New Mexico
Register / Volume XXXVII, Issue 3 / February 10, 2026
This is
an amendment to 16.19.4 NMAC, Section 11 effective 2/10/2026
16.19.4.11 CONSULTANT PHARMACIST:
A. Duties and responsibilities:
(1) To abide by the code of ethics of the American Society of Consultant Pharmacists. Must be qualified to practice as a consultant
pharmacist and is to be aware of all federal and state drug laws, rules and
regulations related to pharmacy services, and to provide the facility with
current information pertaining to drug service.
(2) Ensure that drugs are handled in the
facility in which he/she is the consultant pharmacist, in a manner that
protects the safety and welfare of the patient.
(3) Set the policies and procedures in the
facility as related to all facets of drug handling and distribution; these
policies and procedures to be reviewed and updated on an annual basis.
(4) To visit the facility, commensurate
with their duties, as specified by board regulations relative to the facility
or by written contract with the administration of the facility not inconsistent
with board regulations.
(5) His/her primary goal and objective
shall be the health and safety of the patient, and he/she shall make every
effort to assure the maximum level of safety and efficacy in the provision of
pharmaceutical services.
(6) The consultant pharmacist shall not
condone or participate in any transaction with any practitioner of another
health profession, or any other persons whosoever under which fees are divided,
or rebates or kickbacks paid or caused to be paid, or which may result in
financial exploitation of patients or their families in connection with the
provision of drugs and medication or supplies or pharmaceutical services.
B. Consultant pharmacist serving skilled
nursing facilities and intermediate care facilities - upper level care - long
term care facilities by any other title:
(1) The consultant pharmacist's agreement
with the facility shall include but is not limited to the following duties and
responsibilities.
(a) Serve as a member of appropriate
committees, and attend these meetings.
(b) Development of
the drug control procedures manual.
(c) Monitor on a
routine basis all aspects of the total drug distribution system - to be
accomplished in a manner designed to monitor and safeguard all areas of the
drug distribution system.
(d) Maintain active
pharmacist status registration in the state.
(e) Assume
responsibility for the destruction or removal of unwanted dangerous drugs and
any controlled substances as prescribed by law and regulations.
(f) Maintain a log
of all visits and activities in the facility indicating dates and other
pertinent data; such logs are to be available to inspection by state drug
inspectors upon request.
(g) Furnish and
replenish emergency drug supply in acceptable containers. Maintain a log of use and replacement of
drugs in the emergency tray.
(h) Make routine
inspections of drug storage areas, patient health records, and review drug
regimen of each patient at least once a month.
Report irregularities, contraindication, drug interactions, etc., to the
medical staff.
(i) Provide or make arrangements for provision of pharmacy services to the
facility on a 24-hour, seven days a week basis, including stat orders.
(j) Provide
in-service training of staff personnel as outlined in the procedures manual.
(k) Meet all other
responsibilities of a consultant pharmacist as set forth in the board
regulations and federal or state laws and which are consistent with quality
patient care.
(l) The contract
consultant pharmacist to a SNF or ICF facility, that is required to review
patients' drug regimen as set forth in Subparagraph h of Paragraph (1) of
Subsection B of 16.19.4.11 NMAC, who is under contract as sole supplier of
unit-doses/state of the art medications, shall be exempt from charges of
unprofessional conduct under Paragraph (10) of Subsection B of 16.19.4.9 NMAC.
(m) Return to
pharmacy stock: The consultant
pharmacist to a [SNF or ICF] facility who delivers drugs in a unit-dose
system, [approved by an agent of the board,] which is a tightly sealed,
unopened, individual dose, shall be exempt from the requirements of 16.19.6.14
NMAC pursuant to this subparagraph. The regulation shall not prohibit
the return to the pharmacy stock, where partial credit may be given in
accordance with any federal or state law or regulation, to the patient for such
medication, when the physician discontinues the drug therapy, the patient
expires or for any other reason, other than an outdated drug, subject to the
following:
(i) Patient
medication packages with more than one drug within a container may not be
returned.
(ii) No controlled substance may be
returned.
(iii) Non-Institutional: A patient medication package stored in a
non-institutional setting where there is no assurance of storage standards may
not be returned.
(iv) A
patient medication package with only one drug within a container stored in an
institutional setting where the storage and handling of the drugs are assured
and are consistent with the compendia standards may be returned to the pharmacy
stock provided that: the drug is kept within the sealed and labeled patient
medication package until dispensed; if the drug is repackaged using a process
that involves heat, the expiration date of drug shall become fifty percent of
the time left of the expiration for the drug; and proper record keeping for the
addition of drugs into inventory must be done.
