RULE NO: RULE TITLE
64F-12: REGULATIONS FOR DRUGS, DEVICES AND COSMETICS
64F-12.001: General Regulations; Definitions
64F-12.012: Records of Drugs, Cosmetics and Devices
64F-12.013: Prescription Drugs; Receipt, Storage and Security
64F-12.025: Certification Authority and Digital Signatures For Self-Authenticating Pedigree
64F-12.026: Cancer Drug Donation Program
PURPOSE AND EFFECT: 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 of prescription drugs in certain situations to allow an end user to obtain prescription drugs directly from the manufacturer without first obtaining a pedigree paper; authorized a cancer drug donation program. It is the purpose of this rule development process to enact rules to implement the changes to Chapter 499, Part I, F.S., made by session law 2006-310 (House Bill 371). Other changes or new text within the rule chapters listed above may also be addressed.
SUBJECT AREA TO BE ADDRESSED: The proposed amendments will affect the type of pedigree paper that is to be used in wholesale distributions of prescription drugs. The proposed amendments will affect the type of authentication of pedigree papers required under Chapter 499, Part I, F.S. The rule amendments will implement the drop-ship provisions of House Bill 371. The rule amendments will implement the new cancer drug and supply donation program established in House Bill 371. The rule amendments may also address other issues within the rule chapters listed above.
SPECIFIC AUTHORITY: 499.05, 499.61, 499.701 499.0121, 499.0122, 499.013, 499.014, 499.052, F.S.
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, 49.039, 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, 49.66, 499.67, 499.71, 499.75, F.S.
Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least 5 days before the workshop/meeting by contacting: Rebecca Poston, R.Ph., Board of Pharmacy, and Drugs Devices and Cosmetics Program, 4052 Bald Cypress Way, C-04, Tallahassee, Florida 32308; 850-245-4292; rebecca_poston@doh.state.fl.us. If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, 1(800)955-8771 (TDD) or 1(800)955-8770 (Voice).
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT, IF AVAILABLE, IS: Rebecca Poston, R.Ph., Board of Pharmacy, and Drugs Devices and Cosmetics Program, 4052 Bald Cypress Way, C-04, Tallahassee, Florida 32308; 850-245-4292; rebecca_poston@doh.state.fl.us.
THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS NOT AVAILABLE.
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 of prescription drugs ...
Document Information
- Subject:
- The proposed amendments will affect the type of pedigree paper that is to be used in wholesale distributions of prescription drugs. The proposed amendments will affect the type of authentication of pedigree papers required under Chapter 499, Part I, F.S. The rule amendments will implement the drop-ship provisions of House Bill 371. The rule amendments will implement the new cancer drug and supply donation program established in House Bill 371. The rule amendments may also address other ...
- Purpose:
- 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 of prescription drugs in certain situations to allow an end user to obtain prescription drugs directly from the manufacturer without first obtaining a pedigree paper; authorized a cancer drug donation program. It is the purpose of this rule development process to enact ...
- Rulemaking Authority:
- .003, 499.05, 499.61, 499.701 499.0121, 499.0122, 499.013, 499.014, 499.052, F.S.
- Law:
- 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, 49.039, 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, 49.66, 499.67, 499.71, 499.75, F.S.
- Contact:
- Rebecca Poston, R.Ph., Board of Pharmacy, and Drugs Devices and Cosmetics Program, 4052 Bald Cypress Way, C-04, Tallahassee, Florida 32308; 850-245-4292; rebecca_poston@doh.state.fl.us.
- Related Rules: (5)
- 64F-12.001. General Regulations; Definitions
- 64F-12.012. Records of Drugs, Cosmetics and Devices (Transferred)
- 64F-12.013. Prescription Drugs; Receipt, Storage and Security
- 64F-12.025. Certification Authority and Digital Signatures For Self-Authenticating Pedigree
- 64F-12.026. Cancer Drug Donation Program (Transferred)
- Subject:
