N.M. Admin. Code § 16.19.36.10 - EQUIPMENT
Each facility compounding sterile preparations shall have sufficient equipment for the safe and appropriate storage, compounding, packaging, labeling, dispensing and preparation of compounded sterile preparations drugs and parenteral preparations appropriate to the scope of pharmaceutical services provided and as specified in USP/NF <797> (USP General Chapters: <797> Pharmaceutical Compounding-Sterile Preparations).
A. All
equipment shall be cleaned, maintained, monitored, calibrated, tested, and
certified as appropriate to insure proper function and operation with
documentation retained for three years.
B. Primary and secondary engineering controls
used to provide an aseptic environment shall be tested in the course of normal
operation by an independent qualified contractor and certified as meeting the
requirements presented in USP/NF <797> (USP General Chapters:
<797> Pharmaceutical Compounding-Sterile Preparations) at least
every six months and when relocated, certification records will be maintained
for three years.
C. A library of
current references (hard copy or electronic) shall be available including:
(1) All USP/NF chapters
applicable to the facility's sterile compounding practice;
(2) New Mexico pharmacy laws, rules and
regulations;
(3) specialty
references (stability and incompatibility references, sterilization and
preservation references, pediatric dosing, and drug monograph references) as
appropriate for the scope of services provided.
D. Automated compounding devices shall:
(1) have accuracy verified on a routine basis
at least every 30 days per manufacturer's specifications;
(2) be observed every 30 days by the operator
during the mixing process to ensure the device is working properly;
(3) have data entry verified by a pharmacist
prior to compounding or have accurate final documentation of compounded
preparations to allow for verification of ingredients by a pharmacist prior to
dispensing; and
(4) have accuracy
of delivery of the end product verified according to written policies and
procedures.
Notes
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