(n) Customized patient medication packages: In lieu of dispensing one, two, or more
prescribed drug products in separate containers or standard vial containers, a
pharmacist may, with the consent of the patient, the patient's caregiver, the
prescriber, or the institution caring for the patient, provide a customized
patient medication package. The
pharmacist preparing a patient medication package must abide by the guidelines
as set forth in the current edition of the United States Pharmacopoeia for
labeling, packaging and record keeping.
(o) Repackaging of patient medication packages: In the event a drug is added to or
discontinued from a patient's drug regimen, when a container within the patient
medication package has more than one drug within it, the pharmacist may
repackage the patient's patient medication package and either add to or remove
from the patient medication packaged as ordered by the physician. The same drugs returned by the patient for
repackaging must be reused by the pharmacist in the design of the new patient
medication package for the new regimen, and any drug removed must either be
destroyed, returned to the DEA or returned to the patient properly labeled.
[(p) Return of patient medication package drugs.
(i) Patient
medication packages with more than one drug within a container may not under
any circumstances be returned to a pharmacy stock.
(ii) Patient
medication packages with only one drug within a container: 1 Non-Institutional: A patient medication package stored in a
non-institutional setting where there is no assurance of storage standards may
not be returned to pharmacy stock. 2
Institutional: A patient
medication package stored in an institutional setting where the storage and
handling of the drugs are assured and are consistent with the compendia
standards may be returned to the pharmacy stock provided the following
guidelines are followed: (1) the drug is
to be kept within the patient medication package and it is to remain sealed and
labeled until dispensed; (2) the expiration date of drug shall become fifty
percent of the time left of the expiration for the drug; and (3) no schedule II
- V drugs may be returned to inventory; and (4) proper record keeping for the
addition of drugs into inventory must be done.]
(2) When a consultant pharmacist enters
into a written contractual agreement with a facility to which he/she will
provide service.
(a) The consultant
pharmacist whose practice is not in the immediate vicinity of the facility for
which he has entered into a written service agreement, shall have a written
agreement with a local pharmacist to be available on any emergency basis. The consultant pharmacist shall be
responsible for the proper training and instruction of such local
pharmacist. Said local pharmacist shall
be known as a "co-consultant".
The vendor shall be responsible for the safety and efficacy of back-up
pharmaceutical services he provides.
(b) A copy of these
agreements must be filed with the facility and a copy maintained by the
consultant pharmacist. Any termination
of such agreement shall be reported in writing, within 10 days, of termination
to the administrator.
(c) Should a local
pharmacist (co-consultant) not be available, the consultant pharmacist must
provide an alternative procedure approved by the board. If the consultant is also the vendor, then
such alternative procedure must reasonably assure rapid delivery of drugs;
medical supplies and pharmacy service to the facility.
C. Consultant pharmacist - clinic facility:
(1) The consultant pharmacist providing
services to a clinic shall.
(a) Assume overall
responsibility for clinic pharmaceutical services, for clinic facility
supportive personnel, and for procedures as outlined in the procedures manual,
including all records of drugs procured, administered, transferred,
distributed, repackaged or dispensed from the clinic.
(b) Assume
responsibility for the destruction or removal of unwanted or outdated dangerous
drugs, including controlled substances, as required by laws and regulations.
(c) Develop the
pharmaceutical services procedures manual for the clinic establishing the
system for control and accountability of pharmaceuticals.
(d) Provide
in-service education and training to clinic staff, as applicable.
(e) Report in writing
to the board within 10 days, any termination of services to the clinic.
(f) Comply with all
other provisions of Part 10, limited drug clinics, as applicable to the
individual clinic facility.
(g) The consultant
pharmacist shall personally visit the clinic on the minimum basis described in
Items (i) through (v) of this Subparagraph to ensure that the clinic is
following set policies and procedures.
Visitation schedules are as follows.
(i) Class
A clinics shall have the on-site services of a consultant pharmacist for the
dispensing or distribution of dangerous drugs.
The consultant pharmacist shall comply with Paragraphs (4), (5) and (7)
of Subsection A of 16.19.4.16 NMAC of this regulation.
(ii) Class
B clinics shall have the services of a consultant pharmacist as listed
below: 1. Category 1 clinics shall be visited by the
consultant pharmacist at least every other month. 2.
Category 2 clinics shall be visited by the consultant pharmacist at
least monthly. 3. Category 3 clinics shall be visited by the
consultant pharmacist at least every other week.
(iii) Class
C clinics shall be visited by the consultant pharmacist at least every three
months.
(iv) Class
D clinic shall be reviewed at least once yearly during school session.
