(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.