Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-1 - REGULATIONS FOR DRUGS, DEVICES AND COSMETICS › Section 61N-1.001 - General Regulations; Definitions

Current through Reg. 50, No. 138; July 16, 2024
(1) A
				word or phrase defined in the federal Food, Drug, and Cosmetic Act as defined
				in paragraph 499.002(1)(b),
				F.S., shall have the same meaning as in those provisions unless specifically
				defined otherwise in chapter 499, F.S., or rule chapter 61N-1, F.A.C.
(2) In addition to definitions contained in
				sections 499.003,
				499.028(1),
				499.029(3), and
				499.61, F.S., the following
				definitions apply, to chapter 499, F.S., and to rule chapters 61N-1 and 61N-2,
				F.A.C.:
(a) "Administer" or "administration" -
				means the direct application or introduction of a single dose of drugs by a
				legally authorized person to or into the body of an individual human or animal
				patient whether by injection, inhalation, ingestion or any other
				means.
(b) "Authorized absence" -
				means, for purposes of section 499.012(16)(d)3., F.S., the physical absence of
				the designated representative from the permitted establishment, for a
				cumulative 60 calendar days in any 365 calendar day period for situations such
				as: the birth of the employee's child and to care for the newborn child; the
				placement of a child with the employee for adoption or foster care; the care of
				a family member (child, spouse, or parent) with a health condition, where the
				employee is needed to care for the family member; or the employee's own serious
				health condition makes the employee unable to perform the functions of the
				designated representative.
(c)
				"Authorized recipient" - means a person permitted by or otherwise authorized by
				Florida law, or by the law of the jurisdicition in which the person receives
				the prescription drugs, to purchase, own, receive or possess those prescription
				drugs. The term includes:
1. Any pharmacy
				licensed pursuant to chapter 465, F.S., except a Class I Institutional Pharmacy
				since it is only authorized to possess dispensed prescription drugs and medical
				oxygen for administration to its patients,
2. Any person who is authorized by the law
				where the delivery occurs to purchase, own, receive or possess prescription
				drugs, or
3. A licensed ship
				captain, first officer, or designated medical officer for a vessel engaged in
				international trade or in trade between ports of the United States or for any
				merchant vessel belonging to the U.S. Government. The prescription drugs must
				be intended solely for emergency medical purposes and the wholesale distributor
				must deliver the prescription drugs directly to the ship or transfer possession
				to the appropriate ship's officer as near to the ship as permitted by state and
				federal law.
(d) "Broker"
				- means a person participating in the wholesale distribution of a prescription
				drug by buying, purchasing, or otherwise taking ownership of or title to the
				prescription drug and selling or transferring, or offering to sell or transfer,
				ownership of or title to the prescription drug to a person other than the
				patient or the patient's agent without taking physical possession of the
				prescription drug.
(e) "Change in
				Ownership" - means that there has been a transfer or assignment of a majority
				of the direct ownership or controlling interest of a permitted establishment or
				that a lessee of a permitted establishment agrees to or becomes legally liable
				for the operation of the establishment. A transfer or assignment of a majority
				of direct ownership or controlling interest of a permitted establishment occurs
				where an event or other transaction occurs and the result of such event or
				transaction is that more than 50% of the ownership interest or controlling
				interest of the permitted establishment resides with a person who prior to the
				event or transaction did not own or control more than a 50% ownership interest
				in the permitted establishment. A change in the permitted establishment's
				federal identification number or the taxpayer identification number is
				indicative of a change in ownership, but is not dispositive; a change of
				ownership could occur where the federal identification number or the taxpayer
				identification number does not change. For a publicly traded corporation, the
				changing of officers or directors is not a change in ownership nor is the
				change in ownership of a parent company provided that such change does not
				result in more than a 50% change in the ownership or controlling interest of
				any permitted establishment.
(f)
				"Chief Executive Officer" - means the owner or the highest ranking official of
				a corporation, company, or business.
(g) "Electronic signature" - means a method
				of signing an electronic message that identifies a particular person as the
				source of the message and indicates the person's approval of the information
				contained in the message.
(h)
				"Established safe and effective indication" - means any indication that has
				been approved as safe and effective by the FDA, which is generally recognized
				as safe and effective under conditions established by the FDA, or which is
				otherwise in compliance with FDA's regulations.
(i) "FDA" - means the United States Food and
				Drug Administration.
(j)
				"Intracompany transfer" - means, pursuant to section
				499.003(34),
				F.S., a distribution of a specific unit of a prescription drug between two
				establishments wholly owned and operated by the same business entity.
