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Regulatory Hearings: Proposed Regulations for Compounding Sterile Products October 24, 2002 William Blair, Pharm.D., MBA and Damon Jones, MBA, CQE testified before the California State Board of Pharmacy in Berkeley, California. The Regulatory Hearings were held to discuss the proposed Regulations for Compounding Sterile Products. The testimony by Blair and Jones (along with others) was pivotal in the board deferring the regulations brought forth by the Legislative Analyst. The regulations as written would have severely restricted the compounding of sterile products. After the audience spoke, the Legislative Analyst presented his rationale for the written proposed regulations. He mentioned that there is a July 2003 deadline for pharmacies to be licensed and prior to that, regulations have to be adopted, inspectors hired and trained, application submitted, and inspections completed. There is not much time remaining, and he wanted the regulations adopted at that session. The Hearing was followed by a great deal of discussion by the Board of Pharmacy, and at one point there was a motion to adopt the regulations as is, and fix them later. Fortunately, that never materialized. The Board referred the issue to the Licensing Committee that will meet on December 5, 2002. The California Pharmacists Association will reconvene their subcommittee, including Blair and Jones, prior to December 5, 2002 to attempt to write regulations suitable to the Board of Pharmacy. The Board of Pharmacy is scheduled to act on the Licensing Committee’s recommendation on January 25, 2003.
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