64F-12.001: General Regulations; Definitions
PURPOSE AND EFFECT: The Department proposes to amend the rule to provide a definition for statutory and rule terms and define or revise the terms. The changes will make the definitions set forth in this rule section applicable to both Chapter 64F, Florida Administrative Code and to Chapter 499, Florida Statutes.
SUMMARY: The rule will define or revise the terms “affiliated group”, “distribution point”, “limited quantities”, “intra-company transfer”, “principal address”, “propagation” and “specific drug”.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared.
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
SPECIFIC AUTHORITY: 499.024, 499.025(5), 499.01(6), 499.0121(6), 499.0122(2), 499.012(5) (12), 499.013(3), 499.01(2)(g), 499.014(5), 499.03(4), 499.05, 499.701 FS.
LAW IMPLEMENTED: 499.002, 499.003, 499.004, 499.005, 499.0051, 499.0054, 499.0057, 499.006, 499.007, 499.008, 499.009, 499.01, 499.012, 499.0121, 499.0122, 499.013, 499.014, 499.015, 499.023, 499.024, 499.025, 499.028, 499.03, 499.04, 499.033, 499.035, 499.039, 499.041, 499.05, 499.051, 499.052, 499.055, 499.06, 499.066, 499.067, 499.069, 499.61, 499.62, 499.63, 499.64, 499.65, 499.66, 499.67, 499.701, 499.71, 499.75 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Rebecca Poston, R.PH., Director, Drugs Devices and Cosmetics Program 4052 Bald Cypress Way, Mail Bin C-04, Tallahassee, Florida 32399
THE FULL TEXT OF THE PROPOSED RULE IS:
64F-12.001 General Regulations; Definitions.
(1) A word or phrase defined in 21 U.S.C. ss. 301 et seq. or federal regulations promulgated thereunder in Title 21 Code of Federal Regulations (C.F.R.), (as of 10/1/03) which are incorporated by reference herein, shall have the same meaning as in those provisions unless specifically defined otherwise in Chapter 499, F.S. or Rule Chapter 64F-12, F.A.C.
(2) In addition to definitions contained in Sections 499.003, 499.012(1), 499.0121(6), 499.0122(1), 499.028(1), 499.029(3), and 499.61, F.S., the following definitions apply, to Chapter 499, F.S. and to Rule Chapter 64F-12, F.A.C.:
(a) “Administer” – means the obtaining and giving of a single dose of drugs by a legally authorized person to a patient for his consumption.
(b) “Affiliated group” – for purposes of this rule chapter, means the definition of the term set forth at Section 499.003(2), F.S. the definition set forth in Section 1504 of the Internal Revenue Code (as of April 24, 2003) which is incorporated by reference herein, which is composed of chain drug entities, including at least 50 retail pharmacies, warehouses, or repackagers, which are members of the same affiliated group, if the affiliated group:
1. Discloses to the department the names of all its members; and
2. Agrees in writing to provide records on prescription drug purchases by members of the affiliated group not later than 48 hours after the department requests such records, regardless of the location where the records are stored. For an affiliated group to qualify under Section 499.0121(6)(f)1., F.S., such affiliated group must also meet all the conditions specified by Section 499.0121(6)(f), F.S.
(c) “Authorized absence” – means, for purposes of Section 499.012(16)(11)(d), F.S., the management or owner of a permitted wholesale establishment has approved in writing in a document that is available for inspection under Section 499.051, F.S., at the time of the inspection, the absence of the designated representative for a period not to exceed 60 calendar days 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 employee is needed to care for a family member (child, spouse or parent) with a serious health condition; or the employee’s own serious health condition makes the employee unable to perform the functions of the designated representative.
(d) “Authorized recipient” – means a person permitted by or otherwise authorized by Chapter 499, F.S., to purchase, receive or possess prescription drugs; a pharmacy licensed by 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; a practitioner licensed by Florida law to purchase and receive prescription drugs; or a person who is authorized by the law where the delivery occurs to purchase, receive or possess prescription drugs. A licensed ship captain or first officer for a vessel engaged in international trade or in trade between ports of the United States and any merchant vessel belonging to the U.S. Government is an authorized recipient for prescription drugs intended solely for emergency medical purposes, provided the prescription drugs are delivered by the wholesaler directly to the ship.
(e) “Broker” – means a person participating in the wholesale distribution of a prescription drug that buys or and sells the drug but does not take physical possession of such that the drug is “sold to” the broker and “shipped to” a third party.
(f) “Change in Ownership” – means a majority (more than 50%) of the ownership or controlling interest changes. A change in ownership occurs when there has been any change in a partnership amounting to more than 50% of the ownership or controlling interest. 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.
(g) “Chief Executive Officer” – means the owner or the highest ranking official of a corporation, company, or business.
(h) “Directly from the manufacturer” – means:
1. For the purposes of the a pedigree document as defined at Section 499.01212(2)(b) 499.003(31)(b), F.S., the manufacturer of the specific unit of the prescription drug invoiced and sent that specific unit of the prescription drug directly to the purchasing wholesale distributor or its wholly owned subsidiary., or
2. For the purposes of Section 499.0121(6)(d)5., F.S., the manufacturer of the prescription drug ships the specific unit of the prescription drug directly to the person authorized by Section 499.0121(6)(d)5., F.S., to receive the specific unit of the prescription drug.
(i) “Distribution Point” as used in the definition of “manufacturer” in Section 499.003(31), F.S. means: an establishment, i.e., a place of business at one general physical location from which prescription drugs are shipped, but not sold, into commerce.