(v) Class
E clinic shall be visited by the
consultant pharmacist at least weekly for a clinic with a patient census of 150
or more or with a mobile narcotic treatment program, and at least every other
week for a clinic with a patient census of less than 150.
(h) The consultant
pharmacist shall review the medical records of not less than five percent of a
Class B clinics patients who have received dangerous drugs (as determined by
the dispensing or distribution records) since the consultant pharmacist's last
visit. Such review shall be for the
purpose of promoting therapeutic appropriateness, eliminating unnecessary
drugs, and establishing the medical necessity of drug therapy, by identifying
over-utilization or under-utilization, therapeutic duplication, drug-disease
contraindications, drug-drug contraindications, incorrect drug dosage or
duration of drug treatment, drug-allergy interactions, appropriate medication
indication, and/or clinical abuse/misuse.
Upon recognizing any of the above, the consultant pharmacist shall take
appropriate steps to avoid or resolve the problem which shall, if necessary,
include consultation with the prescriber.
(i) The consultant
pharmacist shall maintain a log or record of all visits and activities in the
clinic. Such record shall include a log
of all medical records reviewed, along with a record of all consultant
pharmacist interventions and/or consultations.
This log or record shall be available for inspection by state drug
inspectors upon request.
(j) Consultant
pharmacist serving a Class D school based emergency medicine clinic shall:
(i) review
records at least annually; this review shall include a review of the self-assessment form, receipt and
disposition records, and storage records; this annual review does not require
an on-site visit by the consultant pharmacist;
(ii) oversee
the removal of expired or unwanted dangerous drugs; removal options are
transfer to another licensed location, return to the legitimate source of
supply or to a reverse distributor; remaining portions of used dangerous drugs
may be destroyed by the consultant pharmacist;
(iii) review
dangerous drug administration records within 72 hours of administration; this
review shall be documented and available for inspection at the licensed
location for three years; review shall include verification of compliance with
procedures and protocols, including administration by properly trained
personnel.
(iv) ensure
required records are available for inspection at the licensed location for
three years, including a log of comments and activities of consultant
pharmacist;
(v) verify
a current list of trained staff, in accordance with New Mexico department of
health requirements, is maintained at the licensed location and available for
inspection;
(vi) approve
a policy and procedures manual outlining procedures for the receipt, storage,
record keeping, administration and accountability of all dangerous drugs; this
includes policies and procedures for the removal and destruction of unwanted,
unused, outdated or recalled dangerous drugs; must verify compliance with all
training and protocols required by the New Mexico department of health.
(k) The consultant
pharmacist of a Class E clinic shall review dispensing, distribution, and
supplying records since the consultant pharmacist’s last visit, to ensure
records are maintained accurately and in proper form. The consultant pharmacist shall also review
the medical records of all clinic patients prior to initiation of take home
dosing, and medical records of not less than five percent of clinic patients
who have received dangerous drugs (as determined by the dispensing,
distribution, or supplying records) since the consultant pharmacist's last
visit. Such review shall be for the
purpose of promoting therapeutic appropriateness, eliminating unnecessary
drugs, and establishing the medical necessity of drug therapy, by identifying
over-utilization or under-utilization, therapeutic duplication, drug-disease
contraindications, drug-drug contraindications, incorrect drug dosage or
duration of drug treatment, drug-allergy interactions, appropriate medication
indication, and/or clinical abuse/misuse.
Upon recognizing any of the above, the consultant pharmacist shall take
appropriate steps to avoid or resolve the problem which shall, if necessary,
include consultation with the prescriber.
A log or record will be maintained in accordance with Subparagraph (i)
of Paragraph (1) of Subsection (C) of 16.19.4.11 NMAC.
(2) A
clinic may petition the board for an alternative visitation schedule as set
forth in Subsection R of 16.19.10.11 NMAC
D. Consultant pharmacists serving custodial
care facilities:
(1) Custodial care facility as used in
this regulation includes: Any facility
or business, including non-profit entity which provides retirement care, mental
care or other facility that provides extended health care to patients.
(2) Any facility which meets the
requirements outlined in Paragraph (1) of Subsection D of 16.19.4.11 NMAC shall
be licensed by the board, engage a consultant pharmacist, whose duties and
responsibilities are indicated in 16.19.4 and 16.19.11 NMAC.
(3) Procurement of drugs or medications
for residents will be on the prescription order of a licensed
practitioner. Refills shall be as
authorized by the practitioner. When
refill authorization is indicated on the original prescription, a refill for a
resident may be requested by the administrator of the licensed facility or his
designee to the providing pharmacy.
(4) The administrator or a designated
employee of the facility will sign a receipt for prescription drugs upon
delivery.
