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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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