The Division proposes the rule amendment to clarify the definitions of terms set forth in Chapter 499, F.S., and the Division’s rules.

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

RULE NO.:              RULE TITLE:

61N-1.001              General Regulations; Definitions

PURPOSE AND EFFECT: The Division proposes the rule amendment to clarify the definitions of terms set forth in Chapter 499, F.S., and the Division’s rules.

SUMMARY: The proposed rule amends several definitions within Rule 61N-1, F.A.C. to provide clarity to the regulated industry.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION: The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: the economic review conducted by the agency.

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.

RULEMAKING AUTHORITY: 499.024, 499.025(5), 499.01(2), 499.01(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.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Dinah Greene, Operations Review Specialist, Division of Drugs, Devices and Cosmetics, Department of Business and Professional Regulation, 1940 North Monroe Street Suite 26A, Tallahassee, Florida 32399-1047, [phone], [e-mail]

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

61N-1.001 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 6/1/15 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 61N-1, 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 61N-1, F.A.C.:

(a) “Administer” or “administration” – means the direct application or introduction obtaining and giving of a single dose of drugs by a legally authorized person to or into the body of an individual human or animal a patient whether by injection, inhalation, ingestion or any other means for his consumption.

(b) “Affiliated group” – means the definition set forth in Section 1504 of the Internal Revenue Code, (as of 6/1/2015 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)(d)3. (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 physical absence of the designated representative from the permitted establishment, for a cumulative period not to exceed 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 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 Florida law, or by the law of the jurisdicition in which the person receives the prescription drugs, Chapter 499, F.S., to purchase, own, receive or possess those prescription drugs. The term includes:;

1. Any a pharmacy licensed purusant to 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;

2. Any 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, own, receive or possess prescription drugs; or .

3. A licensed ship captain, or first officer, or designated medical officer for a vessel engaged in international trade or in trade between ports of the United States or for and any merchant vessel belonging to the U.S. Government. is an authorized recipient for The prescription drugs must be intended solely for emergency medical purposes, and the wholesale distributor must deliver provided the prescription drugs are delivered by the wholesaler 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.

(e) “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 that buys and sells the drug but does not take physical possession such that the drug is “sold to” the broker and “shipped to” a third party.

(f) “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 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) No change.

(h) “Directly from the manufacturer” – means, for purposes other than set forth in Section 499.003(46), F.S., :

1. For the purposes of pedigree as defined by Section 499.003(37)(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 shipped

2. For the purposes of Section 499.0121 499.0121(6)(d)5., F.S., the manufacturer of the prescription drug ships the specific unit of the prescription drug directly to an the person authorized recipient by Section 499.0121(6)(d)5., F.S., to receive the specific unit of the prescription drug.

(i) through (k) No change.

(l) “Intracompany transfer” – means, pursuant to Section 499.003(34)(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.

(m) No change.

(n) “Limited quantities” pursuant to Section 499.01(3) and (4)(b), F.S., means the number of transactions necessary for research and development purposes, the number of transactions necessary for research and development purposes to obtain a final FDA approval, or the number of transactions necessary for research and development purposes to obtain a final approval from a foreign regulatory authority; all transactions must be based on requirements set forth in the acquiring entity’s research and development records created contemporaneously with the research and development activities.

(o) “Pedigree” – means a document that satisfies the requirements of Section 499.003(37)(31)(a) or (b), F.S., as applicable, and the applicable rule requirements of subsection 61N-1.012(3), F.A.C., and any forms adopted therein.

(p)(o) No change.

(q)(p) No change.

(r)(q) “Principal address” or “principal business address” means the person’s primary place of business.

(s) “Product” – anything produced or made either naturally or artificially.

(t)(r) “Propagation” of a drug – means, as used under the definition of “manufacture” at Section 499.003(29)(27), F.S., for purposes of permitting under Section 499.012 499.013, 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.

(s) through (v) renumbered (u) through (x) No change.

(y)(w) “Sale” – includes any transfer of title or ownship whether by barter, exchange or gift.

(x) through (aa) renumbered (z) through (cc) No change.

(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 6/1/2015 1/1/01 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, and the requirements of this chapter. Current good manufacturing practices for cosmetics means the guidelines for manufacturing cosmetics as set forth in Rule 61N-1.010, F.A.C.

(dd) through (gg) are renumbered (ee) through (hh) No change.

(hh) “Wholesale distribution” – means distribution of prescription drugs to persons other than a consumer or patient as set forth in Section 499.012(1)(a), F.S.

(ii) No change.

(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.

Rulemaking Authority 499.003(31), 499.024, 499.025(5), 499.01(2), 499.01(4),  499.01(6), 499.0121(6), 499.0122(2), 499.012(5), 499.012(12), 499.013(3), 499.014(5), 499.025, 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, Formerly 64F-12.001, Amended _______.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Reginald D. Dixon, Division Director

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Ken Lawson, Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: July 21, 2015

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: December 17, 2013