64F-12.011: Wholesale Distribution of Prescription Drugs - Exceptions and Specific Distributions Authorized
PURPOSE AND EFFECT: This rule section is being revised in response to a comment and possible objection received from the Joint Administrative Procedures Committee concerning a “written agreement” requirement in paragraph (1)(j) of the rule section. The written agreement determines the manner and under what conditions undispensed medications would be returned to the Department by community pharmacies who received the medications under the authority of the “emergency medical reasons” exemption from the definition of wholesale distribution in Section 499.003(53), F.S.
SUMMARY: This rule deletes the “written agreement” provision for determining the manner and under what conditions returns of un-dispensed prescription drugs will be returned to the Department by a community pharmacy.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: The proposed changes will not impact small businesses, small counties, or small cities. There should be no transactional costs for any individual or entity related to this rule revision. There is no change to any fees, costs, monitoring or reporting currently required.
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.
SPECIFIC AUTHORITY: 499.003(53)(b), 499.012, 499.03, 499.05 FS.
LAW IMPLEMENTED: 499.003(53)(b), 499.012, 499.03, 499.05 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Rebecca R. Poston, R. Ph., Director, Drugs, Devices and Cosmetics Program, 4052 Bald Cypress Way, Mail Bin #C04, Tallahassee, Florida 32399
THE FULL TEXT OF THE PROPOSED RULE IS:
64F-12.011 Wholesale Distribution of Prescription Drugs – Exceptions and Specific Distributions Authorized.
(1) The exemption from the definition of wholesale distribution in Section 499.003(53)(b)2., F.S., for “emergency medical reasons” includes:
(a) through (i) No change.
(j) Transfers of prescription drugs by or on behalf of the Department of Health to a community pharmacy authorized to purchase prescription drugs, for dispensing to persons in need of emergency medical services, including controlling communicable diseases or providing protection from unsafe conditions that pose an imminent threat to public health., provided that the community pharmacy returns un-dispensed prescription drugs in a manner and under the conditions specified in a written agreement with the Department of Health.
(2) through (4) No change.
Rulemaking 499.003 (53) (b), 499.012, 499.03, 499.05 FS. Law Implemented 499.003 (53) (b), 499.012, 499.03, 499.05 FS. History– New 7-1-96, Formerly 10D-45.0525, Amended 1-26-99, 4-17-01, 1-1-04, 10-4-07, 12-13-09,________.