Regulation Change – Compounded
Sterile Preparations
During the April 24-25, 2014 Board meeting, changes
were approved regarding the regulation concerning compounded
sterile preparations. The previously-approved
regulations were found in 16.19.6 NMAC – Pharmacies.
The portion of this regulation concerning compounded
sterile preparations was repealed and moved to a new
regulation. The new regulation is 16.19.36 NMAC –
Compounded Sterile Preparations.
Also during the April Board meeting, a public hearing
was held to review the proposed new rule 16.19.36
NMAC – Compounded Sterile Preparations. The new
rule was developed and submitted by the Sterile Preparations
Committee (SPC), which serves as an advisory
group to the Board. The primary goal of the SPC was to
establish standards pursuant to those of United States
Pharmacopeia to ensure that New Mexico citizens receive
properly compounded, contaminant-free sterile
prmeparations. SPC members present at the hearing fielded
questions about the proposed rule from the public as
well as fro Board members and Board staff. The Board
unanimously passed the new rule with directions to the
SPC members to expand and clarify 16.19.36.13 NMAC
Requirements for Training and 16.19.36.15 NMAC
Quality Assurance of Compounded Sterile Preparations
at a subsequent Board meeting. Please visit the
Board website to review the current Compounded Sterile
Preparations regulation.
quoted from here
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