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S.F. No. 1425 - Pharmaceutical Waste and Disposal Requirements
Author: Senator Julie A. Rosen
Prepared By: Katie Cavanor, Senate Counsel (651/296-3801)
Date: March 13, 2015


SF 1425 clarifies the requirements for the collection and disposal of legend drugs as pharmaceutical waste.

Section 1 (151.01, subd. 39) adds a definition for “ultimate user” in chapter 151.

Section 2 (151.37, subd. 2) clarifies that no pharmacist employed by or under contract with or working for a pharmacy that is located within the state, and licensed by the Board of Pharmacy or a pharmacy located outside the state and licensed by the board, may dispense a legend drug to a resident of the state based on a prescription that the pharmacist knows, or would reasonably be expected to know, is not valid.

Section 3 (151.37, subd. 6) clarifies that chapter 151 does not prohibit an employee of specified entities, while acting in the course of employment, from possessing a legend drug for the purpose of disposing of it as pharmaceutical waste provided that controlled substances are collected and disposed of as allowed under section 152.105.  Modifies the entities by clarifying that the entities include a law enforcement agency; a hazardous waste transporter that has notified the Pollution Control Agency (PCA) of its activity; and a facility licensed by the PCA or a metropolitan county as a household hazardous waste collection program.

Section 4 (151.37, subd. 6a) authorizes a licensed pharmacy to collect a legend drug from an ultimate user or from a long term care facility on behalf of an ultimate user for the purpose of disposing of the legend drug as pharmaceutical waste provided that controlled substances are collected and disposed of as allowed under section 152.105; and if the pharmacy has established a controlled substance disposal program, it may collect and dispose of noncontrolled substance legend and nonlegend drugs, but only in the same manner in which it collects and disposes controlled substances.

Section 5 (151.37, subd. 7) permits a person for whom a legend drug has been dispensed in accordance with a valid prescription to transfer the drug to an entity identified in section 151.37, subd. 6.  Controlled substances may only be collected, stored, transported, and disposed of as allowed under section 152.105.

Section 6 (152.105) requires controlled substances to be collected and disposed of in accordance with the provisions of the Code of Federal Regulations that are applicable to the disposal of controlled substances.  Disposal of controlled substances, as well as legend and nonlegend drugs must also comply with the requirements of section 116.07 governing the disposal of hazardous waste.



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