64F-12.012 : Records of Drugs, Cosmetics and Devices (Transferred) - Florida Administrative Rules, Law, Code, Register

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Rule: 64F-12.012 Prev Up Next

Rule Title: Records of Drugs, Cosmetics and Devices (Transferred)
Department:	DEPARTMENT OF HEALTH	Add to MyFLRules Favorites
Division:	Division of Family Health Services
Chapter:	REGULATIONS FOR DRUGS, DEVICES AND COSMETICS

Latest version of the final adopted rule presented in Florida Administrative Code (FAC):

	Effective Date:	8/6/2006
	History Notes:	Rulemaking Authority 499.003, 499.05, 499.0121, 499.0122, 499.013, 499.014, 499.052 FS. Law Implemented 499.01, 499.003, 499.012, 499.0121, 499.0122, 499.013, 499.014, 499.028, 499.04, 499.041, 499.05, 499.051, 499.052, 499.06, 499.063, 499.064, 499.066, 499.067 FS. History–New 1-1-77, Amended 12-12-82, 7-8-84, 1-30-85, Formerly 10D-45.53, Amended 11-26-86, 2-4-93, 7-1-96, Formerly 10D-45.053, Amended 1-26-99, 4-17-01, 10-7-03, 1-1-04, 6-15-04, 8-2-04, 1-19-06, 8-6-06, Transferred to 61N-1.012.
	References in this version:	No reference(s).

