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-1.001General 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, 2601 Blair Stone Road, 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 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) “Affiliated group” – means the definition set forth in Section 1504 of the Internal Revenue Code, (as of 6/1/2015) which is incorporated by reference herein, https://www.flrules.org/Gateway/reference.asp?No=Ref-06161.

(c) through (g) renumbered (b) through (f) No change.

(h) “Directly from the manufacturer” – means, for purposes other than set forth in Section 499.003(46), 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 the specific unit of the prescription drug directly to an authorized recipient.

(i) through (n) renumbered (g) through (l) No change.

(m)  “Minimal quantities” for the purpose of distribution of prescription drugs by a licensed retail pharmacy to a license 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.

(n) “Limited quantities” for the purpose of prescription drugs or active pharmaceutical ingredients obtained in “limited quantities” for research and development (“R&D”) purposes pursuant to Sections 499.01(3) and (4)(b), F.S., requires that the entity must identify the R&D requirements, the acquisition schedule and the use of each drug acquired relative to anticipated and ongoing R&D activities.

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

(p) through (v)  renumbered (n) through (t) No change.

(u) “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 s. 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.

(w) through (ii) renumbered (v) through (hh) No change.

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. 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 12-7-15, ____________.

 

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 28, 2016

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: May 5, 2016