(j)(i) “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.
(k)(j) “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.
(l)(k) “FDA” – means the United States Food and Drug Administration.
(m)(l) “Intracompany transfer” – means any transaction or transfer between any parent, division or subsidiary wholly owned by a corporate, pursuant to Section 499.003(31)(b), F.S., a distribution of a specific unit of a prescription drug between two establishments wholly owned and operated by the same business entity.
(n)(m) “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.”
(o) “Limited quantities”, for purposes of the licensure exemption described at Section 499.012(2)(c)3., F.S., for research and development being performed for a specific prescription drug a limited quantity is the amount of an active pharmaceutical ingredient required to perform the research and development for a period no longer than 30 days. No more than two transactions for receipt of an active pharmaceutical ingredient for a specific prescription drug may occur within a 30 day period.
(p)(n) “Pedigree” – means a document that satisfies the requirements of Section 499.01212(a) or (b), 499.003(31)(a) or (b), F.S., as applicable, and the applicable rule requirements of subsection 64F-12.012(3), F.A.C., and any forms adopted therein.
(q)(o) “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.
(r)(p) “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.
(s) “Principal Address” means for all establishments permitted by or required by law to be permitted by the Department, the full physical address of the establishment. For purposes of invoicing a purchaser of drugs, devices or cosmetics, a post office box number can be used as an additional address, in addition to the full physical address on the invoice.
(t)(q) “Product” – anything produced or made either naturally or artificially.
(r) “Propagation” of a drug – means, as used under the definition of “manufacture” at Section 499.003(27), F.S., for purposes of permitting under Section 499.013, 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.
(u)(s) “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 having adequate inventory on hand to fill a variety of prescriptions for a variety of medical conditions that would be required by the public generally.
(v)(t) “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.
(w)(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 1000 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.
(x)(v) “Rx” – means prescription.
(y)(w) “Sale” – includes any transfer of title or ownership, whether by barter, exchange or gift or in some other manner.
(z)(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.
(aa)(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.
(bb)(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.
(cc)(aa) “Specific unit of the 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) “Specified drug” – means all dosage forms, strengths and container sizes of the following prescription drugs:
1. Bextra (valdecoxib);
2. Celebrex (celecoxib);
3. Combivir (lamivudine/zidovudine);
4. Crixivan (indinavir sulfate);
5. Diflucan (fluconazole);
6. Epivir (lamivudine);
7. Epogen (epoetin alfa);
8. Gamimune (globulin, immune);
9. Gammagard (globulin, immune);
10. Immune globulin;
11. Lamisil (terbinafine);
12. Lipitor (atorvastatin calcium);
13. Lupron (leuprolide acetate);
14. Neupogen (filgrastim);
15. Nutropin AQ (somatropin, e-coli derived);
16. Panglobulin (globulin, immune);
17. Procrit (epoetin alfa);
18. Retrovir (zidovudine);
19. Risperdal (risperidone);
20. Rocephin (ceftriaxone sodium);
21. Serostim (somatropin, mannalian derived);
22. Sustiva (efavirenz);
23. Trizivir (abacavir sulfate/lamivudine/zidovudine);
24. Venoglobulin (globulin, immune);
25. Viagra (sildenafil citrate);
26. Videx (didanosine);
27. Viracept (nelfinavir mesylate);
28. Viramune (nevirapine);
29. Zerit (stavudine);
30. Ziagen (abacavir sulfate);
31. Zocor (simvastatin);
32. Zofran (ondansetron);
33. Zoladex (goserelin acetate); and
34. Zyprexa (olanzapine).
(dd)(cc) “State Current Good Manufacturing Practices” means current good manufacturing practices and quality system regulations as prescribed as of 1/1/01 in Title 21 Code of Federal Regulations, Parts 210, 211, 600-610, and 820, and the federal guidelines which are incorporated by reference herein and made a part of this rule, and the requirements of this chapter. Current good manufacturing practices for cosmetics means the guidelines for manufacturing cosmetics as set forth in Rule 64F-12.010, F.A.C.
(ee)(dd) “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.
(ff)(ee) “Usual course of business as common 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 64F-12.012(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.
(gg)(ff) “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.
(hh)(gg) “Verifiable account” – means a number issued by the manufacturer to a wholesale distributor wholesaler when the wholesale distributor wholesaler sets up an account with the manufacturer for the purchase of a prescription drug from that manufacturer that uniquely identifies the wholesale distributor wholesaler and that is to be used on a recurring basis.
(ii)(hh) “Wholesale distribution” – means distribution of prescription drugs to persons other than a consumer or patient as set forth in Section 499.003(54) 499.012(1)(a), F.S.
(jj)(ii) “Wholesale distributor” “Wholesaler” – means a person who engages in the wholesale distribution of a prescription drug.
(kk)(jj) “Written agreement” means any type of written correspondence or documentation to establish an account for ongoing sales of prescription drugs by the manufacturer to that wholesaler.
Specific Authority 499.003(31), 499.024, 499.025(5), 499.01(6), 499.0121(6), 499.0122(2), 499.012(12), 499.013(3), 499.014(5), 499.03(4), 499.05 FS. Law Implemented 499.003, 499.004, 499.005, 499.0054, 499.0057, 499.006, 499.007, 499.008, 499.009, 499.01, 499.012, 499.0121, 499.0122, 499.013, 499.014, 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, 499.069, 499.61, 499.62, 499.63, 499.64, 499.65, 499.66, 499.67, 499.71, 499.75 FS. History–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,_______.