d. Discussion Regarding USP’s 797 Standards and the Regulation Requirements of the Board
of Pharmacy
Background
For a number of years, California has had its own statutory and regulation requirements for
those pharmacies that compound medication or perform parenteral compounding. Since 2001,
again through legislation as well as through regulations, the board has several times developed
additional requirements to respond to emergent public health or regulatory concerns.
Many states rely upon USP 797 components to regulate compounding activities. California,
instead, relies on its own standards for compounders and sterile compounding.
Discussion and Comments of the Committee
Dr. Ratcliff and Dr. Smith presented a crosswalk document that compared CA law to USP 797.
The committee reviewed and compared the two sets of requirements. Ms. Herold advised the
committee that specific requirements in USP 797 may eventually be included in the Board’s
regulation and that the regulations be written as clearly and concisely as possible for the
benefit of everyone.
The committee and public made several comments regarding the best process for making sure
the board’s regulations are inclusive of the requirements in USP 797.
The committee heard several comments from the public on the best path to move for with its
analysis of the two requirements and recommended changes that may result from this analysis
including creation of a list of suggested regulations then invite comments as opposed to having
other associations submit suggestions.
A workgroup was formed to work with staff to create a third column on the crosswalk
document with proposed regulation changes for public comment.
quoted from here
of Pharmacy
Background
For a number of years, California has had its own statutory and regulation requirements for
those pharmacies that compound medication or perform parenteral compounding. Since 2001,
again through legislation as well as through regulations, the board has several times developed
additional requirements to respond to emergent public health or regulatory concerns.
Many states rely upon USP 797 components to regulate compounding activities. California,
instead, relies on its own standards for compounders and sterile compounding.
Discussion and Comments of the Committee
Dr. Ratcliff and Dr. Smith presented a crosswalk document that compared CA law to USP 797.
The committee reviewed and compared the two sets of requirements. Ms. Herold advised the
committee that specific requirements in USP 797 may eventually be included in the Board’s
regulation and that the regulations be written as clearly and concisely as possible for the
benefit of everyone.
The committee and public made several comments regarding the best process for making sure
the board’s regulations are inclusive of the requirements in USP 797.
The committee heard several comments from the public on the best path to move for with its
analysis of the two requirements and recommended changes that may result from this analysis
including creation of a list of suggested regulations then invite comments as opposed to having
other associations submit suggestions.
A workgroup was formed to work with staff to create a third column on the crosswalk
document with proposed regulation changes for public comment.
quoted from here