001 , et seq,, defines “pharmacist” to mean “any person licensed pursuant to this chapter to practice the profession of pharmacy,” and defines “pharmacy” to include “every location where medicinal drugs are compounded, dispensed, stored, or sold. ... ”' Fla. Stat. § 465.003 (10), (11). In addition, the “practice of the profession of pharmacy5’ is defined to include compounding. Fla. Stat. § 465.003 (13)....
...uct for dispensing to a patient or for administration by a practitioner or the practitioner’s agent; and shall specifically include the professional act of preparing a unique finished product containing any ingredient or device defined by Sections 465.003(7) and (8), F.S....
...The term also includes the preparation of nuclear pharmaceuticals and diagnostic kits incident to use of such nuclear pharmaceuticals. The term “commercially available products”, as used in this section, means any medicinal product as defined by Sections 465.003(7) and (8), F.S., that are legally distributed in the State of Florida by a drug manufacturer or wholesaler....
...The language of the statute is clear and unambiguous; it defines "health care provider" as "any person licensed under chapter 458," among other things. In addition, in other provisions of Florida law, the legislature has demonstrated that it knows how to identify physicians licensed in other jurisdictions. For example, section 465.003(13), Florida Statutes (2003) refers to health care providers specifically licensed under certain Florida Statutes "or [a] similar statutory provision in another jurisdiction"; and section 458.303(1)(b), Florida Statutes (2003), refers...
...murky past and no precise meaning that is here employed by the Board to circumvent the intent of the statute. 65. In response, the Board noted two definitions of the term found in the Florida Statutes. Chapter 465 regulates the practice of pharmacy. Section 465.003(8) provides: “Medicinal drugs” or “drugs” means those substances or preparations commonly known as “prescription” or “legend” drugs which are required by federal or state law to be dispensed only on a prescription, but shall not include patents or proprietary preparations as hereafter defined....
...end drug,” “prescription drug,” or “medicinal drug” means any drug, including but not limited to, finished dosage forms, or active ingredients subject to, defined by, or described by s. 503(b) of the Federal Food, Drug, and Cosmetic Act or s. 465.003(8), s.499.007(12), or s....
...The pharmacist shall also provide counseling on proper drug usage, either orally or in writing, if in the exercise of her or his professional judgment counseling is necessary. The actual sales transaction and delivery of such drug shall not be considered dispensing. *329 § 465.003(6), Fla....
...Because a pharmacist did not review the prescription drugs being shipped from the internet pharmacy, the drugs were not dispensed. There was merely a transfer of possession by unsupervised pharmacy techs to the consumer. This blatantly ignores the language of section 465.003(6) which requires that a pharmacist transfer the drugs to the consumer....
...We agree with Block that any person, pharmacist or not, may be charged with selling a prescription drug under 465.015(2)(c). The second illegal action prohibited by section 465.015(2)(c) is dispensing a pre *493 scription drug without a prescription. Unlike selling, dispensing as defined by section 465.003(6), Florida Statutes, can only apply to a pharmacist: “Dispense” means the transfer of possession of one or more doses of a medicinal drug by a pharmacist to the ultimate consumer or her or his agent....
...The actual sales transaction and delivery of such drug shall not be considered dispensing. The administration shall not be considered dispensing. (Emphasis added). The lack of any evidence that Appellant is a pharmacist excludes his actions in this case from the statutory definitions of “dispense” found in 465.003(6), Florida Statutes....
Published | Court of Appeals for the Eleventh Circuit
...ate dose and
quantity were provided. 6 In addition, pharmacy employees had to determine
6
See, e.g., Fla. Admin. Code Ann. r. 64B16-27.211 (limiting the number of times a
pharmacist can refill a particular prescription); Fla. Stat. § 465.003(6) (requiring that before a
47
USCA11 Case: 17-13467 Date Filed: 04/07/2021 Page: 48 of 67
whether the customer had a prescription drug benefit plan that covered the refill
and how much the customer should be charged....
This Florida statute resource is curated by Graham W. Syfert, Esq., a Jacksonville, Florida personal injury and workers' compensation attorney. For legal consultation, call 904-383-7448.
