BILL ANALYSIS Ó AB 389 Page 1 CONCURRENCE IN SENATE AMENDMENTS AB 389 (Mitchell) As Amended January 17, 2012 Majority vote ----------------------------------------------------------------- |ASSEMBLY: |78-0 |(April 28, |SENATE: |37-0 |(June 21, | | | |2011) | | |2012) | ----------------------------------------------------------------- Original Committee Reference: B.,P. & C.P. SUMMARY : Establishes requirements for providers of blood clotting products for home use (providers) to treat hemophilia and other bleeding disorders. The Senate amendments delete provisions related to home nursing services and make technical changes. EXISTING LAW : 1)Specifies certain requirements regarding the proper storage, handling, dispensing, and disposal of drugs, staff training protocols, drug and supply inventory, labeling, and maintenance of patient confidentiality. 2)Allows pharmacists to perform certain procedures under specified conditions, including, among other things, administering drugs and biologics, such as blood clotting products, by injection, pursuant to a prescriber's order. 3)Establishes the Genetically Handicapped Persons Program, administered by the Department of Health Care Services, to provide for the medical care of adults with certain genetic diseases, including hemophilia. 4)Establishes the federal Food and Drug Administration to regulate the manufacture of pharmaceuticals derived from blood and blood components, such as blood clotting products, including establishing standards for those products for shipping, storage, and delivery, inspecting products, approving products for use by patients, and recalling products that may be defective or potentially harmful. AS PASSED BY THE ASSEMBLY , this bill was substantially similar AB 389 Page 2 to the version approved by the Senate. FISCAL EFFECT : According to the Senate Appropriations Committee, pursuant to Senate Rule 28.8, negligible state costs. Analysis Prepared by : Rebecca May / B.,P. & C.P. / (916) 319-3301 FN: 0003016