New Mexico Register
/ Volume XXXVI, Issue 22 / November 18, 2025
This
is an amendment to 16.19.36 NMAC, Section 10 and 16 effective 11/18/2025
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 ensure 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. Routine
viable surface sample testing of classified areas as required by USP/NF
<797> (USP General Chapters: <797> Pharmaceutical
Compounding-Sterile Preparations) may be performed onsite by appropriately
trained personnel.
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.
[16.19.36.10 NMAC - N, 06-28-14; A, 8/13/2024; A, 11/18/2025]
16.19.36.16 COMPOUNDING VETERINARY
PREPARATIONS:
A. Preparations for animals may be compounded based on an order or
prescription from a duly authorized veterinarian.
B. These preparations are to be handled and filled the same as the human
prescriptions.
C. Compounding of drugs for animals must be in accordance with the Animal
Medicinal Drug Use Clarification Act of 1994 or successor Act.
D. A licensed pharmacy may compound veterinary drug preparations in
reasonable quantities to be used by veterinarians in their office for
administration to patients (“office use preparations”) under the following
conditions:
(1) the preparation is necessary for the treatment of an emergency condition;
(2) the preparation is not readily available from an outsourcing facility;
(3) ordering and distribution occur in compliance with applicable state and
federal law;
(4) if the medication is a controlled substance, the pharmacy shall be
registered with the DEA as a manufacturer; and
(5) in addition to other required labeling, such preparations shall bear a
statement “For administration only. Not
for dispensing or resale.”
E. Prohibition on wholesaling:
(1) Office use preparations will not be distributed by a person other than
the pharmacy that compounded such veterinary drug preparations.
(2) This does not prohibit administration pursuant to a prescription drug
order executed in accordance with federal and state law; and the conditions of
this Subsection.
F. Providing samples of compounded veterinary preparations is prohibited.
[16.19.36.16 NMAC - N, 11/18/2025]