History of this Rule since Jan. 6, 2006

Section	Description	ID	Publish Date

Withdrawal 64F-12.012	Records of Drugs, Cosmetics and Devices	10244284	7/29/2011 Vol. 37/30
Public Hearing 64F-12.001 ......	Rule hearing requested on Proposed Amended Rules 64F-12.001, F.A.C., Definitions; Rule 64F-12.012, F.A.C., Records of Drugs, Cosmetics and Devices; .... July 15, 2010, 9:30 a.m. – 1:00 p.m. (EST) Betty Easley Conference Center, 4075 Esplanade Way, Room 152, ....	8831479	7/2/2010 Vol. 36/26
Public Hearing 64F-12.012	Rule Hearing requested on Proposed Amended Rule 64F-12.012 F.A.C., Records of Drugs, Cosmetics and Devices. This hearing is intended to be the .... January 7, 2010, 10:00 a.m. (EST) Conference Call: 1(888)808-6959, Conference Code: 9766152#	8076334	12/24/2009 Vol. 35/51
Petition 64F-12.012	Henry Schein, Inc., 135 Duryea Road, Melville, New York 11747, (631)843-5546; Medline .... The petition seeks a Declaratory Statement from the Department of Health, Drugs Devices and Cosmetics Program regarding the responsibilities ....	8013284	12/11/2009 Vol. 35/49
Public Hearing 64F-12.012	Rule Hearing requested on Proposed Amended Rule 64F-12.012, F.A.C., Records of Drugs, Cosmetics and Devices. December 15, 2009, 10:00 a.m. – 12:00 Noon (EST) Teleconference: 1(888)808-6959, Conference Code: 9766152#	7953338	11/25/2009 Vol. 35/47
Proposed 64F-12.012	The Department proposes to revise the rule language regarding pedigree requirements to be compliant with Chapter 499 F.S. and to delete language that is no longer relevant to pedigrees because of statutory changes. The department ....	7824522	10/23/2009 Vol. 35/42
Development 64F-12.012	The Department proposes to review this section for possible revisions to all records and recordkeeping requirements for Drugs, Devices and Cosmetics. This review includes but is not limited to pedigree requirements for prescription ....	7335545	7/2/2009 Vol. 35/26
Workshop 64F-12.001 ......	Draft language for Rule 64F16-12.001, F.A.C., General Regulations; Definitions; Rule 64F-12.012, F.A.C., Records of Drugs, Cosmetics and Devices; .... Thursday, July 23, 2009, 10:00 a.m. – 1:00 p.m. (EST) Betty Easley Conference Center, 4075 Esplanade Way, Room 180, ....	7333605	7/2/2009 Vol. 35/26
Withdrawal 64F-12.012	Records of Drugs, Cosmetics and Devices	7278509	6/19/2009 Vol. 35/24
Workshop 64F-12.012	Draft language for Rules 64F-12.012, Records of Drugs, Cosmetics and Devices, and 64F-12.013, Prescription Drugs; Receipts, Storage and Secu.... March 12, 2009, 10:00 a.m. 4042 Bald Cypress Way, Room 301, Tallahassee, FL 32399	6782451	2/20/2009 Vol. 35/07
Petition 64F-12.012 ......	Pharmalink, Inc., 12345 Starkey Road, Suite L, Largo, Florida. The petition seeks a Declaratory Statement from the Department of Health, Drugs Devices and Cosmetics Program regarding the creation ....	6771781	2/13/2009 Vol. 35/06
Proposed 64F-12.012	The Department proposes to revise the rule language regarding pedigree requirements to be compliant with Chapter 499, F.S. (2008).	6605038	1/9/2009 Vol. 35/01
Conference 64F-12.001 ......	The Council will discuss rule development for Rules 64F-12.001, 12.012, 12.013, 12.015, 12.018, and 12.024. December 29, 2008, at 9:30 a.m. Conference Number: 1-888-808-6959, Conference Code: 976615....	6569342	12/24/2008 Vol. 34/52
Petition 64F-12.012	Medical Arts Pharmacy, Inc., 2950 Central Avenue, St. Petersburg, Florida 33712. The petition seeks a Declaratory Statement from the Department of Health, Drugs Devices and Cosmetics Program regarding drug pedigrees ....	6193370	9/26/2008 Vol. 34/39
Development 64F-12.012	The Department proposes to review this section for possible revisions to all records and recordkeeping requirements for Drugs, Devices and Cosmetics. This review includes but is not limited to pedigree requirements for prescription ....	5880060	7/18/2008 Vol. 34/29
Withdrawal 64F-12.012	Records of Drugs, Cosmetics and Devices	5875598	7/18/2008 Vol. 34/29
Workshop 64F-12.001 ......	Rule 64F16-12.001-General Regulations; Definitions; 64F-12.012-Records of Drugs, Cosmetics and Devices; 64F-12.013-Prescription Drugs; Receipt, .... August 7, 2008, at 1:00 p.m.-4:00 p.m. Betty Easley Conference Center, 4075 Esplanade Way, Room 152, ....	5876180	7/18/2008 Vol. 34/29
Variances 64F-12.012	Variance from or Waiver of Agency Rule 64F-12.012(6) and (10), F.A.C. from Invivo Corporation. The petition seeks a variance from or waiver of Rule 64F-12.012(6) and (10), F.A.C. regarding storage and retention of records ....	5795476	6/27/2008 Vol. 34/26
Proposed 64F-12.012	The Department intends to enact rules that implement the pedigree provisions of Florida Session Law 2006-310 concerning implementing the direct purchase statement pedigree related provisions of that session law. The Department ....	4432820	8/3/2007 Vol. 33/31
Variances 64F-12.012	Variance from or Waiver of AGency Rule 64F-12.012(3)(a) and (c) F.A.C. This Notice amends the Notice of Emergency Petition for Variance and Waiver published in the Florida Administrative Weekly on June 22, 2007, issue: ....	4367830	7/20/2007 Vol. 33/29
Variances 64F-12.012	Variance from or Waiver of Agency Rule 64F-12.012(3)(a) and (c) F.A.C. The petition seeks an emergency variance from or waiver of Rule 64F-12.012(3)(a) and (c) F.A.C. incorporating be reference prescription drug pedigree ....	4284992	6/22/2007 Vol. 33/25
Final 64F-12.012	Records of Drugs, Cosmetics and Devices (Transferred)	11024455	Effective: 08/06/2006
Final 64F-12.012	Records of Drugs, Cosmetics and Devices (Transferred)	2579635	Effective: 08/06/2006
Development 64F-12 ......	The 2006 Florida legislature enacted session law 2006-310, amending Chapter 499, Part I, F.S., which changed requirements for prescription drug pedigrees in some instances; added a statutory provision authorizing drop shipment ....	532838	8/4/2006 Vol. 32/31
Change 64F-12.012 ......	Records of Drugs, Cosmetics and Devices, Certification Authority and Digital Signatures For Self-Authenticating Pedigree	384816	6/2/2006 Vol. 32/22
Proposed 64F-12.012 ......	A proposed amendment to Rule 64F-12.012, F.A.C., requires an inventory of drugs at each wholesaler establishment, of drugs it has on hand as of June 30, 2006, so as to give the Department information useful to determining ....	292860	4/21/2006 Vol. 32/16
Development 64F-12.001 ......	The 2003 Legislature passed Senate Bill 2312, The Prescription Drug Protection Act amending Chapter 499, Florida Statutes. The Bill provided for a phase-in of enhanced regulation of the wholesaling of prescription drugs ....	109433	3/3/2006 Vol. 32/09

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