General Regulations; Definitions

DEPARTMENT OF HEALTH
Division of Family Health Services

RULE NO: RULE TITLE
64F-12.001: General Regulations; Definitions

NOTICE OF CHANGE

Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol.32,No.16, April 21, 2006 issue of the Florida Administrative Weekly.

The changes are the result of comments received from the public during a rule hearing held on May 15, 2006, or by E-mail, Facsimile transmission or by mail within the time frame allowed by the Department at the public hearing.

Paragraph (2)(m) of Rule 64F-12.001 shall now read as follows:

64F-12.001 General Regulations; Definitions.

(m) “Propagation” of a drug, as used under the definition of “manufacture” at Section  499.003(27), F.S., includes 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 preion 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.

 

Specific Authority 499.05, 499.61, 499.701 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,___________.

 

Rule 64F-12.015. No change to rule text previously published on April 21, 2006.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Rebecca Poston, R. Ph., Executive Director, Board of Pharmacy-Drugs Devices and Cosmetics, 4052 Bald Cypress Way, Mail Bin C-04 Tallahassee, Florida 32399, 850-245-4292