Fla. Admin. Code R. 61N-1.001

Current through Reg. 51, No. 009; January 14, 2025

Section 61N-1.001 - General Regulations; Definitions

(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.

Fla. Admin. Code Ann. R. 61N-1.001

Rulemaking Authority 499.003(48)(m), 499.024, 499.025(5), 499.01(2), (3), (4), 499.0121(6), 499.012(5), 499.012(12), 499.025, 499.03(4), 499.05 FS. Law Implemented 499.003, 499.005, 499.0054, 499.006, 499.007, 499.008, 499.009, 499.01, 499.012, 499.0121, 499.015, 499.023, 499.024, 499.025, 499.028, 499.03, 499.033, 499.035, 499.039, 499.041, 499.05, 499.051, 499.052, 499.06, 499.066, 499.067, 499.61, 499.62, 499.63, 499.64, 499.65, 499.66, 499.67, 499.71, 499.75 FS.

New 1-1-77, Amended 12-12-82, 1-30-85, Formerly 10D-45.31, Amended 11-26-86, 2-4-93, 7-1-96, Formerly 10D-45.031, Amended 1-26-99, 4-17-01, 6-30-03, 10-7-03, 1-1-04, 1-29-04, 5-29-05, 1-19-06, 2-14-06, 8-6-06, 12-27-07, Formerly 64F-12.001, Amended by Florida Register Volume 41, Number 228, November 24, 2015 effective 12/7/2015, Amended by Florida Register Volume 42, Number 188, September 27, 2016 effective 10/10/2016.