(5) All prescription drugs will be stored
in a locked cabinet or room and the key will be assigned to a designated
employee or the administrator as indicated in the procedures manual.
(6) Proper storage as stipulated in the
official compendium USP/NF will be the responsibility of the licensed facility.
(7) Records - the consultant pharmacist
shall be responsible for the following records:
(a) incoming
medications - including refills;
(b) record of
administration;
(c) waste or loss;
This accountability record shall be maintained on a patient log, on forms
meeting requirements of the board of pharmacy.
(8) All prescription containers shall be
properly labeled as required in 16.19.11 NMAC.
No bulk containers of legend drugs will be kept on the premises, except
in a facility with a 24-hour per day and 365 day per year on-site licensed
nurse. Only the following stock
dangerous drugs may be kept:
(a) tuberculin
testing solution; [and]
(b) vaccines [as
recommended by the centers for disease control (CDC) and prevention’s advisory
committee on immunization practices and] appropriate for the facility
population served; [and]
(c) [naloxone] opioid antagonist
for opioid overdose; [and]
(d) epinephrine standard-dose and
pediatric-dose auto-injectors or nasal spray;
(e) authorized dangerous drugs for
medically monitored withdrawal management pursuant to 16.19.11.9 NMAC.
(9) Consultant pharmacist shall include in
the procedures manual the name of individual(s) responsible for the assistance
with medications.
(10) It shall be the responsibility of the
pharmacist to give proper training/instruction to the person(s) at the facility
who have day-to-day responsibility for receipt and administration of
medications to resident when adverse reactions, special diet, or any other
information relative to the administration of a drug is needed by the staff.
(11) The consultant pharmacist shall be
required to maintain a patient profile on each individual, if applicable to the
facility and individual.
(12) The consultant pharmacist shall visit
the facility no less than once a quarter or more often, commensurate with
patient drug regimen review and shall be available in emergencies, when
needed. A log shall be maintained
indicating all visits to the facility and noting any activities or
irregularities to be recorded or reported.
This log shall be available for state drug inspectors' review upon
request.
(13) The consultant shall be responsible for
the preparation of a procedures manual outlining procedures for the receipt,
storage, record keeping, maintenance of patient profiles, administration and
accountability of all legend drugs and procedures for the removal and
destruction of unwanted, unused, outdated or recalled drugs - controlled
substances shall be handled pursuant to state and federal regulations.
(1) the
patients must reside in the same facility;
(2) the
reused medication must have been discontinued from the original patient’s drug
regimen;
(3) the
drug was never out of the possession of the licensee “keep on person”
pharmaceuticals may never be reused;
(4) the
drugs were originally dispensed in packaging that is unopened, single-dose or
tamper-evident containers;
(5) the
patient receiving the re-labeled medication must have a valid
prescription/order for the medication that is to be reused;
(6) repackaging
and re-labeling may only be completed on site by the consultant pharmacist
designated for that facility.] Repackaging, relabeling and reuse in Correctional
Facilities: Prescription drugs (excluding controlled substances) dispensed to
patients residing in the same correctional facility may be relabeled and reused
for another patient in the same facility only if:
(1) The
drug was discontinued from the original patient;
(2) The
drug was never out of possession of the licensee;
(3) "Keep
on person" drugs are excluded;
(4) Drugs
must be in unopened, single-dose, or tamper-evident packaging;
(5) The
patient receiving the relabeled medication must have a valid prescription/order
for the medication being reused;
(6) Recordkeeping,
labeling, and if repackaged using heat, Fifty percent expiration dating rules
apply.
(7) Process must be completed onsite by
the consultant pharmacist;
F. The
consultant pharmacist must maintain records at the facility for three years
containing the following information:
(1) date when the re-labeling occurred;
(2) the name and ID of the patient for
whom the medication was originally intended for and the date in which it was
discontinued from his or her drug regimen;
(3) the name and ID of the patient who
will receive the reused medication;
(4) the name, strength and amount of the
medication being reused;
(5) the name of pharmacist re-labeling the
medication;
(6) pursuant to 16.19.10.11 NMAC the
pharmacist must label the reused pharmaceutical and maintain a dispensing log
for all such re-issued pharmaceuticals and the expiration date for such
re-issued drugs shall be no greater than fifty percent of the time remaining
from the date of repackaging until the expiration date indicated on the
original dispensing label or container.
[8/27/1990; 16.19.4.11 NMAC - Rn, 16 NMAC 19.4.11, 3/30/2002; A,
6/30/2006; A, 10/24/2014; A, 15/07/2015; A,
11/30/2021; A, 9/13/2022; A, 5/07/2024; A, 8/12/2025; A, 2/10/2026]