(k) "Legend Device or Restricted Device" -
				means any device which can be dispensed only by the prescription or order of a
				licensed practitioner and which device on its label bears either the words:
				"Caution: Federal Law restricts this device to sale by or on the order of a
				________, " the blank to be filled with the word "physician, " "dentist, "
				"veterinarian, " or with the descriptive designation of any practitioner
				licensed by law to use or prescribe the device; "Caution: Federal Law prohibits
				dispensing without prescription; "Rx Only;" or "Caution: Florida Law prohibits
				dispensing without prescription."
(l) "Minimal quantities" for the purpose of
				distribution of prescription drugs by a licensed retail pharmacy to a licensed
				practitioner for office use in compliance with chapter 465, F.S., pursuant to
				section 499.003(48)(m),
				F.S., means the total annual dollar volume of prescription drugs sold does not
				exceed five percent of the total dollar volume of that pharmacy's annual
				prescription drug sales.
(m) "Point
				of origin" - means the location from which the manufacturer transfers title,
				and the location from which the manufacturer transfers possession, if
				different, of the specific unit of the prescription drug being transferred or
				sold.
(n) "Practitioner" means a
				person who is duly licensed and authorized by laws of the state to administer,
				prescribe, or dispense, as appropriate, a drug or device for medical
				purposes.
(o) "Principal address"
				or "principal business address" means the person's primary place of
				business.
(p) "Product" - anything
				produced or made either naturally or artificially.
(q) "Propagation" of a drug - means, as used
				under the definition of "manufacture" at section
				499.003(29),
				F.S., for purposes of permitting under section
				499.012, F.S., the holder or
				holders of a New Drug Application (NDA), an Abbreviated New Drug Application
				(ANDA), a Biologics License Application (BLA) or a New Animal Drug Application
				(NADA), provided that such application has become effective or is otherwise
				approved consistent with section
				499.023, F.S.; a private label
				distributor for whom the private label distributor's prescription drugs are
				originally manufactured and labeled for the distributor and have not been
				repackaged; or the distribution point for the manufacturer, contract
				manufacturer or private label distributor whether the establishment is a member
				of the manufacturer's affiliated group or is a contract distribution
				site.
(r) "Provides prescription
				services to the public" - means, for the purposes of the retail pharmacy
				wholesaler permit, holding the pharmacy out to the public through prominently
				displayed pharmacy signs on the exterior of the building and adequate inventory
				on hand to fill a variety of prescriptions for a variety of medical conditions
				that would be required by the public generally.
(s) "Readily available" and "readily
				retrievable" mean that records, either hard copy or computerized, are organized
				in such a manner that they can be quickly and easily retrieved during an
				inspection; individual records can be produced within minutes of the request
				(unless the permitted address is not within the state in which case a 48 hour
				timeframe is available for producing records). Required records that are kept
				by automatic data processing systems or other electronic or mechanized
				recordkeeping systems are kept in such a manner so that they can be separated
				out from all other records in a reasonable time.
(t) "Regular and systematic supplying of a
				drug" for the purpose of distributions of prescription drugs between licensed
				pharmacies operating in end-stage renal dialysis clinics pursuant to section
				499.01(2)(h)5., F.S., means the distribution of that prescription drug where
				the receiving pharmacy:
1. Has failed to
				establish a written policy and procedure for forecasting the pharmacy's
				prescription drug inventory needs based on the pharmacy's historical
				prescription drug dispensing records,
2. Has failed to establish and maintain an
				inventory of prescription drugs based on historical prescription drug
				dispensing records; and,
3. Has
				implemented a business practice where a prescription drug shortage is resolved
				primarily by obtaining prescription drugs from another pharmacy under common
				ownership.
(u)
				"Repackaging or otherwise changing the container, wrapper, or labeling to
				further the distribution" means:
1. Altering a
				packaging component that is or may be in direct contact with the drug, device,
				or cosmetic. For example, repackaging from bottles of 1, 000 to bottles of
				100.
2. Altering a manufacturer's
				package for sale under a label different from the manufacturer. For example, a
				kit that contains an injectable vaccine from manufacturer A; a syringe from
				manufacturer B; alcohol from manufacturer C; and sterile gauze from
				manufacturer D packaged together and marketed as an immunization kit under a
				label of manufacturer Z.
3.
