Effect of Proposed Changes:
Section 1 amends s. 465.0156, F.S., to authorize the department to take regulatory action against a nonresident pharmacy immediately, without waiting 180 days for the pharmacy’s home state to act on alleged conduct that causes or could cause serious injury to a human or animal in this state. Authorized regulatory action is expanded to include conduct that could cause serious injury, without demonstrating that the conduct actually injured a person. Regulatory enforcement action may also occur for conduct that causes or could cause serious bodily injury to an animal in this state or for noncompliance with the requirements of the newly established nonresident pharmacy compounded sterile products permit.
Section 2 creates s. 465.0158, F.S., to establish the nonresident pharmacy compounded sterile products permit. A pharmacy located in another state is required to obtain a nonresident pharmacy compounded sterile products permit prior to shipping, mailing, delivering, or dispensing a compounded sterile product into Florida. This permit is a supplemental permit to registration as a nonresident pharmacy.
The bill allows a registered nonresident pharmacy to become permitted until January 31, 2015 while continuing to send compounded sterile products into this state, if the products meet or exceed the standards required in the bill. However, if a nonresident pharmacy is not registered by July 1, 2014, it must seek registration and obtain the nonresident pharmacy compounded sterile products permit prior to sending compounded sterile products to Florida.
Any sterile compounded product that is sent into this state must have been compounded in a manner that meets or exceeds the standards for sterile compounding in Florida. The owners, officers, and prescription department manager or pharmacist in charge must attest that he or she understands Florida’s laws and rules governing sterile compounding and that any compounded sterile products sent into this state will comply with those standards, unless the board has granted an exemption due to conflicting standards where the nonresident pharmacy is located.
The department is required to notify the permittee when Florida’s laws or rules for sterile compounding change. However, if notification does not occur, the permittee remains obligated to comply with Florida’s standards.
The department is directed to schedule the biennial permit renewal concurrent with the nonresident pharmacy’s biennial registration. The nonresident pharmacy registration expires on February 28th of odd years. The board is authorized to adopt in rule a permit fee that will not exceed $250.
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Section 1 amends s. 465.0156, F.S., to authorize the department to take regulatory action against a nonresident pharmacy immediately, without waiting 180 days for the pharmacy’s home state to act on alleged conduct that causes or could cause serious injury to a human or animal in this state. Authorized regulatory action is expanded to include conduct that could cause serious injury, without demonstrating that the conduct actually injured a person. Regulatory enforcement action may also occur for conduct that causes or could cause serious bodily injury to an animal in this state or for noncompliance with the requirements of the newly established nonresident pharmacy compounded sterile products permit.
Section 2 creates s. 465.0158, F.S., to establish the nonresident pharmacy compounded sterile products permit. A pharmacy located in another state is required to obtain a nonresident pharmacy compounded sterile products permit prior to shipping, mailing, delivering, or dispensing a compounded sterile product into Florida. This permit is a supplemental permit to registration as a nonresident pharmacy.
The bill allows a registered nonresident pharmacy to become permitted until January 31, 2015 while continuing to send compounded sterile products into this state, if the products meet or exceed the standards required in the bill. However, if a nonresident pharmacy is not registered by July 1, 2014, it must seek registration and obtain the nonresident pharmacy compounded sterile products permit prior to sending compounded sterile products to Florida.
Any sterile compounded product that is sent into this state must have been compounded in a manner that meets or exceeds the standards for sterile compounding in Florida. The owners, officers, and prescription department manager or pharmacist in charge must attest that he or she understands Florida’s laws and rules governing sterile compounding and that any compounded sterile products sent into this state will comply with those standards, unless the board has granted an exemption due to conflicting standards where the nonresident pharmacy is located.
The department is required to notify the permittee when Florida’s laws or rules for sterile compounding change. However, if notification does not occur, the permittee remains obligated to comply with Florida’s standards.
The department is directed to schedule the biennial permit renewal concurrent with the nonresident pharmacy’s biennial registration. The nonresident pharmacy registration expires on February 28th of odd years. The board is authorized to adopt in rule a permit fee that will not exceed $250.
read more here
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