				Altering a package of multiple-units, which the manufacturer intended to be
				distributed as one unit, for sale or transfer to a person engaged in the
				further distribution of the product. This does not include:
a. Selling or transferring an individual unit
				which is a fully labeled self-contained package that is shipped by the
				manufacturer in multiple units, or
b. Selling or transferring a fully labeled
				individual unit, by adding the package insert, by a person authorized to
				distribute prescription drugs to an institutional pharmacy permit, health care
				practitioner or emergency medical service provider for the purpose of
				administration and not for dispensing or further
				distribution.
(v) "Rx" - means prescription.
(w) "Sale" - includes any transfer of title
				or ownership whether by barter, exchange or gift.
(x) "Separate and distinct cosmetic product"
				- means a cosmetic product for that establishment which is, or will be sold,
				distributed, or given away. The adding of color, flavor, or scents does not
				make a separate and distinct cosmetic product for each variation.
(y) "Separate and distinct device product" -
				means a device product in its finished form for that manufacturer which is, or
				will be sold, distributed, or given away. The function or use of the device
				determines whether a device is separate and distinct.
(z) "Separate and distinct drug product" -
				means a drug product in the finished form and strength for that manufacturer
				which is, or will be sold, distributed or given away.
(aa) "Specific unit of a prescription drug" -
				means the individual saleable unit of a specific prescription drug being
				transferred or sold, which is capable of being serialized to contain its own
				serial number, which drug is identified by name, strength, dosage form,
				container size, and lot number.
(bb) "State Current Good Manufacturing
				Practices" means current good manufacturing practices and quality system
				regulations as prescribed as of 6/1/2015 in Title 21 Code of Federal
				Regulations, Parts 210, 211, 212, 600-610, and 820, and the federal guidelines
				which are incorporated by reference herein and made a part of this rule,
https://www.flrules.org/Gateway/reference.asp?No=Ref-06161
,
				and the requirements of this chapter. Current good manufacturing practices for
				cosmetics means the requirements for manufacturing cosmetics as set forth in
				rule 61N-1.010, F.A.C.
(cc) "Unapproved new drug" - means any drug
				which has not been approved or otherwise authorized for use under the federal
				act, 21 U.S.C. ss.
				301 et seq., and the regulations promulgated
				thereunder or which does not have a Notice of Claimed Investigational Exemption
				on file with the United States Food and Drug Administration.
(dd) "Usual course of business as carriers" -
				means for purposes of commercial airlines, the purchase, receipt, distribution
				and storage of prescription drugs for emergency medical reasons, which
				includes:
1. The transportation of a
				prescription drug aboard a commercial aircraft where the drug is required by
				14 CFR s.
				121.803 (and appendix A to 14 CFR part 121 ),
				to be on board the aircraft as part of an approved emergency medical kit; and,
2. The purchase of the
				prescription drug by the commercial airline, and receipt of the prescription
				drug by the commercial airline at an establishment operated by the airline,
				provided that, the prescription drug is sold and provided to the commercial
				airline by a person and establishment that is licensed to engage in wholesale
				distribution of prescription drugs. The recordkeeping requirements of
				subsections 61N-1.012(1),
				(2), F.A.C., apply to all distributions of
				prescription drugs under this sub-sub paragraph. In all such distributions to
				commercial airlines, the recipient's license number shall be the registration
				number assigned to the carrier by the Federal Aviation
				Administration.
(ee)
				"Valid client-veterinarian relationship" - means one in which (1) a
				veterinarian has assumed the responsibility for making medical judgments
				regarding the health of an animal and the need for medical treatment, and the
				client (the owner or other caretaker of the animal or animals) has agreed to
				follow the instructions of the veterinarian; (2) there is sufficient knowledge
				of the animal(s) by the veterinarian to initiate at least a general or
				preliminary diagnosis of the medical condition of the animal(s); and (3) the
				veterinarian is readily available for follow-up in case of adverse reactions or
				failure of the regimen of therapy. Such a relationship can exist only when the
				veterinarian has recently seen and is personally acquainted with the keeping
				and care of the animal(s) by virtue of examination of the animal(s), and/or by
				medically appropriate and timely visits to the premises where the animal(s) are
				kept.
(ff) "Verifiable account" -
				means a number issued by the manufacturer to a wholesaler when the wholesaler
				sets up an account with the manufacturer for the purchase of a prescription
				drug from that manufacturer that uniquely identifies the wholesaler and that is
				to be used on a recurring basis.
(gg) "Wholesaler" - means a person who
				engages in the wholesale distribution of a prescription
				drug.